PHYSIOTENS Film-coated tablet Ref.[27735] Active ingredients: Moxonidine

Cases of varying degrees of AV block have been reported in the post-marketing setting in patients undergoing moxonidine treatment. Based on these case reports, the causative role of moxonidine in delaying atrioventricular conduction cannot be completely ruled out. Therefore, caution is recommended when treating patients with a possible predisposition to developing an AV block. When moxonidine is used in patients with 1st degree AV block, special care should be exercised to avoid bradycardia. Moxonidine must not be used in higher degree AV blocks (see section 4.3).

When moxonidine is used in patients with severe coronary artery disease or unstable angina pectoris, special care should be exercised due to the fact that there is limited experience in this patient population.

Caution is advised in the administration of moxonidine to patients with renal impairment as moxonidine is excreted primarily via the kidneys. In these patients careful titration of the dose is recommended, especially at the start of therapy. Dosing should be initiated with 200 micrograms daily and can be increased to a maximum of 400 micrograms daily for patients with moderate renal impairment (GFR above 30 ml/min, but below 60 ml/min), if clinically indicated and well tolerated.

If Moxonidine is used in combination with a beta-blocker and both treatments have to be discontinued, the beta-blocker should be discontinued first and then Moxonidine after a few days.

So far, no rebound-effect has been observed on the blood pressure after discontinuing the treatment with moxonidine. However, an abrupt discontinuance of the moxonidine treatment is not advisable; instead the dose should be reduced gradually over a period of two weeks.

Due to a lack of clinical data supporting the safety in patients with co-existing moderate heart failure, Physiotens must be used with caution in such patients.

The elderly population may be more susceptible to the cardiovascular effects of blood pressure lowering drugs. Therefore therapy should be started with the lowest dose and dose increments should be introduced with caution to prevent the serious consequences these reactions may lead to.

Patients with rare hereditary problems of galactose intolerance, the rare Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Due to a lack of data on safety and efficacy, Physiotens should not be used in children and adolescents below 18 years of age.

Concurrent administration of other antihypertensive agents enhances the hypotensive effect of Physiotens.

Since tricyclic antidepressants may reduce the effectiveness of centrally acting antihypertensive agents, it is not recommended that tricyclic antidepressants be co-administered with moxonidine.

Moxonidine can potentiate the sedative effect of tricyclic anti-depressants (avoid co-prescribing), tranquillisers, alcohol, sedatives and hypnotics.

Moxonidine moderately augmented the impaired performance in cognitive functions in subjects receiving lorazepam. Moxonidine may enhance the sedative effect of benzodiazepines when administered concomitantly.

Moxonidine is excreted through tubular excretion. Interaction with other agents that are excreted through tubular excretion cannot be excluded.

Pregnancy

There are no adequate data from use of moxonidine in pregnant woman. Studies in animals have shown embryo-toxicological effects (see section 5.3). The potential risk for humans is unknown. Moxonidine should not be used during pregnancy unless clearly necessary.

Breast-feeding

Moxonidine is secreted in breast milk and should therefore not be used during breast-feeding.

If therapy with moxonidine is considered absolutely necessary, breast-feeding should be stopped.

No studies on the effects on the ability to drive and use machines have been performed.

Somnolence and dizziness have been reported. This should be borne in mind when performing these tasks.

Most frequent side effects reported by those taking moxonidine include dry mouth, dizziness, asthenia and somnolence. These symptoms often decrease after the first few weeks of treatment.

Undesirable Effects by System Organ Class (observed during placebo-controlled clinical trials with n=886 patients exposed to moxonidine resulted in frequencies below):

^* there was no increase in frequency compared to placebo

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.

No incompatibilities are known.