Zirtek Tablets (OTC)

  • Name:

    Zirtek Tablets (OTC)

  • Company:
    info
  • Active Ingredients:

    Cetirizine Dihydrochloride

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/08/19

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Summary of Product Characteristics last updated on medicines.ie: 1/8/2019

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

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Medicine Name Keppra 1000 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 100mg/ml concentrate for solution for infusion Active Ingredients Levetiracetam
Medicine Name Keppra 250 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 500 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 750 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch Active Ingredients Rotigotine
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Medicine Name Tylex 30mg/500mg Hard Capsules Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
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Medicine Name Vimpat 10 mg/ml solution for infusion Active Ingredients lacosamide
Medicine Name Vimpat 10 mg/ml syrup Active Ingredients lacosamide
Medicine Name Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets Active Ingredients lacosamide
Medicine Name Xyrem 500mg/ml oral solution Active Ingredients Sodium oxybate
Medicine Name Xyzal 0.5mg/ml oral solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg Tablets Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg/ml Oral Drops, Solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Zirtek Oral Solution Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets Active Ingredients Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
1 - 0 of 27 items.Total: Infinity pages

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 1 August 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 1 August 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 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

Date of Revision
November 2017  July 2019

Updated on 17 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

4.2     Posology and method of administration

 

Posology

 

10 mg once daily (1 tablet).

 

Special population

Older people Elderly

Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

 

Patients with moderate to severe rRenal impairment

 

Patients with h Hepatic impairment

No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Patients with moderate to severe renal impairment above).

4.8 Undesirable effects

Psychiatric disorders:
Uncommon: agitation
Rare: aggression, confusion, depression, hallucination, insomnia
Very rare: tics
Not known: suicidal ideation, nightmare

• Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioneurotic oedema, fixed drug eruption
Not known: acute generalized exanthematous pustulosis

• Musculoskeletal and connective tissue disorders
Not known: arthralgia

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: www.hpra.ie; Ee-mail: medsafety@hpra.ie.

5.2     Pharmacokinetic properties


Elderly
 Older people: Following a single 10 mg oral dose, half-life increased by about 50 % and clearance decreased by 40 % in 16 elderly subjects compared to the younger subjects.  The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.


6.6     Special precautions for disposal

 

 

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


10.     DATE OF REVISION OF THE TEXT

 

October 2016 November 2017

 

 

 

 

 

 

 

 

 

 

Updated on 17 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 11 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 January 2018 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 - date of revision

Updated on 21 November 2016 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

In section 6.5 the pack sizes have been amended to "Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30 tablets" (reference to 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets have been deleted).


Updated on 26 October 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Section 4.1, the text has been reworded.

 

Section 4.2, the text has been reformatted and a subheading added for special populations. Also, the paediatric population section has been updated to include wording that the tablet formulation is not indicated for use in children under 6 years of age.

 

Section 4.3, the text has been reworded.

 

Section 4.4 has been updated to include:

·         reference to pruritus and/or urticaria occurring when cetirizine is stopped.

·         recommendation to use a paediatric formulation of cetirizine (under paediatric population sub-heading).

 

Section 4.5 has been updated to include a warning relating to the concurrent use of alcohol or other CNS depressants in sensitive patients (text relocated from section 4.7).

 

Section 4.6, the text under the sub-heading “pregnancy” has been reworded and a new subheading on “Fertility” has been added.

 

Section 4.7 has been updated to include information relating to patient who “experience somnolence”. Also text has been deleted and relocated to section 4.5.

 

Section 4.8, a subheading “Description of selected adverse reactions” has been added and subheadings amended.

 

Section 4.9, the text has been reworded.

 

Section 5.1, subheadings have been added.

 

Section 5.2, subheadings have been added and text reformatted.

 

Section 10, date of revision of the SmPC has been updated.

Updated on 21 October 2016 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 April 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 15 April 2015 PIL

Reasons for updating

  • New PIL for new product