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Ramipril 5 Mg Tablets

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Document: leaflet MAH GENERIC_PL 00289-0679 change

Package leaflet: Information for the patient Ramipril 5 and 10 mg Tablets Ramipril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..

•    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 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Ramipril is and what it is used for

2.    What you need to know before you take Ramipril

3.    How to take Ramipril

4.    Possible side effects

5.    How to store Ramipril

6.    Contents of the pack and other information

1. What Ramipril is and what it is used for

Ramipril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors. Ramipril works 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 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. What you need to know before you take Ramipril

Do not take Ramipril:

• If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of Ramipril listed in section 6.

Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

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•    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 may not be suitable for you

•    If you have kidney problems where the blood supply to your kidney 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

•    If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Do not take Ramipril if any of the above apply to you. If you are not sure, talk to your doctor before

taking Ramipril.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril:

•    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 anaesthetic. This may be given for an operation or any dental work. You may need to stop your Ramipril 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 are taking medicines or have conditions which may decrease sodium levels in your blood. Your doctor may carry out regular blood tests to check the levels of sodium in your blood, especially in elderly patients.

•    If you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin as they may increase the risk of angioedema, a serious allergic reaction.

•    If you have 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 is 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”.

•    If you are taking any of the following medicines used to treat high blood pressure:

-    an angiotensin II receptor blocker (ARBs) (alsoknown as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

-    Aliskiren

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 is not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril 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. Other medicines and Ramipril

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 can affect the way some other medicines work. Also some medicines can affect the way Ramipril works.

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 Anti-Inflammatory 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 Anti-Inflammatory 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).

•    Trimethoprim and co-trimoxazole (for infections caused by bacteria)

•    Temsirolimus (for cancer)

•    Everolimus (for prevention of graft rejection)

•    Vildagliptin (used for treating type 2 diabetes)

•    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 TRITACE” and “Warnings and precautions”).

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 amounts. Check your blood sugar amounts closely while taking Ramipril

•    Lithium (for mental health problems). Ramipril may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked by your doctor.

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”

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril. Ramipril with food and alcohol

•    Drinking alcohol with Ramipril may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.

•    Ramipril may be taken with or without food.

Pregnancy, breast-feeding and fertility

You must tell your doctor if you think you are (or might become) pregnant. You should not take Ramipril in the first 12 weeks of pregnancy, and you must not take them at all after the 13 th week as their use during pregnancy may possibly be harmful to the baby.

If you become pregnant while on Ramipril, 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 if you are breast-feeding.

Ask your doctor for advice before taking any medicine.

Driving and using machines

You may feel dizzy, while taking Ramipril. This is more likely to happen when you start taking Ramipril or start taking a higher dose. If this happens, do not drive or use any tools or machines.

3. How to take Ramipril

Always take this medicine exactly as your doctor has told you. 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/capsules whole with liquid.

•    Do not crush or chew the tablets/capsules.

How much to take

Treatment of high blood pressure

   The recommended 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.

To reduce the risk of you having a heart attack or stroke

   The recommended 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 recommended 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 recommended 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.

If you take more Ramipril 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

•    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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

Not known: frequency cannot be estimated from the available data

•    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

Rare: may affect up to 1 in 1,000 people

•    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:

Uncommon: may affect up to 1 in 100 people

•    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 Rare: may affect up to 1 in 1,000 people

•    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 problems Uncommon: may affect up to 1 in 100 people

•    Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas).

Not known: frequency cannot be estimated from the available data

•    bone marrow problems

•    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:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Common: may affect up to 1 in 10 people

•    Headache or feeling tired

•    Feeling dizzy. This is more likely to happen when you start taking Ramipril or start taking a higher dose

•    Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly

•    Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath

•    Stomach or gut pain, diarrhoea, indigestion, feeling or being sick

•    Skin rash with or without raised area

•    Chest pain

•    Cramps or pain in your muscles

•    Blood tests showing more potassium than usual in your blood.

Uncommon: may affect up to 1 in 100 people

•    Balance problems (vertigo)

•    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

•    Sleep problems

•    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

•    Heartburn, constipation or dry mouth

•    Passing more water (urine) than usual over the day

•    Sweating more than usual

•    Loss or decrease of appetite (anorexia)

•    Increased or irregular heartbeats

•    Swollen arms and legs. This may be a sign of your body holding onto more water than usual

•    Flushing

•    Blurred vision

•    Pain in your joints

•    Fever

•    Sexual inability in men, reduced sexual desire in men or women

•    An increased number of certain white blood cells (eosinophilia) found during a blood test

•    Blood tests showing changes in the way your liver, pancreas or kidneys are working.

Rare: may affect up to 1 in 1,000 people

•    Feeling shaky or confused

•    Red and swollen tongue

•    Severe flaking or peeling of the skin, itchy, lumpy rash

•    Nail problem (e.g. loosening or separation of a nail from its bed)

•    Skin rash or bruising

•    Blotches on your skin and cold extremities

•    Red, itchy, swollen or watery eyes

•    Disturbed hearing and ringing in your ears

•    Feeling weak

•    Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.

Very rare: may affect up to 1 in 10,000 people

•    Being more sensitive to the sun than usual.

Not known: frequency 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.

•    Difficulty concentrating

•    Swollen mouth

•    Blood tests showing too few blood cells in your blood

•    Blood tests showing less sodium than usual in your blood

•    Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)

•    Breast enlargement in men

•    Slowed or impaired reactions

•    Burning sensation

•    Change in the way things smell

•    Hair loss

•    Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms contact your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system Yellow Card Scheme Website: 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

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package. Do not use this medicine after the expiry date that is stated on the outer packaging.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Ramipril contains

•    The active ingredient is ramipril. Each tablet contains 5 or 10 mg of ramipril

•    The other ingredients are microcrystalline cellulose, sodium stearyl fumarate and magnesium hydroxide. The 5 mg tablets also contain the colour, iron oxide (E172).

What Ramipril looks like and contents of the pack

•    Ramipril 5 mg Tablets are pink, round tablets, scored on both sides and debossed with “5” on one side of the score and with “RL” on the other side of the score

•    Ramipril 10 mg Tablets are white to off-white, round tablets, scored on both sides and debossed with “10” on one side of the score and with “RL” on the other side of the score.

•    The 5 mg tablets are available in pack sizes of 14, 20, 28, 30, 50, 56, 98, 100, 200 & 500 tablets. Hospital packs of 50, 300 (10x30) & 500 tablets.

•    The 10 mg tablets are available in pack sizes of 20, 28, 30, 50, 56, 98, 100, 200 & 500 tablets. Hospital packs of 50, 300 (10x30) & 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: September 2016

PL 00289/0679-80

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