MOXONIDINE Film-coated tablet Ref.[7003] 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 1^st 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 kidney. In these patients careful titration of the dose is recommended, especially at the start of therapy.

Dosing should be initiated with 0.2 mg daily and can be increased to a maximum of 0.4 mg daily for patients with moderate renal impairment (GFR >30 ml/min but <60 ml/min) and to a maximum of 0.3 mg daily for patients with severe renal impairment (GFR <30 ml/min), if clinically indicated and well tolerated.

If moxonidine is used in combination with a β-blocker and both treatments have to be discontinued, the β-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.

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, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Concomitant administration of moxonidine and other antihypertensive agents result in an additive effect.

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 women. Studies in animals have shown embryo-toxocological 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 should not be used during lactation as moxonidine is excreted in breast milk. If therapy with moxonidine is considered absolutely necessary, the breast feeding shall be stopped.

The effect of moxonidine on the ability to drive or use machines has not been studied. Since, however, there have been reports of drowsiness and dizziness, the patient should exercise caution with regard to hazardous activities such as driving or using machines.

Especially at the beginning of treatment dry mouth, headache, somnolence, asthenia and dizziness have been described frequently. The frequency and intensity of these symptoms often disappear in the course 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):

Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data).

* there was no increase in frequency compared to placebo

Cardiac disorders

Uncommon: Bradycardia

Ear and labyrinth disorders

Uncommon: Tinnitus

Nervous system disorders

Common: Headache*, dizziness, somnolence, vertigo

Uncommon: Syncope*

Vascular disorders

Uncommon: Hypotension (including orthostatic)

Gastrointestinal disorders

Very common: Dry mouth

Common: Nausea, diarrhoea, vomiting, dyspepsia

Skin and subcutaneous tissue disorders

Common: Rash, pruritus

Uncommon: Angioedema

General disorders and administration site conditions

Common: Asthenia

Uncommon: Oedema

Musculoskeletal and connective tissue disorders

Common: Back pain

Uncommon: Neck pain

Psychiatric disorders

Common: Insomnia

Uncommon: Nervousness

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 (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.