Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Aspen Healthcare Malta Limited, 89, Level 0, Triq is-Siggiewi, Siggiewi, SGW2021, Malta
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.
| 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. 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 hard capsules: hard gelatin capsules, size 1 (overall closed length: 19.1 mm – 19.7 mm) with a white opaque body and white opaque cap, filled with white to off white granules. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Amlodipine |
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. |
|
| Candesartan |
Candesartan is an AIIRA, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity. The antagonism of the angiotensin II (AT1) receptors results in dose related increases in plasma renin levels, angiotensin I and angiotensin II levels, and a decrease in plasma aldosterone concentration. |
|
| Candesartan and Amlodipine |
Combination of two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, candesartan and a dihydropyridinic calcium channel blocker, amlodipine. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate Capsule shell (8 mg/5 mg, 8 mg/10 mg): Quinoline yellow (E 104) Capsule shell (16 mg/10 mg): Titanium dioxide (E 171) Printing ink (8 mg/10 mg, 16 mg/5 mg): Shellac (E904) |
PA/Aluminium/PVC/Aluminium blisters in a carton box.
Pack sizes of 28 hard capsules.
Not all pack sizes may be marketed.
Aspen Healthcare Malta Limited, 89, Level 0, Triq is-Siggiewi, Siggiewi, SGW2021, Malta
8 mg/5 mg: MA1243/00501
8 mg/10 mg: MA1243/00502
16 mg/5 mg: MA1243/00503
16 mg/10 mg: MA1243/00504
Date of first authorization: 9th February 2022
| Drug | Countries | |
|---|---|---|
| CLODIPAN | Malta |
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