Zirtek Allergy Relief 10 mg film-coated tablets (OTC)

II - CCDS.v2.0 - myalgia + renal impairment + excipients

II - CCDS.v2.0 - myalgia + renal impairment + excipients

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 Renal impairment above).

Section 4.8:

• Hepatobiliary disorders

Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)

Not known: hepatitis

Not known frequency of side effects (frequency cannot be estimated from the available data)
– Joint pain
– Rash with blisters containing pus
– Increased appetite
– Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare
– Amnesia, memory impairment
– Vertigo (sensation of rotation or movement)
– Urinary retention (inability to completely empty the urinary bladder)
– Pruritus (intense itching) and/or urticaria upon discontinuation
– Hepatitis (inflammation of the liver) 

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

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.

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).

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.