Clodipan 8 mg/10 mg hard capsules

Country: Malta

Language: English

Source: Malta Medicines Authority

Active ingredient:

CANDESARTAN CILEXETIL, AMLODIPINE

Available from:

Aspen Healthcare Malta Limited 89, Level 0 Triq is-Siggiewi Siggiewi, SGW 2021, , Malta

ATC code:

C09DB07

INN (International Name):

CANDESARTAN CILEXETIL 8 mg AMLODIPINE 10 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

CANDESARTAN CILEXETIL 8 mg AMLODIPINE 10 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-02-09

Patient Information leaflet

PACKAGE LEAFLET
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9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLODIPAN 8 MG/5 MG HARD CAPSULES
CLODIPAN 8 MG/10 MG HARD CAPSULES
CLODIPAN 16 MG/5 MG HARD CAPSULES
CLODIPAN 16 MG/10 MG HARD CAPSULES
candesartan cilexetil/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 Clodipan is and what it is used for
2.
What you need to know before you take Clodipan
3.
How to take Clodipan
4.
Possible side effects
5.
How to store Clodipan
6.
Contents of the pack and other information
1.
WHAT CLODIPAN IS AND WHAT IT IS USED FOR
Clodipan contains two substances called amlodipine and candesartan.
Both of these substances help
to control high blood pressure.
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.
Candesartan
belongs
to
a
group
of
substances
called
“angiotensin-II
receptor
antagonists”.
Angiotensin II is produced by the body and makes the blood vessels
tighten, thus increasing the blood
pressure. Candesartan works by blocking the effect of angiotensin II.
Both of these substances help to stop the blood vessels tightening. As
a result, the blood vessels relax
and blood pressure is lowered.
Clodipan is used to treat high blood pressure in patients whose blood
pressure is already controlled
on the combination of amlodipine and candesartan taken separately at
the same doses as in Clodipan.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLODIPA

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Clodipan 8 mg/5 mg hard capsules
Clodipan 8 mg/10 mg hard capsules
Clodipan 16 mg/5 mg hard capsules
Clodipan 16 mg/10 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clodipan 8 mg/5 mg hard capsules
Each capsule contains 8 mg candesartan cilexetil and 5 mg amlodipine
equivalent to 6.935 mg
amlodipine besilate.
Clodipan 8 mg/10 mg hard capsules
Each capsule contains 8 mg candesartan cilexetil and 10 mg amlodipine
equivalent to 13.87 mg
amlodipine besilate.
Clodipan 16 mg/5 mg hard capsules
Each capsule contains 16 mg candesartan cilexetil and 5 mg amlodipine
equivalent to 6.935 mg
amlodipine besilate.
Clodipan 16 mg/10 mg hard capsules
Each capsule contains 16 mg candesartan cilexetil and 10 mg amlodipine
equivalent to 13.87
mg amlodipine besilate.
Excipient with known effect
Clodipan 8 mg/5 mg hard capsules
Each capsule contains 101.95 mg of lactose monohydrate.
Clodipan 8 mg/10 mg hard capsules
Each capsule contains 211.90 mg of lactose monohydrate.
Clodipan 16 mg/5 mg hard capsules
Each capsule contains 203.90 mg of lactose monohydrate.
Clodipan 16 mg/10 mg hard capsules
Each capsule contains 203.90 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Clodipan 8 mg/5 mg hard capsules: hard gelatin capsules, size 3
(overall closed length: 15.6 mm
– 16.2 mm), with a white opaque body and dark yellow cap, filled
with white to off white
granules.
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Clodipan 8 mg/10 mg hard capsules: hard gelatin capsules, size 1
(overall closed length:
19.1 mm – 19.7 mm) with a white opaque body with black imprint CAN 8
and yellow cap with
black imprint AML 10, filled with white to off white granules.
Clodipan 16 mg/5 mg hard capsules: hard gelatin capsules, size 1
(overall closed length:
19.1 mm – 19.7 mm) with a white opaque body with black imprint CAN
16 and pale yellow
cap with black imprint AML 5, filled with white to off white granules.
Clodipan 16 mg/10 mg h