CETIZAL Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
CETIZAL 5 Film-coated Tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains levocetirizine dihydrochloride 5 mg. <u>Contains sugar:</u> Lactose monohydrate 65,71 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
<u>Film-coated tablet:</u> White, film-coated, scored, round, biconvex tablets debossed with 161 on one side and H on other side.
4.1. Therapeutic indications
CETIZAL 5 is indicated for the relief of symptoms associated with the following allergic conditions: Seasonal allergic rhinitis. Perennial allergic rhinitis. Chronic idiopathic urticaria.
4.2. Posology and method of administration
Posology Adults and adolescents 12 years of age or older The daily recommended dose is one 5 mg tablet. Special populations Elderly population Adjustment of the dose is recommended in elderly patients ...
4.3. Contraindications
The use of CETIZAL 5 is contraindicated in: Hypersensitivity to levocetirizine or to any of the excipients of CETIZAL 5, or to any piperazine derivative. Pregnancy and lactation (see section 4.6). End ...
4.4. Special warnings and precautions for use
Alcohol Precaution is recommended with intake of alcohol (see section 4.5). CETIZAL 5 lacks significant sedative effects. Patients should, however be warned that a small number of individuals may experience ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with CETIZAL 5 (including no studies with CYP3A4 inducers). Studies with the racemate compound cetirizine demonstrated that there were no clinically relevant ...
4.6. Pregnancy and lactation
Pregnancy CETIZAL 5 is contraindicated in pregnancy as the safety has not been established. Breastfeeding Levocetirizine is excreted in breast milk; therefore, CETIZAL 5 is contraindicated in lactating ...
4.7. Effects on ability to drive and use machines
Patients should be warned that CETIZAL 5 may cause somnolence, fatigue and asthenia, and therefore it may interfere with the patients daytime activities. This effect may be compounded by the simultaneous ...
4.8. Undesirable effects
Clinical trial data In therapeutic studies in women and men aged 12 to 71 years, 15,1% of the patients had at least one adverse reaction. In therapeutic trials, the dropout rate due to adverse events was ...
4.9. Overdose
Drowsiness is an expected symptom of overdosage in adults. Overdosage in children may produce agitation and restlessness initially, followed by drowsiness. There is no known specific antidote to CETIZAL ...
5.1. Pharmacodynamic properties
A 5.7.1 Antihistaminics Levocetirizine, the (R) enantiomer of cetirizine, is a histamine H1 receptor antagonist.
5.2. Pharmacokinetic properties
Absorption Levocetirizine is absorbed following oral administration. Distribution Levocetirizine is 90% bound to human plasma proteins. Peak plasma concentrations are achieved 0,9 hour after administration ...
6.1. List of excipients
<u>Tablet core:</u> Colloidal anhydrous silica Lactose monohydrate Magnesium stearate Microcrystalline cellulose <u>Film-coat:</u> Titanium dioxide Hypromellose Macrogol/polyethylene glycol 400 Polysorbate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 25°C. Protect from moisture. Do not remove the blister strips from the cartons until required for use.
6.5. Nature and contents of container
White opaque HDPE container with white opaque polypropylene, plastic cap containing 30 or 180 tablets. Cold form blister pack comprising of cold formable laminated film with a backing of hard tempered ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa
8. Marketing authorization number(s)
46/5.7.1/0329
9. Date of first authorization / renewal of the authorization
06 August 2015
10. Date of revision of the text
04 May 2022
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