Physiotens Tablets 400mcg film-coated Tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

MOXONIDINE

Verfügbar ab:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-Code:

C02AC05

INN (Internationale Bezeichnung):

MOXONIDINE 400 µg

Darreichungsform:

FILM-COATED TABLET

Zusammensetzung:

MOXONIDINE 400 µg

Verschreibungstyp:

POM

Therapiebereich:

ANTIHYPERTENSIVES

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2006-01-16

Gebrauchsinformation

Helvetica Neue LT Pro
8.5 pt
8.5 pt
Physiotens_0.3mg_400mcg_200mcg_28
Leaflet
2189856
NA
2189856
PL 46302/0045, PL 46302/0046,
PL 46302/0047, MA 1187/01501,
MA 1187/01502
Mylan Laboratories SAS
(Chatillon sur Chalaronne - FR)
50074730
4143
400540804;400540792;
400540777
104060886/0120
3
United Kingdom;
Malta
Flat 158x315mm
N/A
1
158 x 315 mm
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v3/Jul 2017
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10:17
10 Jul 20
Package Leaflet: Information for the user
200 micrograms, 300 micrograms and
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 illness 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 yo

Fachinformation

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.
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 (see Section 4.4)
-