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Cipramil Drops 40 mg/ml

Last Updated on eMC 11-Jun-2014 View document  | Lundbeck 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 11-Jun-2014 and displayed until Current

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • 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 - Fertility, pregnancy and lactation
  • 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: 05-Jun-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Includes some rewriting and template changes to Sections 3, 4,3, 4.4, 4.5, 4.6, 4.8.

The main changes are:

Section 4.4 - rewording of information re glaucoma. Revised to:

SSRIs including citalopram may have an effect on pupil size resulting in mydriasis. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in patients pre-disposed. Citalopram should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma.

Section 4.5 - Information concerning use with selegiline now states:

The concomitant use of citalopram and selegiline (in doses above 10 mg daily) is contraindicated.

Information on Medicinal products inducing hypokalaemia/hypomagnesaemia is amended to:
Caution is warranted for concomitant use of hypokalaemia- / hypomagnesaemia-inducing medicinal products as these conditions increase the risk of malignant arrhythmias.


Section 4.6 Pregnancy, Lactation and Fertility: Revision of text in the following paragraph to:

Published data on pregnant women (more than 2500 exposed outcomes) indicate no malformative foeto / neonatal toxicity, however, citalopram should not be used during pregnancy unless clearly necessary and only after careful consideration of risk/benefit.

Section 4.8 Information and frequencies of AEs reported in clinical trials, has been amalgamated into the main table of reported side effects.

Updated on 20-Nov-2012 and displayed until 11-Jun-2014

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

Date of revision of text on the SPC: 13-Nov-2012

Legal Category:POM

Black Triangle (CHM): NO

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In section 4.5, mention of 'fentiazine' has been amended to 'phenothiazine', in the following paragraph:

Pharmacokinetic and pharmacodynamic studies between citalopram and other medicinal products that prolong the QT interval have not been performed.  An additive effect of citalopram and these medicinal products cannot be excluded.  Therefore, co-administration of citalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine) etc., is contraindicated.

Updated on 01-Oct-2012 and displayed until 20-Nov-2012

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 21-Sep-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The changes affect Sections 4.6 and 5.3 of the SmPC.

 

Section 4.6

Addition of:

Fertility

Animal data have shown that citalopram may affect sperm quality (see section 5.3).

Human case reports with some SSRIs have shown that an effect on sperm quality is reversible.

Impact on human fertility has not been observed so far.

Section 5.3

Addition of:

Animal data have shown that citalopram induces a reduction of fertility index and pregnancy index, reduction in the implantation number and abnormal sperm at exposure well in excess of human exposure.

Updated on 13-Feb-2012 and displayed until 01-Oct-2012

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 23-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Updated on 27-Jan-2012 and displayed until 13-Feb-2012

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 23-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 Posology and method of administration

Major Depressive Episodes

Adults: (addition of)

Citalopram should be administered as a single oral dose of 16 mg (8 drops) daily.

Dependent on individual patient response, the dose may be increased to a maximum of 32 mg (16 drops) daily.

Panic Disorder

Adults: (addition of)

A single oral dose of 8 mg (4 drops) is recommended for the first week before increasing the dose to 16 mg (8 drops) daily.  Dependent on individual patient response, the dose may be increased to a maximum of 32 mg (16 drops) daily.

Elderly patients (> 65 years of age)

For elderly patients the dose should be decreased to half of the recommended dose, e.g. 8 mg (4 drops) to 16 mg (8 drops) daily.  The recommended maximum dose for the elderly is 16 mg (8 drops) daily.

Reduced hepatic function

An initial dose of 8 mg (4 drops) daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment.  Depending on individual patient response, the dose may be increased to a maximum of 16 mg (8 drops) daily.  Caution and extra careful dose titration is advised in patients with severely reduced hepatic function (see section 5.2).

Poor metabolisers of CYP2C19

An initial dose of 8 mg (4 drops) daily during the first two weeks of treatment is recommended for patients who are known to be poor metabolisers with respect to CYP2C19.  The dose may be increased to a maximum of 16 mg (8 drops) daily depending on individual patient response, (see section 5.2).

 
Section 4.3 Contraindications

Addition of:

Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome.

Citalopram is contraindicated together with medicinal products that are known to prolong the QT-interval (see section 4.5).


Section 4.4 Special warnings and precautions for use

Addition of:

QT-interval prolongation

Citalopram has been found to cause a dose-dependent prolongation of the QT-interval.  Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT prolongation or other cardiac diseases (see sections 4.3, 4.5, 4.8, 4.9 and 5.1).

Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.

Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant arrhythmias and should be corrected before treatment with citalopram is started.

If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.

 

If signs of cardiac arrhythmia occur during treatment with citalopram, the treatment should be withdrawn and an ECG should be performed.

 

Section 4.5 Interactions

Contraindicated combinations

Addition of:

QT interval prolongation

Pharmacokinetic and pharmacodynamic studies between citalopram and other medicinal products that prolong the QT interval have not been performed.  An additive effect of citalopram and these medicinal products cannot be excluded.  Therefore, co-administration of citalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine) etc., is contraindicated.

