Ramipril 5mg Capsules
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195 mm
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nogen Pharma
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ramipril 1.25mg Capsules Ramipril 2.5mg Capsules
Ramipril 5mg Capsules Ramipril 10mg Capsules
[Ramipril]
Read all ofthis leaflet carefully before you start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading "Do not take Ramipril".
Children: Ramipril Capsules are not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril Capsules in children has not yet been established.
If any of the above applies to you, or you are not sure, talk to your doctor before taking this medicine.
What is in this leaflet:
1. What Ramipril Capsules are and what they are used for
2. What you need to know before you take Ramipril Capsules
3. How to take Ramipril Capsules
4. Possible side effects
5. How to store Ramipril Capsules
6. Contents of the pack and other information
1. WHAT RAMIPRIL CAPSULES ARE AND WHAT THEY ARE USED FOR
Ramipril Capsules contain Ramipril which belongs to a group of medicines called ACE (angiotensin converting enzyme) inhibitors. They work by widening the blood vessels which makes it easier for the heart to pump blood through them, to all parts ofthe body. This helps to reduce blood pressure. It can also help to make the heart work better if it does not pump as well as needed.
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Ramipril Capsules are used to:-
• Reduce the risk of a heart attack, heart disease and stroke and decrease the risk of requiring surgery to increase blood flow to the heart
• Treat high blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL CAPSULES
Do not take Ramipril Capsules ifyou:
• Are allergic (hypersensitive) to ramipril, other ACE inhibitors or any of the other ingredients in the capsules (listed in section 6)
• Have a history of a condition known as angioneurotic oedema (Quincke's Disease)
• Are pregnant (see Pregnancy and Breastfeeding section)
• Have low blood pressure
• Have kidney problems where the blood supply to your kidneys are reduced (renal artery stenosis)
• Are having dialysis or any other type of blood filtration. Depending on the type of machine used, Ramipril Capsules may not be suitable for you
• Have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Ramipril Capsules ifyou:
• Have heart, liver or kidney disease
• Have collagen vascular disease such as scleroderma or systemic lupus erythematosus
• Are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)
• Are going to have an anaesthetic. This may be given for an operation or any dental work. You may need to stop taking your ramipril treatment one day beforehand. Ask your doctor for advice
• Are taking diuretics (water tablets). Your doctor may stop your diuretic medication and correct volume and/or sodium depletion before starting you on Ramipril Capsules
• Have high amounts of potassium in your blood
• Have lost a lot of body salts or fluids (through being sick, diarrhoea, sweating more than usual, being on a low salt diet, or on dialysis)
• Are elderly
• Are taking any of the following medicines used to treat high blood pressure:
. an "angiotensin II receptor blocker" (ARBs) (also known as sartans - for example valsartan, telmisartan, ibesartan, etc.), in particular ifyou have diabetes-related kidney problems.
. aliskiren.
Other medicines and Ramipril Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ramipril Capsules can affect the way some other medicines work. Also, some medicines can affect the way Ramipril Capsules work.
Your doctor may need to change your dose and/or to take other precautions:
• If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Ramipril" and "Warnings and precautions").
In particular tell your doctor ifyou are taking any of the following:
Please tell your doctor if you are taking any of the following medicines. They can make Ramipril work less well:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal AntiInflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)
• Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.
Please tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Ramipril:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal AntiInflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)
• Medicines for cancer (chemotherapy)
• Medicines to stop the rejection of organs after a transplant such as ciclosporin
• Diuretics (water tablets) such as furosemide
• Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning blood)
• Steroid medicines for inflammation such as prednisolone
• Allopurinol (used to lower the uric acid in your blood)
• Procainamide (for heart rhythm problems).
Please tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril:
• Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril may lower your blood sugar. Check your blood sugar closely while taking Ramipril
• Lithium (for mental health problems). Ramipril may increase the amount of lithium in your blood. Your lithium levels will need to be closely checked by your doctor.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Capsules.
Pregnancy and breastfeeding
You must tell your doctor if you think that you are (or might become) pregnant.
You should not take Ramipril Capsules in the first 12weeks of pregnancy, and you must not take them at all after the 13th (2nd and 3rd trimesters) week as their use during pregnancy may possibly be harmful to the baby.
Ifyou become pregnantwhile on Ramipril Capsules, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
You should not take Ramipril Capsules if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Ramipril Capsules with food and alcohol
Drinking alcohol with Ramipril Capsules may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril Capsules, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. Ramipril Capsules may be taken with or without food.
