Ramipril 1.25mg, 2.5mg, 5mg and 10mg Capsules
Please read this leaflet carefully before you start to take your medicine.
It gives you important information about your medicine.
If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.
Keep the leaflet until you have finished the medicine.
What’S In Your Medicine
Ramipril capsules come in four strengths coloured as follows:
- 1.25mg: light grey body and cap.
- 2.5mg: light grey body and light green cap.
- 5mg: light grey body and green cap.
- 10mg: light grey body and dark green cap.
Each capsule contains 1.25mg, 2.5mg, 5mg or 10mg of the active ingredient ramipril.
The capsules also contain starch pregelatinised.
The capsule shell contains: gelatin, water, black iron oxide (E172), titanium dioxide (E171) (all strengths), indigo carmine FD&C Blue 2 (E132) (all strengths except 1.25mg), yellow iron oxide (E172) (all strengths except 1.25mg).
The printing ink contains: shellac (E904), black iron oxide (E172), soya lecithin (E322), antifoam DC 1510.
Ramipril capsules are available in a pack size of 28.
Your capsules are made by
The Marketing Authorisation holder is
About Your Medicine
Ramipril is one of a group of medicines called angiotensin converting enzyme (ACE) inhibitors. These medicines work by reducing blood pressure.
Ramipril may be used to:
- Reduce the risk of heart attack, stroke, or need for revascularisation procedures for patients aged over fifty-five years
- Lower blood pressure if it is too high
- Help your heart to pump blood around the body, if you already have heart failure
- Prevent further weakening of your heart if you have already had a heart attack
- Reduce the risk of myocardial infarctions, stroke, cardiovascular death or need for revascularisation procedures in diabetic patients of fifty-five years or more who have hypertension and/or high cholesterol, and/or low HDL (high density lipoprotein), and/or have microalbinuria (protein in urine), clinical evidence of vascular disease, or who are a current smoker
Before Taking Your Medicine
Do NOT take Ramipril if you answer yes to any of the following:
- Are you pregnant, planning to become pregnant or breast-feeding?
- Have you ever had an allergic reaction to Ramipril or any of the ingredients in the capsule? (An allergic reaction may include a rash, itching or difficulty in breathing)
- Do you have a history of angioneurotic oedema (puffiness or swelling of the face, tongue or body)?
- Do you have heart valve problems?
- Do you have low or very variable blood pressure?
- Do you have problems with narrow blood vessels to the kidneys (renal artery stenosis)?
Make sure you have told your doctor before taking Ramipril if any of the following apply:
- Are you having dialysis (haemodialysis) or a form of blood transfusion called apheresis?
- Are you due to have an operation with or without anaesthetic? You should tell your dentist if appropriate too.
- Do you have other kidney problems or liver problems?
- Do you have either of the collagen vascular conditions lupus erythematosus or scleroderma?
- Have you recently been ill with diarrhoea or vomiting?
- Are you on a low salt diet?
- Do you have severe heart failure?
- Are you taking other medicines, especially
- diuretics or “water tablets” (e.g. spironolactone, amiloride, triamterene),
- other medicines that lower blood pressure such as beta-blockers (e.g. atenolol),
- potassium supplements or medicines containing potassium,
- medicines for diabetes (e.g. insulin, glibenclamide, gliclazide, tolbutamide),
- non-steroidal anti-inflammatory medicines (e.g. aspirin, indometacin),
- lithium,
- allopurinol (for gout) or medicines that suppress the immune system (e.g. prednisolone).
- Alcohol - You are advised NOT to drink alcohol with this medicine. Alcohol may worsen any ill effects you might experience from the Ramipril. Discuss this with your doctor if you have any questions.
- Driving - After the first dose or any increase in dose of Ramipril, you should wait several hours before you drive as Ramipril capsules may make you feel drowsy or dizzy. In all circumstances, make sure you are not affected before you drive or operate machinery.
If you see another doctor or go into hospital, let them know what medicines you are taking.
Taking Your Medicine
Follow your doctor’s instructions. Check the pharmacy label to see how many capsules to take and how often to take them. If you are not sure how to take them ask your pharmacist or doctor.
The usual dosage(s) are described below:
Adults
Reducing the risk of heart attack, stroke, or need for heart by-pass operations: Usual starting dose is 2.5mg Ramipril once daily, gradually increased according to tolerability. Your doctor may double this dose after one week to 5mg Ramipril once daily, then after a further three weeks, double again to 10mg Ramipril once daily (the usual maintenance dose).
Reducing high blood pressure: Usual starting dose is 1.25mg Ramipril once daily. Your doctor usually increases this every one to two weeks according to response, up to a maximum of 10mg Ramipril once daily. The usual maintenance dose is 2.5-5mg once daily. Patients already on diuretic therapy (“water tablets”), may have this stopped by the doctor 2-3 days before starting therapy with Ramipril. The diuretic may be resumed at a later date should it be necessary.
