RAMIPRIL 2.5 мг Таблетки

Содержание инструкции

1. Ramipril ABC 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. WHAT IS RAMIPRIL ABC AND WHAT IS IT USED FOR
   2. BEFORE TAKING RAMIPRIL ABC
   3. HOW TO TAKE RAMIPRIL ABC
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RAMIPRIL ABC
   6. OTHER INFORMATION

Ramipril ABC 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Ramipril

Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Ramipril ABC is and what it is used for
• 2. Before you take Ramipril ABC
• 3. How to take Ramipril ABC
• 4. Possible side effects
• 5. How to store Ramipril ABC
• 6. Further information

1. WHAT IS RAMIPRIL ABC AND WHAT IS IT USED FOR

Ramipril ABC contains a medicine called ramipril which belongs to the group of drugs
called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
RAMIPRIL ABC 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 ABC 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 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. BEFORE TAKING RAMIPRIL ABC

Do not take RAMIPRIL ABC:

• If you are allergic (hypersensitive) to ramipril, to other ACE inhibitor drugs or to any of the other ingredients of RAMIPRIL ABC listed in section 6. Signs of an allergic reaction can include skin rash, 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 in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you are undergoing dialysis or are undergoing any other type of blood filtration. Depending on the machinery used, Ramipril ABC 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 are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take RAMIPRIL ABC if any of the above conditions apply to you. If you are not sure,
ask your doctor before resuming RAMIPRIL ABC

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking RAMIPRIL ABC:

• 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 having dialysis)
• If you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization)
• If you are about to undergo anesthesia. This may be administered for surgery or dental work. You may need to stop taking Ramipril ABC the day before, ask your doctor for advice
• If you have a high amount of potassium in your blood (highlighted by a blood test)
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must inform your doctor if you think you are pregnant (or might become pregnant). Ramipril ABC 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 antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from 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.

See also what is reported in the section "Do not take RAMIPRIL ABC

Children
The use of Ramipril ABC is not recommended in children and adolescents under 18 years of age
because there is no information available for this population.
If any of the above conditions occur (or you are not sure), ask your doctor before
taking RAMIPRIL ABC.

Taking RAMIPRIL ABC with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those without a prescription (including
herbal medicines). This is because RAMIPRIL ABC can affect the
mechanism of action of some other medicines. Also some medicines can affect
the mechanism of action of RAMIPRIL ABC.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with RAMIPRIL ABC by altering its action:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine 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 ABC, can increase the likelihood of side effects:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Cancer medicines (chemotherapy)
• Medicines to prevent organ rejection after transplantation such as cyclosporine
• 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)
• Steroid medicines for the treatment of inflammation such as prednisolone
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems)

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

• Diabetes medicines such as oral hypoglycemic agents and insulin. RAMIPRIL ABC can lower blood sugar levels. Carefully check your blood sugar levels when taking RAMIPRIL ABC.
• Lithium (for psychiatric problems). Ramipril ABC can increase the amount of lithium in the blood. Your lithium levels in your blood must be carefully monitored by your doctor. If any of the above conditions occur (or you are not sure), ask your doctor before taking RAMIPRIL ABC.

Non-steroidal anti-inflammatory drugs and acetylsalicylic acid:when ACE inhibitors are
administered simultaneously with non-steroidal anti-inflammatory drugs (e.g. selective
Cox 2 inhibitors, acetylsalicylic acid starting from 325 mg/day and non-selective NSAIDs), an
attenuation of the antihypertensive effect may occur.
The concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of
worsening renal function including possible acute renal failure and
increased levels of serum potassium especially in patients with pre-existing
impaired renal function. The combination should be administered with caution
especially in the elderly. Patients should be adequately hydrated and monitoring of renal
function should be considered at the beginning of concomitant therapy.
The 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 reported in the section “Do not take RAMIPRIL ABC” and “Warnings and Precautions”

Taking RAMIPRIL ABC with food and alcohol

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

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

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

3. HOW TO TAKE RAMIPRIL ABC

Always take Ramipril ABC exactly as your doctor has told you. You should ask your doctor or pharmacist if you are unsure.

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 ABC.

To reduce the risk of heart attack or stroke

• The 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 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 ABC than you should
Tell 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 the medicine package with you.
This is because the doctor needs to know what you have taken.

If you forget to take Ramipril ABC

• 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 about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ramipril ABC can cause side effects, although not everybody gets them.

Stop taking Ramipril ABC and contact your doctor immediately if you notice the
appearance of any serious side effect – 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 ABC
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blistering and peeling 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, weakness, dizziness or pale skin. These can be signs of problems with blood circulation or the bone marrow
• Severe abdominal pain that extends 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 serious 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 ABC 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, 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(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
• 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 as highlighted by blood tests.

Rare(affect less than 1 in 1000 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 disorders and ringing in the ears
• Feeling of weakness
• Decrease in the number of red blood cells, white blood cells and platelets or hemoglobin concentration, highlighted by blood tests

Very rare(affect less than 1 in 10000 patients in treatment)

• Increased sensitivity to the sun

Other side effects reported:
Tell your doctor if any of the following conditions becomes serious 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 the 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 not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE RAMIPRIL ABC

Do not use RAMIPRIL ABC after the expiry date which is reported on the label. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25 °C
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.

KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

6. OTHER INFORMATION

What Ramipril ABC contains
Ramipril ABC 2.5 mg tablets:
One divisible tablet contains
Active ingredient: 2.5 mg Ramipril
Excipients: hypromellose, pregelatinized starch, microcrystalline cellulose, sodium
stearylfumarate, yellow iron oxide E172.
Ramipril ABC 5 mg tablets:
One divisible tablet contains
Active ingredient: 5 mg Ramipril
Excipients: hypromellose, pregelatinized starch, microcrystalline cellulose, sodium
stearylfumarate, red iron oxide E 172.
Ramipril ABC 10 mg tablets:
One divisible tablet contains
Active ingredient: 10 mg Ramipril
Excipients: hypromellose, pregelatinized starch, microcrystalline cellulose, sodium
stearylfumarate.

Pharmaceutical form and content
RAMIPRIL ABC 2.5 mg tablets
Divisible tablets. Pack of 28 tablets

RAMIPRIL ABC 5 mg tablets
Divisible tablets. Pack of 14 tablets

RAMIPRIL ABC 10 mg tablets
Divisible tablets. Pack of 28 tablets
The tablets can be divided into two equal halves

Marketing Authorisation Holder:ABC FARMACEUTICI S.P.A., Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturer:DOPPEL FARMACEUTICI SRL – Via Volturno, 48 – Quinto De Stampi 20084
Rozzano (MI)