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Package Leaflet: Information for the user
PHYSIOtens
®
Film-coated tablets
200 micrograms, 300 micrograms and 400 micrograms
MOXONIDINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
•
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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Physiotens is and what it is used for
2. Before you take Physiotens
3. How to take Physiotens
4. Possible side effects
5. How to store Physiotens
6. Further 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. 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 Physiot
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产品特点
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 a little 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 l
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