Efracea capsules
- Name:
Efracea capsules
- Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/12/17
(Click to Download)XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What Efracea is and what it is used for
1. What Efracea is and what it is used for
2. What you need to know before you take Efracea
2. What you need to know before you take Efracea
3. How to take Efracea
3. How to take Efracea
4. Possible side effects
4. Possible side effects
5. How to store Efracea
5. How to store Efracea
6. Contents of the pack and other information
6. Contents of the pack and other information
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
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Company Products
When a pharmaceutical company changes any document, 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 4 December 2017 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 4 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 13 April 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 April 2016 PIL
Reasons for updating
- Change to drug interactions
Updated on 13 April 2016 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 3 December 2014 PIL
Reasons for updating
- Addition of manufacturer
Updated on 2 December 2014 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 May 2014 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 April 2014 PIL
Reasons for updating
- Change to side-effects
- Addition of information on reporting a side effect.
Updated on 1 April 2014 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 July 2012 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 3 July 2012 PIL
Reasons for updating
- Change to name of manufacturer
- Introduction of new pack/pack size
Updated on 3 November 2011 SmPC
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 - Additoin of "Concomitant treatment with oral retinoids due to the risk of increased intracranial pressure (See section 4.5).
Section 4.4 - Confirmation that Efracea yields anti-inflammatory plasma levels added to boxed text
Section 4.6 - Addition of "Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance (see section 5.3). The effect of EFRACEA on human fertility is unknown."
Section 4.8 - Addition of "Benign intracranial hypertension and headache (unknown frequency: cannot be estimated from the available data) have been reported during EFRACEA postmarketing surveillance."
Section 6.1 - Deleted 3cP/6cP from Hypromellose
Updated on 25 October 2011 PIL
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 23 June 2010 PIL
Reasons for updating
- New PIL for new product
Updated on 22 June 2010 SmPC
Reasons for updating
- New SPC for new product
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)