Alergix MR Tablet (Modified Release) 10 mg

Uses

Alergix MR Tablet (Modified Release) 10 mg is used for the symptomatic relief of the following conditions:

• Seasonal allergic rhinoconjunctivitis (hay fever)
• Perennial allergic rhinoconjunctivitis
• Urticaria

Alergix MR Tablet (Modified Release) 10 mg is also used to associated treatment for these conditions: Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis, Urticaria

Dosage

Alergix MR Tablet (Modified Release) 10 mg dosage

Adult and children above 12 years: The usual recommended dose is one 10 mg tablet daily.

Children below 12 years: Not recommended.

Side Effects

Alergix MR Tablet (Modified Release) 10 mg is well tolerated in the recommended doses. The usual side effects are dry mouth, diarrhoea, abdominal pain, nausea, drowsiness, headache, dizziness, raised liver enzymes, hypotension, tachycardia and palpitations. Bronchospasm and aggravation of asthma were reported, but in view of the high frequency of asthma in the treated patient population, a causality relationship remains uncertain.

Precaution

Patients should be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated task.

Interaction

Systemically administered Ketoconazole and Erythromycin, antiarrythmics e.g. Amiodarone moderately increase the plasma concentration of Alergix MR Tablet (Modified Release) 10 mg. This could increase the risk of arrythmias. Concurrent use of other potent inhibitor of the cytochrome P 450 3A4 enzyme e.g. Ciclosporin should be approached with caution. No potentiation of the sedation and the alteration in performance caused by alcohol with Alergix MR Tablet (Modified Release) 10 mg has been observed.

Pregnancy & Breastfeeding use

The safety of Alergix MR Tablet (Modified Release) 10 mg for use in human pregnancy has not been established. The evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri and post-natal development. Alergix MR Tablet (Modified Release) 10 mg should be avoided in pregnancy (particularly the 1 st trimester). Alergix MR Tablet (Modified Release) 10 mg is excreted into breast milk, therefore it is not recommended during lactation.

Contraindication

Alergix MR Tablet (Modified Release) 10 mg is contra-indicated in patients with clinically significant cardiac disease or a history of symptomatic arrhythmias and in patients with known or suspected QT prolongation, patients with electrolyte imbalance (particularly hypokalaemia), and in those with clinically significant bradycardia. It is also contra-indicated in patients taking other drugs that decrease its metabolism, patients with significantly impaired liver function, and in patients who are hypersensitive to the drug.

Acute Overdose

In cases of overdosage, general symptomatic surveillance with cardiac monitoring including QT interval and cardiac rhythm for at least 24 hours is recommended, along with standard measures to remove any unabsorbed drug. Studies in patients with renal insufficiency suggest that haemodialysis does not increase clearance of the drug.

Storage Condition

Store in a cool & dry place. Protect from light. It should be kept out of the reach of children.

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