Ramipril Sun

Package leaflet: Information for the patient

Ramipril SUN 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ramipril SUN is and what it is used for
2. What you need to know before taking Ramipril SUN
3. How to take Ramipril SUN
4. Possible side effects
5. How to store Ramipril SUN
6. Contents of the pack and other information

1. What Ramipril SUN is and what it is used for

Ramipril SUN contains a medicine called ramipril. This belongs to a group of medicines
called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril SUN works by:

• Reducing the body's production of substances that can cause an increase in blood pressure.
• Relaxing and widening the blood vessels.
• Helping the heart to pump blood around the body more easily.

Ramipril SUN can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (with or without diabetes).
• To treat heart failure, when the heart is unable to pump enough blood to the rest of the body.
• As a treatment after a heart attack (myocardial infarction) when associated with heart failure.

2. What you should know before taking Ramipril SUN

Do not take Ramipril SUN:

• If you are allergic to ramipril, to other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have previously experienced a severe allergic reaction called "angioedema". Symptoms include itching, hives, red spots 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 taking or have taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).
• If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril SUN may not be suitable for you.
• If you have kidney problems due to insufficient blood supply to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section below “Pregnancy, breastfeeding and fertility”).
• If your blood pressure is excessively low or unstable. Your doctor must assess this.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Ramipril SUN if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Ramipril SUN.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril SUN:

• If you have heart, liver, or kidney problems.
• If you have lost significant amounts of salts or body fluids (due to illness such as vomiting, diarrhoea, excessive sweating, a low-salt diet, prolonged use of diuretics, or after dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are scheduled to receive anaesthesia, which may be administered during surgery or dental procedures. It may be necessary to stop taking Ramipril SUN the day before; consult your doctor.
• If you have high levels of potassium in your blood (detected by a blood test).
• If you are taking any of the following medicines, as the risk of angioedema may be increased:
  • Racecadotril, a medicine used to treat diarrhoea.
  • Medicines used to prevent rejection of transplanted organs or to treat cancer (such as temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.
• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you may be pregnant (or could become pregnant). Ramipril SUN is not recommended during the first trimester of pregnancy and can cause severe harm to the unborn baby after the first three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”).
• If you are taking any of the following medicines for high blood pressure:
  • An angiotensin-II receptor antagonist (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the section "Do not take Ramipril SUN".

Children and adolescents

The use of Ramipril SUN is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril SUN in children has not yet been established.

If any of the above conditions apply (or if you are unsure), consult your doctor before taking Ramipril SUN.

Other medicines and Ramipril SUN

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

This is because Ramipril SUN may affect how some other medicines work. In addition, some medicines may affect how Ramipril SUN works.

Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Ramipril SUN and alter its effect:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor should monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these with Ramipril SUN may increase the likelihood of side effects:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
• Cancer medicines (chemotherapy).
• Medicines to prevent rejection of transplanted organs, such as ciclosporin.
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (used to make the blood less likely to clot).
• Trimethoprim and cotrimoxazole (used for bacterial infections).
• Steroid medicines used to treat inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (used for heart rhythm problems).
• Temsirolimus (used to treat cancer).
• Sirolimus, everolimus (used to prevent transplant rejection).
• Vildagliptin (used to treat type 2 diabetes).

Your doctor may consider it necessary to adjust your dose and/or take additional precautions if you are taking an angiotensin-II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Ramipril SUN" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by Ramipril SUN:

• Medicines for diabetes, such as oral hypoglycaemics and insulin. Ramipril SUN may lower blood sugar levels. Monitor your blood glucose levels carefully when taking Ramipril SUN.
• Lithium (used for psychiatric conditions). Ramipril SUN may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels closely.

In particular, inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).

If any of the above conditions apply (or if you are unsure), consult your doctor before taking Ramipril SUN.

Ramipril SUN with food, drinks and alcohol

• Drinking alcohol together with Ramipril SUN may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol, if any, is safe to drink while taking Ramipril SUN, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril SUN can be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You must inform your doctor if you think you may be pregnant (or could become pregnant).

You must not take Ramipril SUN during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as it may harm the unborn baby.

If you become pregnant while taking Ramipril SUN, inform your doctor immediately. Before planning a pregnancy, you should switch to an alternative treatment more suitable for use during pregnancy.

Breastfeeding

You must not take Ramipril SUN if you are breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ramipril SUN may cause dizziness, especially when you first start taking it or after an increase in dose. If this occurs, do not drive or operate tools or machinery.

3. How to take Ramipril SUN

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
How much you should take
Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust your dose until your blood pressure is under control.
• The maximum daily dose is 10 mg.
• If you are already taking diuretics, your doctor may stop or reduce them before starting your treatment with Ramipril SUN.

To reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase your dose.
• The usual dose is 10 mg once daily.

Treatment to reduce or prevent 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 your dose accordingly.
• 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 your dose.
• The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Treatment after a heart attack

• The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose accordingly.
• The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Elderly patients
Your doctor will reduce the initial dose and adjust treatment more slowly.
How to take the medicine

• Take the medicine orally at the same time each day.
• Swallow the tablets whole with liquid.
• Do not break or chew the tablets.

