Consumer medicine information

1. Why am I taking PERINDOPRIL-WGR?

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

2. What should I know before I take PERINDOPRIL-WGR?

Do not take if you have ever had an allergic reaction to perindopril erbumine 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 take PERINDOPRIL-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PERINDOPRIL-WGR 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 take PERINDOPRIL-WGR?

The dose of PERINDOPRIL-WGR you may need each day will be decided and adjusted by your doctor. This will normally be 2 mg, 4 mg or 8 mg tablet once daily for high blood pressure and coronary artery disease or 2 mg to 4 mg tablet 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 take PERINDOPRIL-WGR? in the full CMI.

5. What should I know while taking PERINDOPRIL-WGR?

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 PERINDOPRIL-WGR 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 PERINDOPRIL-WGR. 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 PERINDOPRIL-WGR, 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 erbumine.

2 Qualitative and Quantitative Composition

Each tablet contains perindopril erbumine as the active ingredient.
Peridopril-WGR tablets. Each tablet contains 2 mg, 4 mg or 8 mg perindopril erbumine as the active ingredient.
Excipients with known effect. Sugars as lactose.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Perindopril-WGR tablets. 2 mg tablets. White, round, biconvex tablets, engraved "APO" on one side and "PE2" on the reverse.
4 mg tablets. White, capsule shaped, biconvex tablets, engraved "PE" bisect "4" on one side, and "APO" on the reverse.
8 mg tablets. White, capsule shaped, biconvex tablets, engraved "PE" bisect "8" on one side, and "APO" on the reverse.

4 Clinical Particulars

4.9 Overdose

Limited data are available for overdose in humans.
Symptoms. Symptoms associated with overdose of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
Treatment. 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.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Results from a broad set of assays for gene mutation and chromosomal damage with perindopril 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 2 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 ACE inhibitors to cause this effect in humans is unknown. Moreover, the progression of oxyphilic cells to oncocytomas is rare in humans and when this occurs, it is considered benign.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Perindopril is a dipeptide monoacid monoester with a perhydroindole group and no sulfhydryl radical. Perindopril erbumine is a white powder, readily soluble in purified water, 95% ethanol and chloroform. Perindopril has five asymmetric centres and is synthesised stereoselectively so that it is a single enantiomer (all S stereochemistry).
Perindopril erbumine is an angiotensin converting enzyme inhibitor.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPERERB.gif Chemical name: 2-Methylpropan-2-amine (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1(ethoxycarbonyl)butyl]amino]propanoyl]octahydro-1H-indole-2-carboxylate.
Molecular formula: C₁₉H₃₂N₂O₅,C₄H₁₁N.
CAS number. 107133-36-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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