PREXUM Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
PREXUM Perindopril arginine.
2. Qualitative and quantitative composition
Each PREXUM 2.5 tablet contains 2.5 mg of perindopril arginine. Each PREXUM 5 tablet contains 5 mg of perindopril arginine. Each PREXUM 10 tablet contains 10 mg of perindopril arginine. <u>Excipient with ...
3. Pharmaceutical form
PREXUM 2.5 is a white, round, convex, film-coated tablet. PREXUM 5 is a light-green, rod-shaped, film-coated tablet engraved with a Servier logo on one face and scored on both edges. PREXUM 10 is a green, ...
4.1. Therapeutic indications
PREXUM is indicated for: the treatment of hypertension; the treatment of heart failure. In such patients it is recommended that PREXUM be given with a diuretic and/or digoxin under close medical supervision. ...
4.2. Posology and method of administration
Hypertension The usual starting dose is one PREXUM 5 tablet once daily, taken in the morning. Optimum control of blood pressure is achieved by increasing the dose, titrating it against the blood pressure ...
4.3. Contraindications
PREXUM is contraindicated: in patients with a history of previous hypersensitivity to the active ingredient perindopril, ACEinhibitors or any of the excipient ingredients present in PREXUM during pregnancy ...
4.4. Special warnings and precautions for use
Hyperkalaemia Since ACE inhibitors reduce angiotensin II formation resulting in decreased production of aldosterone, increases in serum potassium have been observed in some patients treated with ACE inhibitors ...
4.5. Interaction with other medicinal products and other forms of interaction
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated ...
4.6. Fertility, pregnancy and lactation
Effects on fertility The effects of perindopril arginine on fertility have not been investigated. Studies in rats showed no impairment of male or female fertility at oral perindopril erbumine doses up ...
4.7. Effects on ability to drive and use machines
The antihypertensive effect in individual cases may be symptomatic. Treatment with any blood pressure lowering agent may, therefore, affect the ability to drive, cross the road safely or operate machinery, ...
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
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia). Limited data are available for overdose in humans. Symptoms associated with overdose of ACE inhibitors ...
5.1. Pharmacodynamic properties
Mechanism of action Perindopril (prodrug), following hydrolysis to perindoprilat, inhibits angiotensin converting enzyme (ACE) both in vitro and in vivo. It is thought that ACE inhibitors reduce blood ...
5.2. Pharmacokinetic properties
Absorption Following oral administration, PREXUM is rapidly absorbed with bioavailability of 24%. Elimination is rapid, occurring predominantly via the urine. Plasma half-life is approximately one hour. ...
5.3. Preclinical safety data
Genotoxicity Results from a broad set of assays for gene mutation and chromosomal damage with perindopril arginine suggest no genotoxic potential at clinical doses. Carcinogenicity No evidence of carcinogenic ...
6.1. List of excipients
<u>PREXUM 2.5, PREXUM 5 & PREXUM 10:</u> Hydrophobic colloidal silica anhydrous Lactose monohydrate Macrogol 6000 Magnesium stearate Maltodextrin Sodium starch glycollate (type A) Glycerol Hypromellose ...
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 30°C.
6.5. Nature and contents of container
Thirty (30) tablets supplied in a white HDPE bottle equipped with a white induction-sealed child resistant-closure and desiccant sachets. PREXUM 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 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
12 February 2013
10. Date of revision of the text
4 July 2022
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