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Gerard Laboratories
Unit 36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13,
Telephone: +353 1 832 2250
Fax: +353 1 466 1912
Medical Information Direct Line: +353 1800 272 272
Medical Information e-mail: sales@gerard-laboratories.ie
Summary of Product Characteristics last updated on medicines.ie: 13/08/2010
SPC Ciprager 10mg & 20mg Film Coated Tablets

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

Updated on 13/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   30-Jul-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
4.6 Pregnancy and lactation

Paragraph added:

Epidemiological data have suggested that the use of SSRIs in pregnancy, particular 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.

4.8 Undesirable effects

Paragraph added:

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 01/10/2008 and displayed until 13/08/2010
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
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

Sections 4.3, 4.4, 4.5 of the SmPC updated to include information on  a contraindication with Linezolid (MAOI)
Updated on 24/07/2008 and displayed until 01/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Sections 4.4 & 4.8 updated  with the recommended PhVWP wording re: suicide/suicidal thoughts;
Updated on 07/08/2007 and displayed until 24/07/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The renewal for Ciprager was approved June 07. The SmPC changes reflect changes during renewal assessment

 

Section 2. –      The quantity of Lactose monohydrate is now listed under Excipients.

 

Section 3. –      Text debossed on each tablet has changed to: “CM over 10” and  “CM

                          scoreline 20.

 

Section 4.2 –    Section on Withdrawal Symptoms added.

-       Section on Poor CYP2C19 Metabolisers added.

 

Section 4.4 -   ‘Use in children & adolescents under 18 years of age’ paragraph 

                         moved to start of section 4.4.

-       Section on Suicide/suicidal thoughts added. Previous paragraph removed.

-       Section on Akathisia/psychomotor Restlessness added.

-       Section on Withdrawal Symptoms added.

 

Section 4.5 -     Section on QT prolongation added.

-       Section on Seizures added.

-       Section on Escitalopram added.

 

Section 4.6 -    This section has been entirely updated.

 

Section 4.8 -    This section has been entirely updated. Table has new column and        

                         data added.           

 

Section 4.9 -     Symptoms and Treatment sections updated.                  

 

Section 5.2 -    Biotransformation section updated.

 

Section 5.3 -    Section on Embryotoxicity studies updated.

 

Section 6.4 -    Wording changed.

 

Sections 9 & 10 – Dates are changed

Updated on 04/09/2006 and displayed until 07/08/2007
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
 
The SPC for Ciprager 10mg and 20mg is now combined. Section 6.5 updated to include registered pack size of 10 for Ciprager 20mg.
Updated on 05/05/2004 and displayed until 04/09/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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