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Ramipril 1.25mg, 2.5mg, 5mg
and 10mg capsules
Read all of this leaflet carefully before you start taking this
• you must tell your doctor if you think that you are (or might medicine.
become) pregnant. Ramipril capsules are not recommended in
• Keep this leaflet. You may need to read it again. the first 3 months of pregnancy and may cause serious harm to • If you have any further questions, ask your doctor or your baby after 3 months of pregnancy, see section “Pregnancy • This medicine has been prescribed for you. Do not pass it Children
on to others. It may harm them even if their symptoms are Ramipril capsules are not recommended for use in children and adolescents below 18 years of age because there is no • If any of the side effects get serious, or if you notice any information available in this population. side effects not listed in this leaflet, please tell your doctor If any of the above apply to you (or you are not sure), talk to your In this leaflet:
Taking Ramipril capsules with other medicines
Please tell your doctor or pharmacist if you are taking or have 1 What Ramipril capsules are and what they are
recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines). 2 Before you take
This is because Ramipril capsules can affect the way some other medicines work. Also some medicines can affect the way Ramipril 3 How to take
4 Possible side effects
Please tell your doctor if you are taking any of the following 5 How to store
medicines. They can make Ramipril capsules work less well: 6 Further information
• medicines used to relieve pain and inflammation (e.g. Non-
Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or 1 What Ramipril capsules are and what they are
• medicines used for the treatment of low blood pressure,
shock, cardiac failure, asthma or allergies such as ephedrine,
Ramipril capsules contain a medicine called ramipril. This belongs noradrenaline (norepinephrine) or adrenaline (epinephrine). to a group of medicines called ACE inhibitors (Angiotensin Your doctor will need to check your blood pressure. Please tell your doctor if you are taking any of the following Ramipril capsules work by:
medicines. They can increase the chance of getting side effects if • decreasing your body’s production of substances that could
• medicines used to relieve pain and inflammation (e.g. Non- • making your blood vessels relax and widen steroidal Anti-inflammatory Drugs (NSAIDs) such as ibuprofen or • making it easier for your heart to pump blood around your body. • medicines for cancer (chemotherapy)
Ramipril capsules can be used:
• medicines to stop the rejection of organs after a transplant
• to treat high blood pressure (hypertension)
• to reduce the risk or delay the worsening of kidney problems • diuretics (water tablets) such as furosemide
• medicines which can increase the amount of potassium in
• to treat your heart when it cannot pump enough blood to the your blood such as spironolactone, triamterene, amiloride,
potassium salts and heparin (for thinning blood) • as treatment following heart attack (myocardial infarction) • steroid medicines for inflammation such as prednisolone
• allopurinol (used to lower the uric acid in your blood)
2 Before you take
• procainamide (for heart rhythm problems).
Do not take Ramipril capsules and tell your doctor if:
Please tell your doctor if you are taking any of the following • you are allergic (hypersensitive) to ramipril, any other ACE
medicines. They may be affected by Ramipril capsules: inhibitor medicine or any of the ingredients of Ramipril capsules • medicines for diabetes such as oral glucose lowering medicines
listed in section 6. Signs of an allergic reaction may include a and insulin. Ramipril capsules may lower your blood sugar rash, swallowing or breathing problems, swelling of your lips, amounts. Check your blood sugar amounts closely while taking • you have ever had a serious allergic reaction called
• lithium (for mental health problems). Ramipril capsules may
“angioedema”. The signs include itching, hives (urticaria), red
increase the amount of lithium in your blood. Your lithium marks on the hands, feet and throat, swelling of the throat and amount will need to be closely checked by your doctor. tongue, swelling around the eyes and lips, difficulty breathing If any of the above apply to you (or you are not sure), talk to your • you are having dialysis or any other type of blood filtration.
Depending on the machine that is used, Ramipril capsules may Food and alcohol
Drinking alcohol with Ramipril capsules may make you feel dizzy • you have kidney problems where the blood supply to your
or light-headed. If you are concerned about how much you can kidney is reduced (renal artery stenosis) drink while you are taking Ramipril capsules, discuss this with • you are in the last 6 months of pregnancy (see section below
your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. Ramipril capsules may be taken • your blood pressure is abnormally low or unstable. Your doctor
Pregnancy and breast-feeding
Do not take Ramipril capsules if any of the above apply to you. You must tell your doctor if you think that you are (or might If you are not sure, talk to your doctor before taking Ramipril You should not take Ramipril capsules in the first 12 weeks of Check with your doctor or pharmacist before taking your
pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the • have heart, liver or kidney problems
• have lost a lot of body salts or fluids (through being sick
If you become pregnant while on Ramipril capsules, tell your (vomiting), having diarrhoea, sweating more than usual, being doctor immediately. A switch to a suitable alternative treatment on a low salt diet, taking diuretics (water tablets) for a long time should be carried out in advance of a planned pregnancy. You should not take Ramipril capsules if you are breast-feeding. • are going to have treatment to reduce your allergy to bee or
Ask your doctor or pharmacist for advice before taking any wasp stings (desensitization)
• are going to receive an anaesthetic. This may be given for
Driving and using machines
an operation or any dental work. You may need to stop your You may feel dizzy, while taking Ramipril capsules. This is more Ramipril capsules treatment one day beforehand; ask your likely to happen when you start taking Ramipril capsules or start taking a higher dose. If this happens, do not drive or use any tools • have high amounts of potassium in your blood (shown in
• have collagen vascular disease such as scleroderma or systemic
Soya warning
Ramipril capsules contain soya lecithin. If you are allergic to peanut or soya, do not use this medicine.
Ramipril 1.25mg, 2.5mg, 5mg & 10mg Capsules 28pk PIL - UK Technical Approval
3 How to take
• Heartburn, constipation or dry mouth Always take Ramipril capsules exactly as your doctor has told you. • Passing more water (urine) than usual over the day You should check with your doctor or pharmacist if you are not • Loss or decrease of appetite (anorexia) Take this medicine by mouth at the same time of the day each • Swollen arms and legs. This may be a sign of your body holding day. Swallow the capsules with liquid.
• Treatment of high blood pressure
The usual starting dose is 1.25mg or 2.5mg once daily. Your doctor will adjust the amount you take until your blood pressure • Sexual inability in men, reduced sexual desire in men or women is controlled. The maximum dose is 10mg once daily. If you are • An increased number of certain white blood cells (eosinophilia) already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning • Blood tests showing changes in the way your liver, pancreas or • Treatment to reduce or delay the worsening of kidney
problems
Rare (affects less than 1 in 1,000 people)
You may be started on a dose of 1.25mg or 2.5mg once daily. Your doctor will adjust the amount you are taking. The usual • Severe flaking or peeling of the skin, itchy, lumpy rash • Nail problem (e.g. loosening or separation of a nail from its bed) • Treatment of heart failure
The usual starting dose is 1.25mg once daily. Your doctor will • Blotches on your skin and cold extremities adjust the amount you take. The maximum dose is 10mg daily. Two administrations per day are preferable. • Disturbed hearing and ringing in your ears • Treatment after you have had a heart attack
The usual starting dose is 1.25mg once daily to 2.5mg twice • Blood tests showing a decrease in the number of red blood cells, daily. Your doctor will adjust the amount you take. The usual white blood cells or platelets or in the amount of haemoglobin. dose is 10mg daily. Two administrations per day are preferable. Very rare (affects less than 1 in 10,000 people)
• Elderly
• Being more sensitive to the sun than usual. Your doctor will reduce the initial dose and adjust your Other side effects reported:
Please tell your doctor if any of the following gets serious or lasts If you take more Ramipril capsules than you should
Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with • Blood tests showing too few blood cells in your blood you. This is so the doctor knows what you have taken. • Blood tests showing less sodium than usual in your blood • Fingers and toes changing colour when you are cold and If you forget to take Ramipril capsules
then tingling or feeling painful when you warm up (Raynaud’s If you miss a dose, take your normal dose when it is next due. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask 4 Possible side effects
Like all medicines, Ramipril capsules can cause side effects, If you notice any side effects not listed in this leaflet, please tell Stop taking Ramipril capsules and contact your doctor
immediately,
if you notice any of the following serious side How to store
effects - you may need urgent medical treatment: Keep out of the reach and sight of children.
• Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Ramipril capsules. Do not use Ramipril capsules after the expiry date which is stated • Severe skin reactions including rash, ulcers in your mouth, on the carton and the blister or the tablet container. The expiry worsening of a pre-existing skin disease, reddening, blistering or date refers to the last day of that month.
detachment of skin (such as Stevens-Johnson syndrome, toxic Medicines should not be disposed via wastewater or household epidermal necrolysis or erythema multiform). waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the Contact your doctor immediately if you notice any of the
• Faster heart rate, uneven or forceful heartbeat (palpitations), 6 Further information
chest pain, tightness in your chest or more serious problems What Ramipril capsules contain
The active substance is ramipril. • Shortness of breath or a cough. These could be signs of lung Each capsule contains either 1.25mg, 2.5mg, 5mg or 10mg of the • Bruising more easily, bleeding for longer than normal, any The other ingredients are starch pregelatinised, gelatin, water, sign of bleeding (e.g. bleeding from the gums), purple spots black iron oxide (E172), titanium dioxide (E171), shellac (E904), blotching on the skin or getting infections more easily than soya lecithin (E322) and antifoam DC 1510. usual, sore throat and fever, feeling tired, faint, dizzy or having 2.5mg, 5mg and 10mg capsules also contain indigo carmine FD&C pale skin. These can be signs of blood or bone marrow problems blue 2 (E132), yellow iron oxide (E172).
• Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas). What Ramipril capsules look like and contents of the
• Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs 1.25mg capsules are hard, gelatin capsules, light grey body and of liver problems such as hepatitis (inflammation of the liver) or 2.5mg capsules are hard, gelatin capsules, light grey body and Tell your doctor if you notice any of the following side effects
5mg capsules are hard, gelatin capsules, light grey body and or they get worse:
Common (affects less than 1 in 10 people)
10mg capsules are hard, gelatin capsules, light grey body and • Feeling dizzy. This is more likely to happen when you start taking Ramipril capsules or start taking a higher dose • Fainting, hypotension (abnormally low blood pressure), Marketing Authorisation Holder
especially when you stand or sit up quickly • Dry tickly cough, inflammation of your sinuses (sinusitis) or Manufacturer
• Stomach or gut pain, diarrhoea, indigestion, feeling or being sick Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjoudur, Iceland.
• Skin rash with or without raised area This leaflet was last revised in April 2011.
• Blood tests showing more potassium than usual in your blood.
Uncommon (affects less than 1 in 100 people)
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia) • Loss or change in the way things taste • Feeling depressed, anxious, more nervous than usual or restless • Blocked nose, difficulty breathing or worsening of asthma • A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea Ramipril 1.25mg, 2.5mg, 5mg & 10mg Capsules 28pk PIL - UK Technical Approval

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