Moxamar 0,4 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MOXONIDINE 0,4 mg/stuk

Beschikbaar vanaf:

Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

C02AC05

INN (Algemene Internationale Benaming):

MOXONIDINE 0,4 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Moxonidine

Product samenvatting:

Hulpstoffen: CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON K 25 (E 1201); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

NL/H/0399/01-03
NL/H/0405/01-03
Moxonidine 0.2_0.3_0.4 mg film-coated tablets
PIL, 16.05.13
1
PACKAGE LEAFLET:
Information for the user
_MOXAMAR 0,2 MG, FILMOMHULDE TABLETTEN _
_MOXAMAR 0,3 MG, FILMOMHULDE TABLETTEN _
_MOXAMAR 0,4 MG, FILMOMHULDE TABLETTEN _
_ _
Active substance: 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 /…/ is and what it is used for
2.
What you need to know before you take /…/
3.
How to take /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /.../ IS AND WHAT IT IS USED FOR
_/.../ _
is a centrally acting agent used to lower high blood pressure.
_/.../_
is used
-
in the treatment of high blood pressure (primary or essential
hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _/.../_
DO NOT TAKE _/.../_
-
if you are allergic to moxonidine or any of the other ingredients of
this medicine (listed in section 6).
-
if you have sick sinus syndrome (a kind of heart rhythm disorder) or
sinoatrial block (a disturbance in
the conduction [flow] of electrical impulses through the heart as they
pass between the sinus node and
the heart’s upper chamber)
-
if your heart rate is extremely slow (below 50 beats per minute at
rest)
-
if you have second or third-degree AV block (severe disturbances in
the conduction [flow] of electrical
impulses passing from the upper to the lower chambers of the heart)
-
if you suffer from heart muscle weakness
WARNINGS AND PRECAUTIONS_ _
Talk to your doctor or pharmacist before t

Productkenmerken

NL/H/0399/01-03
NL/H/0405/01-03
Moxonidine 0.2_0.3_0.4 mg film-coated tablets
SPC, 16.05.13
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Moxamar 0,2 mg, filmomhulde tabletten
Moxamar 0,3 mg, filmomhulde tabletten
Moxamar 0,4 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.2 mg moxonidine.
Each tablet contains 0.3 mg moxonidine.
Each tablet contains 0.4 mg moxonidine.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Appearance: All tablets are round, approximately 6 mm in diameter.
The 0.2 mg tablet is light pink, the 0.3 mg tablet is pink and the 0.4
mg tablet is dark pink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Treatment must be instituted with the lowest dosage of Moxonidine.
This means a daily dose of
0.2 mg moxonidine in the morning.
If the therapeutic effect is insufficient, the dose can be increased
after three weeks to 0.4 mg.
This dose can be given as a single dose (to be taken in the morning)
or as a divided daily dose
(morning and evening).
If the results are still insufficient after a further three weeks, the
dosage can be increased further
to a maximum of 0.6 mg given divided in the morning and evening. A
single dose of 0.4 mg
Moxonidine and a daily dose of 0.6 mg Moxonidine should not be
exceeded.
_Paediatric population _
NL/H/0399/01-03
NL/H/0405/01-03
Moxonidine 0.2_0.3_0.4 mg film-coated tablets
SPC, 16.05.13
2
Moxonidine should not be given to children and adolescents under 16
years of age as
insufficient therapeutic data are available for this.
_Elderly _
Provided that renal function is not impaired, dosage recommendation is
the same as for adults.
The treatment should not be stopped abruptly, but withdrawn over a
period of two weeks (see
also section 4.4).
Method of administration
As concomitant ingestion of food does not