MOXONIDINE

Posology Adults Treatment must be instituted with the lowest dose 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. Paediatric population Moxonidine should not be given to children and adolescents under 16 years of age as insufficient therapeutic data are available for this.

Elderly Provided that renal function is not impaired, dosage recommendation is the same as for adults. 4 mg moxonidine.

Hepatic impairment:

No studies are available in patients with impaired hepatic function. However, as moxonidine lacks extensive hepatic metabolism no major influence on the pharmacokinetics may be expected and dosage recommendation is the same for patients with mild to moderate hepatic impairment as for adults.

4). 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 adverse reactions 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 MedDRA System Organ Class Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Cardiac disorders Bradycardia Ear and labyrinth disorders Tinnitus Nervous system disorders Headache*, dizziness, somnolence, vertigo Syncope* Vascular disorders Hypotension (including orthostatic) Gastrointestinal disorders Dry mouth Diarrhoea, nausea, vomiting, dyspepsia Skin and subcutaneous tissue disorders Rash, pruritus Angioedema General disorders and administration site conditions Asthenia Oedema Musculoskeletal and connective tissue disorders Back pain Neck pain Psychiatric disorders Insomnia Nervousness Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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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. 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. 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 medicinal products. 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.

Moxonidine contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

1 - sick sinus syndrome - bradycardia (resting heart rate <50 beats/minute) - AV-block 2nd and 3rd degree - cardiac insufficiency