Mizollen

/ Sanofi

Adults, including the elderly, and children 12 years of age and over: The recommended daily dose is one 10mg tablet.

Mizolastine is a long acting H1- antihistamine indicated for the symptomatic treatment of seasonal allergic rhino-conjunctivitis (hay fever), perennial allergic rhino-conjunctivitis and urticaria.                      

Hypersensitivity to the active ingredient or to any of the excipients. Concomitant administration with macrolide antibiotics or systemic imidazole antifungals. Significantly impaired hepatic function. Clinically significant cardiac disease or a history of symptomatic arrhythmias. Patients with known or suspected QT prolongation or with electrolyte imbalance, in particular hypokalaemia. Clinically significant bradycardia. Drugs known to prolong the QT interval, such as Class I and III anti-arrhythmics.  

Mizolastine has a weak potential to prolong the QT interval in a few individuals. The degree of prolongation is modest and has not been associated with cardiac arrhythmias. The elderly may be particularly susceptible to the sedative effects of mizolastine and the potential effects of the drug on cardiac repolarisation. Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Dry mouth, diarrhea, abdominal pain (including dyspepsia), nausea, drowsiness often transient, headache, dizziness, asthenia often transient, increased appetite associated with weight gain.
For full details see prescribing information.

Although the bioavailability of mizolastine is high and the drug is principally metabolised by glucuronidation, systemically administered ketoconazole and erythromycin moderately increase the plasma concentration of mizolastine and their concurrent use is contraindicated. Concurrent use of other potent inhibitors or substrates of hepatic oxidation (cytochrome P450, 3A4) with mizolastine should be approached with caution. These would include cimetidine, ciclosporin, and nifedipine. Alcohol: In studies with mizolastine, no potentiation of the sedation and the alteration in performance caused by alcohol has been observed.      

Pregnancy: The safety of mizolastine 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. However, as with all drugs, mizolastine should be avoided in pregnancy, particularly during the first trimester.
Lactation: Mizolastine is excreted into breast milk, therefore its use by lactating women is not  recommended.

In cases of overdose, 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.