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Cialis 2.5mg, 5mg, 10mg & 20mg film-coated tablets

Last Updated on eMC 26-Apr-2017 View document  | Eli Lilly and Company Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 26-Apr-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 23-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes (all strengths)

 

Added (bold) deleted (strikethrough)

 

 

5.1       Pharmacodynamic properties

               

               

Paediatric population

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen. The randomised, double‑blind, placebo‑controlled, parallel, 3‑arm study of tadalafil was conducted in 331 boys aged 7‑14 years with DMD receiving concurrent corticosteroid therapy. The study included a 48‑week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was ‑51.0 meters (m) in the placebo group, compared with ‑64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and ‑59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538). In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study. The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids.

 

The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information on paediatric use.

 

6.6       Special precautions for disposal 

 

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

 

10.       DATE OF REVISION OF THE TEXT

 

23 February 2017 23 March 2017

Updated on 23-Mar-2017 and displayed until 26-Apr-2017

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC: 23-Feb-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Added (bold) deleted (strikethrough)

 

 

4.4       Special warnings and precautions for use

               

               

Vision

 

Visual defects and cases of NAION have been reported in connection with the intake of CIALIS and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking CIALIS and consult a physician immediately (see section 4.3).

Updated on 10-Mar-2017 and displayed until 23-Mar-2017

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 23-Feb-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes (all strengths)

 

Added (bold) deleted (strikethrough)

 

 

4.4       Special warnings and precautions for use

 

Decreased or sudden hearing loss

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

 

Renal and hepatic impairment

Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment.

 

 

10.       DATE OF REVISION OF THE TEXT

 

22 July 201623 February 2017

Updated on 02-Aug-2016 and displayed until 10-Mar-2017

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 22-Jul-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Added (bold) deleted (strikethrough)

 

 

4.8          Undesirable effects

 

Tabulated summary of adverse reactions

 

The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 80227116 patients on CIALIS and 44223718 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

 

Frequency convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000) and Not known (cannot be estimated from the available data).

 

 

Very common

Common

 

Uncommon

 

Rare

 

Immune system disorders

 

 

Hypersensitivity reactions

Angioedema2

Nervous system disorders

 

Headache

Dizziness

Stroke1 (including haemorrhagic events),

Syncope,

Transient ischaemic attacks1,

Migraine2,

Seizures2,

Transient amnesia

Eye disorders

 

 

Blurred vision, Sensations described as eye pain

Visual field defect, Swelling of eyelids, Conjunctival hyperaemia, Non-arteritic anterior ischaemic optic neuropathy (NAION)2, Retinal vascular occlusion2

Ear and labyrinth disorders

 

 

Tinnitus

Sudden hearing loss

Cardiac disorders1

 

 

Tachycardia, Palpitations

Myocardial infarction, Unstable angina pectoris2, Ventricular arrhythmia2

Vascular disorders

 

Flushing

Hypotension3, Hypertension

 

 

 

Respiratory, thoracic and mediastinal disorders

 

Nasal congestion

Dyspnoea,

Epistaxis

 

Gastrointestinal disorders

 

Dyspepsia,

Gastro-oesophageal reflux

Abdominal pain, Vomiting, Nausea, Gastro-oesophageal reflux

 

Skin and subcutaneous tissue disorders

 

 

Rash,

Hyperhydrosis (sweating)

Urticaria,

Stevens-Johnson syndrome2,

Exfoliative dermatitis2, Hyperhydrosis (sweating)

Renal and urinary disorders

 

 

Haematuria

 

Musculoskeletal, connective tissue and bone disorders

 

Back pain,

Myalgia, Pain in extremity

 

 

Renal and urinary disorders

 

 

Haematuria

 

Reproductive system and breast disorders

 

 

Prolonged erections Penile haemorrhage, Haematospermia

Prolonged erections, Priapism2, Penile haemorrhage, Haematospermia

General disorders and administration site conditions

 

 

Chest pain1, Peripheral oedema, Fatigue

Facial oedema2, Sudden cardiac death1,2

                               (1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4).

