Tetralysal 300 Capsules | Patient Info | Galderma International S.A.S. c/o Galderma (U.K) Ltd.

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Tetralysal 300 Capsules

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Name:
Tetralysal 300 Capsules
Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
Active Ingredients:
Lymecycline
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

(Click to Download)

XPIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

1. WHAT TETRALYSAL IS AND WHAT IT IS USED FOR

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TETRALYSAL

3. HOW TO TAKE TETRALYSAL

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE TETRALYSAL

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Summary of Product Characteristics last updated on medicines.ie: 19/6/2020

Click on this link to Download PDF directly

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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 4.2: Updated method of administration information
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

Section 4.8 updated to include hepatitis as adverse event.

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

Information about how to report a side effect has been added to section 4.8

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

Information about how to report side effects has been added to section 4.8

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

Additional undesirable effects added to section 4.8 of the SPC in order to update the SPC in line with the Core Data Sheet.

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

The product name has been updated to comply with current legislation

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)