MIZOLLEN Modified-release tablet Ref.[8631] Active ingredients: Mizolastine

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 medicinal product on cardiac repolarisation.

Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Mizolastine contains hydrogenated castor oil which can cause stomach upset and diarrhoea.

Although the bioavailability of mizolastine is high and the medicinal product 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 medicinal products, mizolastine should be avoided in pregnancy, particularly during the first trimester.

Breast-feeding

Mizolastine is excreted into breast milk, therefore its use by lactating women is not recommended.

Most patients taking mizolastine may drive or perform tasks requiring concentration. However, in order to identify sensitive people who have unusual reactions to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

Gastro-intestinal disorders

Common: dry mouth, diarrhoea, abdominal pain (including dyspepsia), nausea.

Not known: vomiting.

Central nervous system disorders and psychiatric disorders

Common: drowsiness often transient, headache, dizziness.

Uncommon: anxiety and depression.

Liver disorders

Uncommon: raised liver enzymes.

Haematological disorders

Very rare: low neutrophil count.

Body as a whole

Common: asthenia often transient, increased appetite associated with weight gain.

Very rare: allergic reactions including anaphylaxis, angioedema, generalized rash/urticaria, pruritus and hypotension.

Cardiovascular disorders:

Uncommon: hypotension, tachycardia, palpitations.

Very rare: vasovagal attack.

Musculoskeletal disorders:

Uncommon: arthralgia and myalgia.

Description of selected adverse reactions

There were reports of bronchospasm and aggravation of asthma but in view of the high frequency of asthma in the patient population being treated, a causal relationship remains uncertain.

Treatment with certain antihistamines has been associated with QT interval prolongation increasing the risk of serious cardiac arrhythmias in susceptible subjects.

Minor changes in blood sugar and electrolytes have been observed rarely. The clinical significance of these changes in otherwise healthy individuals remains unclear. Patients at risk (diabetics, those susceptible to electrolyte imbalance and cardiac arrhythmias) should be monitored periodically.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.