(2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.

(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products.

 

Description of selected adverse reactions

 

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.

 

Other special populations

 

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.

 

 

             10.              DATE OF REVISION OF THE TEXT

 

03 May 201622 July 2016

 

 

*CIALIS (tadalafil) is a trademark of Eli Lilly and Company.                                                                                          CI265M

               

Updated on 11-May-2016 and displayed until 02-Aug-2016

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 03-May-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes

 

Added (bold) deleted (strikethrough)

 

 

6.5          Nature and contents of container

 

For 2.5 and 5 mg: Aluminium/PVC/PE/ PCTFE blisters in cartons of 2, 14, 28 or 84 film-coated tablets.

 

For 10 and 20 mg: Aluminium/PVC blisters in cartons of 2, 4, 8, 10 and 12 film-coated tablets.

 

Aluminium/PVC blisters in cartons of 2, 4, 8, 10, 12, 14, 18 and 28 film-coated tablets.

 

Not all pack sizes may be marketed.

 

 

 

                10.           DATE OF REVISION OF THE TEXT

 

15 March 201603 May 2016

 

 

*CIALIS (tadalafil) is a trademark of Eli Lilly and Company.                                                                                          CI245M

Updated on 30-Mar-2016 and displayed until 11-May-2016

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 15-Mar-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Added (bold) deleted (strikethrough)

 

 

6.5          Nature and contents of container

 

For 2.5 and 5 mg: Aluminium/PVC/PE/ PCTFE blisters in cartons of 2, 4, 8, 10, 12, 14, 28 or 84 film-coated tablets.

 

For 10 and 20 mg: Aluminium/PVC/PE/PCTFE blisters in cartons of 2, 4, 8, 10 and 12 film-coated tablets.

 

Not all pack sizes may be marketed.

 

 

 

                10.           DATE OF REVISION OF THE TEXT

 

01 January 201615 March 2016

 

 

*CIALIS (tadalafil) is a trademark of Eli Lilly and Company.                                                                                          CI234M

               

Updated on 15-Jan-2016 and displayed until 30-Mar-2016

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC: 01-Jan-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes

 

(New text bold.  Text struck-through removed.)

 

 

 

 

7.         MARKETING AUTHORISATION HOLDER

 

Eli Lilly Nederland B.V.

Papendorpseweg 83,
3528 BJ Utrecht

Grootslag 1-5,
NL-3991 RA, Houten

The Netherlands

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

            14 August 201501 January 2016

 

 

Updated on 03-Sep-2015 and displayed until 15-Jan-2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-Aug-2015

Legal Category:POM

Black Triangle (CHM): NO

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Changes

 

Added (bold) deleted (strikethrough)

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

deleted (strikethrough)

Each 2.5 mg tablet contains 2.5mg tadalafil.

 

Excipient(s) with known effect: Each coated tablet contains 87 mg of lactose (as monohydrate).

 

Each 5 mg tablet contains 5mg tadalafil.

 

Excipient(s) with known effect:  Each coated tablet contains 121 mg of lactose (as monohydrate).

 

Each 10 mg tablet contains 10mg tadalafil.

 

Excipient(s) with known effect:  Each coated tablet contains 170 mg of lactose (as monohydrate).

 

Each 20 mg tablet contains 20mg tadalafil.

 

Excipient(s) with known effect:  Each coated tablet contains 233 mg of lactose (as monohydrate).

 

For the full list of excipients, see section 6.1

 

 

4.3       Contraindications

 

Added (bold)

CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

 

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

 

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Added (bold)

 

Riociguat

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.  In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.  There was no evidence of favourable clinical effect of the combination in the population studied.  Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).  

 

 

4.8       Undesirable effects

 

Added (bold)

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie, United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

 

 

10.          DATE OF REVISION OF THE TEXT

 

14 August 2015

Updated on 03-Apr-2013 and displayed until 03-Sep-2015

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 26-Mar-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 6.5, Nature and contents of container, new pack size 84 is added.

In Section 8, Marketing Authorisation numbers, new MA number iss added for Cialis 5mg pack size 84.

In Section 10, Date of revision of the text, the revision date is updated.

Updated on 30-Jan-2013 and displayed until 03-Apr-2013

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 17-Jan-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.         Clinical particulars

4.8       Undesirable effects

 

Added (bold) deleted (strikethrough):

Note: reference numbers throughout table have been change to match corresponding footnote changes.

 

Very common

Common

Uncommon

Rare

 

Ear and labyrinth disorders

 

 

Tinnitus

Sudden hearing loss2

Cardiac disorders1

 

 

Tachycardia, Palpitations

Myocardial infarction, Unstable angina pectoris2, Ventricular arrhythmia2

Renal and urinary disorders

 

 

Haematuria

 

Reproductive system and breast disorders

 

 

Penile haemorrhage, Haematospermia

Prolonged erections, Priapism32

 

(1)Most of the patients had pre-existing cardiovascular risk factors (see section 4.4).

(2) Sudden decrease or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including tadalafil.

(2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.

(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

               

                17 January 2013

Updated on 08-Nov-2012 and displayed until 30-Jan-2013

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 24-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.             Clinical particulars

 

4.1          Therapeutic indications

 

Added (bold):

 

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

 

Added:

 

5mg only: Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

 

4.2          Posology and method of administration

 

Added:

 

Benign prostatic hyperplasia in adult men

The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. Patients who are unable to tolerate tadalafil 5 mg for the treatment of  benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5mg for the treatment of benign prostatic hyperplasia has not been demonstrated.

 

Men with Renal Impairment

 

Added (bold):

 

Dose adjustments are not required in patients with mild to moderate renal impairment.  For patients with severe renal impairment, 10mg is the maximum recommended dose for on-demand treatment.  Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment. (See sections 4.4 and 5.2.)

 

Men with Hepatic Impairment

 

For the treatment of erectile dysfunction using on-demand CIALIS the recommended dose of CIALIS is 10mg taken prior to anticipated sexual activity and with or without food.  There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.  There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment.  Once-a-day dosing of CIALIS both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. (See sections 4.4 and 5.2.)

 

4.4          Special warnings and precautions for use

 

Added (bold):

 

Before treatment with CIALIS

A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is considered.

 

Added:

 

Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see section 4.3).

 

Added (bold):

 

There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh class C). Once-a-day administration either for the treatment of erectile dysfunction or benign prostatic hyperplasia has not been evaluated in patients with hepatic insufficiency. If CIALIS is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Added:

 

5- alpha reductase inhibitors

In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs.

 

4.8          Undesirable effects

 

Added (bold):

 

Summary of the safety profile

 

The most commonly reported adverse reactions in patients taking CIALIS for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of CIALISThe adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with CIALIS once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

 

Tabulated summary of adverse reactions

 

The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 7116 patients on CIALIS and 3718 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

 

Very common

Common

 

Uncommon

 

Rare

 

Musculoskeletal, connective tissue and bone disorders

 

Back pain,

Myalgia, Pain in extremity

 

 

 

Added:

 

Other special populations

 

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil 5mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.

 

 

5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

Mechanism of action

 

Added (bold):

 

Tadalafil has no effect in the treatment of erectile dysfunction in the absence of sexual stimulation.

 

Added:

 

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced. These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder.

 

Added:

 

Benign prostatic hyperplasia

CIALIS was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia.  The improvement in the total international prostate symptom score with CIALIS 5mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2,     -3.6, -3.8 and -4.2 with placebo. The improvements in total international prostate symptom score occurred as early as 1 week.  In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with CIALIS 5mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.

  

One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in patients with both conditions. The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with CIALIS 5 mg compared to 1.8 and -3.8 with placebo, respectively.  The mean per-subject proportion of successful sexual intercourse attempts was 71.9% with CIALIS      5 mg compared to 48.3% with placebo.

