Physiotens Tablets 400mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MOXONIDINE

Available from:

Mylan Products Limited

ATC code:

C02AC05

INN (International Name):

MOXONIDINE

Pharmaceutical form:

TABLET

Composition:

MOXONIDINE 400 µg

Prescription type:

POM

Therapeutic area:

ANTIHYPERTENSIVES

Authorization status:

Authorised

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Page 2 of 9
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
-
bradycardia (below 50 beats/minute at rest)
-
severe heart failure