Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Moxonidine
Sandoz Ltd
C02AC05
Moxonidine
300microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050200; GTIN: 05015915947086
OBJECT 1 MOXONIDINE 300 MICROGRAM FILM-COATED TABLETS Summary of Product Characteristics Updated 21-Dec-2016 | Sandoz Limited 1. Name of the medicinal product Moxonidine 300 microgram film-coated tablets 2. Qualitative and quantitative composition Each tablet contains 0.3 mg moxonidine. Excipient: lactose monohydrate For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Appearance: All tablets are round, approximately 6 mm in diameter. The tablet is pink 4. Clinical particulars 4.1 Therapeutic indications Mild to moderate essential hypertension. 4.2 Posology and method of administration Posology Adults Treatment must be instituted with the lowest dosage of Moxonidine. This means a daily dose of 0.2 mg moxonidine in the morning. If the therapeutic effect is insufficient, the dose can be increased after three weeks to 0.4 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). If the results are still insufficient after a further three weeks treatment, the dosage can be increased further to a maximum of 0.6 mg given divided in the morning and evening. A single dose of 0.4 mg Moxonidine and a daily dose of 0.6 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. _Older people_ Provided that renal function is not impaired, dosage recommendation is the same as for adults. Renal impairment: In patients with moderately impaired renal function (GFR > 30 ml/min but < 60 ml/min), the single dose should be not more than 0.2 mg and the daily dose not more than 0.4 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 Lestu allt skjalið