RAMIPRIL 10 mg Коированная Таблетка

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1. Ramipril ratiopharm Italia 10 mg tablets
   1. What is Ramipril ratiopharm Italia and what it is used for
   2. What you need to know before taking Ramipril ratiopharm Italia
   3. How to take Ramipril ratiopharm Italia
   4. Possible side effects
   5. How to store Ramipril ratiopharm Italia
   6. Contents of the pack and other information

Ramipril ratiopharm Italia 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ramipril ratiopharm Italia is and what it is used for

2. What you need to know before you take Ramipril ratiopharm Italia

3. How to take Ramipril ratiopharm Italia

4. Possible side effects

5. How to store Ramipril ratiopharm Italia

6Contents of the pack and other information

1. What is Ramipril ratiopharm Italia and what it is used for

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

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

Ramipril ratiopharm Italia can be used:

• To treat high blood pressure (hypertension)
• To reduce the risk of having a heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems (whether or not diabetes is present)
• To treat its heart when it cannot pump a sufficient volume of blood to 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 ratiopharm Italia

Do not take Ramipril ratiopharm Italia

• If you are allergic to ramipril, to other ACE inhibitor drugs 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 the lips, face, throat or tongue.
• If you have had a serious allergic reaction called “angioedema”. These signs include itching, skin rash (urticaria), red patches on the hands, feet and throat, swelling

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of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

• If you are in dialysis or undergoing any other type of blood filtration. Depending on the machinery used, Ramipril ratiopharm Italia may not be suitable for you.
• If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
• 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.
• If you have taken or are taking 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 in areas such as the throat).

Do not take Ramipril ratiopharm Italia if any of the above conditions apply to you. If you are not
sure, ask your doctor before taking Ramipril ratiopharm Italia.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril ratiopharm Italia:

• 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, diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis)
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization)
• If you are taking any of the following medicines used to treat high blood pressure: an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes. aliskiren. Your doctor should check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under "Do not take Ramipril ratiopharm Italia”.
• If you are about to undergo anesthesia. This may be given for surgery or dental treatment. You may need to stop taking Ramipril ratiopharm Italia 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 medicines or have conditions that can reduce the levels of sodium in your blood. Your doctor may prescribe blood tests at regular intervals, especially to check the levels of sodium in your blood, particularly if you are elderly
• If you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-black patients
• If you are taking any of the following medicines, the risk of angioedema, a serious allergic reaction (rapid swelling under the skin in areas such as the throat) may be increased: racecadotril, a medicine used to treat diarrhea; 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 might become pregnant). Ramipril ratiopharm Italia is not recommended in the first 3 months of pregnancy and it can cause

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serious harm to the baby after the third month of pregnancy (see section “Pregnancy
and breastfeeding”).

Children and adolescents
The use of Ramipril ratiopharm Italia is not recommended in children and adolescents under the age of 18
years as the safety and efficacy of Ramipril ratiopharm Italia in children have not
been established.
If any of the above conditions apply to you (or you are not sure), ask your doctor before
taking Ramipril ratiopharm Italia.

Other medicines and Ramipril ratiopharm Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Ramipril ratiopharm Italia can affect the mechanism
of action of some other medicines. Also some medicines can affect the mechanism
of action of Ramipril ratiopharm Italia.
Tell your doctor if you are taking any of the following medicines. These medicines can interfere
with Ramipril ratiopharm Italia altering its action:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin)
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor should check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken with
Ramipril ratiopharm Italia, can increase the likelihood of side effects:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril ratiopharm Italia”)
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin)
• Cancer medicines (chemotherapy)
• Diuretics such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots)
• Steroid medicines for treating inflammation such as prednisolone
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems)
• Medicines that are more often used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (used to treat diarrhea).

Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see
also what is stated under "Do not take Ramipril ratiopharm Italia” and “Warnings and
precautions”).
Tell your doctor if you are taking any of the following medicines. The mechanism of action of these
medicines may be affected by Ramipril ratiopharm Italia:
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• Diabetes medicines such as oral hypoglycemic agents and insulin. Ramipril ratiopharm Italia can lower the amount of sugar in the blood. Carefully check your blood sugar levels when taking Ramipril ratiopharm Italia.
• Lithium (for psychiatric problems). Ramipril ratiopharm Italia can increase the amount of lithium in the blood. Your doctor must carefully monitor the level of lithium in your blood.

If any of the above conditions apply to you (or you are not sure), ask your doctor before
taking Ramipril ratiopharm Italia.

Ramipril ratiopharm Italia with food and alcohol

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or there is a possibility of starting
a pregnancy).
You must not take Ramipril ratiopharm Italia in the first 12 weeks of pregnancy and must not
take it at all after the 13th week because its use during pregnancy can be
harmful to the baby. If you become pregnant while taking Ramipril ratiopharm Italia,
tell your doctor immediately. Before planning a pregnancy, a switch to another more suitable drug must be made.
Breastfeeding
You must not take Ramipril ratiopharm Italia if you are breastfeeding.

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

Ramipril ratiopharm Italia contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

Ramipril ratiopharm Italia contains sodium
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Ramipril ratiopharm Italia

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

How much to take

Treatment of high blood pressure

• The recommended starting dose is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the quantity you take until your blood pressure is under control.
• The maximum daily dose is 10 mg.

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• If you are already taking diuretics, your doctor may interrupt them or reduce the quantity before starting treatment with Ramipril ratiopharm Italia.

To reduce the risk of heart attack or stroke

• The recommended starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the amount you are taking.
• The usual dose is 10 mg per 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.
• The doctor will adjust the quantity you are taking.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

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

Elderly
The doctor will reduce the initial dose and adjust the treatment more slowly.

Taking this medicine

• Take the medicine by mouth at the same time of day, every day.
• Swallow the tablets with some liquid.
• Do not break the tablets or chew them.
• The tablet can be divided into equal doses.

If you take more Ramipril ratiopharm Italia than you should
Inform your doctor or go to the emergency room of the nearest hospital. Do not drive to go
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 ratiopharm Italia

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

If you have any doubts about the use of this medicine, consult 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 ratiopharm Italia and contact your doctor immediately if you notice the onset of any serious side effect – you may need urgent medical treatment:
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• 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 ratiopharm Italia.
• 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).

Tell 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 can 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 easy onset of infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These can be signs of circulatory or bone marrow problems.
• Severe stomach pain that can 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 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 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 therapy with Ramipril ratiopharm Italia is just started or you have just increased the 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 unwell or malaise
• Rash with or without swelling
• Chest pain
• Cramps or muscle pain
• Blood tests show a higher than normal level of potassium.

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

• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• 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
• Impaired kidney function, acute renal failure
• Increased sweating than usual

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• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat
• Arms and legs swelling. This may be a sign that your body is retaining more water than usual
• Hot flushes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increased number of white blood cells (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 disturbances 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 10000)
• Increased sensitivity to the sun.

Not known:frequency cannot be estimated based on available data

• Concentrated urine (dark in color), feeling unwell, muscle cramps, confusion and seizures that may be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Difficulty concentrating
• Mouth ulcers
• Blood tests showing increased levels of antibodies
• Blood tests showing a low number of blood cells
• Blood tests showing a low level of sodium in the blood
• Fingers of the hands and feet that change color when cooled and that 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
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5. How to store Ramipril ratiopharm Italia

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ramipril ratiopharm Italia contains
The active ingredient is ramipril.
Each tablet contains 10 mg of ramipril
The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, croscarmellose
sodium, pregelatinized starch, sodium stearyl fumarate

Description of the appearance of Ramipril ratiopharm Italia and contents of the pack
White to off-white, capsule-shaped, uncoated, flat tablets, 11.0 x 5.5 mm, engraved on
one side and on the lateral walls, with R/4 imprinted.
Packs of 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets in blisters or in PP container with
desiccants and PE cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Italy: Ramipril ratiopharm Italia 10 mg tablets
ask your doctor or pharmacist if you have any questions or are unsure about something.
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