COVERAM 10 MG/5 MG Oral tablet

Land: Tanzania

Språk: engelska

Källa: Tanzania Medicinces & Medical Devices Authority

Aktiva substanser:

*PERINDOPRIL 10MG AND AMLODIPINE 5MG TABLET

Tillgänglig från:

LES LABORATOIRES SERVIER, FRANCE

INN (International namn):

*PERINDOPRIL 10MG AND AMLODIPINE 5MG TABLET

Dos:

10+ 5

Läkemedelsform:

Oral tablet

Tillverkad av:

SERVIER (IRELAND) INDUSTRIES LIMITED, REPUBLIC OF IRELAND

Produktsammanfattning:

Physical description: White triangular-shaped tablet (9.5 mm x 8.8 mm x 8.8 mm), engraved with "10/5" on one face and break line on the other face; Local technical representative: MAHIMBI ABBAS MAHIMBI (2472)

Bemyndigande status:

Registered/Compliant

Tillstånd datum:

2022-10-07

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coveram 5mg/5mg tablets
Coveram 5mg/10mg tablets
Coveram 10mg/5mg tablets
Coveram 10mg/10mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 6.935 mg
amlodipine besilate equivalent to 5 mg amlodipine.
[One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 13.870 mg
amlodipine besilate equivalent to 10 mg amlodipine]
[One tablet contains 6.790 mg perindopril equivalent to 10 mg
perindopril arginine and 6.935 mg
amlodipine besilate equivalent to 5 mg amlodipine]
[One tablet contains 6.790 mg perindopril equivalent to 10 mg
perindopril arginine and 13.870 mg
amlodipine besilate equivalent to 10 mg amlodipine]
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3
.
PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet engraved with 5/5 on one face and
on the other face.
[White, square-shaped tablet engraved with 5/10 on one face and
on the other face.]
[White, triangular-shaped tablet engraved with 10/5 on one face and
on the other face.]
[White, round tablet engraved with 10/10 on one face and
on the other face.]
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coveram is indicated as substitution therapy for treatment of
essential hypertension and/or stable
coronary artery disease, in patients already controlled with
perindopril and amlodipine given
concurrently at the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prescription Only Medicine
_Posology_
Oral route.
One tablet per day as a single dose, preferably to be taken in the
morning and before a meal.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, the dose of Coveram could be
modified or individual titration
with free combination may be considered.
_Special populations_
_Renal impairment and elderly (see sections 4.4 and 5.2)_
Elimination
of
perindoprilat
is
decr