Influence of other medicinal products on the pharmacokinetics of citalopram

Cimetidine

Cimetidine (potent CYP2D6, 3A4 and 1A2 inhibitor) caused a moderate increase in the average steady state levels of citalopram.  Caution is advised when administering citalopram in combination with cimetidine.  Dose adjustment may be warranted.

 

 

Section 4.8 Undesirable effects

 

Addition to table:

Frequency not known: ventricular arrhythmia including torsade de pointes

 

Addition below table:

Cases of QT-prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT prolongation or other cardiac diseases (see sections 4.3, 4.4, 4.5, 4.9 and 5.1).

 

 

Section 4.9 Overdose

 

Addition of:

ECG monitoring is advisable in case of overdose in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT interval, or in patients with altered metabolism, e.g. liver impairment.

 

 

Section 5.1 Pharmacodynamic properties

 

Addition of:

In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 7.5 (90%CI 5.9-9.1) msec at the 20 mg/day dose and 16.7 (90%CI 15.0-18.4) msec at the 60 mg day/dose (see sections 4.3, 4.4, 4.5, 4.8 and 4.9).

Updated on 04-Apr-2011 and displayed until 27-Jan-2012

Reasons for adding or updating:

  • 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 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 28-Mar-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



As a result of an EU work sharing procedure for citalopram, the SPC for  Cipramil has been revised.

 

The changes affects Sections, 4.3, 4.4, 4.5, 4.7 and 4.9 with extensive revisions of the text in these sections.

 

In addition, in Section 4.6 the following text has been added in the section on pregnancy: “A large amount of data on pregnant women (more than 2500 exposed outcomes) indicate no malformative foeto / neonatal toxicity.  Citalopram can be used during pregnancy if clinically needed, taking into account the aspects mentioned below.”

Additionally the following has been added in the Section on lactation: “It is estimated that the suckling infant will receive about 5% of the weight related maternal daily dose (in mg/kg).  No or only minor events have been observed in the infants.  However, the existing information is insufficient for assessment of the risk to the child. Caution is recommended.”

 

In Section 4.8 the table of undesirable effects has been reformatted, with some events moved into different headings: 

 “purpura”, formerly under “Blood and lymphatic disorders”, now appears under “Skin and subcutaneous tissue disorders”;

“abnormal orgasm”, formerly under “Reproductive system and breast disorders” is now included under “Psychiatric disorders”;

“weight decreased” and “weight increased”, formerly under “Investigations ” have been added to the information under “Metabolism and nutrition disorders”;
“dizziness” and “paraesthesia”, formerly under “General disorders and administration site conditions” are now under “Nervous system disorders”.  

Updated on 11-Oct-2010 and displayed until 04-Apr-2011

Reasons for adding or updating:

  • Correction of spelling/typing errors

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

Legal Category:POM

Black Triangle (CHM): NO

Updated on 12-Jul-2010 and displayed until 11-Oct-2010

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • 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: 06-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

Section 4.6 Pregnancy and lactation

 

Addition of: Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).  The observed risk was approximately 5 cases per 1000 pregnancies.  In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.

 

Section 4.8 Undesirable effects

Addition of:

Class effects
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.  The mechanism leading to this risk is unknown.

Updated on 27-Nov-2009 and displayed until 12-Jul-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: 13-Oct-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 - rewritten/amended, including adverse events reported in clinical trials

Updated on 03-Nov-2009 and displayed until 27-Nov-2009

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 10 date of revision of the text

Date of revision of text on the SPC: 18-Sep-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 of the SmPC has been updated to include relevant warnings for serotonin syndrome, hyponatraemia and glaucoma.

Section 4.8 has been updated to include mydriasis (which may lead to acute narrow angle glaucoma).

Updated on 25-Nov-2008 and displayed until 03-Nov-2009

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC: 11-Aug-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3 Contraindications 

Addition of: Concomitant treatment with pimozide (see section 4.5).

 

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

Addition of: A pharmacokinetic/pharmacodynamic interaction study in healthy volunteers with concomitant administration of citalopram and metoprolol (a CYP2D6 substrate) showed a twofold increase in metoprolol concentrations, but no statistically significant increase in the effect of metoprolol on blood pressure and heart rate.

Addition of: Pimozide. Co administration of a single dose of pimozide 2 mg to subjects treated with racemic citalopram 40 mg/day for 11 days caused an increase in AUC and Cmax of pimozide, although not consistently throughout the study.  The co-administration of pimozide and citalopram resulted in a mean increase in the QTc interval of approximately 10 msec.  Due to the interaction noted at a low dose of pimozide, concomitant administration of citalopram and pimozide is contraindicated.

Updated on 07-Apr-2008 and displayed until 25-Nov-2008

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 10 date of revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The changed texts are as follows:

SmPC Section 4.4 - Replacement Paragraphs

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which Cipramil is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

SmPC Section 4.8 - New Paragraph

Cases of suicidal ideation and suicidal behaviours have been reported during citalopram therapy or early after treatment discontinuation (see section 4.4).

Updated on 05-Sep-2007 and displayed until 07-Apr-2008

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 4.9 - Overdose
  • Change to section 10 date of revision of the text
  • Change to section 5.1 - Pharmacodynamic Properties

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

  The changes affect Sections 4.2, 4.4, 4.8, 4.9 and 5.1.

Section 4.2, Revision of paragraphs on dosage in major depressive episodes and panic disorder.

Addition of: “Withdrawal symptoms seen on discontinuation of citalopram
Abrupt discontinuation should be avoided.  When stopping treatment with citalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4.4 Special Warnings and Special Precautions for Use and section 4.8 Undesirable Effects).  If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.  Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.”

Section 4.4 Revision of paragraphs on Suicide/suicidal thoughts
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).  This risk persists until significant remission occurs.  As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.  It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which citalopram is prescribed can also be associated with an increased risk of suicide-related events.  In addition, these conditions may be co-morbid with major depressive disorder.  The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.  In addition, there is a possibility of an increased risk of suicidal behaviour in young adults.

Patients (and caregivers of patients) should be alerted about the need to monitor for the emergence of such events and to seek medical advice immediately if these symptoms present.

Addition of paragraph on akathisia/psychomotor restlessness
The use of citalopram has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.  This is most likely to occur within the first few weeks of treatment.  In patients who develop these symptoms, increasing the dose may be detrimental.”

Addition of paragraphs on withdrawal symptoms seen on discontinuation of SSRI treatment
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects).  In clinical trials adverse events seen on treatment discontinuation occurred in approximately 40% of patients treated with citalopram.

The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.  Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions.  Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.  They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.  Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).  It is therefore advised that citalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient’s needs (see “Withdrawal symptoms seen on discontinuation of citalopram”, Section 4.2 Posology and Method of Administration).

Section 4.8: Addition of paragraph on discontinuation symptoms:
Withdrawal symptoms seen on discontinuation of SSRI treatment
Discontinuation of citalopram (particularly when abrupt) commonly leads to withdrawal symptoms.  Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions.  Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged.  It is therefore advised that when citalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special Warnings and Special Precautions for use).

Section 4.9 Overdose: revision of text:
Fatal dose is not known.  Patients have survived ingestion of more than 2 g citalopram.
The effects may be potentiated by alcohol taken at the same time.
Potential interaction with TCAs, MAOIs and other SSRIs.

Symptoms
Nausea, dizziness, tachycardia, tremor, drowsiness and somnolence may occur.  At higher doses convulsions may occur within a few hours after ingestion.  Hyperventilation, hyperpyrexia and coma have been reported.
ECG changes including nodal rhythm, prolonged QT intervals and wide QRS complexes may occur and rarely rhabdomolysis.  Fatalities have been reported.
Prolonged bradycardia with severe hypotension and syncope has also been reported.
Rarely, features of the "serotonin syndrome" may occur in severe poisoning.  This includes alteration of mental status, neuromuscular hyperactivity and autonomic instability.  There may be hyperpyrexia and elevation of serum creatine kinase.  Rhabdomyolysis is rare.
Treatment
There is no specific antidote. An ECG should be taken.
Consider oral activated charcoal in adults and children who have ingested more than 5 mg/kg body weight within 1 hour.  Activated charcoal given ½ hour after ingestion of citalopram has been shown to reduce absorption by 50%.
Control convulsions with intravenous diazepam if they are frequent or prolonged
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable.
Section 5.1 Addition of paragraph on dose response:
“In the fixed dose studies there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses.  However, it is clinical experience that up-titrating the dose might be beneficial for some patients.”

Updated on 17-Jan-2007 and displayed until 05-Sep-2007

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of the following two paragraphs of text to Section 4.6 Use n Pregnancy and lactation. 
 
Neonates should be observed if maternal use of citalopram continues into the later stages of pregnancy, particularly in the third trimester.  Abrupt discontinuation should be avoided in pregnancy.

The following symptoms may occur in the neonates after maternal SSRI/SNRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping.  These symptoms could be due to either serotonergic effects or discontinuation symptoms.  In a majority of instances the complications begin immediately or soon (<24 hours) after delivery.

Updated on 24-Sep-2006 and displayed until 17-Jan-2007

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Rewording of para in Section 4.4 concerning use in children and adolescents.

Updated on 25-Sep-2003 and displayed until 24-Sep-2006

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Updated on 05-Sep-2002 and displayed until 25-Sep-2003

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text

Updated on 03-Aug-2001 and displayed until 05-Sep-2002

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Company contact details

Lundbeck Limited

Company image
Address

Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG

Fax

+44 (0)1908 647 888

Medical Information e-mail
Telephone

+44 (0)1908 649 966

Medical Information Direct Line

+44 (0)1908 638 972

Customer Care direct line

+44 (0)1908 638 935

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Active ingredients

citalopram hydrochloride

Legal categories

POM - Prescription Only Medicine

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