RAMIPRIL 2.5 mg Coated tablets

Зміст інструкції

1. Ramipril SUN 2,5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is Ramipril SUN and what is it 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. Package Contents and Other Information

Ramipril SUN 2,5 mg tablets, 5 mg tablets, 10 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Ramipril SUN and what it is used for
• 2. What you need to know before you take 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 is Ramipril SUN and what is it used for

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

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure.
• Relaxing and widening blood vessels.
• Making it easier for the heart to pump blood around the body.

Ramipril SUN can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether or not diabetes is present).
• To treat the heart when it cannot pump enough blood around the rest of the body (heart failure).
• As treatment after a heart attack (myocardial infarction) if associated with heart failure.

2. What you need to know before taking Ramipril SUN

Do not take Ramipril SUN:

• If you are allergic to ramipril, to other ACE inhibitor medicines or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
• If you have had a serious allergic reaction called “angioedema”. The signs include itching, hives, red patches 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 taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).
• If you are on dialysis or undergoing any other type of blood filtration. Depending on the machine 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 will need to make this assessment.
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take Ramipril SUN if any of the above conditions apply to you. If you are not sure, ask 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 a lot of salts or body fluids (due to an illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are going to receive an anaesthetic. This may be given for surgery or dental treatment. It may be necessary to stop taking Ramipril SUN the day before; ask your doctor for advice.
• If you have a high amount of potassium in your blood (shown by a blood test).
• If you are taking any of the following medicines, the risk of angioedema may be increased.
• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you may be pregnant (or there is a possibility of starting a pregnancy). Ramipril SUN is not recommended during the first trimester of pregnancy, and can cause serious harm to the baby after the first 3 months of pregnancy, see section “Pregnancy, breastfeeding and fertility”).
• If you are taking one of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans, for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Also see what is stated in the section "Do not take Ramipril SUN”.

Children and adolescents
The use of Ramipril SUN is not recommended in children and adolescents under the age of 18 years
because the safety and efficacy of Ramipril SUN in children has not yet been established.
If any of the above conditions occur (or you are not sure), ask 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 can affect the mechanism of action of some other medicines.
Also some medicines can affect the mechanism of action of Ramipril SUN.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with Ramipril SUN by altering its action:

• 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 will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, when taken 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 organs after transplantation, such as ciclosporin.
• Diuretics such as furosemide.
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to make the blood more fluid).
• Trimethoprim and cotrimoxazole (for infections caused by bacteria).
• Steroid medicines for the treatment of inflammation such as prednisolone.
• Allopurinol (used to lower the amount of uric acid in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for the treatment of cancer).
• Sirolimus, everolimus (for the prevention of rejection after transplantation).
• Vildagliptin (used to treat type 2 diabetes).
• Your doctor may need to adjust the dose and/or take other precautions: If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated in the section "Do not take Ramipril SUN" and "Warnings andprecautions”).

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

• Medicines for diabetes such as oral hypoglycaemics and insulin. Ramipril SUN can lower the amount of sugar in the blood. Check your blood sugar levels carefully when taking Ramipril SUN.
• Lithium (for psychiatric problems). Ramipril SUN can increase the amount of lithium in the blood. Your doctor must check your lithium levels carefully.

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

• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that could increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots)

If any of the above conditions occur (or you are not sure), ask your doctor before
taking Ramipril SUN.

Ramipril SUN with food, drinks and alcohol

• Drinking alcoholic beverages together with Ramipril SUN may cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking Ramipril SUN, discuss this with your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• Ramipril SUN can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or there is a possibility of starting a
pregnancy).
You must not take Ramipril SUN in the first twelve weeks of pregnancy and must not
absolutely take it after the thirteenth week because its use can be harmful
to the baby.
If you become pregnant while taking Ramipril SUN, inform your doctor immediately. Before
planning a pregnancy, a switch to another more suitable alternative treatment must be made.

Breastfeeding
You must not take Ramipril SUN if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You may feel dizzy while taking Ramipril SUN. This is more likely when you have
just started taking Ramipril SUN or have just increased the dose. If this happens, do not
drive or use tools or machinery.

3. How to take Ramipril SUN

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.

How much to take
Treatment of high blood pressure

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

To reduce the risk of a heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the dosage you take.
• The usual dose is 10 mg once a day.

Treatment to reduce or prevent worsening of kidney problems

• You may be given to start a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

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

Elderly
Your doctor will reduce the starting dose and adjust the treatment more slowly.

Taking the medicine

• Take the medicine by mouth at the same time of day, every day.
• Swallow the tablets whole with some liquid.
• Do not break or chew the tablets.

If you take more Ramipril SUN than you should
Inform your doctor or go to the emergency room of the nearest hospital. Do not drive to
the hospital, have someone accompany you or call an ambulance. Bring with you the box of the
medicine. This is because the doctor needs to know what you have taken.

If you forget to take Ramipril SUN

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a missed dose.

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 everyone will experience them.

Stop taking Ramipril SUN and contact your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Swelling of the face, lips or throat that makes it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to Ramipril SUN.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath or cough. These may be signs of lung problems.
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, fainting, dizziness or pale skin. These may be signs of circulatory 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 becomes severe or persists for more 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 SUN or start taking a higher dose.
• Fainting, hypotension (unusually low blood pressure), especially when standing up or getting up quickly.
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhea, indigestion, feeling sick or unwell.
• Rash with or without swelling.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing a higher than normal level of potassium.

Not common(may affect up to 1 in 100 people):

• Problems with balance (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or creeping sensations (paresthesia).
• Loss or change of taste.
• Difficulty sleeping.
• Depressed mood, anxiety, increased nervousness than usual or irritability.
• Blocked nose, difficulty breathing or worsening of asthma.
• Swelling of the intestine called “intestinal angioedema” and which presents with symptoms such as abdominal pain, vomiting and diarrhea.
• Heartburn, constipation or dry mouth.
• Increased amount of urine during the day.
• Increased sweating than usual.
• Loss or decrease of appetite (anorexia).
• Fast or irregular heartbeat.
• Swollen arms and legs. This may be a sign that the body is retaining more water 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 in the blood (eosinophilia) found during blood tests.
• Changes in liver, pancreas or kidney function highlighted by blood tests.

Rare(may affect up to 1 in 1000 people):

• Feeling faint or confused.
• Swollen and red tongue.
• Severe flaking or peeling of the skin, itching, rash characterized by pustules.
• Problems with nails (such as loss or separation of the nail from its bed).
• Rash or bruising.
• Spots on the skin and cold extremities.
• Red, swollen, watery or itchy eyes.
• Hearing disorders and ringing in the ears.
• Feeling weak.
• Decrease in the number of red blood cells, white blood cells and platelets in the blood or hemoglobin concentration, highlighted by blood tests.

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

• Increased sensitivity to the sun.

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

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

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests showing too few blood cells.
• Blood tests showing a low level of sodium in the blood.
• Fingers and toes that change color when cooled and tingle or hurt when warmed (Raynaud's phenomenon).
• Increased breast volume in men.
• Slowed or altered reactions.
• Burning sensation.
• Change in the perception of smells.
• Hair loss.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . Reporting side effects helps to 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 which is 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 particular storage conditions.
• Do not dispose of any medicine in 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 ingredient is ramipril.
• Each tablet contains 2.5 mg of ramipril.
• Each tablet contains 5 mg of ramipril.
• Each tablet contains 10 mg of ramipril.
• Other ingredients are: hypromellose, microcrystalline cellulose, pregelatinized starch (corn), yellow iron oxide (in 5 and 10 mg) (E172), red iron oxide (in 2.5 mg) (E172), sodium stearyl fumarate.

Description of the appearance of Ramipril SUN and package contents

• Ramipril SUN 2.5 mg are tablets of colour from pink to mottled red, 8.1x4.1x3.1 mm, oblong with R and 18 on both sides of the score line on one side and score line on the other side. The tablet can be divided into two equal doses.
• Ramipril SUN 5 mg are tablets of colour from yellow to mottled yellow, 8.1x4.1x3.15 mm, oblong with R and 19 on both sides of the score line on one side and score line on the other side. The tablet can be divided into two equal doses.
• Ramipril SUN 10 mg are tablets of colour from yellow to mottled yellow, 12.1x6.0x3.75 mm, oblong with R and 20 on both sides of the score line on one side and score line on the other side. The tablet can be divided into two equal doses.

Ramipril SUN is dispensed in:
cold-formed blister packs (OPA/Al/PVC/Al) and cold-formed blister packs with incorporated desiccant
(OPA/Al/PE/desiccant/HDPE/Al).
Packs of:
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 Authorisation Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Netherlands

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
France: Ramipril SUN 2.5 mg, divisible tablet/Ramipril RPG 5 mg, divisible tablet/
Ramipril SUN 10 mg, divisible tablet
Spain: Ramipril Ranbaxy 5 mg film-coated tablets EFG/Ramipril
Ranbaxy 10 mg film-coated tablets EFG
Italy: Ramipril SUN
Lithuania: Ramipril Ranbaxy 5 mg tablets/Ramipril Ranbaxy 10 mg tablets
Poland: Ramicor
Romania: Ramiran 2.5 mg tablets/ Ramiran 5 mg tablets/Ramiran 10 mg
tablets
Sweden: Ramipril Ranbaxy 2.5 mg tablets/Ramipril Ranbaxy 5 mg tablets

This leaflet was last approved on: