Source: Υπουργείο Υγείας (CY) Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine derivatives.
Patients with severe renal impairment at less than 10 mL/min creatinine clearance.
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 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.
Caution is recommended in epileptic patients and patients at risk of convulsions.
Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
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. It is recommended to use a paediatric formulation of cetirizine.
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day).
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance, although cetirizine does not potentiate the effect of alcohol (0.5 g/L blood levels).
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.
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.
Limited data is available on human fertility but no safety concern has been identified. Animal data show no safety concern for human reproduction.
Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg. However, patients who experience somnolence should refrain from driving, engaging in potentially hazardous activities or operating machinery. They should not exceed the recommended dose and should take their response to the medicinal product into account.
Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.
Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.
Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
From this pooling, the following adverse reactions were reported for cetirizine 10 mg in the placebo-controlled trials at rates of 1.0 % or greater:
| Adverse reactions (WHO-ART) | Cetirizine 10 mg (n=3260) | Placebo (n=3061) |
|---|---|---|
| General disorders and administration site conditions | ||
| Fatigue | 1.63 % | 0.95 % |
| Nervous system disorders | ||
| Dizziness | 1.10 % | 0.98 % |
| Headache | 7.42 % | 8.07 % |
| Gastro-intestinal system disorders | ||
| Abdominal pain | 0.98 % | 1.08 % |
| Dry mouth | 2.09 % | 0.82 % |
| Nausea | 1.07 % | 1.14 % |
| Psychiatric disorders | ||
| Somnolence | 9.63 % | 5.00 % |
| Respiratory, thoracic and mediastinal, disorders | ||
| Pharyngitis | 1.29 % | 1.34 % |
Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Adverse reactions at rates of 1 % or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical trials are:
| Adverse reactions (WHO-ART) | Cetirizine (n=1656) | Placebo (n=1294) |
|---|---|---|
| Gastro-intestinal system disorders | ||
| Diarrhoea | 1.0 % | 0.6 % |
| Psychiatric disorders | ||
| Somnolence | 1.8 % | 1.4 % |
| Respiratory, thoracic and mediastinal disorders | ||
| Rhinitis | 1.4 % | 1.1 % |
| General disorders and administration site conditions | ||
| Fatigue | 1.0 % | 0.3 % |
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).
Very rare: thrombocytopenia.
Rare: hypersensitivity.
Very rare: anaphylactic shock.
Not known: increased appetite.
Uncommon: agitation.
Rare: aggression, confusion, depression, hallucination, insomnia.
Very rare: tics.
Not known: suicidal ideation, nightmare.
Uncommon: paraesthesia.
Rare: convulsions.
Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia.
Not known: amnesia, memory impairment.
Very rare: accommodation disorder, blurred vision, oculogyration.
Not known: vertigo.
Rare: tachycardia.
Uncommon: diarrhoea.
Rare: hepatic function abnormal (increased transaminases, alkaline, phosphatase, γ-GT and bilirubin).
Not known: hepatitis.
Uncommon: pruritus, rash.
Rare: urticaria.
Very rare: angioneurotic oedema, fixed drug eruption.
Not known: acute generalized exanthematous pustulosis.
Not known: arthralgia.
Very rare: dysuria, enuresis.
Not known: urinary retention.
Uncommon: asthenia, malaise.
Rare: oedema.
Rare: weight increased.
After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.
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 the national reporting system:
Cyprus: Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.
Not applicable.
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