Tetralysal 300 Capsules
- Name:
Tetralysal 300 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: 30/07/20

XPIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. WHAT TETRALYSAL IS AND WHAT IT IS USED FOR
1. WHAT TETRALYSAL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TETRALYSAL
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TETRALYSAL
3. HOW TO TAKE TETRALYSAL
3. HOW TO TAKE TETRALYSAL
4. POSSIBLE SIDE EFFECTS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TETRALYSAL
5. HOW TO STORE TETRALYSAL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Click on this link to Download PDF directly
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
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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 30 July 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
Updated on 19 June 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 February 2020 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 June 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 7 April 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 7 April 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 April 2017 SPC
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 7 - Marketing authorisation holder
- 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: Relocation of contraindications - Use in children under 8 years and concurrent use with oral retinoids
Section 4.4: Addition of warning relating to Oesophageal irritation and ulceration, and addition of subsection headings
Section 4.5: Inclusion of additional interactions magnesium/aluminium and calcium hydroxides, oxides, salts and activated charcoal, cholestyramine, bismuth chelates, sucralfate and penicillin antibiotics
Section 4.6: Structuring of information into subheadings
Section 4.8: Addition of side effects - Oesophageal irritation and ulceration
Section 4.9: Rewording of information in this section
Section 7: Typographical change
Updated on 7 April 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 25 July 2016 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Addition of special warning relating to myasthenia gravis
Updated on 25 July 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 4 June 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 30 May 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 15 January 2014 SPC
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 14 January 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 13 November 2013 SPC
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 12 July 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 15 June 2011 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 30 April 2010 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 15 January 2010 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 28 August 2007 PIL
Reasons for updating
- Change to side-effects
Updated on 27 July 2007 SPC
Reasons for updating
- Change to section 4 - Clinical particulars
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4 of the SPC
Updated on 19 March 2007 PIL
Reasons for updating
- Change to marketing authorisation holder address
Updated on 1 September 2006 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 7 - Change of office address from Galderma House, Church Lane, Kings Langley, Hertfordshire, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
Updated on 9 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)