MOXONIDINE

Posology Adults Treatment must be instituted with the lowest dosage of moxonidine. 2 mg moxonidine in the morning. 4 mg. This dose can be given as a single dose (to be taken in the morning) or as a divided daily dose (morning and evening).

6 mg given divided in the morning and evening. 6 mg moxonidine should not be exceeded. 4). 4). Paediatric population Moxonidine should not be given to children and adolescents under 18 years of age as insufficient safety and therapeutic data are available for this.

Method of administration As concomitant ingestion of food does not affect the pharmacokinetics of moxonidine, Moxonidine can be taken before, during or after meals. The tablets should be taken with sufficient fluid.

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 Very common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1,000, <1/100) Very rare (<1/10,000) Endocrine disorders Gynaecomastia, impotence and Very common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1,000, <1/100) Very rare (<1/10,000) loss of libido Psychiatric disorders Altered thought processes, insomnia Anxiety, nervousness, anorexia Nervous system disorders Sleep disturbances, headache*, dizziness, vertigo, somnolence Sedation, syncope* Eye disorders Dry, itching or burning sensation of the eye Ear and labyrinth disorders Tinnitus Cardiac disorders Bradycardia Vascular disorders Vasodilatation Hypotension (including orthostatic), paraesthesia of extremities, peripheral circulation disorders Gastrointestinal disorders Dry mouth Diarrhoea, nausea / vomiting / dyspepsia*, constipation and other gastrointestinal disorders Hepatobiliary disorders Hepatic reactions Skin and subcutaneous tissue disorders Rash / Pruritus, Angioedema Musculosketal and connective tissue disorders Back pain Neck pain General disorders and administration site conditions Asthenia Oedema of different location, leg weakness, fluid retention, Very common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1,000, <1/100) Very rare (<1/10,000) parotid pain *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. uk/yellowcard.

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. 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. Due to lack of clinical evidence supporting safe use in patients with co-existing moderate cardiac insufficiency, moxonidine should be administered with caution in these patients.

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.

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 on blood pressure has been observed after the discontinuation of treatment with moxonidine. However, it is advisable not to stop taking moxonidine abruptly, but to reduce it gradually over a period of two weeks.

The elderly population may be more susceptible to the CV 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.

1. - sick sinus syndrome - bradycardia (resting HR <50 beats/minute) - 2nd or 3rd degree atrioventricular block - cardiac insufficiency