Tetralysal 300 Capsules *
Pharmacy Only: Prescription

Updated on 15 August 2022

File name

62fa0f59d7b49.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

62fa0dac675c3.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)_1637314336.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

Other medicines and Tetralysal

 

You should tell your doctor if you are taking any treatment with lithium, this medicine may increase the lithium levels.

4. POSSIBLE SIDE EFFECTS

Not known: frequency cannot be estimated from the available data

 

  • depression
  • nightmare

 

Reporting of side effects

 

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,

 

Updated on 24 August 2021

File name

ie-spc-clean-Feb 21_1629802686.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

 

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; Website: http://hpra.ie; 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_1596111050.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_1592576365.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_1581289794.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 4.2: 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 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

Section 4.8 updated to include hepatitis as adverse event.

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

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

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

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

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

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

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

The product name has been updated to comply with current legislation

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)