Ramipril 1.25mg Capsules
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Module 1 - Administrative and Prescribing Information
Module 1.3 - Product Information
Text to appear on the Patient Information Leaflet (combined)
Patient Information Leaflet
Ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg Capsules
What you should know about Ramipril Capsules
Please read this carefully before you start to take your medicine. Please keep this leaflet, you may need to read it again. This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
What is in your medicine and what is it used for?
The name of your medicine is Ramipril 1.25mg, 2.5mg, 5mg, or 10mg Capsules.
The active substance in your Ramipril Capsules is Ramipril. Ramipril Capsules are available in four strengths. The 1.25 mg capsules are light grey in colour, with "R” marked on the capsule cap and 1.25 on the capsule body. The 2.5 mg capsules have a light green cap marked "R” and a light grey capsule body marked 2.5. The 5 mg capsules have a green cap marked "R” and a light grey capsule body marked 5. The 10 mg capsules have a dark green cap marked "R” and a light grey capsule body marked 10.
Each capsule contains 1.25 mg, 2.5 mg, 5 mg, or 10 mg of Ramipril, the active ingredient. The other ingredients are starch, gelatin and the colourings, black iron oxide (E172) and titanium dioxide (E171). The 2.5 mg, 5 mg and 10 mg capsules also contain the colourings indigo carmine (E132) and yellow iron oxide (E172). The printing ink on the capsules contains the following additional ingredients: shellac, soya lecithin (E322) and antifoam.
Ramipril Capsules are supplied in blister packs of 7, 21, 28, 30, 50 and 100 capsules.
Ramipril is one of a group of medicines called ACE (angiotensin converting enzyme) inhibitors.
These work by widening blood vessels which makes it easier for the heart to pump blood through them, to all parts of the body. This helps to reduce raised blood pressure. It can also help the heart to work better, if the heart does not pump as well as is needed.
The Product Licence holder is: Crescent Pharma,3&4 Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED
Manufactured by: Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland.
Uses
Your doctor has probably prescribed Ramipril Capsules for one of the following reasons:
• To reduce the risk of a heart attack, to decrease the risk of requiring a surgical procedure, to increase the blood flow to the heart and to reduce your chance of having a stroke. This applies to patients of 55 years or more who have clinical evidence of cardiovascular disease (previous MI, unstable angina or multivessel CABG or multivessel PTCA), stroke or peripheral vascular disease.
• In diabetic patients, of 55 years or more, who show symptoms of high blood pressure, high cholesterol, peripheral vascular disease, have known microalbuminuria (small amounts of a protein called albumin in the urine), or are smokers. In these patients, Ramipril Capsules can reduce the risk of heart attack, heart disease and stroke and decrease the risk of requiring surgery to increase blood flow to the heart.
• To lower mild to moderately high blood pressure.
• You have a heart condition which means that the heart is not working as well as it did.
Ramipril will help your heart to pump the blood around your body. Ramipril capsules are taken as additional medication with water tablets.
• If you have had a heart attack (myocardial infarction) with heart failure. Although you may have no symptoms at present, there is a risk that you may develop heart failure if your heart weakens further. Ramipril capsules may slow down or prevent the onset of heart failure, and as a result, may reduce mortality (risk of death).
Before taking your medicine
Do not take Ramipril Capsules and tell your doctor if:
• you are hypersensitive (allergic) to Ramipril or any of the other ingredients listed above;
• you are more than 3 months pregnant. (It is also better to avoid Ramipril Capsules in early pregnancy - see pregnancy section);
• you are breast-feeding;
• you have a history of the condition known as angioneurotic oedema;
• you have kidney problems which affect your heart rate;
• you have low or changing blood pressure;
• you have been told by your doctor that you have any of the following heart conditions; aortic valve stenosis, mitral valve stenosis or outflow obstruction.
Take special care with Ramipril Capsules if:
• you must tell your doctor if you think you are (or might become) pregnant. Ramipril Capsules are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
• you have heart problems or if you have any kidney or liver disease. Your doctor may need to monitor you and change the dose of your medicine.
• you are on haemodialysis using high flux polyacrylonitrile (AN69) membranes, or on another type of blood filtration to lower your blood fat, using dextran sulphate (called low-density lipoprotein apheresis). Inform your doctor of this so a different technique can be chosen to prevent hypersensitivity reactions.
• you take a high dose of diuretic medication (water tablets).
• you have lupus erythematosus or have been told by your doctor that you have scleroderma (a rare disease that may cause thickening of the skin, joint stiffness and problems with other internal organs).
• you are taking any medications which may affect your blood picture, your doctor can advise you of this.
• you need an operation or an anaesthetic; tell the doctor or dentist that you are taking Ramipril capsules.
• you are taking medication for low potassium levels.
• you are taking diuretic medication (water tablets). Your doctor may discontinue diuretic therapy and correct volume and/or salt depletion before starting treatment with Ramipril.
• you are taking allopurinol and/or other immunosuppressants as this may increase the likelihood of blood picture changes.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Ramipril Capsules before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ramipril Capsules. Ramipril Capsules are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Ramipril Capsules are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
It is not advisable to drive or operate machinery for several hours after the first dose of Ramipril capsules or after an increase in dose. You should not drive or operate machinery if you feel dizzy or tired while taking Ramipril capsules. Drinking alcohol may make the dizziness or sleepiness worse.
Using other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
You should especially inform your doctor if you have been taking any of the following:
• diuretics (water tablets) particularly potassium sparing diuretics (spironolactone, amiloride, triamterene)
• medicines for high blood pressure, e.g. quinapril, lisinopril, atenolol
• medicines for diabetes
• lithium
• non steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, diclofenac
• treatment for gout, e.g. NSAIDs, colchicine, allopurinol
• corticosteroids, e.g. hydrocortisone,
• drugs to depress the immune system, e.g. ciclosporin, prednisolone
• medicines containing potassium.
Taking your medicine
Always follow your doctor’s instructions as to how and when to take your medicine, your pharmacist may be able to advise you if you are not sure. Exactly how many capsules, and how often you must take them, will be written on the label. Please read it carefully. The recommended doses are given below. However, doctors sometimes prescribe different doses from these: if this applies to you, discuss it with your doctor, if you have not already done so.
Swallow the capsules whole with a glass of water. Take the dose at approximately the same time each day.
Adults and elderly patients over 65 years:
Reducing the risk of heart attack, stroke and the need for surgery to improve blood flow to your heart: the usual starting dose is one 2.5 mg capsule once a day. This dose will be increased gradually by your doctor. After three weeks of treatment the dose is usually 10 mg once a day.
Hypertension (high blood pressure): the usual starting dose for patients is one 1.25 mg capsule once a day. Your doctor may decide to increase the dose after one to two weeks of treatment. Most people with hypertension need doses of 2.5 mg or 5 mg once a day, but your doctor may decide you need a different dose, up to a maximum of 10 mg once a day.
If you are taking diuretic medications (water tablets) or you have a heart condition known as congestive heart failure then the required dosage may be different, your doctor will advise you of the dosage and treatment you will require.
Heart failure: the usual starting dose is one 1.25 mg capsule once a day, although your doctor may decide to increase the dose after one or two weeks of treatment. Most people need doses of 2.5 mg or 5 mg once or twice a day, but again your doctor may decide that you need a different dose up to a maximum of 10 mg.
If you are taking diuretic medication (water tablets) then your doctor may decide to reduce the dose before starting treatment with Ramipril capsules.
Heart attack: Following a heart attack, treatment with Ramipril capsules may be started in hospital. The usual starting dose is 2.5 mg twice a day which may be increased to 5 mg twice a day after the first couple of days. In some cases the dose may be reduced to 1.25 mg twice a day and gradually increased again to 2.5 mg and 5 mg twice a day. If the dose is unable to be increased to 2.5 mg twice a day then treatment may be stopped.
Kidney disease: For patients with kidney disease (renal impairment with creatinine clearance less than 30 ml/min), the initial dose of Ramipril is usually 1.25 mg once daily. This may be increased to 2.5 mg or 5 mg once daily depending on the type of kidney disease.
Liver problems: For patients with liver problems, treatment with Ramipril is usually started at a dose of 1.25 mg once daily under close medical supervision.
Elderly: If you are elderly and taking water tablets or have heart, kidney or liver problems your doctor may start your treatment with a low dose of Ramipril and increase it if needed.
Children: Ramipril Capsules are not recommended for use in children and adolescents below 18 years of age because the safety and efficacy of Ramipril Capsules in children has not yet been established.
If you wish to stop treatment, discuss this with your doctor first as your original symptoms will return.
If you have the impression that the effect of Ramipril Capsules is too strong or too weak, talk to your doctor or pharmacist.
If you have forgotten to take your medicine, take the missed dose as soon as you remember, unless it is nearly time for the next dose. Do not double the next dose to make up for the missed one.
If you are at all concerned about this you should consult your doctor or pharmacist.
If you have taken too many Ramipril capsules, contact your doctor or local hospital accident and emergency department immediately. You may experience low blood pressure which will result in dizziness.
Possible side effects
Ramipril capsules may cause undesirable effects in some people. The most common of these effects include feeling sick, dizziness and headache.
Other possible, but less common, side effects are described below.
Blood circulation and heart problems: low blood pressure with dizziness, weakness and feeling sick. Fainting. Rare reports of chest pain, fast or changing heart beat and angina. If these symptoms are severe, you should tell your doctor at once as, in extreme cases, very low blood pressure could lead to heart attack or stroke.
Kidney problems: In some people Ramipril may affect the kidneys. Pre-existing proteinurea (elevated protein levels in the urine) may deteriorate.
Gastrointestinal: dry mouth, irritation or swelling in the mouth, stomach pains, diarrhoea or constipation, feeling or being sick, changes in liver enzymes (including jaundice). Rare reports of pancreatitis (inflammation of the pancreas).
Allergic reactions: itchy skin, rash, shortness of breath and sometimes fever.
Skin: rash or other kind of eruption or lesion on the skin, reddening of skin areas with accompanying heat sensation, conjunctivitis (eye infection), pronounced hair loss and reduced circulation to the hands and/or feet (Raynaud’s phenomenon). As with other medicines of this type (i.e. ACE inhibitors) sensitivity of the skin to light and effects on the nails (loosening) has been observed.
Respiratory tract: dry tickling cough, bronchitis, and a runny or stuffy nose.
Angioneurotic oedema: in very rare cases this condition has occurred which includes symptoms such as swelling of the face, tongue and throat.
Other effects: disturbance of balance, headache, nervousness, restlessness, tremor, problems with sleeping, confusion, loss of appetite, depressed mood, feeling of anxiety, pins and needles, muscle cramps, muscle and joint pains, fever, vasculitis (inflammation of the blood vessels), sexual inability in men, and reduced sexual desire (libido). A very small number of people find that this medicine affects their sense of taste.
Blood tests may show an increase in some liver test results. An increase in blood urea nitrogen, creatinine levels, serum potassium levels and a decrease in serum sodium levels may also be observed. Taking Ramipril may result in an increase in the number of so-called eosinophilic blood cells.
Tell your doctor at once if:
• you feel ill after your first dose (a few people may react to their first dose and feel very dizzy, weak, faint and sick).
• you get a lot of infections with sore throats or mouth ulcers.
• you notice a rash, skin eruption or other effects on your skin or eyes, itching or a high temperature.
• you notice swelling of the face, tongue or throat Ask your doctor if you should continue taking the capsules.
Stop taking Ramipril Capsules immediately and go to your doctor or casualty department if:
• your breathing becomes difficult and noisy
• you get any swelling of the face, tongue or throat
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storing your medicine
Do not take this medicine after the expiry date stated on the carton. Any out of date medicines should be returned to your pharmacist for disposal.
If you notice any visible signs of deterioration in the capsules, take them to your pharmacist for advice before taking them.
Unused capsules should be taken back to the pharmacist for safe disposal.
Do not store above 25°C. Store in the original packaging.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others, it may harm them even if their symptoms are the same as yours.
This leaflet applies to Ramipril Capsules 1.25 mg, 2.5 mg, 5 mg, and 10 mg only.
Date of preparation: April 2013
LB - October 2014