Consumer medicine information

1. Why am I using RAMIPRIL-WGR?

RAMIPRIL-WGR contains the active ingredient Ramipril. RAMIPRIL-WGR is used to treat hypertension, heart failure following a heart attack, kidney problems and to prevent cardiovascular problems and complications.
For more information, see Section 1. Why am I using RAMIPRIL-WGR? in the full CMI.

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

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

3. What if I am taking other medicines?

Some medicines may interfere with RAMIPRIL-WGR and affect how it works. Tell your doctor or pharmacist if you are taking any other medicines.
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 RAMIPRIL-WGR?

• The usual dose of RAMIPRIL-WGR is 1.25 to 10 mg per day depending on the condition treated.

• More instructions can be found in Section 4. How do I use RAMIPRIL-WGR? in the full CMI.

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

6. Are there any side effects?

Common side effects: Feeling light-headed, dizziness, dry cough, headache, nausea or vomiting, stomach pain or discomfort, diarrhoea, indigestion, taste disturbance, muscle cramps or spasms, ringing or buzzing in the ears.
Serious side effects: Severe dizziness or confusion, visual disturbances, speech problems, swelling of face/lips/mouth/tongue/throat causing difficulty in breathing, severe blisters, or bleeding.
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

Ramipril.

2 Qualitative and Quantitative Composition

Ramipril-WGR tablets come in three strengths and contain 1.25 mg, 2.5 mg and 5 mg of ramipril.
Ramipril-WGR capsules contain 10 mg of ramipril.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ramipril-WGR 1.25 mg tablets are white to off-white, oval-shaped tablet marked "RP 1" on one side.
Ramipril-WGR 2.5 mg tablets are white to off-white, oval-shaped tablet marked "RP 2" on one side and scoreline on other side.
Ramipril-WGR 5 mg tablets are white to off-white, oval-shaped tablet marked "RP 5" on one side and scoreline on other side.
Ramipril-WGR 10 mg capsules are white and blue opaque capsule with "RP 10" printed in black.

4 Clinical Particulars

4.9 Overdose

Symptoms. In cases of overdose, the following may occur: excessive peripheral vasodilation, severe hypotension, shock, bradycardia, electrolyte disturbances, and renal failure. Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital.
Treatment. The treatment given depends on how and when the drug was taken and on the type and severity of symptoms. Steps must be taken to eliminate ramipril which has not yet been absorbed (e.g. administration of adsorbants during the first 30 minutes if possible). Vital and organ functions must be monitored under intensive care conditions, and safeguarded if necessary. In case of hypotension, administration of α₁-adrenergic agonists should be considered in addition to volume and salt substitution.
No experience is available concerning the efficacy of forced diuresis, altering urine pH, haemofiltration or dialysis in speeding up the elimination of ramipril or ramiprilat. If dialysis or haemofiltration is considered, consideration must be given to the fact that ramipril is contraindicated with certain high-flux filtration membranes and with dextran sulphate LDL aphaeresis (see Section 4.3 Contraindications).
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. No data available.
Carcinogenicity. No evidence of a carcinogenic effect was found when ramipril was given to rats (up to 500 mg/kg/day for 24 months) or to mice (up to 1,000 mg/kg/day for 18 months).
An increased incidence of oxyphilic cells in the renal tubules and oxyphilic microadenomas was observed in rats treated for 24 months with ramipril (3.2 to 500 mg/kg/day). Data from historical control animals showed that the spontaneous occurrence of oxyphilic cells in rat kidney is age-related, is higher in males, and reaches a level similar to that seen in the ramipril treated group. There is no evidence in humans that the occurrence of oxyphilic cells is age-related. Moreover, progression of oxyphilic cells to neoplasia (oncocytoma) is rare and, when it occurs, is considered to be benign. Whether this finding in rats represents any potential risk to humans is therefore unclear.
Fibromuscular pad formation. In several repeated dose studies in rats, especially male animals treated with ramipril (3.2 to 500 mg/kg bodyweight/day) showed an increased incidence of so-called fibromuscular pad formation in the basal region of the gastric mucosa. The findings suggest an increased connective tissue formation and also partly increased formation of smooth muscle (lamina muscularis mucosae) due to a predominantly round cell inflammatory reaction. In all studies (1 to 24 month, carcinogenicity) the changes were always of the same type and no tendency of proliferation was obvious. Thus, it seems to be rather a reactive process with circumscribed scar tissue formation. The changes in the rat stomach mucosa could not be reproduced in other species (i.e. mouse, dog, rabbit, monkey).
This lesion was also observed when rats were treated with a relatively high dose (90 mg/kg/day for 3 to 6 months) of another ACE inhibitor. In the light of the available data, fibromuscular pad formation in the rat would not appear to present a serious risk in humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ramipril is a white to almost white, crystalline powder soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C.
Chemical structure. The chemical name for ramipril is (2S,3aS,6aS)-1-[(S)-N-[(S)-1-carboxy)-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid, 1-ethyl ester. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRAMIPR.gif Its empiric formula is C₂₃H₃₂N₂O₅, and its molecular weight is 416.5.
Ramipril is a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative. It has five chiral centres with an S-configuration in all five asymmetric carbon atoms.
CAS number. 87333-19-5.

7 Medicine Schedule (Poisons Standard)

Prescription Medicine (Schedule 4).

Summary Table of Changes

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