IDROQUARK 2.5 мг/12.5 мг Таблетки

Содержание инструкции

1. Idroquark 2.5 mg +12.5 mg tablets, 5 mg +25 mg tablets
   1. WHAT IS IDROQUARK 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

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

Ramipril + Hydrochlorothiazide

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 IS IDROQUARK AND WHAT IT IS USED FOR

Idroquark is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors). It works:

• By decreasing the production, by the body, of substances that can cause an increase in blood pressure
• By relaxing and widening its blood vessels
• By making it easier for its heart to pump blood around the body

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or oral diuretics. It
works by increasing the amount of water (urine) that is produced. This lowers 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 one component alone does not work.

2. WHAT YOU NEED TO 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 drugs similar to Idroquark (other ACE inhibitors or medicines derived from sulfonamides) 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, 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 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).
• If you are taking any of the following medicines, 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 any other type of blood filtration. Depending on the machinery 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 insufficient blood supply to the kidney (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 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 Idroquark if any of the above conditions apply to you. If you are unsure, ask 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 lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhoea, 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 (desensitisation)
• If you are about to have an anaesthetic that may be given for surgery or dental treatment. It may be necessary to stop taking Idroquark 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 have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Idroquark.
• You must tell your doctor if you think you may be pregnant (or might become pregnant). Idroquark 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 have blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within hours to weeks after taking Idroquark. This could lead to permanent vision loss

if left untreated. If you have previously had an allergic reaction to penicillin or
sulphonamides, you may be at higher risk of developing this.
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 stated under "Do not take Idroquark"

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

Other medicines and Idroquark
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is because Idroquark can affect the mechanism of action of some other medicines. Also
some medicines can affect the mechanism of action of Idroquark.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere with
Idroquark 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. The doctor will need to check your blood pressure. In particular, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines. These medicines, if taken 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 can lower the amount of potassium in your blood. These include medicines for constipation, diuretics, amphotericin B (used for fungal infections) and adrenocorticotropic hormone (used to check if your adrenal glands are working properly)
• Medicines for cancer treatment (chemotherapy)
• Medicines for heart problems, including problems with the heartbeat
• Diuretics such as furosemide
• Medicines that can increase the amount of potassium in your blood (including potassium supplements and salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride, potassium salts, other medicines that may increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole 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
• Calcium supplements
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heartbeat problems)
• Cholestyramine (to reduce the amount of fat in the blood)
• Carbamazepine (for the treatment of epilepsy)

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

• Medicines for diabetes such as oral hypoglycaemic agents and insulin. Idroquark can lower the amount of sugar in your blood. Carefully monitor your blood sugar levels when taking Idroquark.
• Lithium (for psychiatric problems). Idroquark can increase the amount of lithium in your blood. Your doctor must carefully monitor the level of lithium in your blood.
• Muscle relaxants
• Quinine (for the treatment of malaria)
• Medicines containing iodine, these may be used in hospital before an X-ray or scan
• Penicillin (for the treatment of infections)
• Medicines that thin the blood taken orally (oral anticoagulants) such as warfarin.

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 Idroquark" and "Warnings and precautions “)
If any of the above conditions occur (or you are unsure), ask your doctor before taking
Idroquark.

Checks
Tell your doctor or pharmacist before taking this medicine.

• If you are having a check for parathyroid function. Idroquark may alter the results of the check
• If you are an athlete who needs to undergo a doping control. Idroquark may give a positive result.

Idroquark with food and alcohol

• Drinking alcoholic beverages together with Idroquark may cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking Idroquark, discuss this with your doctor. In fact, alcohol increases the effects of blood pressure medications.
• Taking Idroquark can be done 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 should not take Idroquark in the first 12 weeks of pregnancy and should not absolutely
take it after the 13th week because its use may be harmful to the baby.
If you become pregnant while taking Idroquark, tell your doctor immediately. Before
planning a pregnancy, you should switch to another medicine.

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

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

3. HOW TO TAKE IDROQUARK

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

Taking this medicine

• Take the medicine by mouth at the same time of day, every 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
The doctor will adjust the amount you take until your blood pressure is under
control.

