REAPTAN 5/5 Tablets
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
28-04-2024
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Składnik aktywny:
PERINDOPRIL ARGININE AMLODIPINE BESYLATE
Dostępny od:
Les Laboratoires Servier
INN (International Nazwa):
PERINDOPRIL ARGININE AMLODIPINE BESYLATE
Dawkowanie:
5/5
Forma farmaceutyczna:
Tablets
Typ recepty:
Product subject to prescription which may be renewed (B)
Status autoryzacji:
Withdrawn
Data autoryzacji:
2013-07-03
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REAPTAN 5mg/5mg 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
Excipient : lactose monohydrate.
For a 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REAPTAN 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
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 REAPTAN could be modified or individual titration with free
combination may be considered.
_Special populations_
_Patients with renal impairment and elderly (see sections 4.4 and 5.2)_
Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical
follow-up will include frequent monitoring of creatinine and potassium.
REAPTAN can be administered in patients with Clcr
60ml/min, and is not suitable for patients with Clcr < 60ml/min.
In these patients, an individual dose titration with the monocomponents is recommended.
Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are
recommended in the elderly, but increase of the dosage should take place with care. Changes in a
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