Quark

Italy
Brand name Quark
Form tablets
Active substance / Dosage
RAMIPRIL
Prescription type Prescription only
ATC code
C09AA05
Registration number 027162
Manufacturer POLIFARMA S.P.A.

Table of Contents

Patient Information Leaflet

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

ramipril
Please read all of this leaflet carefully before you take this medicine because 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 others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 a group of medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
QUARK works by:

  • Reducing the body's production of substances that can cause an increase in blood pressure
  • Relaxing and widening your blood vessels
  • Helping your heart pump blood more easily around the body.

QUARK can be used:

  • To treat high blood pressure (hypertension)
  • To reduce the risk of heart attack or stroke
  • To reduce the risk or delay the worsening of kidney problems (with or without diabetes)
  • To treat heart failure, when your heart is unable to pump enough blood to the rest of the body
  • As a treatment after a heart attack (myocardial infarction), when 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 medicines (other ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
  • If you have previously experienced a severe allergic reaction called "angioedema." These signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
  • If you are taking or have taken 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 beneath the skin, for example in the throat).
  • If you are taking any of the following medicines, as 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 are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, QUARK 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 assess this.
  • If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take QUARK if any of the above conditions apply to you. If you are unsure, consult 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 significant amounts of salts or body fluids (due to illness such as vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of oral diuretics, or after dialysis).
  • If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
  • If you are about to undergo anaesthesia, which may be administered during surgery or dental procedures. You may need to stop taking QUARK the day before; consult your doctor.
  • If you have high levels of potassium in your blood (shown by a blood test).
  • If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
  • You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). QUARK is not recommended during the first three months of pregnancy and may cause serious harm to the unborn child if taken after the third month 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), particularly if you have kidney problems related to diabetes.
    • Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.

See also information under "What you need to know before taking QUARK".

Children and adolescents
The use of QUARK is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of QUARK in children have not yet been established.

If any of the above conditions apply (or if you are unsure), consult 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 may affect the way some other medicines work. Also, some medicines may affect the way QUARK works.

Inform your doctor if you are taking any of the following medicines. These medicines may interfere with QUARK, altering its effect:

  • 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 monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these 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, indometacin, aspirin).
  • Cancer treatments (chemotherapy).
  • Diuretics such as furosemide.
  • Medicines that may increase potassium levels in the blood (including potassium supplements and salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium salts, and other medicines that could increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections, ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs, and heparin, a medicine used to thin the blood and prevent clotting).
  • Steroid medicines used to treat inflammation, such as prednisolone.
  • Allopurinol (used to lower uric acid levels in the blood).
  • Procainamide (for heart rhythm problems).

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

  • Medicines for diabetes such as oral hypoglycaemics and insulin. QUARK may lower blood sugar levels. Monitor your blood sugar levels carefully when taking QUARK.
  • Lithium (for psychiatric conditions). QUARK may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

  • If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under "Before taking QUARK" and "Take special care with QUARK").

If any of the above conditions apply (or if you are unsure), consult your doctor before taking QUARK.

QUARK with food and alcohol

  • Drinking alcohol while taking QUARK may cause dizziness or drowsiness. Discuss with your doctor how much alcohol you can safely drink while taking QUARK, as blood pressure-lowering medicines and alcohol may have additive effects.
  • QUARK can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
You must not take QUARK during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as its use during pregnancy may harm the unborn child.
Inform your doctor immediately if you become pregnant while taking QUARK. Before planning a pregnancy, you should switch to an appropriate alternative treatment.

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

Driving and using machines
You may experience dizziness while taking QUARK. This is more likely when you first start taking QUARK or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

3. How to take QUARK

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Taking this medicine

  • Take the tablet at the same time each day, by mouth.
  • 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 daily.
  • Your doctor will adjust your dose until your blood pressure is under control.
  • The maximum daily dose is 10 mg.
  • If you are already taking diuretics, your doctor may stop or reduce them before starting your treatment with QUARK.

To reduce the risk of heart attack or stroke

  • The initial dose is 2.5 mg once daily.
  • Your doctor may decide to increase your dose.
  • The usual dose is 10 mg once daily.

Treatment to reduce or prevent worsening of kidney problems

  • You may be started on a dose of 1.25 mg or 2.5 mg once daily.
  • Your doctor will adjust your dose accordingly.
  • The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

  • The usual starting dose is 1.25 mg once daily.
  • Your doctor will adjust your dose.
  • The maximum dose is 10 mg per day. It is preferable to divide this dose into two daily administrations.

Treatment after a heart attack

  • The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
  • Your doctor will adjust your dose.
  • The usual dose is 10 mg per day. It is preferable to divide this dose into two daily administrations.

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

If you take more QUARK than you should
Contact your doctor or go to the nearest hospital emergency department immediately. Do not drive yourself—have someone drive you or call an ambulance. Bring the medicine pack with you, so the doctor knows what you have taken.

If you forget to take QUARK

  • If you miss a dose, take your usual dose at the next scheduled time.
  • Do not take a double dose to make up for the missed tablet.

If you have further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to QUARK.
  • Severe skin reactions including rash, mouth ulcers, 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:

  • Rapid heartbeat, irregular or forceful 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
  • Easy 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, weak, dizzy or pale appearance. These may be signs of blood or bone marrow problems
  • Severe stomach pain that may spread to the back. This could be a sign of pancreatitis (inflammation of the pancreas)
  • Fever, chills, tiredness, 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:
Tell your doctor if any of the conditions listed below become severe or persist for longer than a few days:
Common (affects less than 1 in 10 patients taking the medicine)

  • Headache or feeling tired
  • Dizziness. This is more likely when treatment with QUARK has just started or the dose has recently been increased
  • Weakness, low blood pressure (hypotension), especially when standing up or getting up quickly
  • Dry, persistent cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
  • Stomach or intestinal pain, diarrhoea, indigestion, nausea or feeling unwell
  • Rash with or without swelling
  • Chest pain
  • Muscle cramps or muscle pain
  • Blood tests show higher than normal potassium levels.

Uncommon (affects less than 1 in 100 patients taking the medicine)

  • Balance problems (dizziness)
  • Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling sensations (paraesthesia)
  • Loss or change in taste
  • Sleep problems
  • Depressed mood, anxiety, increased nervousness or irritability
  • Stuffy nose, breathing difficulties or worsening of asthma
  • Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea
  • Heartburn, constipation or dry mouth
  • Increased amount of urine during the day
  • Increased sweating
  • Loss of appetite or reduced appetite (anorexia)
  • Fast or irregular heartbeat
  • Swollen arms and legs. This may indicate your body is retaining more fluid than usual
  • Hot flushes
  • Blurred vision
  • Joint pain
  • Fever
  • Impotence in men, reduced sex drive in men and women
  • Increased number of white blood cells (eosinophilia) found in blood tests
  • Changes in liver, pancreas or kidney function detected by blood tests.

Rare (affects less than 1 in 1,000 patients taking the medicine)

  • Feeling faint or confused
  • Swollen and red tongue
  • Severe peeling or shedding of the skin, itching, rash with pustules
  • Nail problems (such as nail loss or separation of the nail from its bed)
  • Skin rash or bruising
  • Skin spots and cold extremities
  • Red, swollen, watery or itchy eyes
  • Hearing disturbances and ringing in the ears
  • Feeling weak
  • Decreased number of red blood cells, white blood cells and platelets or decreased haemoglobin concentration, shown by blood tests.

Very rare (affects less than 1 in 10,000 patients taking the medicine)

  • Increased sensitivity to sunlight.

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

  • Concentrated (dark-coloured) urine, feeling unwell, muscle cramps, confusion and seizures which may be due to inappropriate ADH secretion (anti-diuretic hormone [antidiuretic hormone]). If you experience these symptoms, contact your doctor promptly.

Other side effects observed:
Tell your doctor if any of the following conditions become severe or persist for longer than a few days.

  • Difficulty concentrating
  • Mouth swelling
  • Blood tests showing too low a number of blood cells
  • Blood tests showing low sodium levels in the blood
  • Fingers of hands and feet changing colour when exposed to cold, and tingling or pain upon warming (Raynaud's phenomenon)
  • Breast enlargement in men
  • Slowed or altered reactions
  • Burning sensation
  • Change in sense of smell
  • Hair loss.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps 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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What QUARK contains
Quark 2.5 mg tablets
Each tablet contains:
The active substance is: ramipril 2.5 mg.
The other excipients are: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate, yellow iron oxide E 172.

Quark 5 mg tablets
Each tablet contains:
The active substance is: ramipril 5 mg.
The other excipients are: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide E 172.

Quark 10 mg tablets
Each tablet contains:
The active substance is: ramipril 10 mg.
The other excipients are: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate.

Description of the appearance of QUARK and pack contents
Tablets.
Quark 2.5 mg tablets
Divided tablets. Carton pack containing 28 tablets.

Quark 5 mg tablets
Divided tablets. Carton pack containing 14 tablets.
Divided tablets. Carton pack containing 28 tablets.

Quark 10 mg tablets
Divided tablets. Carton pack containing 28 tablets.

Marketing Authorization Holder
Marketing Authorization Holder (MAH):
POLIFARMA S.p.A. Viale dell’Arte, 69 – 00144 ROME, ITALY

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