Tetralysal 300 Capsules
*Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 August 2022
File name
ie-text-pil-clean-tetralysal.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- XPIL Updated
Free text change information supplied by the pharmaceutical company
Bulk Type IAIN national variation approved by HPRA 19May2022 to standardise the MAH name and address.
Updated on 15 August 2022
File name
ie-spc-clean - approved 19May2022 by HPRA.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Bulk Type IAIN national variation approved by HPRA 19May2022 to standardise the MAH name and address.
Updated on 19 November 2021
File name
(021603) P23477-13 !TETRALYSAL300 28CAP IRL LEAFLET (3).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
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Other medicines and Tetralysal
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You should tell your doctor if you are taking any treatment with lithium, this medicine may increase the lithium levels. |
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4. POSSIBLE SIDE EFFECTS Not known: frequency cannot be estimated from the available data
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Reporting of side effects
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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Website: www.hpra.ie,
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Updated on 24 August 2021
File name
ie-spc-clean-Feb 21.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
4.5 Interaction with other medicinal products and other forms of interaction
Some adverse effects have been reported with tetracycline therapy when used in combination with lithium; an interaction between lithium and the tetracycline class is a recognized interaction. Specifically, a combination of lymecycline with lithium may cause an increase in serum lithium levels.
4.8 Undesirable effects
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Psychiatric disorders |
Unknown |
Depression Nightmare |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; // e-mail:medsafety@hpra.ie
10 DATE OF REVISION OF THE TEXT
August 2021
Updated on 30 July 2020
File name
Tetralysal 300 28 Caps PIL IRE (P23477-12) Jul 20.pdf
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
File name
Tetralysal SPC IRE - June 20.pdf
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 09 February 2020
File name
ie-spc-current-Tetralysal-Jun19.pdf
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 07 June 2018
File name
Tetralysal 300 28 Caps PIL IRE (P23477-10) EMC.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 07 April 2017
File name
PIL_7838_690.pdf
Reasons for updating
- New PIL for new product
Updated on 07 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 April 2017
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 07 April 2017
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
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
Reasons for updating
- Change to warnings or special precautions for use
Updated on 04 June 2014
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
Reasons for updating
- Change to side-effects
Updated on 15 January 2014
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
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 13 November 2013
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
Reasons for updating
- Change to side-effects
Updated on 15 June 2011
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
Reasons for updating
- Change of trade or active ingredient name
Updated on 15 January 2010
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
Reasons for updating
- Change due to user-testing of patient information
Updated on 28 August 2007
Reasons for updating
- Change to side-effects
Updated on 27 July 2007
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
Reasons for updating
- Change to marketing authorisation holder address
Updated on 01 September 2006
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 09 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)