• 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 signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 and difficulty in 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 Capsules 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 Capsules if any of the above apply to you. If you are not sure, talk to your doctor before taking this medicine.

Talk to your doctor or pharmacist before taking Ramipril Capsules:

• 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 treatment with Ramipril Capsules 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, 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) or vildagliptin, neprilysen (NEP) inhibitors (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Capsules”
• 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 Capsules 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 below on “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) (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 Capsules”.

Ramipril is 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 apply to you (or you are not sure), talk to your doctor before taking Ramipril Capsules.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because ramipril can affect the way some other medicines work. Also, some medicines can affect the way ramipril works.

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.

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 Capsules

• Sacubitril/valsartan – used for treating a type of long term (chronic) heart failure in adults (see section 2 ‘Do not take Ramipril Capsules’)
• 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, trimethoprim alone or in combination with sulfamethoxazole (for infections) 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)
• 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 Capsules” and “Warnings and precautions”.

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 Capsules
• Lithium (for mental health problems) as ramipril 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 Capsules.

• 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 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.

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant.

You should not take Ramipril Capsules 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 Capsules, 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 Capsules if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

The 2.5mg and 5mg capsules contain sunset yellow (E110).

The 5mg capsules contain carmoisine (E122).

The 2.5mg and 10mg capsules contain ponceau 4R (E124).

These colourants can cause allergic reactions including asthma. Allergy is more common in patients who are allergic to aspirin.

Treatment of high blood pressure

• The recommended 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.
• 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 Capsules.

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

• The recommended starting dose is 2.5mg once daily.
• Your doctor may then decide to increase the amount you take.
• The usual dose is 10mg once daily.

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 recommended 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 recommended starting dose is 1.25mg once daily to 2.5mg twice daily.
• Your doctor will adjust the amount you 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.

• Take this medicine by mouth at the same time each day.
• Swallow the capsules whole with liquid.
• Do not crush or chew the capsules.

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 miss a dose, take your normal dose when it is next due.
• Do not take a double dose to make up for a forgotten capsule.

• 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
• 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).

• 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 or any sign of bleeding (e.g. bleeding from the gums). Purple spots, blotching on the skin, 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.

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 problems (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
• 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.

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 www.mhra.gov.uk/yellowcard 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.

The active substance is ramipril (each capsule contains 1.25mg, 2.5mg, 5mg or 10mg of ramipril).

The other ingredients are pregelatinized maize starch, gelatin, purified water, sodium lauryl sulfate and titanium dioxide (E171).

In addition the capsules also contain the following colourants in the capsule shell:

• 1.25mg capsules: yellow iron oxide (E172)
• 2.5mg capsules: ponceau 4R (E124), patent blue V (E131) and sunset yellow (E110)
• 5mg capsules: sunset yellow (E110), carmoisine (E122) and quinoline yellow (E104)
• 10mg capsules: ponceau 4R (E124), indigo carmine (E132) and black iron oxide (E172).

The black printing ink contains shellac, ethanol, isopropanol, butanol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide (E172).

Your medicine is in the form of hard gelatin capsules.

The 1.25mg capsules have a white body and yellow cap with ‘RP 1.25’ printed in black.

The 2.5mg capsules are orange with ‘RP 2.5’ printed in black.

The 5mg capsules are red with ‘RP 5’ printed in black.

The 10mg capsules are purple with ‘RP 10’ printed in black.

Ramipril Capsules are available in blister packs or containers of 7, 14, 20, 21, 28, 30, 50, 56, 98, 100, 500 and 1000 capsules (not all pack sizes / types may be marketed).

Other sources of information:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only).

Please be ready to give the following information:

Product name Reference number

Ramipril 1.25mg Hard Capsules PL 29831/0621

Ramipril 2.5mg Hard Capsules PL 29831/0622

Ramipril 5mg Hard Capsules PL 29831/0623

Ramipril 10mg Hard Capsules PL 29831/0624

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