Cetirizine 10 Gulf 10 mg Tablets

Cetirizine 10 Gulf is indicated for symptomatic relief of allergic conditions in adults and children 6 years and older such as allergic rhinitis, and allergic skin conditions such as urticaria.

Adults or children 12 years of age or older: one 10 mg tablet once daily

Children 6 to 12 years old: one 10 mg tablet once daily or 5 mg (half a tablet) twice daily. This dosage form is not suitable for children younger than 6 years.

No dose adjustment is necessary in healthy elderly patients with normal renal function.

Dosage in renal impairment: In patients with renal impairment, where the creatinine clearance is less than 40 ml / min, the recommended daily dose of Cetirizine 10 Gulf should be halved.

Dosage in hepatic impairment: In patients with moderate to severe hepatic impairment, the recommended daily dose of Cetirizine 10 Gulf should be halved.

Hypersensitivity to Cetirizine 10 Gulf or any of the ingredients.

Hypersensitivity to hydroxyzine

Cetirizine 10 Gulf is contra-indicated in lactating women, since the active ingredient is excreted in breast-milk.

Cetirizine 10 Gulf is contra-indicated in pregnancy, as safety has not been established.

Children under the age of two years, as safety and efficacy have not been demonstrated.

Cetirizine 10 Gulf may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant medicines. The patientu2019s ability to perform hazardous activities requiring mental alertness or physical co-ordination such as driving or operating machinery may be impaired.

Porphyria: Use with Caution

Cetirizine 10 Gulf lacks significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see 4.5 Interaction with other medicines and other forms of interaction).

Laboratory tests: Since Cetirizine 10 Gulf may interfere with skin tests for allergy, it must be withdrawn well before such tests are performed.

Contains lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose should not take CETIRIZINE 10 GULF.

Concomitant use of alcohol and other sedating medicines should be avoided. There is no evidence of an interaction between cetirizine and cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizide, and pseudoephedrine.

Safety in pregnancy and lactation has not been established (see 4.3 CONTRAINDICATIONS). Cetirizine is excreted in breast milk.

Patients should be warned that some individuals may experience sedation. It is therefore advisable to determine individual response before driving a vehicle or operating machinery. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

Gastro-intestinal system disorders: Frequent: nausea, gastro-intestinal discomfort, increased or loss of appetite, dry mouth and constipation or diarrhoea

Respiratory thoracic and mediastinal disorders: Frequent: thickening of mucous

Ear and labyrinth disorders: Frequent: tinnitus

Eye disorders: Frequent: blurred vision, diplopia

Nervous system disorders: Less frequent: drowsiness, fatigue, dizziness, headache, anxiety, nervousness, asthenia, insomnia and tremors have been reported.

Skin and subcutaneous tissue disorders: Less frequent: skin rash, urticaria, pruritus, angioedema, photosensitivity, increased sweating

Musculoskeletal, connective tissue and bone disorders: Less frequent: malaise

Immune system disorders: Less frequent: anaphylaxis

Hepatobiliary disorders: Less frequent: urinary retention or frequency and dysuria

Drowsiness is an expected symptom of overdosage. Overdosage in children may produce agitation, somnolence, pruritus, rash, urinary retention, fatigue, tremor and tachycardia. In the case of massive overdosage, gastric lavage should be performed together with usual supportive measures. There is no specific antidote. Cetirizine 10 Gulf is not effectively removed by dialysis. FURTHER TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.