If you take more Ramipril SUN than you should
Inform your doctor or go to the nearest hospital emergency department immediately. Do not drive to the hospital; have someone accompany you or call an ambulance. Bring the medicine pack with you, so the doctor knows what you have taken.
If you forget to take Ramipril SUN

• If you miss a dose, take your usual dose at the next scheduled time.
• Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Ramipril SUN and contact your doctor immediately if you experience any of the
following serious side effects; you may need urgent medical treatment:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching or skin rash. This could be a sign of a serious allergic reaction to Ramipril SUN.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more serious problems such as heart attack or stroke.
• Shortness of breath or cough. These may be signs of lung problems.
• Easy bruising, prolonged bleeding more than usual, any signs of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling of tiredness, fainting, dizziness or pale appearance. These may be signs of blood circulation or bone marrow problems.
• Severe stomach pain that may extend to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other side effects include
Inform your doctor if any of the following conditions become severe or persist for more than a few days:
Common (may affect up to 1 in 10 people):

• Headache or feeling of tiredness.
• Dizziness. This is more likely when you first start taking Ramipril SUN or when you start taking a higher dose.
• Fainting, hypotension (unusually low blood pressure), especially when standing up or rising quickly.
• Dry, persistent cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or malaise.
• Rash with or without swelling.
• Chest pain.
• Muscle cramps or muscle pain.
• Blood tests showing higher than normal potassium levels.

Uncommon (may affect up to 1 in 100 people):

• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling sensations (paraesthesia).
• Loss or change in taste.
• Sleep problems.
• Depressed mood, anxiety, increased nervousness or irritability.
• Stuffy nose, breathing difficulties or worsening of asthma.
• Swelling in the intestine called "intestinal angioedema", presenting with symptoms such as abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dry mouth.
• Increased amount of urine during the day.
• Increased sweating.
• Loss or decrease in appetite (anorexia).
• Fast or irregular heartbeat.
• Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, reduced sexual desire in men and women.
• Increase in the number of white blood cells (eosinophilia) detected in blood tests.
• Changes in liver, pancreas or kidney function as shown by blood tests.

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

• Feeling faint or confused.
• Swollen and red tongue.
• Severe peeling or shedding of the skin, itching, rash characterized by pustules.
• Nail problems (such as nail loss or separation of the nail from its bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Red, swollen, watery or itchy eyes.
• Hearing problems and ringing in the ears.
• Feeling of weakness.
• Decrease in the number of red blood cells, white blood cells, platelets or haemoglobin concentration, as shown by blood tests.

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

• Increased sensitivity to sunlight.

Not known (frequency cannot be estimated from the available data):

• Concentrated urine (dark in colour).
• Feeling unwell or malaise.
• Muscle cramps.
• Confusion and seizures which may be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experience these symptoms, contact your doctor promptly.

Other reported side effects:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.

• Difficulty in concentrating.
• Mouth swelling.
• Blood tests showing too low a number of blood cells.
• Blood tests showing low sodium levels in the blood.
• Fingers of hands and feet changing colour when cold and tingling or painful when warmed (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or altered reactions.
• Burning sensation.
• Change in perception of smells.
• Hair loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ramipril SUN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after “Exp.” The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ramipril SUN contains

• The active substance is ramipril.
• Each tablet contains 2.5 mg of ramipril.
• Each tablet contains 5 mg of ramipril.
• Each tablet contains 10 mg of ramipril.
• The other components are: hypromellose, microcrystalline cellulose, pregelatinized starch (maize), yellow iron oxide (in 5 mg and 10 mg) (E172), red iron oxide (in 2.5 mg) (E172), sodium stearil fumarate.

Description of the appearance of Ramipril SUN and package contents

• Ramipril SUN 2.5 mg are mottled pink to red tablets, 8.1 x 4.1 x 3.1 mm, oblong, marked with R and 18 on both sides of the breakline on one side and a breakline on the other side. The tablet can be divided into two equal doses.
• Ramipril SUN 5 mg are mottled yellow tablets, 8.1 x 4.1 x 3.15 mm, oblong, marked with R and 19 on both sides of the breakline on one side and a breakline on the other side. The tablet can be divided into two equal doses.
• Ramipril SUN 10 mg are mottled yellow tablets, 12.1 x 6.0 x 3.75 mm, oblong, marked with R and 20 on both sides of the breakline on one side and a breakline on the other side. The tablet can be divided into two equal doses.

Ramipril SUN is dispensed in:
Cold-formed blisters (OPA/Al/PVC/Al) and cold-formed blisters with incorporated desiccant
(OPA/Al/PE/desiccant/HDPE/Al).
Pack sizes:
Ramipril SUN 2.5 mg: 28, 30, 90, 100 tablets.
Ramipril SUN 5 mg: 14, 28, 30, 90, 100 tablets.
Ramipril SUN 10 mg: 28, 30, 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Manufacturers
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, Hoofddorp 2132 JH, The Netherlands
Terapia S.A., 124 Fabricii Str., 400 632 Cluj-Napoca, Romania

This medicinal product is authorized in the European Economic Area countries under the
following names:
France: Ramipril SUN 2.5 mg, comprimé sécable / Ramipril RPG 5 mg, comprimé sécable /
Ramipril SUN 10 mg, comprimé sécable
Spain: Ramipril Ranbaxy 5 mg comprimidos recubiertos con película EFG / Ramipril
Ranbaxy 10 mg comprimidos recubiertos con película EFG
Italy: Ramipril SUN
Lithuania: Ramipril Ranbaxy 5 mg tabletės / Ramipril Ranbaxy 10 mg tabletės
Poland: Ramicor
Romania: Ramiran 2.5 mg comprimate / Ramiran 5 mg comprimate / Ramiran 10 mg
comprimate
Sweden: Ramipril Ranbaxy 2.5 mg tabletter / Ramipril Ranbaxy 5 mg tabletter

This leaflet was last approved on: