Last Updated on eMC 16-04-2018 View medicine  | Chiesi 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.

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-03-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Following the approval of a Type II grouping variation, details are as follows;

-           Product Information Harmonisation 

-           Implementation of the PSUSA Outcome to include "vision blurred" and "central serous chorioretinopathy" in the product information

-           Implementation of PRAC recommendation to include “concomitant use of strong CYP3A inhibitors” in the product information

 

Section 3 Pharmaceutical Form – formatting change from colourless to yellowish solution to Colourless to yellowish solution.

 

Section 4.4 Special warnings and precautions for use

the following information has been added –

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

 

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

without involvement of cytochrome P450 system has been removed

The following has been added - Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.

 

 Section 4.8 Undesirable effects Eye disorders - Adverse Reaction - Vision, blurred (see also section 4.4) Frequency - Unknown has been included

Section 6.3 Shelf life

The following has been added - Prior to dispensing to the patient:

Store in a refrigerator (2-8°C) for a maximum of 15 months.

After dispensing: do not store above 25°C for a maximum of 5 months

 

Section 6.4 Special precautions for storage

Prior to dispensing to the patient: the following has been removed (for a maximum of 15 months).

After dispensing: the following has been removed  (for a maximum of 5 months).

For in-use storage conditions, see section 6.3. has been added

 

Section 10 Date of revision of Text – July 2016 changed to March 2018

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4       Special warnings and precautions for use – the following has been added :

Pneumonia in patients with COPD

An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.

 

4.8     Undesirable effects

Infections and Infestations - pneumonia (in COPD patients) common -  has been added

Influenza, oral fungal infection, oropharyngeal candidiasis  oesophageal candidiasis, vulvovaginal candidiasis, gastroenteritis, sinusitis, rhinitis – uncommon – pneumonia has been removed

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.2 Posology and method of administration- COPD- Method of administration- Fostair inhaler is provided with a counter on the back of the actuator, which shows how many doses are left. For the 120 doses presentation each time the patient press the canister, a puff of medicine is released and the counter counts down by one. For the 180 presentation, each time the patient press the canister the counter rotates by a small amount and the number of puffs remaining is displayed in intervals of 20. Patients should be advised not to drop the inhaler as this may cause the counter to count down.

Testing the inhaler

the patient should release – added

should be released- removed

After testing the inhaler for the first time, the counter should read 120 or 180. –added

Use of the inhaler

The steps below should be followed – removed

1      Patients should – added

2      Patients should – added

3      Patients should – added

do not -  removed

bite changed to biting

4      patients should – added

they should – added

5      Patients should –added

they should – added

Patients should not – added

Should changed to - To inhale

Be needed changed to - patients should

IMPORTANT: patients should not perform steps 2 to 5 too quickly. – added

Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20. They should stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to release a full dose. – added

After use, patients should close the inhaler with protective cap and check the dose counter. – extra wording added

Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20. They should stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to release a full dose. – added

IMPORTANT: do not perform steps 2 to 5 too quickly.

Cleaning - remove the canister from the actuator and should not –wording added

Section 10 – Date of revision of Text – February 2014 changed to July 2016

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-07-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 7 – Marketing Authorisation Holder -  Chiesi Limited, Cheadle Roya; Business Park, Highfield, Cheadle, SK8 3GY UK Changed to Chiesi Limited, 333 Styal Road, Manchester M22 5LG UK

Section 10 – Date of Revision of Text – October 2014 Changed to July 2015

Reasons for adding or updating:

  • 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:01-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 5.1 (Pharmacological Properties) ATC -Code:R03AK07 has been changed to ATC - code: R03 AK08
In section 10 (Date of Revision of the Text) March 2014 has changed to October 2014

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:01-03-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Information regarding new indication for COPD added.

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 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:19-12-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Information regarding therapetic indication, posology and method of aministration, special warnings and precautions for use and pharmacodynamic properties updated to reflect new posology as maintenance and reliever therapy.

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 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:07-10-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - wording changed with regards to use in children
Section 4.4 - additional systemic effects
Section 4.8 - additional undesirable effects

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC:31-01-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Black Triangle has been removed.

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 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC:20-07-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Addition to Section 4.2:

Patients who find it difficult to synchronise aerosol actuation with inspiration of breath, may use the AeroChamber Plus™ spacer device. They should be advised by their doctor, pharmacist or a nurse in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. This may be obtained by the patients using AeroChamber Plus™ by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.


Addition to Section 4.4:

Single dose pharmacokinetic data (see section 5.2) have demonstrated that the use of Fostair with Aerochamber Plus™ spacer device in comparison to the use of standard actuator, does not increase the total systemic exposure to

formoterol and reduces the systemic exposure to beclometasone-17-monopropionate, while there is an increase for unchanged beclometasone dipropionate that reaches systemic circulation from the lung; however, since the total systemic exposure of beclometasone dipropionate plus its active metabolite does not change, there is no increased risk of systemic effects when using Fostair with the named spacer device.

 

 



Addition to Section 5.2:

The use of Aerochamber Plus™ spacer increased the lung delivery of beclometasone dipropionate active metabolite

beclometasone 17-monopropionate and formoterol of 41% and 45% respectively, in comparison to the use of standard actuator in a study conducted in healthy volunteers. The total systemic exposure was unchanged for formoterol, reduced by 10% for beclometasone 17-monopropionate and increased for unchanged beclometasone dipropionate.

 

 

Reasons for adding or updating:

  • Company name change or merger

Date of revision of text on the SPC:23-12-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 7: 'Trinity-Chiesi Pharmaceuticals Ltd' has now changed name to 'Chiesi Limited'

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:01-08-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.3: Shelf life extended from 18 to 20 months.

Section 6.4: Maximum shelf-life after dispensing extended from 3 months to 5 months.

Section 6.5: Added '2 pressurised containers which provide 120 actuations each'

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES