Ramipril 1.25mg, 2.5mg, 5mg and 10mg Tablets
- 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
- Actavis supplies Ramipril Tablets in four strengths.
- Each tablet contains 1.25mg, 2.5mg, 5mg or 10mg of the active ingredient Ramipril.
- The tablets also contain sodium hydrogen carbonate, lactose monohydrate, croscarmellose sodium, pregelatinised starch 1500 and sodium stearyl fumarate. 2.5mg tablets also contain yellow iron oxide (E172). 5mg tablets contain red and yellow iron oxide (E172).
- Ramipril Tablets are available in a pack size of 28.
- Your tablets are made by
who are also the Marketing Authorisation holder.
About Your Medicine
Ramipril is one of a group of medicines called angiotensin converting enzyme (ACE) inhibitors. These medicines work by reducing blood pressure so helping your heart pump blood around the body more easily.
Ramipril Tablets may be used to:
- Reduce the likelihood of death, heart attack, stroke, further heart or circulation problems or the need for surgery such as a heart bypass operation in people aged 55 years or more who have
- signs of heart or blood vessel disease, or
- type 2 diabetes with another risk factor such as high blood pressure, high cholesterol or smoking
- Lower blood pressure if it is high
- Reduce the likelihood of death in patients with heart failure who have had a recent heart attack
Before Taking Your Medicine
Do not take Ramipril Tablets if you:
- Have ever had an allergic reaction to Ramipril Tablets, any of the ingredients in the tablet or to any other ACE inhibitor (e.g. captopril, enalapril, fosinopril, lisinopril, perindopril). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
- Have ever experienced swelling of any part of the body (angioedema) without knowing the cause or as a result of taking an ACE inhibitor in the past
- Have a family history of angioedema
- Are in the last 6 months of pregnancy, (see section ‘Pregnancy and breastfeeding’)
- Have kidney problems including narrowing of the blood vessels supplying them
Check with your doctor or pharmacist before taking Ramipril Tablets if you:
- Have recently been ill with diarrhoea or vomiting
- Are on a low salt diet
- Have kidney problems or have had a kidney transplant
- Are having dialysis (haemodialysis) treatment or an infusion procedure called “LDL apheresis”
- Have severe heart failure, heart valve problems or poor blood circulation to the heart tissues
- Have ever experienced swelling of any part of the body (angioedema) as a result of taking other medication in the past
- Have low blood pressure (systolic less than 100mm Hg)
- Have recently had a heart attack and your heart and circulation problems are not under control
- Have been told you have a condition where your body produces too much of a hormone called aldosterone
- Are having treatment to make you less allergic to wasp or bee stings
- Have liver problems
- Have collagen vascular disease or vasculitis (inflammation of blood vessels)
- Are due to have an operation or surgery involving an anaesthetic
- Are diabetic
- Are of black origin as this medicine may be less effective. You may also more readily get the side effect ‘angioedema’. Your doctor may adjust the dose or choose an alternative treatment.
- Think you are (or might be) pregnant. Ramipril is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section ‘Pregnancy and breastfeeding’)
- Are breast-feeding
- Have been told by your doctor you have an intolerance to some sugars as this medicine contains lactose
- Develop a dry, persistent cough during treatment with Ramipril Tablets
Check with your doctor or pharmacist if you are taking any of the following:
- Diuretics (“water tablets”) such as amiloride, bendroflumethiazide, bumetanide, spironolactone or triamterene
- Other medicines that lower blood pressure such as nitrates
- Medicines to prevent rejection of transplanted organs such as azathioprine or ciclosporin
- Allopurinol for gout
- Procainamide for irregular heart beat
- Potassium supplements, potassium-containing salt substitutes (e.g. Lo-Salt) or medicines containing potassium
- Medicines for diabetes such as insulin, glibenclamide or metformin
- Lithium or other treatments for mental illness
- Antidepressants such as amitriptyline or imipramine
- Anaesthetics such as Lidocaine
- Strong pain killers such as morphine or pethidine
- Anti-inflammatory medicines such as aspirin, ibuprofen, indometacin, celecoxib or meloxicam
- Decongestants such as pseudoephedrine or asthma relievers such as salbutamol
- The antibiotics trimethoprim or co-trimoxazole
Pregnancy and Breast-feeding:
You must tell your doctor if you think that you are (or might be) pregnant. Usually, your doctor will advise you to take another medicine instead of Ramipril, as Ramipril is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
An appropriate antihypertensive drug must usually replace Ramipril before starting a pregnancy. The product should not be used during the 2nd and 3rd trimester of pregnancy.
Your doctor will normally advise you to stop taking Ramipril as soon as you know you are pregnant.
If you become pregnant during therapy with Ramipril, please contact your doctor without delay.
Ramipril should not be taken during breast-feeding.
Driving and using machines:
Ramipril Tablets may sometimes make you feel tired or dizzy and can rarely affect your vision. Make sure you are not affected before you drive or operate machinery.
Taking Your Medicine
Follow your doctor’s instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are still unsure ask your pharmacist or doctor.
The usual adult oral dosage(s) are described below:
Reducing risk of death or illness in patients aged 55 years or over with risk factors
Usual starting dose is 2.5mg once daily. Your doctor may increase this, according to response after two or three weeks of treatment, up to a maximum of 10mg once daily. The usual maintenance dose is 10mg once daily.
High Blood Pressure
Usual starting dose is 1.25mg to 2.5mg once daily. Your doctor may increase this, according to response after two or three weeks of treatment, up to a maximum of 10mg once daily.
Reducing risk of death in heart failure patients after a heart attack
Treatment usually begins three to ten days after the heart attack. Usual starting dose is 1.25-2.5mg twice daily (morning and evening). The maximum daily dose is 10mg, which may be taken as a single or divided dose (i.e. 5mg twice daily).
Special Patient Populations
Patients taking diuretics (“water tablets”)
Your doctor may stop your diuretic 2-3 days before starting ramipril or use a lower dose.
Patients with very poor kidney function
Your doctor may prescribe a lower starting dose.
Elderly patients
Your doctor may prescribe a different dose according to your kidney function.
Patients with poor liver function
Your doctor may prescribe a lower dose and monitor you more closely.
Children
Not recommended.
- Swallow these tablets whole with a glass of water regardless of food at the same time(s) each day.
- Take this medicine for as long as your doctor tells you to.
If you take more Ramipril Tablets than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If an overdose has been taken there may be signs such as a severe drop in blood pressure causing you to feel faint and a slow heart beat. An upset to blood chemistry and kidney function can also occur but won’t show symptoms.
If you forget to take Ramipril Tablets
If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.
After Taking Your Medicine
Like all medicines, Ramipril Tablets can sometimes cause unwanted side effects.
If the following happens, STOP taking Ramipril Tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:
- An allergic reaction (angioedema): skin rash, swelling of the face, lips, tongue, throat, hands or feet, and/or difficulty breathing or swallowing. This is a very serious but rare side effect.
- Pemphigus- a very rare but serious blistering of the skin.
- Toxic epidermal necrolysis- a very rare but severe rash involving reddening, swelling and peeling of the skin. Equivalent in appearance to severe burns.
- Stevens-Johnson syndrome- a very rare but severe and widespread reddening of the skin with blistering
- Erythema multiforme- a very rare but painful reddening of the skin with lumps and blisters
You may need urgent medical attention or hospitalisation with any of these reactions.
Other known side effects are:
Common (occur in more than 1 in 100 people): dizziness, headache, feeling faint on standing up due to low blood pressure, cough, diarrhoea, vomiting and kidney problems.
Uncommon (occur in more than 1 in 1000 but less than 1 in 100 people): mood changes, pins and needles, vertigo, taste disturbances, problems sleeping, heart attack, stroke, shortness of breath, runny nose, feeling sick, stomach ache, indigestion, reduced appetite, rash, itching, loss of sexual performance in men (impotence), tiredness, weakness or loss of strength, changes in blood chemistry including raised urea, creatinine, potassium and liver enzyme levels.
Rare (occur in more than 1 in 10000 but less than 1 in 1000 people): reduced haemoglobin and lower blood cell volume, confusion, dry mouth, kidney failure, enlarged breasts in men, raised blood levels of bilirubin and low levels of sodium.
Very rare (occur in less than 1 in 10000 people): weakened immunity, changes in types and numbers of blood cells causing various types of anaemia, lymph node disease, a condition where the immune system attacks your own body, low blood sugar levels, asthma, inflammation of the sinuses, allergic lung disorders, inflammation and collection of fluid in the lungs, inflammation of the pancreas or liver causing jaundice (yellowing of the whites of the eyes and skin), swelling of the intestines, sweating.
Combinations of the above and other side effects have occurred in some people. One combination includes fever, inflammation of blood vessels, muscle and joint pain, oversensitivity of skin to light, other skin reactions and changes in blood chemistry and cells.
Tell your doctor if you notice or are worried by any of the side effects listed or notice any other effects not listed.
Storing Your Medicine
- Do not use the tablets after the end of the expiry month (use by date) shown on the product packaging.
- Do not store above 25°C.
- Store in the original packaging. Do not transfer them to another container.
- KEEP RAMIPRIL TABLETS OUT OF THE REACH AND SIGHT OF CHILDREN IN A SECURE PLACE.
- REMEMBER that 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.
- Return all unused medicines to your pharmacist for safe disposal.
Date of last revision: March 2008.
If you would like a leaflet with larger text, please contact 01271 311257.
ACTPL053