 

The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with CIALIS 5mg.

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

date of revision:

 

24 October 2012

Updated on 12-Oct-2012 and displayed until 08-Nov-2012

Reasons for adding or updating:

  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

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9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Added:

 

Date of last renewal:             12 November 2012

 

 

 

 

10.       DATE OF REVISION OF THE TEXT

 

date of revision:

 

01 October 2012

 

               

 

 

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

Updated on 28-Sep-2012 and displayed until 12-Oct-2012

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 10-Sep-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Please note: Sections re-ordered and subheadings added throughout per renewal and QRD template changes.

In Section 2 Qualitative and quantitative composition, quantity of lactose is updated for each strength.

In Section 4.2 Posology and method of administration, the following text is added - 'There is no relevant use of CIALIS in the paediatric population with regard to the treatment of erectile dysfunction.’ and the following text is deleted - 'CIALIS should not be used in individuals below 18 years of age.'

In Section 4.6 Fertility, pregnancy and lactation, the following text is added under the sub-header Fertility - 'Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).'

In Section 4.7 Effects on ability to drive and use machines, the following text is added – ‘CIALIS has negligible influence on the ability to drive or use machines.’ and the following text is deleted – ‘No studies on the effect on the ability to drive and use machines have been performed.’

In Section 4.8 Undesirable effects, the following text, next to Hypotension is moved into a footnote – ‘more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents’; ‘Dyspnoea’ with uncommon frequency is added under Respiratory, thoracic and mediastinal disorders, the frequency ofGastro-oesophageal reflux’ has been changed to common.

In Section 5.1 Pharmacodynamic properties, ‘Urologicals’ is added next to Pharmacotherapeutic Group; and the following text is added under the sub-header Paediatric Population – ‘The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information on paediatric use.’

In Section 10 Date of revision of the text, the date of revision is updated.

Updated on 03-Mar-2011 and displayed until 28-Sep-2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 21-Feb-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.         Clinical particulars

 

4.2       Posology and method of administration

 

Deleted (strikethrough):

 

In responder patients to on-demand regimen who anticipate a frequent use of CIALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician’s judgement.

 

 

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1       Pharmacodynamic properties

 

Tadalafil at doses of 2.5, 5, and 10 mg taken once a day was initially has been evaluated in 3 clinical studies involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies. Most patients in all three studies were responders to previous on-demand treatment with PDE5 inhibitors. In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67% on CIALIS 5mg, 50% on CIALIS 2.5mg as compared to 31 and 37% with placebo. In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on CIALIS 5mg and 2.5mg, respectively, as compared to 28% with placebo. Most patients in these three studies were responders to previous on-demand treatment with PDE5 inhibitors. In a subsequent study, 217 patients who were treatment-naive to PDE5 inhibitors were randomized to CIALIS 5mg once a day vs. placebo.  The mean per-subject proportion of successful sexual intercourse attempts was 68% for CIALIS patients compared to 52% for patients on placebo.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

date of revision:

 

                21 February 2011

Updated on 24-Sep-2010 and displayed until 03-Mar-2011

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 06-Sep-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



*This SPC has been re-formatted in its entirety due to QRD changes.

 

4.         Clinical particulars

 

4.1       Therapeutic indications

 

Added (bold):

 

Treatment of erectile dysfunction in adult males.

 

4.2       Posology and method of administration

 

Added (bold) deleted (strikethrough):

 

Method of administration

 

For oral use. CIALIS is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.

 

4.4       Special warnings and precautions for use

 

Added (bold) deleted (strikethrough):

 

The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take CIALIS with such combinations. Therefore, the use of such combinations is not recommended.

 

4.6       Pregnancy and lactation

 

Added (bold) deleted (strikethrough):

 

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of CIALIS during pregnancy.

 

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. CIALIS should not be used during breast feeding. For tadalafil no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

 

4.8       Undesirable effects

 

Added (bold) deleted (strikethrough):

 

b.                                Tabulated summary of adverse reactions

 

The table below lists the adverse reactions reported induring erectile dysfunction placebo-controlled clinical trials for registrationin patients treated with CIALIS on demand and daily dosing with doses within the currently approved dosing range for CIALIS.  Adverse reactions are also included that have been reported from postmarketing surveillance in patients taking CIALIS on demand.

 

Note: Table re-formatted in entirety- see SPC

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1       Pharmacodynamic properties

 

Added (bold):

 

Pharmacotherapeutic group: Drugs used in erectile dysfunction, ATC Code: G04BE08.

 

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

date of revision:

 

                06 September 2010

Updated on 23-Apr-2010 and displayed until 24-Sep-2010

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 18-Mar-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



6.             PHARMACEUTICAL PARTICULARS

 

6.5          Nature and contents of container

 

Added (bold):

 

Aluminium/PVC/PE/ PCTFE blisters in cartons of 2, 4, 8, 10, 12, 14 and 28 film-coated tablets.

 

 

 

8.             MARKETING AUTHORISATION NUMBERS

 

Added:

 

EU/1/02/237/009                                CIALIS 20mg x 10 film-coated tablets.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

date of revision:

 

18 March 2010

Updated on 19-Feb-2010 and displayed until 23-Apr-2010

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 09-Feb-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes

 

 

 

 

4.             Clinical particulars

 

4.8          Undesirable effects

 

Added (bold):

 

System Organ Class: Nervous system disorders

Headache

Dizziness

 

Stroke1 (including haemorrhagic events),

Syncope,

Transient ischaemic attacks1,

Migraine

Seizures,

Transient amnesia

 

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

date of revision:

 

9 February 2010

 

Updated on 16-Sep-2008 and displayed until 19-Feb-2010

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 03-Sep-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.         Clinical particulars

 

4.4       Special warnings and precautions for use

 

Deleted (strikethrough) Added (bold):

 

In patients who are taking alpha1 blockers, such as doxazosin, concomitant administration of CIALIS may lead to symptomatic hypotension in some patients (see section 4.5). Therefore, the combination of tadalafil and alpha blockers

doxazosin is not recommended.

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Deleted (strikethrough) Added (bold):

 

The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect lasts at least twelve hours and may be symptomatic, including syncope. Therefore this combination is not recommended (see section 4.4).

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted.

In subjects receiving concomitant tadalafil (20 mg) and doxazosin (8 mg daily), an alpha (1)adrenergic receptor blocker, there was an augmentation of the blood‑pressure‑lowering effect of doxazosin. This effect was still present at 12 hours postdose and had generally disappeared at 24 hours. The number of subjects with potentially clinically significant standing‑blood‑pressure decreases was greater for the combination. Some subjects experienced dizziness but no cases of syncope were reported. Lower doses of doxazosin have not been studied. Therefore, the combination of tadalafil and alpha blockers is not recommended. In a single study in 18 healthy volunteers, tadalafil (10 mg and 20 mg) had no clinically significant effect on blood pressure changes due to tamsulosin, a selective alpha (1A)-adrenergic receptor blocking agent. It is not known how this extrapolates to other alpha (1A)-adrenergic receptor blocking agents.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

date of revision:

 

03 September 2008

Updated on 16-Jun-2008 and displayed until 16-Sep-2008

Reasons for adding or updating:

  • Introduction of new strength

Date of revision of text on the SPC: 17-Mar-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Addition:

 

This SPC has been revised in its entirety adding CIALIS OAD – 2.5mg/5mg text throughout – there are no other content changes.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

date of revision:

 

17 March 2008

Updated on 27-Mar-2008 and displayed until 16-Jun-2008

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Mar-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.             Clinical particulars

 

Section 4.8 Changed in its entirety

 

 

4.8          Undesirable effects

 

The most commonly reported adverse reactions were headache and dyspepsia.  The adverse reactions reported were transient, and generally mild or moderate. Adverse reaction data are limited in patients over 75 years of age..

 

The table below lists the adverse reactions reported during placebo-controlled clinical trials for registration in patients treated with CIALIS on demand and daily dosing.  Adverse reactions are also included that have been reported from postmarketing surveillance in patients taking CIALIS on demand.

 

Adverse Reactions

Frequency estimate: Very common (³1/10), Common (³1/100 to <1/10), Uncommon (³1/1000 to <1/100), Rare (³1/10,000 to <1/1000), Very Rare (<1/10,000) and Not known (events not reported in registration trials cannot be estimated from postmarketing spontaneous reports).

 

Very common (³1/10)

Common

(³1/100 to <1/10)

Uncommon

(³1/1000 to <1/100)

Rare

(³1/10,000 to <1/1000)

Not known

System Organ Class: Immune system disorders

 

 

Hypersensitivity reactions

 

 

System Organ Class: Nervous system disorders

Headache

Dizziness

 

Stroke1, Syncope, Transient ischaemic attacks1, Migraine

Seizures,

Transient amnesia

System Organ Class: Eye disorders

 

 

Blurred vision, Sensations described as eye pain,

Swelling of eyelids, Conjunctival hyperaemia

Visual field defect

Non-arteritic anterior ischemic optic neuropathy (NAION),

Retinal vascular occlusion

System Organ Class: Ear and labyrinth disorders

 

 

 

 

Sudden deafness2

System Organ Class: Cardiac disorders1

 

Palpitations

Tachycardia

Myocardial infarction

Unstable angina pectoris, Ventricular arrhythmia

System Organ Class: Vascular disorders

 

Flushing

Hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents), Hypertension

 

 

System Organ Class: Respiratory, thoracic and mediastinal disorders

 

Nasal congestion

Epistaxis

 

 

System Organ Class: Gastrointestinal disorders

Dyspepsia

Abdominal pain, Gastro-oesophageal reflux

 

 

 

System Organ Class: Skin and subcutaneous tissue disorders

 

 

Rash,

Urticaria, Hyperhydrosis (sweating)

 

Stevens-Johnson syndrome,

Exfoliative dermatitis

System Organ Class: Musculoskeletal, connective tissue and bone disorders

 

Back pain,

Myalgia

 

 

 

System Organ Class: Reproductive system and breast disorders

 

 

 

Prolonged erections

Priapism

System Organ Class: General disorders and administration site conditions

 

 

Chest pain1

Facial oedema

Sudden cardiac death1

 

1 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors (see section 4.4).

2 Sudden decrease or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including tadalafil.

 

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date of revision:

 

17 March 2008

Updated on 29-Oct-2007 and displayed until 27-Mar-2008

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

7.             MARKETING AUTHORISATION HOLDER

 

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA, Houten
The Netherlands

 

 

 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first Authorisation: 12 November 2002

 

Date of last renewal:   12 November 2007

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date of revision:

 

18 October 2007

Updated on 19-Oct-2007 and displayed until 29-Oct-2007

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

               

Added:

               

10mg: Each coated tablet contains 179mg lactose monohydrate.

 

20mg: Each coated tablet contains 245mg lactose monohydrate

 

 

 

3.             PHARMACEUTICAL form

 

Added text in bold:

 

Film-coated tablet (tablet).

 

The 10mg tablets are light yellow and almond shaped, marked ‘C 10’ on one side.

 

The 20mg tablets are yellow and almond shaped, marked ‘C 20’ on one side.

 

 

4.             CLINICAL PARTICULARS

 

4.2          Posology and method of administration

 

Text added following the approval of 2.5 and 5mg tablet strengths.

 

CIALIS is 2.5, 5, 10 and 20mg film-coated tablets.

 

Added text in bold:

 

Use in Adult Men

 

In general, the recommended dose is 10mg taken prior to anticipated sexual activity and with or without food.  In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried.  It may be taken at least 30 minutes prior to sexual activity.

 

The maximum dose frequency is once per day.

 

Added new dosing instructions following approval of 2.5 and 5mg tablet strengths.

 

In responder patients to on-demand regimen who anticipate a frequent use of CIALIS (ie., at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician’s judgement.

 

In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day.  The dose may be decreased to 2.5mg once a day based on individual tolerability.

 

The appropriateness of continued use of the daily regimen should be reassessed periodically.

 


Added:

 

Use in Elderly Men

 

Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment. (See sections 4.4 and 5.2.)

 

Use in Men With Impaired Hepatic Function

 

Once-a-day dosing has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (See section 5.2.)

 

4.3          Contra-indications

 

Moved the following text from the end off the section to the top of the section.

 

Hypersensitivity to the active substance or to any of the excipients.

 

4.4          Special warnings and precautions for use

 

Added text in bold:

 

There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency.

 

Deletions in strikethrough text:

 

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.  It is not known if CIALIS is effective in patients with spinal cord injuries and patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

 

Slightly reworded and moved sentence to the bottom of the section:

 

CIALIS contains lactose monohydrate.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Replaced medicinal products to substances in the following heading:

 

Effects of other substances on tadalafil

 

Reworded paragraph (changes in bold):

 

A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10mg).  This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown.  Other inducers of CYP3A4, such as phenobarbital, phenytoin, and carbamazepine, may also decrease plasma concentrations of tadalafil.

 

Added text in bold:

 

Thus, in a patient prescribed any dose of CIALIS (2.5mg - 20mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of Cialis before nitrate administration is considered.

 


Moved the following text to bottom of the section:

 

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.  Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9, and CYP2C19.

 

Tadalafil (10 and 20mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.

 

Tadalafil (10 and 20mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid.

 

Changed the word ‘medication’ to ‘medicines’ in several places within section.

 

4.6          Pregnancy and lactation

 

Reworded section to read:

 

CIALIS is not indicated for use by women.

 

For tadalafil, no clinical data on exposed pregnancies are available.  Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

 

4.7          Effects on ability to drive and use machines

 

Cialis is expected to have no or negligible influence on the ability to drive and/or use machines.  No specific studies have been performed to evaluate a potential effect.

 

Changed to:

 

No studies on the effect of the ability to drive and use machines have been performed.

 

4.8          Undesirable effects

 

                Reformatted entire section:

               

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness within the clinical trial adverse reaction tables.

 

Postmarketing adverse reactions reported for Cialis is now presented in table format with frequency classifications.

 

 

5.             PHARMACOLOGICAL PROPERTIES

 

5.3          Preclinical safety data

 

Added text in bold:

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.

 

 

 

6.             PHARMACEUTICAL PARTICULARS

 

6.4          Special precautions for storage

 

Added text in bold:

 

Store in the original package in order to protect from moisture.

 


6.5          Nature and contents of container

 

Changes in bold text:

 

Aluminium/PVC/PE/ PCTFE blisters in cartons of 4 film-coated tablets.

 

Aluminium/PVC/PE/ PCTFE blisters in cartons of 2, 4, 8 and 12 film-coated tablets.

 

 

 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Changes in bold text:

 

Date of first Authorisation: 12 November 2002

 

Date of last renewal: 12 November 2007

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date of revision:

 

October 2007

Updated on 07-Sep-2006 and displayed until 19-Oct-2007

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 01-Jul-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.             CLINICAL PARTICULARS

 

4.2          Posology and method of administration

 

Added:

 

Tadalafil 10 and 20mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

 

Deleted:

 

Continuous daily use of the medication is strongly discouraged because the long-term safety after prolonged daily dosing has not been established and also because the effect of tadalafil usually lasts for longer than one day.  See section 4.4, last paragraph, and section 5.1.

