RAMIPRIL 2.5 мг Коированные таблетки

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1. Ramipril Mylan Generics 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. WHAT IS RAMIPRIL MYLAN GENERICS AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING RAMIPRIL MYLAN
   3. HOW TO TAKE RAMIPRIL MYLAN GENERICS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RAMIPRIL MYLAN GENERICS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Ramipril Mylan Generics 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Generic Equivalent 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 Ramipril Mylan Generics is and what it is used for
• 2. What you need to know before you take Ramipril Mylan Generics
• 3. How to take Ramipril Mylan Generics
• 4. Possible side effects
• 5. How to store Ramipril Mylan Generics 6 Contents of the pack and other information

1. WHAT IS RAMIPRIL MYLAN GENERICS AND WHAT IS IT USED FOR

Ramipril Mylan Generics contains a medicine called ramipril which belongs to the
group of drugs called ACE inhibitors (Angiotensin Converting Enzyme
Inhibitors).
Ramipril Mylan Generics 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 Mylan Generics 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 you have diabetes).
• To treat your 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 MYLAN

GENERICS
Do not take Ramipril Mylan Generics

• If you are allergic (hypersensitive) to ramipril, to other ACE inhibitor medicines or to any of the other ingredients of Ramipril Mylan Generics 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 (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 are on dialysis or undergoing any other type of blood filtration. Depending on the machinery used, Ramipril Mylan Generics 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 Mylan Generics if any of the above conditions apply to you. If
you are not sure, ask your doctor before taking Ramipril Mylan Generics.

Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL MYLAN GENERICS:

• 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 about to have an anaesthetic. This may be given for surgery or dental treatment. You may need to stop taking Ramipril Mylan Generics 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 are in conditions that may cause the levels of sodium in your blood to decrease. 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 have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
• You must tell your doctor if you think you may be pregnant (or might become pregnant). Ramipril Mylan Generics is not recommended during the first trimester of pregnancy and can cause serious harm to the baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you are taking any 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.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) 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.

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 what is stated under "Do not take Ramipril Mylan Generics"

Children and adolescents
The use of Ramipril Mylan Generics is not recommended in children and adolescents under
the age of 18 years because the safety and efficacy of Ramipril Mylan Generics in
children have not yet been established..

Other medicines and Ramipril Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This is because Ramipril Mylan Generics can
influence the mechanism of action of some other medicines. Also some medicines
can influence the mechanism of action of Ramipril Mylan Generics.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with Ramipril Mylan Generics by 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 will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken
with Ramipril Mylan Generics, 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).
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), angiotensin receptor blockers and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for treating bacterial infections; cyclosporine, an immunosuppressant medicine 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).
• Vildagliptin (oral medicine to lower glucose). See section “Warnings and precautions”.
• Temsirolimus (used for cancer). See section “Warnings and precautions”.
• Sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults. See section “Do not take Ramipril Mylan Generics”
• Racecadotril (used for the treatment of diarrhoea). See section “Warnings and precautions”.
• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “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 Mylan Generics:

• Medicines for diabetes such as oral hypoglycaemic agents and insulin. Ramipril Mylan Generics may lower the amount of sugar in your blood. Carefully check your blood sugar levels when taking Ramipril Mylan Generics.
• Lithium (for psychiatric problems). Ramipril Mylan Generics may increase the amount of lithium in your blood. The level of lithium in your blood must be carefully monitored by your doctor.

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 under "Do not take Ramipril Mylan Generics" and "Warnings and precautions “)

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

Taking Ramipril Mylan Generics with food and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant).
You must not take Ramipril Mylan Generics during the first 12 weeks of pregnancy and you must not
absolutely take it after the 13th week because its use could be
harmful to the baby.
If you become pregnant while taking Ramipril Mylan Generics, inform
your doctor immediately.
Before planning a pregnancy, a switch to another medicine must be
made.
Breastfeeding
You must not take Ramipril Mylan Generics if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

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

Important information about some of the ingredients of Ramipril Mylan Generics
Ramipril Mylan Generics contains lactose sugar.
If you have been diagnosed with intolerance to some sugars, contact your doctor before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. HOW TO TAKE RAMIPRIL MYLAN GENERICS

Always take Ramipril Mylan Generics exactly as your doctor has told you.
Ask your doctor or pharmacist if you are not sure.

Taking this medicine

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

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 Mylan Generics.

Treatment 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.

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

If you forget to take Ramipril Mylan Generics

• 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 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, Ramipril Mylan Generics can cause side effects, although
not everyone gets them.

Stop taking Ramipril Mylan Generics and contact your doctor immediately
if you notice any serious side effect – you may need
urgent medical treatment:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to Ramipril Mylan Generics.
• 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:

• Fast heartbeat, 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 of
tiredness, weakness, dizziness or pale skin. These can 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, nausea, 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(affect less than 1 in 10 patients in treatment)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to happen when treatment with Ramipril Mylan Generics is just started or has just been increased.
• Weakness, low blood pressure (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, nausea or vomiting.
• Rash with or without swelling.
• Chest pain.
• Muscle cramps or pain.
• Blood tests show a higher than normal level of potassium.

Uncommon(affect less than 1 in 100 patients in treatment)

• Problems with balance (dizziness).
• 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.
• Increased sweating than usual.
• Loss or decrease of appetite (anorexia).
• Fast or irregular heartbeat.
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in males, reduced sexual desire in men and women.
• Increase in the number of white blood cells (eosinophilia) found during blood tests.
• Changes in liver, pancreas or kidney function highlighted by blood tests.

Rare(affect less than 1 in 1,000 patients in treatment)

• 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 problems 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(affect less than 1 in 10,000 patients in treatment)

• Increased sensitivity to the sun.

Not known

• concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate production of ADH (anti-diuretic hormone). If you experience these symptoms contact your doctor promptly

Other side effects observed:
Tell 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 a too low number of blood cells.
• Blood tests showing a low level of sodium in the blood.
• Fingers of hands and feet that change color when cooled and that tingle or hurt when warmed (Raynaud's phenomenon).
• Increase in the volume of the breast in men.
• Slowed or altered reactions.
• Burning sensation.
• Change in the perception of smells.
• Hair loss.

If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE RAMIPRIL MYLAN GENERICS

Keep Ramipril Mylan Generics out of sight and reach of children .
Do not store at a temperature above 25°C.
Do not use Ramipril Mylan Generics after the expiry date which is stated on the
packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of 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 Mylan Generics contains
The active ingredient is ramipril.
The excipients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose,
pregelatinized starch, sodium stearyl fumarate, yellow iron oxide (E172) (only in the
2.5 and 5 mg tablets), red iron oxide (E172) (only in the 5 mg tablets).

Description of the appearance of Ramipril Mylan Generics and contents of the pack
Packs of 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets in Al/Al blisters.
Not all pack sizes may be marketed.
Appearance of the tablets:
2.5 mg: yellow, capsule-shaped, uncoated, flat tablets, 10.0 x 5.0 mm, with a fracture line
on one side and imprinted with “R2” on both sides.
5 mg: pink, capsule-shaped, uncoated, flat tablets, 8.8 x 4.4 mm, with a fracture line on
one side and imprinted with “R3” on both sides.
10 mg: white to off-white, capsule-shaped, uncoated, flat tablets, 11.0 x 5.5
mm with a fracture line on one side and imprinted with “R4” on both sides.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturers responsible for batch release:
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun
ZTN 3000
Malta
Actavis hf.
Reykjavikurvegur 76-78
220 Hafnarfjörður,
Iceland

This leaflet was last revised on: