Physiotens 300microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Moxonidine

Available from:

Viatris UK Healthcare Ltd

ATC code:

C02AC05

INN (International Name):

Moxonidine

Dosage:

300microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050200; GTIN: 5012781046202

Summary of Product characteristics

OBJECT 1
PHYSIOTENS TABLETS 300 MICROGRAMS
Summary of Product Characteristics Updated 01-Nov-2016 | Mylan
Products Limited
1. Name of the medicinal product
Physiotens
®
Tablets 300 micrograms
2. Qualitative and quantitative composition
Each tablet contains 300 micrograms moxonidine.
Excipients:
95.7 mg lactose per tablet
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets.
Pale red, round, biconvex, film-coated tablets imprinted '0.3' 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