 

4.4          Special warnings and precautions for use

 

Deleted:

 

In dogs given tadalafil daily for 6 to 12 months at doses of 25mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7-18.6] than seen in humans at a 20mg single dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.  Results from two 6-month studies in volunteers suggest that this effect is unlikely in humans (see section 5.1).  The effects of longer-term daily dosing have not been established.  Therefore, daily use of the medication is strongly discouraged.

 

4.8          Undesirable effects

 

Added:

 

Nervous system: Migraine.

 

Respiratory system: Epistaxis.

 

5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

Two studies were conducted in men to assess the potential effect of Cialis 10mg and 20mg administered daily for 6 months on spermatogenesis.  The results of these studies demonstrate no difference from placebo with respect to the proportion of men showing a 50% or greater decrease in sperm concentration.  In addition, in comparison with placebo, there were no adverse effects observed with respect to mean change in sperm count, sperm morphology, or sperm motility at either dose.  However, in the study of 10mg Cialis taken daily for 6 months, results showed a decrease in mean sperm concentration relative to placebo.  This effect was not seen in the study where the higher dose, 20mg, Cialis was taken daily for 6 months.  In addition, there was no effect on mean concentrations of testosterone, luteinizing hormone, or follicle stimulating hormone with either 10 or 20mg of Cialis compared to placebo.  The effects of longer-term daily dosing have not been established.  See also sections 4.4 and 5.3.

 

Changed to:

 

Three studies were conducted in men to assess the potential effect on spermatogenesis of Cialis 10mg (one 6-month study) and 20mg (one 6-month and one 9-month study) administered daily.  In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.  These effects were not associated with changes in other parameters, such as motility, morphology, and FSH.

 

5.3          Preclinical safety data

 

Rephrased in bold (previously “Preclinical …”):

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction.

 

6.             PHARMACEUTICAL PARTICULARS

 

6.4          Special precautions for storage

 

Added:

 

Do not store above 30°C.

 

10.          DATE OF REVISION OF THE TEXT

 

New date of revision:

 

28 July 2006

Updated on 05-Jul-2006 and displayed until 07-Sep-2006

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 01-Jun-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.             CLINICAL PARTICULARS

 

4.3                Contra-indications

 

Added:

 

Cialis is contra-indicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

 

4.4          Special warnings and precautions for use

 

Deleted:

 

The use of PDE5 inhibitors is not recommended in patients with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION).

 

Added:

 

Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with the intake of Cialis and other PDE5 inhibitors.  The patient should be advised that in case of sudden visual defect, he should stop taking Cialis and consult a physician immediately (see section 4.3).

 

4.8          Undesirable effects

 

Deleted:

 

Eye disorders: Non-arteritic anterior ischaemic optic neuropathy (NAION), blurred vision, visual field defect, retinal vascular occlusion.

 

Added:

 

Eye disorders: Blurred vision, visual field defect, retinal vascular occlusion.  Non-arteritic anterior ischaemic optic neuropathy (NAION) has been reported at an unknown frequency.

 

8.             MARKETING AUTHORISATION NUMBERS

 

EU/1/02/237/001:        4 x 10mg tablets

EU/1/02/237/003:        4 x 20mg tablets

EU/1/02/237/004:        8 x 20mg tablets

 

Changed to:

 

EU/1/02/237/001-005

 

10.          DATE OF REVISION OF THE TEXT

 

New date of revision:

 

12 June 2006

Updated on 17-Jan-2006 and displayed until 05-Jul-2006

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text

Updated on 22-Dec-2004 and displayed until 17-Jan-2006

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Updated on 18-Mar-2004 and displayed until 22-Dec-2004

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text

Updated on 08-Dec-2003 and displayed until 18-Mar-2004

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Updated on 15-Jan-2003 and displayed until 08-Dec-2003

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Eli Lilly and Company Limited

Company image
Address

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL

Medical Information e-mail
Telephone

+44 (0)1256 315 000

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

tadalafil

Legal categories

POM - Prescription Only Medicine

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