Consumer medicine information

1. Why am I using COVERSYL?

COVERSYL contains the active ingredient perindopril arginine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. COVERSYL is used to lower high blood pressure, treat heart failure or coronary artery disease. For more information, see Section 1. Why am I using COVERSYL? in the full CMI.

2. What should I know before I use COVERSYL?

Do not use if you have ever had an allergic reaction to perindopril, any other ACE inhibitor or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use COVERSYL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with COVERSYL and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use COVERSYL?

The dose of COVERSYL you may need each day will be decided and adjusted by your doctor. This will normally be 2.5 mg, 5 mg or 10 mg once daily for high blood pressure and coronary artery disease; or 2.5 mg to 5 mg once daily for heart failure.
Swallow your tablet(s) with water, preferably in the morning before a meal.More instructions can be found in Section 4. How do I use COVERSYL? in the full CMI.

5. What should I know while using COVERSYL?

6. Are there any side effects?

All medicines can have side effects. Sometimes they are serious, most of the time they are not. If you do not feel well while you are taking COVERSYL then tell your doctor or pharmacist as soon as possible.
Angioedema (a severe allergic reaction) has been reported in patients treated with ACE inhibitors, including COVERSYL. This may occur at any time during treatment. If you develop swelling of your limbs, hands or feet, lips, face, mouth, tongue or throat, a fast and irregular heartbeat, purple spots with occasional blisters on the front of your arms and legs and/or around your neck and ears (a rare condition known as Stevens-Johnson Syndrome), difficulty in breathing, severe blisters, skin rash, itching, erythema multiforme or other allergic reactions after taking COVERSYL - please seek urgent medical attention. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Perindopril arginine.

2 Qualitative and Quantitative Composition

Each Coversyl 2.5 tablet contains 2.5 mg of perindopril arginine. Each Coversyl 5 tablet contains 5 mg of perindopril arginine. Each Coversyl 10 tablet contains 10 mg of perindopril arginine.
Excipient with known effect. Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Coversyl 2.5 is a white, round, convex, film-coated tablet.
Coversyl 5 is a light-green, rod-shaped, film-coated tablet engraved with a Servier logo on one face and scored on both edges.
Coversyl 10 is a green, round, biconvex film-coated tablet with a Servier logo on one face and a heart logo on the other face.

4 Clinical Particulars

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 may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough. The recommended treatment of overdose is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with intravenous catecholamines may also be considered. Perindopril may be removed from the general circulation by haemodialysis (see Section 4.4 Special Warnings and Precautions for Use). Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.

5 Pharmacological Properties

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 activity was observed in mice and rats when perindopril erbumine was administered via drinking water at levels up to 7.5 mg/kg/day for two years. At least one ACE inhibitor has caused an increase in the incidence of oxyphilic renal tubular cells and oncocytomas in rats. The potential of the ACE inhibitor class to cause this effect in man is unknown. Moreover, the progression of oxyphilic cells to oncocytomas is rare in humans and when this occurs, it is considered as benign.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The active component of Coversyl is perindopril arginine which has the chemical name, L-arginine (2S,3aS,7aS)-1-[(2S)-2- [[(1S)-1-(ethoxycarbonyl) butyl] amino] propanoyl] octahydro-1H-indole-2-carboxylate. Perindopril is a dipeptide monoacid monoester with a perhydroindole group and no sulfhydryl radical. Perindopril arginine is a white powder, readily soluble in purified water, slightly soluble in 95% ethanol and practically insoluble in chloroform. Perindopril has five asymmetric centres and is synthesised stereoselectively so that it is a single enantiomer (all S stereochemistry).
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPERARG.gif CAS number. 612548-45-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/COVERSST.gif