Physiotens Tablets 400mcg film-coated Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Διαθέσιμο από:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

Φαρμακολογική κατηγορία (ATC):

C02AC05

INN (Διεθνής Όνομα):

MOXONIDINE 400 µg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

MOXONIDINE 400 µg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTIHYPERTENSIVES

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-01-16

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET
PHYSIOTENS
® FILM COATED TABLETS
200 micrograms, 300 micrograms, 400 micrograms
Moxonidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illess are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Physiotens is and what it is used for
2.
What you need to know before you take Physiotens
3.
How to take Physiotens
4.
Possible side effects
5.
How to store Physiotens
6.
Contents of the pack and other information
1.
WHAT PHYSIOTENS IS AND WHAT IT IS USED FOR
Physiotens contains a medicine called moxonidine. This medicine
belongs to a group of medicines
called ‘anti-hypertensives’.
Physiotens is used to treat high blood pressure (hypertension). It
works by making your blood vessels
relax and widen. This helps to lower your blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHYSIOTENS
DO NOT TAKE PHYSIOTENS IF:
-
you are allergic (hypersensitive) to moxonidine or any of the other
ingredients of Physiotens
(listed in Section 6)
-
you have a slow heart rate caused by a heart problem called “sick
sinus syndrome” or “2
nd
or 3
rd
degree AV-block”
-
you have heart failure.
-
you have serious kidney problems
Do not take Physiotens if any of the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Physiotens.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Physiotens if:
-
You have a heart problem called “1
st
degree AV-block”
-
You have a severe heart problem such as angina or chest pain at rest
-
You have kidney problems. Your doctor may need to adj

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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.
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.
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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 fai