Ramipril 10mg Tablets
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Ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg Tablets
Ramipril
Read all of this leaflet carefully before you start taking this medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ramipril Tablets are and what they are used for
2. Before you take Ramipril Tablets
3. How to take Ramipril Tablets
4. Possible side effects
5. How to store Ramipril Tablets
6. Further Information
1. What Ramipril Tablets are and what they are used for
Ramipril Tablets belong to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors).
Ramipril Tablets work by:
■ Decreasing your body's production of substances that could raise your blood pressure
■ Making your blood vessels relax and widen
■ Making it easier for your heart to pump blood around your body.
Ramipril Tablets can be used:
■ To treat high blood pressure (hypertension)
■ To reduce the risk of you having a heart attack or stroke
■ To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)
■ To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)
■ As treatment following heart attack (myocardial infarction) complicated with heart failure.
2. Before you take Ramipril Tablets
Do not take Ramipril Tablets:
■ If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the other ingredients of Ramipril Tablets (see Section 6)
Signs of an allergic reaction may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
■ If you have ever had a serious allergic reaction called "angioedema”. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
■ If you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Ramipril Tablets may not be suitable for you If
you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis)
■ During the last 6 months of pregnancy (see section below on "Pregnancy and breastfeeding)
■ If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment.
■ Do not take Ramipril Tablets if any of the
above apply to you. If you are not sure, talk to your doctor before taking Ramipril Tablets.
Take special care with Ramipril Tablets:
Check with your doctor or pharmacist before taking your medicine:
■ If you have heart, liver or kidney problems
■ If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis)
■ If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)
■ If you are going to receive an anesthetic. This may be given for an operation or any dental work. You may need to stop your Ramipril Tablets treatment one day beforehand; ask your doctor for advice
■ If you have high amounts of potassium in your blood (shown in blood test results)
■ If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
■ You must tell your doctor if you think that you are (or might become) pregnant. Ramipril Tablets are
not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section "Pregnancy and breast-feeding".
Children
Ramipril Tablets are not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril Tablets in children has not yet been established.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Tablets. Taking Ramipril Tablets with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines). This is because Ramipril Tablets can affect the way some other medicines work. Also, some medicines can affect the way Ramipril Tablets work. Please tell your doctor if you are taking any of the following medicines. They can make Ramipril Tablets work less well:
■ Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin 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 Tablets:
■ Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin 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 Tablets:
■ Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril Tablets may
lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril Tablets
■ Lithium (for mental health problems). Ramipril Tablets may increase the amount of lithium in your blood. Your lithium amount 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 tablets.
Taking Ramipril Tablets with food and drink
■ Drinking alcohol with Ramipril Tablets may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril Tablets, discuss this with
your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.
■ Ramipril Tablets may be taken with or without food.
Pregnancy and breast-feeding
You must tell your doctor if you think you are (or might become) pregnant. You should not take Ramipril Tablets in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week, as their use during pregnancy may possibly be harmful to the baby.
If you become pregnant while on Ramipril Tablets, 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 Tablets if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy, while taking Ramipril tablets. This is more likely to happen when you start taking Ramipril tablets or start taking a higher dose. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Ramipril Tablets
Ramipril Tablets include a type of sugar called lactose anhydrous. If you have been told by your doctor that you are intolerant to some sugars and have to avoid them, contact your doctor before taking this medicine.
3. How to Take Ramipril Tablets
Always take Ramipril Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
■ Take this medicine by mouth at the same time of the day each day.
■ Swallow the tablets whole with liquid.
■ Do not crush or chew the tablets.
How much to take
Treatment of high blood pressure
■ The usual starting dose is 1.25 mg or 2.5 mg once daily.
■ Your doctor will adjust the amount you take until your blood pressure is controlled.
■ The maximum dose is 10 mg once daily.
■ If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Ramipril Tablets.
To reduce the risk of you having a heart attack or stroke
■ The usual starting dose is 2.5 mg once daily.
■ Your doctor may then decide to increase the amount you take.
■ The usual dose is 10 mg once daily.
Treatment to reduce or delay the worsening of kidney problems
■ You may be started on a dose of 1.25 mg or 2.5 mg once daily.
■ Your doctor will adjust the amount you are taking.
■ The usual dose is 5 mg or 10 mg once daily. Treatment of heart failure
■ The usual starting dose is 1.25 mg once daily.
■ Your doctor will adjust the amount you take.
■ The maximum dose is 10 mg daily. Two administrations per day are preferable.
Treatment after you have had a heart attack
■ The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
■ Your doctor will adjust the amount you take.
■ The usual dose is 10 mg daily. Two administrations per day are preferable.
Elderly
Your doctor will reduce the initial dose and adjust your treatment more slowly.
Ramipril has not been studied in children.
If you take more Ramipril Tablets 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.
If you forget to take Ramipril Tablets
■ 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 stop taking Ramipril Tablets
If you are having no problems with Ramipril Tablets, do not stop taking them without first talking to your doctor. If you nave any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Ramipril Tablets can cause side effects, although not everybody gets them.
Stop taking Ramipril Tablets and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
■ Swelling of the face, lips or throat which makes it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Ramipril Tablets
■ Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).
Tell your doctor immediately if you experience:
■ Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke
■ Shortness of breath or a cough. These could be signs of lung problems
■ Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems
■ Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas).
■ Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.
