Olmesartan medoxomil/Amlodipine/HCT STADA 40/10/25 mg filmomhulde tabletten

Nchi: Uholanzi

Lugha: Kiholanzi

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

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
27-01-2021
Tabia za bidhaa Tabia za bidhaa (SPC)
27-01-2021

Viambatanisho vya kazi:

AMLODIPINEBESILAAT SAMENSTELLING overeenkomend met ; AMLODIPINE ; HYDROCHLOORTHIAZIDE ; OLMESARTANMEDOXOMIL

Inapatikana kutoka:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

INN (Jina la Kimataifa):

AMLODIPINEBESILAAT COMPOSITION corresponding to ; AMLODIPINE ; HYDROCHLOROTHIAZIDE ; OLMESARTANMEDOXOMIL

Dawa fomu:

Filmomhulde tablet

Tungo:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Njia ya uendeshaji:

Oraal gebruik

Idhini ya tarehe:

2020-05-29

Taarifa za kipeperushi

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 20/5/12,5 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/5/12,5 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/10/12,5 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/5/25 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/10/25 MG FILMOMHULDE
TABLETTEN
olmesartan medoxomil/amlodipine/hydrochlorothiazide
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
 contains three active substances called olmesartan
medoxomil, amlodipine
(as amlodipine besilate) and hydrochlorothiazide. All three substances
help to control high
blood pressure.
•
OLMESARTAN MEDOXOMIL belongs to a group of medicines called
“angiotensin-II receptor
antagonists”, which lowers blood pressure by relaxing the blood
vessels.
•
AMLODIPINE
belongs
to
a
group
of
substances
called
“calcium
channel
blockers”.
Amlodipine also lowers blood pressure by relaxing blood vessels.
•
HYDROCHLOROTHIAZIDE is one of a group of medicines called thiazide
diuretics (“water
tablets”). It lowers blood pressure by making your kidneys produce
more urine, thus
helping the body
                                
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Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Olmesartan medoxomil/Amlodipine/HCT STADA 20/5/12,5 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/5/12,5 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/10/12,5 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/5/25 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/10/25 mg filmomhulde
tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
 20 mg/5 mg/12.5 mg film-coated tablets:
Each
film-coated
tablet
contains
20 mg
olmesartan
medoxomil,
5 mg
amlodipine
(as
amlodipine besilate) and 12.5 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 99.30 mg lactose (as monohydrate).
 40 mg/5 mg/12.5 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
5 mg
amlodipine
(as
amlodipine besilate) and 12.5 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 217.07 mg lactose (as monohydrate).
 40 mg/10 mg/12.5 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
10 mg
amlodipine
(as
amlodipine besilate) and 12.5 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 210.48 mg lactose (as monohydrate).
 40 mg/5 mg/25 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
5 mg
amlodipine
(as
amlodipine besilate) and 25 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 205.19 mg lactose (as monohydrate).
 40 mg/10 mg/25 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
10 mg
amlodipine
(as
amlodipine besilate) and 25 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 198.61 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
 20 mg/5 mg/12.5
                                
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