PHYSIOTENS 0.4MG TABLET

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

MOXONIDINE

Inapatikana kutoka:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Jina la Kimataifa):

MOXONIDINE

Vitengo katika mfuko:

28 Tablet Tablets; 98 Tablet Tablets; 98Tablet Tablets; 28Tablet Tablets

Viwandani na:

Mylan Laboratories SAS

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
PHYSIOTENS® TABLET
_ _
Moxonidine (0.2mg, 0.3mg, 0.4mg)
1
WHAT IS IN THIS LEAFLET
1. What Physiotens® is used for
2. How Physiotens® works
3. Before you use Physiotens®
4. How to use Physiotens®
5. While you are using it
6. Side effects
7. Storage and disposal of
Physiotens®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT PHYSIOTENS®
IS USED FOR
Physiotens® contains a medicine
called moxonidine. This medicine
belongs to a group of medicines
called “anti-hypertensives”.
It is used to treat high blood pressure
(hypertension)
HOW PHYSIOTENS® WORKS
Physiotens® works by making your
blood vessels relax and widen. This
helps to lower your blood pressure
BEFORE YOU USE PHYSIOTENS®
_- When you must not use it _
•
If you are allergic to
moxonidine or any of the
ingredients listed at the end
of this leaflet
•
If you have a slow heart rate
caused by a heart problem
called “sick sinus syndrome”
or “2nd or 3rd degree AV-
block”
Do not use Physiotens® if any of the
above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking
Physiotens®.
_ _
_- Before you start to use it _
Discuss with your doctor or
pharmacist before taking your
medicine if:
-
you have a heart problem
called “1
st
degree AV-block”
-
you have severe heart artery
disease or unstable heart
pain (angina)
-
you have kidney problems.
Your doctor may need to
adjust your dose.
_- Taking other medicines _
It is particularly important to tell your
doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This also
concerns medicines obtained without
a prescription including herbal
medicines. Tell your doctor or
pharmacist if you are taking any of
the following medicines:
•
other medicines to lower
your blood pressure.
Physiotens® increase the
effects of these medicines.
•
Medicines for depression
•
Tranquillisers, sedatives or
sleeping tablets such as
benzodiazepine

Tabia za bidhaa

Physiotens ® 0.4 mg
film-coated tablets
0.4 mg moxonidine
Physiotens 0.4 mg is a round, convex, dull red, film coated tablet with a stamp “0.4” on one face, for oral
administration (to be taken by mouth) containing 0.4 mg moxonidine.
Excipients (non-medicinal ingredients): Lactose monohydrate, povidone K25, crospovidone, magnesium
stearate, hypromellose, ethylcellulose, macrogol 6000, talc, red ferric oxide, titanium dioxide.
Indications
Physiotens is indicated for the treatment of hypertension (high blood pressure).
Dosage and administration
The usual initial dose of Physiotens is 0.2 mg daily with maximum daily dose is 0.6 mg given as two
divided doses. The maximum single dose to be administered is 0.4mg. Adjustments in daily dose should
be individualized to the patient’s response.
Physiotens can be taken with or without food.
In patients with moderate to severe renal impairment the starting dose of 0.2 mg daily. If necessary and
well tolerated the dose can be increased to 0.4 mg daily inpatients with moderate renal impairment and to
0.3mg daily in patients with severe renal impairment (see section “Special warnings and precautions for
use”).
In patients undergoing hemodialysis the starting dose is 0.2 mg daily. If necessary and well tolerated can
be increased to 0.4 mg daily.
Physiotens is not recommended for use in children and adolescents under below18 years due to lack of
data on safety and efficacy.
Contraindications
Physiotens is contraindicated in patients with:
• hypersensitivity to moxonidine or to any of the excipients,
• sick sinus syndrome
• bradycardia (resting HR < 50 beats /minute)
• AV-block 2
nd and 3 rd degree
• Cardiac insufficiency
Warnings and special precautions for use
Cases of varying degrees of AV block have been reported in the post-marketing setting in patients
undergoing moxonidine treatment. Based on these case reports, the causative role of moxonidine in
delaying atrioventricular conduction cannot be completely ruled out. Therefore, caution is
recommended when