Cetirizine EG 10 mg film-coat. tabl. 100

Cetirizine 10mg Eg 100 tabl

Therapeutic Indications:

Adults and adolescents.
Symptomatic treatment of allergic rhinitis (seasonal and year-round by), associated allergic conjunctivitis and chronic idiopathic urticaria.
Children from 6 to 12 years.
Symptomatic treatment of allergic rhinitis (seasonal and year round) and chronic idiopathic urticaria .

Qualitative and quantitative composition:

A film coated tablet contains 10 mg cetirizine dihydrochloride.
For excipients, see List of excipients.

Pharmaceutical form:

Film-coated tablet.
White, round, film-coated tablet with a breaking groove on one side and the other plane.

Posology and method of administration:

Adults and adolescents: 1 film-coated tablet once daily.
When drowsiness may occur to the tablet in the evening administration.
Children from 6 to 12 years: 1 tablet (10 mg) once daily in a single dose or twice daily ½ tablet (5 mg) (morning and evening).
Children less than 30 kg : ½ tablet (5 mg) once daily.
Children No clinical studies longer than 4 weeks, carried.
Cetirizine is contraindicated in patients with severe renal insufficiency result. In patients with moderate renal impairment the dose should be adjusted to 5 mg (½ tablet per day). Caution is advised in patients with mild to moderate renal or hepatic impairment (see 'Special warnings and precautions for use').
There was no evidence that a modification of the dose in healthy elderly people is needed.
Treatment duration may according to the symptoms vary.

This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.

Contraindications:

for a
Hypersensitivity of the constituents of the drug.
Children younger than 6 years.
Patients with severe renal insufficiency.

Special warnings and precautions for use:

In some patients prolonged treatment with 10 mg Cetirizine EC to an increased risk of caries due to lead a dry mouth. Patients should therefore be informed about the importance of good oral hygiene.
In impaired renal and hepatic function may reduce the elimination of cetirizine. Caution is advised when administering cetirizine to these patients (see Dosage and method of administration 'and' Contra-indications ').
Cetirizine may potentiate the effects of alcohol. Therefore, caution is recommended for concomitant use of alcohol.
Caution is recommended for concomitant use of drugs that suppress the central nervous system.

Pregnancy and lactation:

The data from the limited number of exposed pregnancies indicate no side effect of cetirizine on pregnancy or the health of the fetus / neonate to. To date, no other relevant epidemiological data available.
Animal studies do not indicate direct or indirect harmful effects with regard to pregnancy, embryonal / fetal development, birth or develop after birth (see 'Preclinical safety data). Caution is advised when prescribed to pregnant women.
Lactation: there are no data on the excretion of cetirizine in breast milk. Cetirizine should be avoided during breastfeeding.

Undesirable effects:

Dry mouth, headache, dizziness, drowsiness, somnolence in children and adults, agitation, abdominal complaints and digestive disorders.
Exceptional cases of allergic reactions such as skin reactions and angioneurotic edema have been reported.

Effects on ability to drive and use machines:

Cetirizine has a mild or moderate influence on the responsiveness of the patient. This should be taken as full attention is required, eg driving a vehicle. Cetirizine may potentiate the effects of alcohol and drugs that suppress the central nervous system, strengthen.

Overdose:

toxicity: there is limited experience with overdose. A dose of 20 mg to a 2-year, from 30 mg to a 3-year and 40 mg of an 11-year-old gave no symptoms. A dose of 60 mg to a 4-year old caused mild intoxication, 400 mg in a 14-year old gave mild symptoms, while a dose of 400 to 500 mg in an adult caused no symptoms.
Symptoms of overdose during treatment with antihistamines: somnolence, unconsciousness and / or excitation (principally in children). Ataxia, tremor, headache, hallucinations, convulsions, dry mouth, flushing, hyperthermia, mydriasis, urinary retention, tachycardia and, in cases of very high doses, may reduce blood pressure and arrhythmia. Nausea and vomiting. Extrapyramidal symptoms are also possible. Cetirizine has a light sedative and anticholinergic effects.
Sedation is a symptom of overdose and can occur after a single dose of less than 50 mg.
Treatment : There is to date no specific antidote. There is limited experience with overdosage and to date, no serious overdose. Primary treatment should, if necessary, a gastric lavage and activated charcoal should be. Symptomatic treatment should be started in case of acute overdose, such as diazepam for seizures or acute dystonia.

List of excipients:

Lactosum monohydratum - Cellulosum microcristallinum - Silica colloidalis anh. - Magnesii stearas - Opadry Y-1-7000 (consisting of titanium dioxide (E171) - Hypromellosum Macrogol and 400).

Interaction with other medicinal products and other forms of interaction:

Allergy Test: use of cetirizine to 3 days before allergy testing be stopped. Cetirizine may potentiate the effects of alcohol. Therefore, caution is recommended for concomitant use of alcohol. Caution is recommended for concomitant use of drugs that suppress the central nervous system.

Incompatibilities:

Not applicable.