Consumer medicine information

1. Why am I using ENALAPRIL-WGR?

ENALAPRIL-WGR contains the active ingredient enalapril maleate. ENALAPRIL-WGR is used to lower high blood pressure, which doctors call hypertension. It is also used to treat heart failure.
For more information, see Section 1. Why am I using ENALAPRIL-WGR? in the full CMI.

2. What should I know before I use ENALAPRIL-WGR?

Do not use if you have ever had an allergic reaction to ENALAPRIL-WGR 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 ENALAPRIL-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ENALAPRIL-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 use ENALAPRIL-WGR?

• Your doctor will tell you how many tablets you need to take each day.

• This depends on your condition and whether you are taking other medicines.

5. What should I know while using ENALAPRIL-WGR?

6. Are there any side effects?

Common side effects include headache, light-headedness or dizziness, fatigue, dry cough, mild stomach upsets and muscle cramps. Serious side effects include fast or irregular heartbeat, fainting, yellowing of the skin or eyes, skin rash, worrying or frequent infections, signs of dehydration or symptoms of as allergic reaction (i.e. swelling of the face or throat, hives, shortness of breath etc.).
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

Enalapril maleate.

2 Qualitative and Quantitative Composition

Each tablet (5 mg, 10 mg and 20 mg) contains enalapril maleate 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

5 mg tablets. White to off white, round, flat-face beveled edge tablets with breakline on one side and "5" debossed on the other side.
10 mg tablets. White to off white, round, flat-face beveled edge tablets with breakline on one side and "10" debossed on the other side.
20 mg tablets. White to off white, round, flat-face beveled edge tablets with breakline on one side and "20" debossed on the other side.

4 Clinical Particulars

4.9 Overdose

Symptoms. Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension, beginning approximately six hours after ingestion of tablets, concomitant with blockade of the renin-angiotensin system, and stupor, which can be treated, if necessary, by intravenous infusion of normal saline solution. Several hypertensive patients in clinical studies have received as much as 80 mg of enalaprilat intravenously over a fifteen minute period. No adverse effects, other than those associated with recommended dosages, were observed.
Treatment. Enalaprilat may be removed from the general circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Neither enalapril maleate nor the active diacid was mutagenic in the Ames microbial mutagen test with or without metabolic activation. Enalapril was also negative in the following genotoxicity studies: rec-assay, reverse mutation assay with E. coli, sister chromatid exchange with cultured mammalian cells, and the micronucleus test with mice, as well as in an in vivo cytogenic study using mouse bone marrow.
Carcinogenicity. There was no evidence of a carcinogenic effect when enalapril was administered for 106 weeks to rats at doses up to 90 mg/kg/day. Enalapril has also been administered for 94 weeks to male and female mice at doses up to 90 mg and 180 mg/kg/day, respectively, and showed no evidence of carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Enalapril-WGR Tablets contain the maleate salt of enalapril, the ethyl ester of the parent diacid, enalaprilat. Enalapril (enalapril maleate) is the maleate salt of enalapril, a derivative of two amino acids, L-alanine and L-proline. Following oral administration, enalapril is rapidly absorbed and then hydrolysed to enalaprilat, which is a specific, long-acting, angiotensin converting enzyme inhibitor.
Enalapril maleate is a white or almost white crystalline powder with a melting point of about 144°C and a pKa of 3 and 5.4. It is sparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides. It lacks a sulphydryl group.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSENALMA.gif Chemical name: (2S)-1-[(2S)-2- [[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl] amino]propanoyl] pyrrolidine-2-carboxylic acid, (Z)-2- butenedioate salt (1:1).
Molecular formula: C₂₀H₂₈N₂O₅.C₄H₄O₄.
Molecular weight: 492.5.
CAS number. 76095-16-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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