Physiotens 400microgram tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Moxonidine

Tilgængelig fra:

Viatris UK Healthcare Ltd

ATC-kode:

C02AC05

INN (International Name):

Moxonidine

Dosering:

400microgram

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 02050200; GTIN: 5012781046158

Produktets egenskaber

OBJECT 1
PHYSIOTENS TABLETS 400 MICROGRAMS
Summary of Product Characteristics Updated 01-Nov-2016 | Mylan
Products Limited
1. Name of the medicinal product
Physiotens
®
Tablets 400 micrograms
2. Qualitative and quantitative composition
Each tablet contains 400 micrograms moxonidine.
Excipients:
95.6 mg lactose per tablet
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets.
Dull red, round, biconvex, film-coated tablets imprinted '0.4' on one
face.
4. Clinical particulars
4.1 Therapeutic indications
Mild to moderate essential or primary hypertension.
4.2 Posology and method of administration
_Adults (including the elderly):_
Treatment should be started with 200 micrograms of Physiotens 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 Physiotens 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.
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.
Paediatric population
Physiotens is not recommended for use in children and adolescents
below 18 years due to lack of data on
safety and efficacy.
4.3 Contraindications
Physiotens should not be used in cases of:
- hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
- sick sinus syndrome or sino-atrial block
- 2nd or 3rd degree atrioventricular block
- brady