Olmesartan medoxomil/Amlodipine Ascend 40 mg/10 mg Film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC code:

C09DB02

INN (International Name):

OLMESARTAN MEDOXOMIL 40 mg AMLODIPINE BESILATE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

OLMESARTAN MEDOXOMIL 40 mg AMLODIPINE BESILATE 10 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2023-09-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 20 MG/5 MG
OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 40 MG/5 MG
OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND 40 MG/10 MG
FILM-COATED TABLETS
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 Olmesartan medoxomil/Amlodipine Ascend is and what it is used for
2.
What you need to know before you take Olmesartan medoxomil/Amlodipine
Ascend
3.
How to take Olmesartan medoxomil/Amlodipine Ascend
4.
Possible side effects
5.
How to store Olmesartan medoxomil/Amlodipine Ascend
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND IS AND WHAT IT IS USED FOR
Olmesartan medoxomil/Amlodipine Ascend 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 of these substances contribute to stopping the
tightening of blood vessels, so that
blood vessels relax and blood pressure decreases.
This medicine is used for the treatment of high blood pressure in
pat

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine Ascend 20 mg/5 mg Film-coated tablets
Olmesartan medoxomil/Amlodipine Ascend 40 mg/5 mg Film-coated tablets
Olmesartan medoxomil/Amlodipine Ascend 40 mg/10 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil/Amlodipine Ascend
20 mg/5 mg Film-coated tablets:
Each
film-coated
tablet
of
Olmesartan medoxomil/Amlodipine Ascend
contains
20
mg
of
olmesartan
medoxomil and 5 mg of amlodipine (as amlodipine besilate).
Olmesartan medoxomil/Amlodipine Ascend
40 mg/5 mg Film-coated tablets:
Each
film-coated
tablet
of
Olmesartan medoxomil/Amlodipine Ascend
contains
40
mg
of
olmesartan
medoxomil and 5 mg of amlodipine (as amlodipine besilate).
Olmesartan medoxomil/Amlodipine Ascend
40 mg/10 mg Film-coated tablets:
Each
film-coated
tablet
of
Olmesartan medoxomil/Amlodipine Ascend
contains
40
mg
of
olmesartan
medoxomil and 10 mg of amlodipine (as amlodipine besilate).
Excipients with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND
20 mg/5 mg Film-coated tablets:
White to off white, round shaped, biconvex, film coated tablets
debossed with “A22” on one side and plain
on other side.
The tablet diameter is approximately 6.10 mm.
OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND
40 mg/5 mg Film-coated tablets:
Cream to light yellow, round shaped, biconvex, film coated tablets
debossed with “A23” on one side and
plain on other side.
The tablet diameter is approximately 8.10 mm.
OLMESARTAN MEDOXOMIL/AMLODIPINE ASCEND
40 mg/10 mg Film-coated tablets:
Brownish red, round shaped, biconvex, film coated tablets debossed
with “A21” on one side and plain on
other side.
The tablet diameter is approximately 8.10 mm.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan medoxomil/Amlodipine Ascend is indicated in adult patients
whose blood pressure is not
adequately c