Idroquark

Package leaflet: Information for the patient

Idroquark 2.5 mg + 12.5 mg tablets, 5 mg + 25 mg tablets

Ramipril + Hydrochlorothiazide
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IDROQUARK IS AND WHAT IT IS USED FOR

Idroquark is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines known as "ACE inhibitors" (Angiotensin-Converting Enzyme inhibitors). It works by:

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

Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics" or oral diuretics. It works by increasing the amount of water (urine) your body produces. This helps lower blood pressure.
Idroquark is used to treat high blood pressure (hypertension). The two active ingredients work together to lower blood pressure. They are used in combination when treatment with either component alone is not effective.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IDROQUARK

Do not take Idroquark:

• If you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to medicines similar to Idroquark (other ACE inhibitors or sulfonamide-derived medicines). 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 recently taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as 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 on dialysis or undergoing another type of blood filtration. Depending on the equipment used, Idroquark may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal levels of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems due to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section below “Pregnancy and breastfeeding”).
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Idroquark if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Idroquark.

Warnings and precautions

Talk to your doctor or pharmacist before taking Idroquark:

• If you have heart, liver, or kidney problems.
• If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Idroquark, contact a doctor immediately.
• If you have lost significant body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of oral diuretics, or after undergoing 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 Idroquark the day before; consult your doctor.
• If you have high levels of potassium in your blood (detected by a blood test).
• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
• If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Idroquark.
• You must inform your doctor if you think you are pregnant (or might become pregnant). Idroquark is not recommended during the first trimester of pregnancy and may 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 for high blood pressure: an angiotensin II receptor antagonist (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, or aliskiren.
• If you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur from a few hours to weeks after taking Idroquark. This could lead to permanent vision loss if not treated. If you have previously had an allergic reaction to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Your doctor may regularly monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood.
See also the information under the heading "Do not take Idroquark".

Children and adolescents
Idroquark is not recommended for children and adolescents under 18 years of age, as this medicine has never been studied in this age group.
If any of the above conditions apply to you or you are unsure, consult your doctor before taking Idroquark.

Other medicines and Idroquark
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is because Idroquark may affect how some other medicines work. Conversely, some medicines may affect how Idroquark works.
Inform your doctor if you are taking any of the following medicines. These may interfere with Idroquark and alter 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 may need to monitor your blood pressure.

In particular, inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines. Taking these with Idroquark 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).
• Medicines that may lower potassium levels in the blood. These include laxatives, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to check if your adrenal glands are functioning properly).
• Medicines for cancer (chemotherapy).
• Medicines for heart problems, including heart rhythm disorders.
• 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 may raise blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
• Steroid medicines used to treat inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Cholestyramine (to reduce blood fat levels).
• Carbamazepine (for the treatment of epilepsy).

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

• Medicines for diabetes such as oral hypoglycaemics and insulin. Idroquark may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Idroquark.
• Lithium (for psychiatric conditions). Idroquark may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
• Muscle relaxants.
• Quinine (for the treatment of malaria).
• Medicines containing iodine, which may be used in hospital before X-ray or scanning procedures.
• Penicillin (for treating infections).
• Oral anticoagulants (blood thinners) such as warfarin.

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 "Do not take Idroquark" and "Warnings and precautions").

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

Tests
Inform your doctor or pharmacist before taking this medicine:

• If you are undergoing a test for parathyroid function. Idroquark may alter test results.
• If you are an athlete undergoing anti-doping testing. Idroquark may produce a positive test result.

Idroquark with food and alcohol

• Drinking alcohol while taking Idroquark may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking Idroquark, discuss this with your doctor. Alcohol may enhance the blood pressure-lowering effects of the medicine.
• Idroquark can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or might become pregnant).
You must not take Idroquark during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as it may harm the unborn baby.
If you become pregnant while taking Idroquark, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine.

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

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

3. HOW TO TAKE IDROQUARK

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
Taking this medicine

• Take the medicine by mouth at the same time each day, usually in the morning.
• Swallow the tablets whole with a liquid.
• Do not break or chew the tablets.

How much to take
Treatment of high blood pressure
Your doctor will adjust your dose until your blood pressure is under
control.
Elderly patients
Your doctor will reduce the initial dose and adjust treatment more slowly.
If you take more Idroquark than you should
Inform your doctor or go to the nearest hospital emergency department. Do not drive to the hospital;
have someone drive you or call an ambulance. Take the medicine pack with you.
This is because the doctor needs to know what you have taken.
If you forget to take Idroquark

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

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop taking Idroquark and contact your doctor immediately if you notice any serious adverse reaction – 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 Idroquark.
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin conditions, redness, blistering, and skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath, cough, fever lasting for 2 to 3 days, and reduced appetite. These may be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat, fever, feeling tired, weakness, dizziness, or pale appearance. These may be signs of blood circulation or bone marrow problems.
• Severe stomach pain that may radiate to the back. This could 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 may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other adverse reactions include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.
Common (affects fewer than 1 in 10 patients receiving treatment)

• Headache or feeling weak or tired
• Dizziness. This is more likely to occur when treatment with Idroquark has just started or the dose has recently been increased
• Dry, irritating cough or bronchitis
• Blood tests show higher than normal sugar levels. If you have diabetes, this may worsen
• Blood tests show higher than normal levels of uric acid or fats
• Painful, red, and swollen joints

Uncommon (affects fewer than 1 in 100 patients receiving treatment)

• Rash with or without swelling
• Flushing, weakness, hypotension (unusually low blood pressure), especially when standing up or rising quickly
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling, or burning (paresthesia)
• Loss or change in taste
• Sleep disturbances
• Depressed mood, anxiety, increased nervousness or irritability
• Nasal congestion, sinus inflammation (sinusitis), shortness of breath
• Inflammation of the gums (gingivitis), mouth swelling
• Red, swollen, watery, or itchy eyes
• Ringing in the ears
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach or intestinal pain
• Indigestion or feeling unwell
• Increased amount of urine during the day
• Increased sweating or thirst
• Loss or decrease in appetite (anorexia), reduced feeling of hunger
• Rapid or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual
• Fever
• Impotence in males
• Decrease in the number of red blood cells, white blood cells, or platelets, or in hemoglobin concentration, as shown by blood tests
• Changes in liver, pancreas, or kidney function as shown by blood tests
• Blood tests show lower than normal potassium levels

Very rare (affects fewer than 1 in 10,000 patients receiving treatment)

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion)
• Feeling unwell, causing diarrhea or stomach burning
• Swollen and red tongue or dry mouth
• Blood tests show higher than normal potassium levels

Not known (frequency cannot be estimated from available data)

• Concentrated urine (dark-colored), feeling unwell, muscle cramps, confusion, and seizures that may be due to inappropriate secretion of ADH (anti-diuretic hormone [antidiuretic hormone]). If you experience these symptoms, contact your doctor promptly
• Skin and lip cancer (non-melanoma skin cancer)

Other adverse reactions reported:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.

• Difficulty concentrating, feeling restless or confused
• Fingers of hands and feet changing color when cold, and tingling or painful when warmed (Raynaud’s phenomenon)
• Breast enlargement in males
• Blood clots
• Hearing disorders
• Eyes less moist than normal
• Objects appear yellow
• Dehydration
• Swelling, pain, and redness of the cheeks (inflammation of a salivary gland)
• Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting, and diarrhea
• Increased sensitivity to sunlight
• Severe peeling or shedding of the skin, itching, rash, or other skin reactions such as redness of the face or forehead
• Rash or bruising
• Spots on the skin and cold extremities
• Nail problems (such as nail loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetany)
• Muscle weakness or cramps
• Reduced sexual desire in men and women
• Presence of blood in the urine. This could be a sign of a kidney problem (interstitial nephritis)
• Higher than normal amount of sugar in the urine
• Increased number of certain white blood cells in the blood (eosinophilia) detected during blood tests
• Low number of blood cells shown by blood tests (pancytopenia)
• Changes in blood levels of electrolytes such as sodium, calcium, magnesium, and chloride, as shown by blood tests
• Slowed or altered reactions
• Changes in smell perception
• Breathing difficulties or worsening of asthma
• Rapid-onset difficulty seeing distant objects (acute myopia), decreased vision, or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IDROQUARK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp) stated on the blister pack and outer carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 PACKAGE AND OTHER INFORMATION

What Idroquark contains
Idroquark 2.5 mg + 12.5 mg tablets
One tablet contains:
Active substances: ramipril 2.5 mg + hydrochlorothiazide 12.5 mg;
Other components: hypromellose, pregelatinized maize starch, microcrystalline cellulose and
sodium stearyl fumarate.

Idroquark 5 mg + 25 mg tablets
One tablet contains:
Active substances: ramipril 5 mg + hydrochlorothiazide 25 mg;
Other components: hypromellose, pregelatinized maize starch, microcrystalline cellulose and
sodium stearyl fumarate.

Description of the appearance of Idroquark and contents of the pack
Idroquark 2.5 mg + 12.5 mg: oval white to almost white tablets, with a score line, marked on both sides with HNV and company logo. The tablet can be divided into equal parts.
Pack size of 14 and 28 tablets in PVC/aluminum blisters.

Idroquark 5 mg + 25 mg: oval white to almost white tablets, with a score line, marked on both sides with HNW and company logo. The tablet can be divided into equal parts.
Pack size of 14 and 28 tablets in PVC/aluminum blisters.

Marketing Authorization Holder
POLIFARMA S.p.A. Viale dell’Arte, 69 – 00144 - ROMA
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)