COMPOSITION: Each film-coated ALLECET tablet contains 10 mg cetirizine dihydrochloride.
PHARMACOLOGICAL CLASSIFICATION: A 5.7.1 Antihistaminics.
PHARMACOLOGICAL ACTION: Cetirizine is an anti-allergic medicine. Experimental and clinical pharmacology has shown cetirizine to be a histamine H1-receptor antagonist without any significant anticholinergic or antiserotonergic effects. The anti-allergic activity of cetirizine is mainly due to its ability to inhibit the release of certain mediators (especially histamine), as well as its selective blocking of H1-receptors. In addition, cetirizine reduces eosinophil recruitment induced by antigen-antibody reactions. Pharmacokinetics: Cetirizine reaches peak blood levels within one hour after administration of oral doses. The terminal half-life in adults is approximately 10 hours, while in children it is 6 hours and 5 hours in those aged 6 to 12 years and 2 to 6 years, respectively. These findings are confirmed by the urinary excretion half-life of cetirizine. Approximately two thirds of a dose is excreted in the urine in both adults and children. The apparent plasma clearance is higher in children compared to adults. There is a linear relationship between plasma levels and dosage. Cetirizine is predominantly bound to plasma proteins in humans.
INDICATIONS: ALLECET is indicated for the treatment of allergic conditions, which respond to histamine H1- receptor antagonists:
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Cutaneous: Allergic skin conditions associated with pruritus, e.g. urticaria.
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Respiratory: Allergic rhinitis, hay fever.
CONTRA-INDICATIONS: Known hypersensitivity to cetirizine or any of the other components in the formulation.
INTERACTIONS: Studies with diazepam, and cimetidine have shown no evidence of interactions with cetirizine. Excessive alcohol consumption should be avoided in conjunction with cetirizine.
PREGNANCY AND LACTATION: The safety of cetirizine has not been established in pregnancy. ALLECET is contra-indicated in breastfeeding women as cetirizine has been shown to be excreted in breast milk.
DOSAGE AND DIRECTIONS FOR USE: Adults, and children 12 years and older: 10 mg (one tablet) daily. Children 6 to 12 years old: 10 mg (one tablet) once daily, or, alternatively, 5 mg (half a tablet) twice daily. Elderly: Currently there are no data available to suggest that dose reduction is required in this population. Renal impairment: The dosage should be reduced to half the usual recommended dose in these patients.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
ALLECET lacks significant sedative effects. A small number of patients may however experience sedation. Determination of individual responses to cetirizine is therefore recommended before the patients drive vehicles or perform other complicated tasks. The simultaneous intake of alcohol or other central nervous system depressants may exacerbate this effect. Subjective side-effects including drowsiness, dizziness, headache, agitation, increased appetite, dry mouth, gastro-intestinal discomfort and nervousness, have been reported occasionally. These subjective adverse effects are usually mild and transient.
Some individuals may develop hypersensitivity reactions, including skin reactions and angioedema. Special Precautions: Antihistamines should be discontinued several days before allergic skin testing as they may suppress the cutaneous histamine response to allergen extracts.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Patients may present with drowsiness following overdosage. Alternatively, overdosage may cause agitation in children. In cases of massive overdosage gastric lavage should be performed. Furthermore, standard symptomatic and supportive measures should be employed. No specific antidote has been identified to date.
IDENTIFICATION: White, circular, biconvex, film-coated tablets with "A" embossed on one side and a deep score on the other.
PRESENTATION: Blister strips of 10 tablets, packed in 10's and 30's.
STORAGE INSTRUCTIONS: Store in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 37/5.7.1/0034
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: Cipla Life Sciences (Pty) Ltd
Rosen Heights, Pasita Street,
Rosen Park, Bellville 7530 RSA
DATE OF PUBLICATION OF THIS PACKAGE INSERT: April 2004
ALLECET (tablets)