MOXONIDINE

Posology Adults (including the elderly):

Treatment should be started with 200 micrograms of Moxonidine in the morning. The dose may be titrated after three weeks to 400 micrograms, given as one dose or as divided doses (morning and evening) until a satisfactory response has been achieved.

If the response is still unsatisfactory after a further three weeks’ treatment, the dosage can be increased up to a maximum of 600 micrograms in divided doses (morning and evening). A single dose of 400 micrograms of Moxonidine and a daily dose of 600 micrograms in divided doses (morning and evening) should not be exceeded.

In patients with moderate renal dysfunction (GFR above 30 ml/min, but below 60 ml/min), the single dose should not exceed 200 micrograms and the daily dose should not exceed 400 micrograms of moxonidine. Paediatric population Moxonidine is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.

Method of administration The tablets should be taken with sufficient liquid. As the intake of food has no influence on the pharmacokinetic properties of moxonidine, the tablets may be taken before, during or after the meal.

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): MedDRA system organ Very Common Common Uncommon class ≥1/10 ≥1/100, <1/10 ≥1/1,000, <1/100 Cardiac disorders Bradycardia Ear and labyrinth Tinnitus disorders Nervous system Headache*, Syncope* disorders Dizziness/Vertigo, Somnolence Vascular disorders Hypotension* (including orthostatic) Gastrointestinal Dry mouth Diarrhoea, disorders Nausea/Vomiting/ Dyspepsia Skin and subcutaneous Rash/ Pruritus Angioedema tissue disorders General disorders and Asthenia Oedema administration site reactions Musculoskeletal and Back pain Neck pain connective tissue disorders Psychiatric disorders Insomnia Nervousness * 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.

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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 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, Moxonidine 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.

4) - severe renal dysfunction (GFR <30 ml/min, serum creatinine concentration >160 μmol/l).