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

If you take more Idroquark than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital,
have someone drive 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 Idroquark

• 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 further questions on the use of 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 Idroquark 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 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 Idroquark.
• 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:
• 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, cough, fever lasting 2 to 3 days and decreased feeling of hunger. These may be signs of lung problems, including inflammation.
• 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, weak, dizzy or pale skin. These may be signs of circulatory or bone marrow problems.
• Severe stomach pain that can extend 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 may 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 undergoing treatment)

• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to happen when therapy with Idroquark is just started or you have just increased the dose
• Dry, irritating cough or bronchitis
• Blood tests show a higher than normal sugar level. If you have diabetes, this may worsen
• Blood tests show a higher than normal uric acid or fat level
• Painful, red and swollen joints

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

• Rash with or without swelling
• Hot flashes, weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Stuffy nose, inflammation of the sinuses (sinusitis), shortness of breath
• Inflammation of the gums (gingivitis), swelling of the mouth
• Red, swollen or 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 feeling thirsty than usual
• Loss or decrease of appetite (anorexia), decreased feeling of hunger
• Fast or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual
• Fever
• Impotence in men
• Decreased number of red blood cells, white blood cells and platelets in the blood or hemoglobin concentration, as shown by blood tests
• Changes in liver, pancreas or kidney function as shown by blood tests.
• Blood tests show a lower than normal potassium level.

Very Rare(affect less than 1 in 10,000 patients undergoing treatment)

• Feeling unwell, causing diarrhea or heartburn
• Swollen and red tongue or dry mouth
• Blood tests show a higher than normal potassium level.

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

• Concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which 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 side effects observed:
Tell your doctor if any of the following conditions becomes severe or persists for more than a few
days.

• Difficulty concentrating, feeling restless or confused
• Fingers of hands and feet that change color when cooled and tingle and hurt when warmed (Raynaud's phenomenon)
• Increased breast volume in men
• Blood clots
• Hearing disorders
• Eyes less moist than usual
• Objects appear yellow
• Dehydration
• Swelling, pain and redness of the cheeks (inflammation of a salivary gland)
• Swelling of the intestine called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Increased sensitivity to the sun
• Severe flaking or scaling 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 loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetanus)
• Muscle weakness or cramps
• Decreased sexual desire in men and women
• Presence of blood in the urine. This may be a sign of a kidney problem (interstitial nephritis)
• Higher amount of sugar in the urine than normal
• Increased number of certain white blood cells in the blood (eosinophilia) found during blood tests
• Too low number of blood cells as shown by blood tests (pancytopenia)
• Change in the level of salts such as sodium, calcium, magnesium and chlorine in the blood as shown by blood tests
• Slowed or altered reactions
• Change in the perception of smells
• Difficulty breathing or worsening of asthma
• , blurred vision or vision with halos of light, headache, widespread tearing or nausea, vomiting, decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects 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) which is stated on the blister and the packaging.
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 in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Idroquark contains
Idroquark 2.5 mg + 12.5 mg tablets
One tablet contains:

The active ingredients are: ramipril 2.5 mg + hydrochlorothiazide 12.5 mg;

The other ingredients are:hypromellose, pregelatinized maize starch, microcrystalline cellulose and
sodium stearylfumarate.
Idroquark 5 mg + 25 mg tablets
One tablet contains:

The active ingredients are: ramipril 5 mg + hydrochlorothiazide 25 mg;

The other ingredients are:hypromellose, pregelatinized maize starch, microcrystalline cellulose and
sodium stearylfumarate.

Description of the appearance of Idroquark and contents of the pack

Idroquark 2.5 mg + 12.5 mg: oblong tablets, from white to almost white, with a fracture line

marked on one side with HNV. The tablet can be divided into equal parts.Pack of 14
tablets in PVC/aluminium blisters.

Idroquark 5 mg + 25 mg: oblong tablets from white to almost white, with a fracture line

marked on both sides with P/IK. The tablet can be divided into equal parts.Pack
of 14 tablets in PVC/aluminium blisters.

Marketing Authorisation 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)