Other side effects include:
The frequency of side effects is classified as follows:
■ very common (more than 1 out of 10 persons),
■ common (more than 1 out of 100 persons and less than 1 out of 10 persons),
■ uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons),
■ rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons)
■ very rare (less than 1 out of 10,000 persons),
■ not known (cannot be estimated from the available data).
Please tell your doctor if any of the following gets serious or lasts longer than a few days.
Heart and blood circulation disorders
Common: Fainting, hypotension (abnormally low
blood pressure), especially when you stand or sit up quickly.
Uncommon: Increased or irregular heart beats.
Swollen arms and legs. This may be a sign of your body holding onto more water then usual. Flushing.
Rare: Narrowing of blood vessels. Blotches on
your skin and cold extremities. Skin rash or bruising.
Not known: Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon).
Blood and lymphatic disorders
Uncommon: An increased number of certain white blood cells (eosinophilia) found during a blood test.
Rare: Blood tests showing a decrease in the
number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.
Not known: Blood tests showing too few blood cells in your blood.
Nervous system disorders
Common: Headache, feeling dizzy. This is more
likely to happen when you start taking Ramipril Tablets or start taking a higher dose.
Uncommon: Balance problems (vertigo). Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia). Loss or change in the way things taste.
Rare: Feeling shaky.
Not known: Slowed or impaired reactions. Burning
sensation. Change in the way things smell.
Eye disorders
Uncommon: Blurred vision.
Rare: Red, itchy, swollen or watery eyes.
Ear disorders
Rare: Disturbed hearing or ringing in your ears.
Respiratory disorders
Common: Dry tickly cough. Inflammation of your
sinuses (sinusitis) or bronchitis. Shortness of breath.
Uncommon: Blocked nose. Difficulty breathing or worsening of asthma.
Gastrintestinal disorders
Common: Stomach or gut pain. Diarrhoea.
Indigestion. Feeling or being sick. Uncommon: Blood tests showing changes in the way your pancreas is working. A swelling in your gut called "intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea. Heartburn. Constipation or dry mouth.
Rare: Red and swollen tongue.
Not known: Swollen mouth.
Urinary disorders
Uncommon: Kidney dysfunction. Kidney failure.
Worsening of pre-existing kidney disease including passing of more protein in urine, passing more water (urine) than usual over the day. Blood tests showing changes in the way your kidneys are working.
Skin disorders
Common: Skin rash with or without raised area.
Uncommon: Itching. Sweating more than usual.
Rare: Severe flaking or peeling skin, itchy, lumpy
rash. Nail problems (e.g. loosening or separation of a nail from its bed).
Very Rare: Being more sensitive to the sun than usual.
Not known: Hair loss.
Muscle disorders
Common: Cramps or pain in your muscles.
Uncommon: Pain in your joints.
Digestion disorders
Common: Blood tests showing more potassium than
usual in your blood.
Uncommon: Loss or decrease of appetite (anorexia). Not known: Blood tests showing less sodium than usual in your blood.
Immune system disorders
Not known: Sudden onset (or rapidly progessive) severe systemic allergic reaction.
Liver and biliary disorders
Uncommon: Blood tests showing changes in the way your liver is working.
Not known: Severe liver damage (acute hepatic failure).
Reproductive system and breast disorders
Uncommon: Sexual inability in men, reduced sexual desire in men or women.
Not Known: Breast enlargement in men.
Psychiatric disorders
Uncommon: Feeling depressed, anxious, more
nervous than usual or restless. Sleep problems.
Rare: Confused.
Not known: Difficulty concentrating.
General disorders
Common: Chest pain. Feeling tired.
Uncommon: Fever.
Rare: Feeling weak.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to Store Ramipril Tablets
Keep out of the reach and sight of children.
Store below 25°C. Store in the original package in order to protect from moisture.
Do not use Ramipril Tablets after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of 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. Further Information
What Ramipril Tablets contain
■ The active substance is Ramipril.
■ The other ingredients are glycerol dibehenate, lactose anhydrous, sodium starch glycolate, sodium stearyl fumarate, ferric oxide yellow E172 (2.5 mg tablets only), and ferric oxide red E172 (5 mg tablets only).
What Ramipril Tablets look like and contents of the pack
Ramipril Tablets are available in four strengths: 1.25 mg, 2.5 mg, 5 mg and 10 mg.
■ 1.25 mg tablets are white, circular biconvex tablets with "B" embossed on one side of the tablet and ”48” on the other.
■ 2.5 mg tablets are light yellow coloured, capsule shaped, biconvex tablets with a score line on one side of the tablet, with "B" and "49" embossed on either side of the score line.
■ 5 mg tablets are light pink coloured, capsule shaped, biconvex tablets with a score line on one side of the tablet, with "B" and "50" embossed on either side of the score line.
■ 10 mg tablets are white, capsule shaped, biconvex tablets with a score line on one side of the tablet, with "B" and "51" embossed on either side of the score line.
Ramipril Tablets are available in blister packs of: 1.25 mg, 2.5 mg and 10 mg (28 tablets) and 5mg only (14 and 28 tablets).
Marketing Authorisation Holder
Niche Generics Limited, 1 The Cam Centre,
Wilbury Way, Hitchin, Herts, SG4 0TW, U.K.
Manufacturer
Niche Generics Limited, Unit 5, 151 Baldoyle Industrial Estate, Dublin, Ireland.
This leaflet was last approved in August 2012.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Ramipril 1.25 mg, 2.5 mg, 5 mg & 10 mg Tablets IE: Ramipril Niche 1.25 mg, 2.5 mg, 5 mg & 10 mg Tablets