Berzin® Film coated tablet 10 mg, each film coated tablet contains : Cetirizine hydrochloride 10 mg.
Berzin® with Cetirizine hydrochloride as active ingredient is available in 5 mg/5 ml syrup and 10 mg film coated tablet.
Berzin® is indicated for the treatment of perennial rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.
DOSAGE AND ADMINISTRATIONS :
- Adult and children 12 years or above :
10 mg daily during the evening meal (1 tablet or 10 ml of oral solution).
- Children from 6 – 12 years :
10 mg daily either as single dose (1tablet or 10 ml of oral solution at once) or as divided doses 5 mg (1/2 tablet or 5 ml of oral solution) in the morning and in the evening.
- Children from 2 – 6 years :
5 mg (1/2 tablet or 5 ml of oral solution) daily during the evening meal or as divided doses 2.5 mg (2.5 ml of oral solution) in the morning and in the evening.
At present there are no data to suggest that the dose need to be reduced in elderly patients. In patients with renal insufficiency dosage should be reduced to half the usual recommended dose.
Drowsiness can be a symptom of overdosage. Overdosage in children may produce agitation. In the case of massive overdosage, gastric lavage should be performed together with the usual supportive measures. To date, there is no specific antidote.
- Hypersensitivity to any of the constituents of this formulation, to Hydroxyzine or to any Piperazine derivatives.
- Patients with severe renal impairment at less than 10 ml/min creatinine clearance.
- Berzin® is contraindicated in lactating women since the active ingredients, Cetirizine hydrochloride is excreted in breast milk.
WARNINGS AND PRECAUTIONS :
- Studies in healthy volunteers at 20 or 25 mg/day have not revealed effects on alertness or reaction time, however patients are advised not to exceed the recommended dose if driving or operating machinery.
- Pediatric : Safety and efficacy in children under the age of 6 months have not been established. Not recommended for children under 6 months old.
- Pregnancy : No adverse effects have been reported from animal studies. There has been little or no use of Cetirizine hydrochloride in pregnancy. As with other drugs the use of Cetirizine hydrochloride in pregnancy should be avoided.
DRUG INTERACTIONS :
To date, there are no known interactions with other drugs. Studies with Diazepam and Cimetidine have revealed no evidence of interactions. As with other antihistamines, it is advisable to avoid excessive alcohol consumption.
ADVERSE REACTIONS :
- Central nervous system disorder : Somnolence, fatigue, dizziness, headache, paradoxical CNS stimulation, micturition difficulty, elevated hepatic enzymes accompanied by elevated bilirubin.
- Gastrointestinal disorder : Abdominal pain, dry mouth, nausea, diarrhea.
- Body as a whole general disorder : Fatigue.
- Psychiatric disorder : Somnolence.
- Respiratory system disorder : Pharyngitis, rhinitis.
Adverse reaction that arise post-marketing :
- Blood and lymphatic system disorders
Very rare : Thrombocytopenia.
- Immune system disorders
Rare : Hypersensitivity.
Very rare : Anaphylactic shock.
- Metabolism and nutrition disorders
Not known : Increased appetite.
- Psychiatric disorders
Uncommon : Agitation.
Rare : Aggression, confusion, depression, hallucination, insomnia.
Very rare : Tic.
Not known : Suicidal ideation.
- Nervous system disorders
Uncommon : Paraesthesia.
Rare : Convulsions.
Very rare : Dysgeusia, dyskinesia, dystonia, syncope, tremor.
Not known : Amnesia, memory impairment.
- Eye disorders
Very rare : Accommodation disorder, blurred vision, oculogyration.
- Cardiac disorders
Rare : Tachycardia.
- Gastrointestinal disorders
Uncommon : Diarrhea.
- Hepatobiliary disorders
Rare : Hepatic function abnormal, transaminase increased, blood bilirubin increased, blood alkaline phosphate increased, gamma-glutamyltransferase increased.
- Skin and subcutaneous tissue disorders
Uncommon : Pruritus, rash.
Rare : Urticaria.
Very rare : Angioedema, drug eruption.
- Renal and urinary disorders
Very rare : Dysuria, enuresis.
Not known : Urinary retention (see section WARNINGS AND PRECAUTIONS).
- General disorders and administration site condition
Uncommon : Asthenia, malaise.
Rare : Oedema.
Rare : Weight gain.
Berzin® Film coated tablet 10 mg Box, 10 blisters @ 10 film coated tablets
Reg. No. DKL1902358317A1
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia