Amoltens 40 mg/10 mg, filmomhulde tabletten

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

Tersedia dari:

S.F Group S.r.l. Via Tiburtina 1143 00156 ROME (ITALIË)

Kode ATC:

C09DB02

INN (Nama Internasional):

AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

Bentuk farmasi:

Filmomhulde tablet

Komposisi:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TALK (E 553 B)

Rute administrasi :

Oraal gebruik

Area terapi:

Olmesartan Medoxomil And Amlodipine

Tanggal Otorisasi:

1900-01-01

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOLTENS 20 MG/5 MG, FILMOMHULDE TABLETTEN
AMOLTENS 40 MG/5 MG, FILMOMHULDE TABLETTEN
AMOLTENS 40 MG/10 MG, FILMOMHULDE TABLETTEN
_ _
olmesartan medoxomil/amlodipine
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 AMOLTENS is and what it is used for
2.
What you need to know before you take AMOLTENS
3.
How to take AMOLTENS
4.
Possible side effects
5.
How to store AMOLTENS
6.
Contents of the pack and other information
1.
WHAT AMOLTENS IS AND WHAT IT IS USED FOR
AMOLTENS contains two substances called olmesartan medoxomil and
amlodipine (as amlodipine
besilate). Both of these substances help to control high blood
pressure.
-
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II receptor
antagonists” which lower blood pressure by relaxing the blood
vessels.
-
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine
stops calcium from moving into the blood vessel wall which stops the
blood vessels from
tightening thereby also reducing blood pressure.
The actions of both these substances contribute to stopping the
tightening of blood vessels, so that
blood vessels relax and blood pressure decreases.
AMOLTENS is used for the treatment of high blood pressure in patients
whose blood pressure is not
controlled enough with either olmesartan medoxomil or amlodipine
alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOLTENS
DO NOT TAKE AMOLTENS
-
if you are allergic to olmesartan medoxomil or to amlodipin

Karakteristik produk

1
1.
NAME OF THE MEDICINAL PRODUCT
AMOLTENS 20 mg/5 mg, filmomhulde tabletten
AMOLTENS 40 mg/5 mg, filmomhulde tabletten
AMOLTENS 40 mg/10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMOLTENS 20 mg/5 mg film-coated tablets:
Each film-coated tablet of AMOLTENS contains 20 mg of olmesartan
medoxomil and 5 mg of
amlodipine (as amlodipine besilate).
AMOLTENS 40 mg/5 mg film-coated tablets:
Each film-coated tablet of AMOLTENS contains 40 mg of olmesartan
medoxomil and 5 mg of
amlodipine (as amlodipine besilate).
AMOLTENS 40 mg/10 mg film-coated tablets:
Each film-coated tablet of AMOLTENS contains 40 mg of olmesartan
medoxomil and 10 mg of
amlodipine (as amlodipine besilate).
Excipient with known effect
Each 20 mg/5 mg tablet contains 12.30 mg lactose monohydrate
Each 40 mg/5 mg tablet contains 24.60 mg lactose monohydrate
Each 40 mg/10 mg tablet contains 24.60 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
AMOLTENS 20 mg/5 mg film-coated tablets:
White, round convex, approximately 6.8 mm diameter film-coated
tablets, debossed with “5” on one
side, the other side is scored and debossed with “2” on the left
side of the score and “0” on the right
side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal
doses.
AMOLTENS 40 mg/5 mg film-coated tablets:
Yellowish, round convex, approximately 8.6 mm diameter film-coated
tablets, debossed with “5” on
one side, the other side is scored and debossed with “4” on the
left side of the score and “0” on the
right side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into
equal doses.
AMOLTENS 40 mg/10 mg film-coated tablets:
Brownish-red, round convex, approximately 8.6 mm diameter film-coated
tablets, debossed with “10”
on one side, the other side is scored and debossed with “4” on the
left side of the score and “0” on the
right side. The tablet can be divided into equal doses.
4.
CLINICA