Treating heart failure: Usual starting dose is 1.25mg Ramipril once daily. The dose may be increased according to response. If increased, the doctor may double the dose every one to two weeks. Daily doses of 2.5mg or more may be taken as a single dose or as two divided doses. The maximum recommended daily dose is 10mg Ramipril once daily. Where patients have high dose diuretic therapy as well, the doctor may reduce the diuretic dose before starting Ramipril.
Preventing further weakening of your heart if you have had a heart attack: The starting dose is 2.5mg Ramipril twice daily, increased after 2 days to 5mg twice daily. If the initial 2.5mg dose is not tolerated, a lower dose of 1.25mg twice daily is given. The maintenance dose is 2.5 to 5mg twice daily.
If you are elderly and taking diuretics (“water tablets”) or have any heart, liver or kidney problems: your doctor may use a lower starting dose and possibly a lower maintenance dose too.
Children
Ramipril is not recommended.
Swallow these capsules whole with a glass of water. The effect of Ramipril is unaffected by the timing of the dose and food intake. This medicine should be taken for as long as your doctor tells you to, it may be dangerous to stop without their advice.
If you forget to take a dose, take one as soon as you remember, unless it is time for the next dose anyway. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.
Do not take more Ramipril capsules than your doctor tells you to. If you ever take too many, contact the nearest hospital casualty department or tell your doctor immediately. Do not go unaccompanied if you feel unwell. Take the container and any remaining Ramipril capsules with you to show to the doctor.
After Taking Your Medicine
This medicine sometimes causes unwanted effects in some people.
These are generally mild and transient, not requiring therapy to be discontinued.
The most commonly report adverse effects are nausea, dizziness and headache.
Other less common effects include:
Effects on the heart and circulation: Rarely, low blood pressure with dizziness, weakness and nausea after the initial dose of Ramipril or after an increase in dose. This may occur in patients with severe dehydration or low salt levels, such as those also taking diuretics, on dialysis or with severe heart failure. Fainting has been observed rarely. Other effects that may occur include heart attack or damage to blood vessels in the brain, chest pain, palpitations, heart rhythm disturbances and angina. Inflammation of blood vessels (vasculitis).
Effects on airways or breathing: Dry and tickly cough, runny nose, inflammation of the sinus, bronchitis and asthma (especially in patients with the dry tickly cough).
Effects on digestive system: Mouth dryness, irritation or inflammation of the lips, tongue or mouth, disturbances in digestion, constipation, diarrhoea, feeling or being sick, stomach pain or upper abdominal pain, increases in some liver enzyme results and possibly bilirubin levels in blood tests, yellowing of the skin or eyes due to obstructed bile flow (cholestatic jaundice) or liver damage (hepatitis) and reduced liver function.
Effects on the skin: Reddening and warming of areas of skin, itching, itchy rash, various skin/mucosal spots and rashes, occasional pronounced hair loss. With other ACE inhibitors, other types of skin rash including some resembling psoriasis, loosening of nails from nail beds and sensitivity of skin to light have been observed.
Effects on the kidneys: impaired kidney function.
Other effects: Muscle and joint pains. Rarely, inflammation of the pancreas. Disturbances of balance, headache, nervousness, restlessness, shakiness of the arms or legs, problems sleeping, confusion, loss of appetite, depressed mood, anxiety, numbness, tingling or pins and needles, loss of or changes in taste, muscle cramps and reduced sexual drive and ability in men. Causing or worsening of Raynaud’s syndrome (attacks of pain, numbness, coldness and blueness of the fingers). Conjunctivitis (red, sore, itching or weeping eyes). Pre-existing proteinuria (elevated protein levels in the urine) may deteriorate. An increase in blood urea nitrogen, creatinine levels, serum potassium levels and a decrease in serum sodium levels, and increased numbers of white blood cells called eosinophils.
Hypersensitivity reactions with itching, rash, breathlessness and sometimes fever may occur. These usually resolve on stopping Ramipril. In very rare cases angioneurotic oedema (a puffy swollen face, tongue or body) may occur. If throat noises or swelling of the face, tongue or voice box occurs, STOP taking Ramipril and contact your doctor immediately or arrange to be taken to the nearest hospital emergency department.
If you are concerned about any of these effects or get any other unusual effects, tell your doctor immediately. Please do not be worried. Most people taking this medicine will not experience any problems.
Storing Your Medicine
Do not use the Ramipril capsules after the expiry (use by) date shown on the product packaging. Keep the capsules stored below 25°C and store in the original container.
KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.
Date of last revision: March 2007
ACTPL031
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