RAMIPRIL 5 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take ramipril tablets

Do not take Ramipril Tablets

! If you are allergic to ramipril, any other ACE inhibitor medicine or any of the ingredients of this medicine 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.

! 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 have taken or are currently taking sacubitril/ valsartan, a medicine used to treat a type of long term (chronic) heart failure in adults

! 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 kidney is reduced (renal artery stenosis).

! During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”).

! 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 Tablets if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ramipril Tablets:

! 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 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 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”).

! If you are taking medicines or have conditions which may decrease sodium levels in your blood. Your doctor may carry out regular blood tests, particularly for checking the levels of sodium in your blood especially if you are elderly.

! If you are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadotril) or sacubitril/val­sartan. For sacubitril/val­sartan, see section 2 ‚Do not take Ramipril Capsules‘.

! If you 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, 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 Tablets”.

Children and adolescents

Ramipril Tablets are not recommended for use in children and adolescents below 18 years of age because the 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.

Other medicines and Ramipril Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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.

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 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.

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:

! Sacubitril/val­sartan – used for treating a type of long term (chronic) heart failure in adults (see section 2 ‚Do not take Ramipril tablets‘)

! 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, trimethoprim alone or in combination with sulfamethoxazole, also known as co-trimoxazole (for infections), potassium salts and heparin (for thinning blood).

! an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the body's immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”.

! Steroid medicines for inflammation such as prednisolone.

! Allopurinol (used to lower the uric acid in your blood).

! Procainamide (for heart rhythm problems).

! Temsirolimus (for cancer).

! Sirolimus, everolimus (for prevention of graft

rejection).

! Vildagliptin (used for treating type 2 diabetes).

! Racecadotril (used against diarrhoea)

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 Tablets” and “Warnings and precautions”).

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 alcohol

! 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

Pregnancy

You must tell your doctor if you think that 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.

Breast-feeding

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.

Information about ingredients

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium-free‘.

3. how to take ramipril tablets

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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.

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.

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 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 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:

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 Tablets 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 change 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.

Other side effects reported:

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.

! 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.

! 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.

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store ramipril tablets

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

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

6. contents of the pack and other information

What Ramipril Tablets contain

! The active substance is ramipril.

! The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, croscarmellose sodium, pregelatinised starch and sodium stearyl fumarate. The 2.5 mg and 5mg tablets also contain yellow iron oxide and the 5 mg tablets also contain red iron oxide.

What Ramipril Tablets look like and contents of the pack

Ramipril 1.25 mg Tablets: white to off white, oval shaped, flat tablets.

Ramipril 2.5 mg Tablets: yellow, oval shaped flat tablets scored on one side and side walls. Marked R2.

Ramipril 5 mg Tablets: pink oval shaped, flat tablets, scored on one side and side walls. Marked R3.

Ramipril 10 mg Tablets: white to off white, oval shaped, flat tablets scored on one side and side walls. Marked R4.

Pack sizes:

The tablets are supplied in blister packs of 7, 14, 21, 28, 30, 50 and 100. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd.

Unit C, Harcourt Way

Leicester, LE19 1WP, UK

Manufacturer

Actavis Limited

Reykjavikurvegur

78 IS-220

Hafnarfjordur Iceland.

This leaflet was last revised in August 2020.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.