ATARAX Film-coated tablets (2016)
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Περιεχόμενα
Name of the medicinal product
Atarax 10mg Film-coated tablets.
Qualitative and quantitative composition
Hydroxyzine hydrochloride 10mg. Excipient(s) with known effect: Lactose (anhydrous) 47.3mg Sunset Yellow (E110) 0.24mg For the full list of excipients, see section 6.1.
Pharmaceutical form
10mg film-coated tablets, coloured orange and coded on one side with AX.
Therapeutic indications
Atarax is indicated to assist in the management of anxiety in adults. Atarax is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical ...
Posology and method of administration
Posology Atarax should be used at the lowest effective dose and for the shortest possible duration. In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day. Anxiety Adults ...
Contraindications
Atarax is contra-indicated in the following: Patients who have shown previous hypersensitivity to hydroxyzine hydrochloride, cetirizine, other piperazine derivatives, aminophylline or ethylenediamine, ...
Special warnings and precautions for use
Cardiovascular effects Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been cases of QT interval prolongation ...
Interaction with other medicinal products and other forms of interaction
Associations contraindicated Co-administration of hydroxyzine with drugs known to prolong the QT interval and/or induce Torsade de Pointes e.g. class IA (e.g. quinidine, disopyramide) and III antiarrhythmics ...
Pregnancy and lactation
Pregnancy Atarax should not be used during pregnancy (see section 4.3 Contraindications). Clinical data in humans are inadequate to establish safety in early pregnancy. The use of sedating antihistamines ...
Effects on ability to drive and use machines
Patients should be warned that Atarax may impair their ability to perform activities requiring mental alertness or physical co-ordination such as operating machinery or driving a vehicle. Concomitant use ...
Undesirable effects
The most common adverse effect of the sedating antihistamines is CNS depression. Effects vary from slight drowsiness to deep sleep, and include lassitude, dizziness, and incoordination. Paradoxical stimulation ...
Overdose
Overdosage with sedating antihistamines is associated with antimuscarinic, extrapyramidal, and CNS effects. If CNS stimulation predominates over CNS depression, ataxia, excitement, seizures, tremors, psychoses, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anxiolytics ATC code: N05BB01 Atarax is unrelated chemically to benzodiazepines, phenothiazines, reserpine and meprobamate. Mechanism of action Hydroxyzine is a first generation ...
Pharmacokinetic properties
Absorption Hydroxyzine is rapidly absorbed from the gastrointestinal tract. After a single oral dose of hydroxyzine, 0.7 mg/kg (mean dose 39.0 +/- 5.4 mg) a mean maximum serum hydroxyzine concentration ...
Preclinical safety data
None stated.
List of excipients
Tablet core: Lactose anhydrous Calcium phosphate dibasic anhydrous Pregelatinised starch Magnesium stearate Sodium lauryl sulfate Silicon dioxide Tablet coating: Opadry II Orange 85G23730 (10mg only) - ...
Incompatibilities
Hydroxyzine hydrochloride has been reported to be incompatible with aminophylline, benzylpenicillin salts, chloramphenicol sodium succinate, dimenhydrinate, doxorubicin hydrochloride (in a liposomal formulation), ...
Shelf life
Shelf life: 24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
White opaque 250/51 micron PVC/PCTFE (Aclar) - 20 micron aluminium foil blister strips containing 84 10mg tablets, (6 blister strips per carton).
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, United Kingdom
Marketing authorization number(s)
PL 16853/0094
Date of first authorization / renewal of the authorization
27 April 1987/30 July 1997
Date of revision of the text
20 June 2016
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