Zirtek Oral Solution
- Name:
Zirtek Oral Solution
- Company:
UCB (Pharma) Ireland Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/07/19

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UCB (Pharma) Ireland Limited
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Company Products
Medicine Name | Active Ingredients |
---|---|
Medicine Name Zirtek Tablets | Active Ingredients Cetirizine Dihydrochloride |
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 3 July 2019 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 23 April 2019 SmPC
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 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 18 April 2019 SmPC
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
Pregnancy
For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should nevertheless be exercised when prescribing to pregnant women.
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 SmPC
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: updated to May 2018
Updated on 27 June 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 12 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 11 July 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 11 July 2017 SmPC
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 3 July 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 3 July 2017 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to how the medicine works
Updated on 20 November 2014 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2
Method of administration:
The solution can be swallowed as such.
Duration of continuous treatment should not be longer than 30 days, after this period, patients should also consult with their doctor.
Updated on 15 November 2012 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 2 April 2012 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 ml of solution contains 1 mg cetirizine dihydrochloride
Excipients with known effect:
- one ml of solution contains 450 mg sorbitol (solution at 70 %, non crystallizing)
- one ml of solution contains 1.35 mg methylparahydroxybenzoate
- one ml of solution contains 0.15 mg propylparahydroxybenzoate
For the full list of excipients, see section 6.1
4.2 Posology and method of administration
Method of administration:
The solution can be swallowed as such.
Paediatric population
Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.
4.6 Fertility, pregnancy and lactation
Breast-feeding
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 18 July 2011 PIL
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 10 June 2011 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 13 May 2011 SmPC
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.
Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
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
Preagnancy
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 12 January 2011 PIL
Reasons for updating
- Deletion of a pack size
Updated on 13 December 2010 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 6 May 2009 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 30 April 2009 SmPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change to storage instructions
Updated on 8 May 2008 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 6.4 - Special precautions for storage
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 10 August 2007 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 July 2007 PIL
Reasons for updating
- Change to date of revision
Updated on 17 July 2007 SmPC
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 7 February 2006 PIL
Reasons for updating
- Change of manufacturer
Updated on 6 October 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 May 2004 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Supply through pharmacy only
Updated on 23 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only