REAPTAN Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
REAPTAN Perindopril arginine / Amlodipine besilate.
2. Qualitative and quantitative composition
The active components of REAPTAN are perindopril arginine and amlodipine besilate. Each REAPTAN 5/5 tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine (as besilate‡) Each REAPTAN 5/10 ...
3. Pharmaceutical form
REAPTAN 5/5 is a white, rod-shaped tablet engraved with 5/5 on one face and the Servier company logo on the other face. REAPTAN 5/10 is a white, square-shaped tablet engraved with 5/10 on one face and ...
4.1. Therapeutic indications
REAPTAN is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given ...
4.2. Posology and method of administration
REAPTAN (perindopril arginine/ amlodipine) is available in strengths of 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg as substitution therapy for patients already controlled with separate doses of ...
4.3. Contraindications
REAPTAN is contraindicated In patients with a history of previous hypersensitivity to either of the active ingredients; perindopril or amlodipine, ACE inhibitors, dihydropyridines or excipient ingredients ...
4.4. Special warnings and precautions for use
Related to REAPTAN Lactose intolerance As REAPTAN contains lactose monohydrate, patients with rare hereditary problems of galactose intolerance, glucose galactose malabsorption, or total lactase deficiency ...
4.5. Interaction with other medicinal products and other forms of interaction
Shared by Perindopril and amlodipine Combined use which requires SPECIAL CARE Baclofen Baclofen may increase the antihypertensive effect of REAPTAN. Monitor blood pressure and renal function and adjust ...
4.6. Fertility, pregnancy and lactation
Effects on fertility No animal studies with REAPTAN have been performed. Related to Perindopril component The effects of perindopril arginine on fertility have not been investigated. Studies in rats showed ...
4.7. Effects on ability to drive and use machines
No studies on the effects of REAPTAN on the ability to drive and use machines have been performed. The antihypertensive effect in individual cases may be symptomatic. Treatment with any blood pressure ...
4.8. Undesirable effects
Reporting suspected adverse effects Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal ...
4.9. Overdose
<b>For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).</b> There is no information on overdosage with REAPTAN in humans. Related to perindopril component ...
5.1. Pharmacodynamic properties
Mechanism of action Pharmacology of Perindopril Perindopril (prodrug) following hydrolysis to perindoprilat, inhibits angiotensin converting enzyme (ACE) both in vitro and in vivo. It is thought that ACE ...
5.2. Pharmacokinetic properties
Pharmacokinetics of REAPTAN Three studies have demonstrated bioequivalence between one tablet of the fixed combination of perindopril/amlodipine and the co-administration of one tablet of perindopril plus ...
5.3. Preclinical safety data
Genotoxicity No genotoxicity studies of perindopril in combination with amlodipine have been conducted. Related to Perindopril component Results from a broad set of assays for gene mutation and chromosomal ...
6.1. List of excipients
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in a dry place below 25⁰C. Keep the container tightly closed and protect from light.
6.5. Nature and contents of container
Thirty (30) tablets supplied in a white HDPE bottle equipped with a white induction-sealed child resistantclosure and desiccant sachets. REAPTAN 5/5 only, is also supplied in a 10-tablet bottle.
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.
7. Marketing authorization holder
Servier Laboratories (Aust.) Pty Ltd, www.servier.com.au, Level 4, Building 9, 588A Swan Street, Burnley, 3121, Victoria
9. Date of first authorization / renewal of the authorization
4 November 2010
10. Date of revision of the text
07 September 2022
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