QUARK 2.5 мг Коированная таблетка

Содержание инструкции

1. QUARK 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. WHAT QUARK IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING QUARK
   3. HOW TO TAKE QUARK
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE QUARK
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

QUARK 2.5 mg tablets, 5 mg tablets, 10 mg tablets

ramipril

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 give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT QUARK IS AND WHAT IT IS USED FOR

QUARK contains a medicine called ramipril which belongs to the group of medicines called
ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
QUARK 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.

QUARK 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 QUARK

Do not take QUARK:

• If you are allergic (hypersensitive) to ramipril, to other similar drugs (other ACE inhibitors) 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 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, QUARK may not be suitable for you
• If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
• In the last 6 months of pregnancy(see section below “Pregnancy and breastfeeding”)
• If your blood pressure is excessively low or unstable. The 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 QUARK if any of the above conditions apply to you. If you are not sure, ask your
doctor before taking QUARK.

Warnings and precautions
Talk to your doctor or pharmacist before taking QUARK:

• 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 the allergy to bee or wasp stings (desensitization)
• If you are about to undergo anesthesia. This may be administered for surgery or dental work. It may be necessary to stop treatment with QUARK 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 should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). QUARK is not recommended in the first three months of pregnancy and can cause serious harm to the baby if taken after three months of pregnancy (see section below “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
• The 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 under "What you need to know before taking QUARK"

Children and adolescents
The use of QUARK is not recommended in children and adolescents under the age of 18 because
the safety and efficacy of QUARK in children have not yet been established.
If any of the above conditions occur (or you are not sure), ask your doctor before
taking QUARK.

Other medicines and QUARK
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
This is because QUARK can influence the mechanism of action of some other medicines. Also
some medicines can influence the mechanism of action of QUARK.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere
with QUARK 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. The 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
QUARK, 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, 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).
• Trimethoprim and cotrimoxazole (for infections caused by bacteria)
• Temsirolimus (for cancer)
• Everolimus (to prevent graft rejection)

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

• Diabetes medicines such as oral hypoglycemic agents and insulin. QUARK may lower blood sugar levels. Carefully check your blood sugar levels when taking QUARK.
• Lithium (for psychiatric problems). QUARK may increase the amount of lithium in the blood. Your lithium levels in the blood must be carefully monitored by your doctor.
• 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 under “Before taking QUARK” and “Pay particular attention with
QUARK”
If any of the above conditions occur (or you are not sure), ask your doctor before
taking QUARK.

QUARK with food and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant).
You should not take QUARK in the first 12 weeks of pregnancy and should not take it at all
after the thirteenth week as use during pregnancy can be harmful to the baby.
Immediately inform your doctor if you are pregnant while being treated with Quark. In
advance of a planned pregnancy, a transition to an adequate alternative treatment should be performed.

Breastfeeding
You should not take QUARK if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine

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

3. HOW TO TAKE QUARK

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

Taking this 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.

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 QUARK. To reduce the risk of a 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 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 QUARK 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 QUARK

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

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Stop taking QUARK and contact your doctor immediately if you notice any of the following serious side effects – 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 skin rash. This could be a sign of a severe allergic reaction to QUARK.
• Severe skin reactions including skin 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, fever, feeling tired, weak, dizziness or pale skin. These can be signs of problems with blood circulation or bone marrow
• Severe stomach pain that can extend to the back. This can 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 (liver inflammation) 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 people being treated)

• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when treatment with QUARK is first started or the dose has just been increased
• Weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or generally unwell
• Skin 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 people being treated)

• 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 diarrhoea
• 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 can 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
• 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 1000 people being treated)

• 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 concentration of hemoglobin, highlighted by blood tests.

Very rare(affect less than 1 in 10000 people being treated)

• Increased sensitivity to the sun.

Not known(the frequency cannot be estimated on the basis of the available data)

• Concentrated urine (dark in colour), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (anti-diuretichormone[antidiuretic 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 too few blood cells.
• Blood tests showing a low level of sodium in the blood
• Fingers of the hands and feet that change colour 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, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. Reporting of side effects helps to provide more information on the safety of this medicine.”

5. HOW TO STORE QUARK

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 pack after “Scad”. 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. CONTENTS OF THE PACK AND OTHER INFORMATION

What QUARK contains

Quark2.5 mg tablets
One divisible tablet contains:

The active ingredient is: ramipril 2.5 mg.

The other excipients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose,
sodium stearylfumarate, yellow iron oxide E 172.

Quark 5 mg tablets
One divisible tablet contains:

The active ingredient is: ramipril 5 mg.

The other excipients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose,
sodium stearylfumarate, red iron oxide E 172.

Quark 10mg tablets
One divisible tablet contains:

The active ingredient is: ramipril 10 mg.

The other excipients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose,
sodium stearylfumarate.

Description of the appearance of QUARK and contents of the pack
Tablets.

Quark 2.5 mg tablets
Divisible tablets. Pack of 28 tablets.

Quark 5 mg tablets
Divisible tablets. Pack of 14 tablets.

Quark 10 mg tablets
Divisible tablets. Pack of 28 tablets.

Marketing Authorisation Holder
AIC Holder:
POLIFARMA S.p.A. Viale dell’Arte, 69 – 00144 ROMA

Manufacturer:
Sanofi S.p.A. S.S. n. 17, km. 22 – 67019 Scoppito (AQ)
Istituto De Angeli S.r.l. – Località Prulli 103/C – 50066 Reggello (FI)