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Driving and using machines
You may feel dizzy, while taking Ramipril Capsules. This is more likely to happen when you start taking Ramipril Capsules or start taking a higherdose. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE RAMIPRIL CAPSULES
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Always take Ramipril Capsules exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Take this medicine by mouth at the same time of the day each day.
Swallow the capsules with liquid.
Doses:
• 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 is controlled. The maximum dose is 10mg once daily. Ifyou are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Ramipril Capsules.
• Treatment to reduce or delay the worsening of kidney problems
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 dose is 5mg or 10mg once daily.
• Treatment of heart failure
The usual starting dose is 1.25mg once daily. Your doctor will adjust the amount you take. The maximum dose is 10mg daily.
Two administrations per day are preferable.
• Treatment after you have had a heart attack
The usual starting dose is 1.25mg once daily to 2.5mg twice daily. Your doctor will adjust the amountyou take. The usual dose is 10mg daily. Two administrations per day are preferable.
• Elderly
Your doctor will reduce the initial dose and adjust your treatment more slowly.
Ifyou 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 you. This is so the doctor knows what you have taken.
Ifyou forget to take Ramipril Capsules
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 dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Ifyou stop taking Ramipril Capsules
Do not stop taking Ramipril Capsules without first consulting your doctor, as your original symptoms will return.
• Dry mouth, irritation or swelling in the mouth, stomach pains, diarrhoea or constipation, feeling or being sick, changes in liver enzymes (including jaundice) have been reported. Rare reports ofpancreatitis (inflammation of the pancreas)
• Reddening of the skin areas with accompanying heat sensation
• Hair loss
• Reduced circulation to the hands and/or feet (Raynaud's phenomenon)
• Sensitivity of the skin to light and effects on the nails (loosening) has been observed
• Dry, tickling cough, bronchitis and a runny or stuffy nose
• Conjunctivitis (eye infection)
• 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)
• Change in 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
• An increase in the number of eosinophilia blood cells has also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE RAMIPRIL CAPSULES
Keep out of the sight and reach of children. Do not store above 25°C.
Store in the original container.
Do not use Ramipril Capsules after the expiry date which is stated on the carton and the blister or the capsule container. The expiry date refers to the last day of that month. Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ifyou experience any ofthe following side effects STOP taking Ramipril and seek immediate medical help:
• Your breathing becomes difficult and noisy
• You get any swelling of the face, tongue or throat.
These could be signs ofan allergic reaction and urgent medical help should be sought.
Talk to your doctor immediately 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 a lot of sore throats and mouth ulcers
• You notice a rash, skin eruption or 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 to take Ramipril Capsules.
The most common side effects include feeling sick, dizziness and headache. Other possible, but less common side effects are described below:
• Angioneurotic (Quincke's oedema): in very rare cases this condition has occurred which includes symptoms such as swelling of the face, tongue and throat. Itchy skin, rash, shortness ofbreath sometimes fever
• Low blood pressure with dizziness, weakness and feeling sick
• Fainting
• Rare reports of chest pain, fast or changing heart beat and angina
• Ramipril may affect the kidneys. Preexisting proteinurea (elevated protein levels) may deteriorate
What Ramipril Capsules contain:
Ramipril Capsules contain 1.25mg, 2.5mg, 5mg and 10mg of the active substance ramipril.
The other ingredients are: starch pregelatinised, gelatin and the colourings black iron oxide (E172) and titanium dioxide (E171). The 2.5mg, 5mg and 10mg also contain the colourings FD&C Blue (E132) and yellow iron oxide (E172).
The printing ink contains shellac (E904) and potassium hydroxide (E525).
What Ramipril Capsules look like and contents of the pack
Ramipril 1.25mg: Hard gelatin capsule. Capsule body: light grey. Capsule cap: light grey. Marked with “R" on cap and “1.25” on body. Capsule contains white or almost white powder
Ramipril 2.5mg: Hard gelatin capsule. Capsule body: light grey. Capsule cap: light green. Capsule contains white or almost white powder. Marked with “R” on the cap and “2.5” on the body.
Ramipril 5mg: Hard gelatin capsule. Capsule body: light grey. Capsule cap: green. Capsule contains white or almost white powder.
Marked with “R” on the cap and “5” on the body
Ramipril 10mg : Hard gelatin capsule.
Capsule body: light grey. Capsule cap: dark green. Capsule contains white or almost white powder. Marked with “R” on the cap and “10” on the body.
Ramipril Capsules are packed in blisters of 28 capsules
Manufacturer and Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last amended in October 2014.
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