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ZIRTEK Allergy Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zirtek Allergy 10 mg film-coated tablets.

Qualitative and quantitative composition

Each 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 ...

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.

Therapeutic indications

Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in adults and paediatric patients 6 years and above: For the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. ...

Posology and method of administration

Posology 10 mg once daily (1 tablet). Special population Elderly Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. Renal impairment ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment with a creatinine clearance ...

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. ...

Interaction with other medicinal products and other forms of interaction

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic ...

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 ...

Effects on ability to drive and use machines

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 ...

Undesirable effects

Clinical studies Overview 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 ...

Overdose

Symptoms Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported after an intake of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamine for systemic use, piperazine derivatives ATC code: R06AE07 Mechanism of action Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist ...

Pharmacokinetic properties

Absorption The steady-state peak plasma concentrations is approximately 300 ng/ml and is achieved within 1.0 ± 0.5 h. The distribution of pharmacokinetic parameters such as peak plasma concentration (C ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

List of excipients

Microcrystalline cellulose Lactose-monohydrate Colloidal anhydrous silica Magnesium stearate Opadry Y-1-7000 which consists of: Hydroxypropylmethylcellulose (E464) Titanium dioxide (E171) Macrogol 400 ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

The tablets are enclosed in a transparent, colorless, inert PVC blister strip thermo-sealed with a lacquered aluminium foil. These blister strips are housed in a carton box. Boxes of 1, 4, 5, 7, 10, 14, ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE

Marketing authorization number(s)

PL 00039/0542

Date of first authorization / renewal of the authorization

12 December 2005

Date of revision of the text

August 2018

Πηγαίο έγγραφο

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