Zirtek Tablets
*Company:
UCB (Pharma) Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 October 2023
File name
ie-pil-zirtek-fct.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 08 July 2022
File name
ie-pil-zirtek-fct-en-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
CCDS.v2.0 - myalgia + renal impairment + excipients wording re-submission - QRD template update + removal of CMS SE
Updated on 08 July 2022
File name
ie-spc-zirtek-fct-en-clean.pdf
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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
CCDS.v2.0 - myalgia + renal impairment + excipients wording re-submission - QRD template update + removal of CMS SE
Updated on 03 July 2019
File name
master-pil-zirtek-fct-ie.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 23 April 2019
File name
ie-tab-spc-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
minor updates to section 4.6 upon clarification with RMS, "Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma depending on sampling time after administration” should remain in section 4.6.
Updated on 18 April 2019
File name
Zirtek PIL IE tablets.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 18 April 2019
File name
Zirtek SPC IE tablets clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.6 Fertility, pregnancy and lactation
[...]
Breast-feeding
Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.
Updated on 27 June 2018
File name
Zirtek SPC IE tablets.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Change to section 4.8- Undesirable effects: Addition of hepatitis
Change to section 10- Date of revision of the text: it has been updated to May 2018
Updated on 27 June 2018
File name
Zirtek PIL IE tablets.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 May 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 11 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 11 July 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
- Updates to section 4.8 “Undesirable effects” as follows:
- Addition of ADRs “nightmare” and “arthralgia”
- Addition of ADR “acute generalized exanthematous pustulosis”
- Updates to sections 4.2 and 5.2, to align some wording with QRD.
Updated on 03 July 2017
File name
PIL_8483_460.pdf
Reasons for updating
- New PIL for new product
Updated on 03 July 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 June 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Heading “Special population” added.
- Some text added and deleted.
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.2. Posology and Method of Administration
- Heading “Special population” added.
4.4 Special warnings and precautions for use
- Some text added and deleted.
4.8. Undesirable Effects
· Some text added and deleted.
10 DATE OF REVISION OF THE TEXT
· Date of revision updated.
Updated on 17 June 2016
Reasons for updating
- Change to how the medicine works
Updated on 15 November 2012
Reasons for updating
- Change of inactive ingredient
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 15 October 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.
4.8 Undesirable effects
Metabolism and nutrition disorders:
Not known: increased appetite
Psychiatric disorders:
Not known: suicidal ideation
Ear and labyrinth disorders:
Not known: vertigo
Renal and urinary disorders:
Not known: urinary retention
Updated on 13 June 2012
Reasons for updating
- Change to improve clarity and readability
Updated on 02 April 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg cetirizine dihydrochloride
Excipients with known effect: one film-coated tablet contains 66.40 mg lactose-monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Film-coated tablets
White, oblong, film-coated tablet, with breakline and Y-Y logo
The tablet can be divided into 2 equal doses.
4.2 Posology and method of administration
The tablets need to be swallowed with a glass of liquid.
4.4 Special warnings and precautions for use
Paediatric population
The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
Updated on 18 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
Updated on 31 May 2011
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 13 May 2011
Reasons for updating
- 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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/l). Nevertheless, precaution is recommended if alcohol is taken concomitantly.
Caution in epileptic patients and patients at risk of convulsions is recommended.
The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
4.6 Fertility, pregnancy and lactation
Pregnancy
For cetirizine very rare clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Lactation
Cetirizine is excreted in human milk at concentrations representing 0.25 to 0.90 those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.
4.8 Undesirable effects
Post-marketing experience
In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have been reported in post-marketing experience.
Undesirable effects are described according to MedDRA System Organ Class and by estimated
frequency based on post-marketing experience.
Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon
(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be
estimated from the available data)
Psychiatric disorders:
Uncommon: agitation
Rare: aggression, confusion, depression, hallucination, insomnia
Very rare: tics
Nervous system disorders:
Uncommon: paraesthesia
Rare: convulsions
Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Not known: amnesia, memory impairment
Updated on 06 May 2009
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 30 April 2009
Reasons for updating
- Change to section 4 - Clinical particulars
- Change to section 5 - Pharmacological properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 11 June 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 08 May 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 10 August 2007
Reasons for updating
- Change to date of revision
Updated on 17 July 2007
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 07 February 2006
Reasons for updating
- Change of manufacturer
Updated on 06 October 2004
Reasons for updating
- Improved electronic presentation
Updated on 24 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 07 August 2004
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through pharmacy only
Updated on 27 May 2004
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 23 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only