UNIPRILDIUR 2.5 мг/12.5 мг Таблетки

Содержание инструкции

1. UNIPRILDIUR 2.5 mg+12.5 mg tablets, 5 mg+ 25 mg tablets
   1. What is UNIPRILDIUR and what is it used for
   2. What you need to know before taking UNIPRILDIUR
   3. How to take UNIPRILDIUR
   4. Possible side effects
   5. How to store UNIPRILDIUR
   6. Contents of the pack and other information

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

Ramipril/Hydrochlorothiazide

Read this leaflet carefully before taking this medicinebecause 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is UNIPRILDIUR and what is it used for

UNIPRILDIUR 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.
UNIPRILDIUR 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 a
single component does not work.

2. What you need to know before taking UNIPRILDIUR

Do not take UNIPRILDIUR:

• If you are allergic to ramipril, hydrochlorothiazide or any other of the ingredients of this medicine (listed in section 6).
• If you are taking sacubitril/valsartan concomitantly (for long-term treatment of heart failure).
• If you are allergic to drugs similar to UNIPRILDIUR (other ACE inhibitors or medicines derived from sulfonamide).

Signs of an allergic reaction can be skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

• If you have had a severe 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 on dialysis or undergoing any other type of blood filtration. Depending on the machinery used, UNIPRILDIUR may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal levels of salts (calcium, potassium, sodium) in the 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 “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section “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 UNIPRILDIUR if any of the above conditions apply to you. If you are not sure, ask your doctor before taking UNIPRILDIUR.

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

• 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 UNIPRILDIUR
• 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 taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin or neprilysin inhibitors (NEP) (e.g. racecadotril and sacubitril/valsartan) as they may increase the risk of angioedema, a severe allergic reaction.
• If you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization).
• If you are about to have an anesthetic that may be given for surgery or dental work. You may need to stop taking UNIPRILDIUR 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 decreased 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 a period ranging from a few hours to a week after taking UNIPRILDIUR. This can lead to permanent vision loss if left untreated. If you have previously experienced an allergy to penicillins or sulfonamides, you may be at higher risk of developing it.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Uniprildiur, consult a doctor immediately.
• You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). UNIPRILDIUR 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.

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 under “Do not take UNIPRILDIUR”.

Children
UNIPRILDIUR 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 not sure, ask your doctor before taking UNIPRILDIUR.

Other medicines and UNIPRILDIUR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because UNIPRILDIUR can affect the mechanism of action of some other medicines. Also, some medicines can affect the mechanism of action of UNIPRILDIUR. Your doctor may need to change the dose and/or take other precautions.
Do not use UNIPRILDIUR with sacubitril/valsartan (for the long-term treatment of heart failure)
Tell your doctor if you are taking any of the following medicines. These medicines can interfere with UNIPRILDIUR 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, 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 UNIPRILDIUR, 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 the blood. These include medicines for constipation, diuretics, amphotericin B (used in fungal infections) and adrenocorticotropic hormone (used to check if your adrenal glands are working properly)
• Cancer medicines (chemotherapy).
• Temsirolimus (for cancer treatment).
• Medicines for heart problems, including heartbeat problems.
• Medicines to prevent organ rejection after transplantation such as cyclosporine.
• Sirolimus (for transplant rejection prevention).
• Everolimus (for transplant rejection prevention and cancer treatment).
• Diuretics such as furosemide.
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (used to make the blood more fluid).
• Steroid medicines for the treatment of 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).
• An angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported under “Do not take UNIPRILDIUR” and “Warnings and precautions”).
• Vildagliptin (for the treatment of diabetes mellitus).
• Racecadotril (used to treat diarrhea).
• Sacubitril/valsartan (for the long-term treatment of heart failure).

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

• Diabetes medicines such as oral hypoglycemic agents and insulin. UNIPRILDIUR may lower blood sugar levels. Carefully monitor your blood sugar levels when taking UNIPRILDIUR.
• Lithium (for psychiatric problems). UNIPRILDIUR may increase the amount of lithium in the blood. Your doctor must carefully monitor your lithium levels.
• 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).
• Blood-thinning medicines to be taken orally (oral anticoagulants) such as warfarin.

If any of the above conditions occur (or you are not sure), ask your doctor before taking UNIPRILDIUR.

Checks
Tell your doctor or pharmacist before taking this medicine:

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

UNIPRILDIUR contains sodium
UNIPRILDIUR contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take UNIPRILDIUR

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

Taking this medicine

• Take this 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 people
The doctor will reduce the initial dose and adjust the treatment more slowly.

If you take more UNIPRILDIUR than you should
Inform your doctor or go to the emergency room of the nearest hospital. Do not drive to go
to the hospital, have someone drive you or call an ambulance. Bring the package of the
medicine with you. This is because the doctor needs to know what you have taken.

If you forget to take UNIPRILDIUR

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

If you have any 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 everyone will experience them.

Stop taking UNIPRILDIUR and contact your doctor immediately if you notice the onset of
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 rash. This could be a sign of a severe allergic reaction to UNIPRILDIUR.
• 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).

Inform 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 for 2 to 3 days and decreased feeling of hunger. These may be signs of lung problems, including inflammation.
• Easier bruising, prolonged bleeding than usual, any signs of bleeding (e.g. bleeding gums) purple spots on the skin or easy onset of infections, sore throat and fever, feeling tired, fainting, dizziness or pale skin. These may be signs of circulatory or bone marrow problems.
• Severe abdominal pain that may 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:
Inform your doctor if any of the following conditions becomes serious or persists for
longer than a few days:
Common(affect less than 1 in 10 patients)

• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to happen when therapy with UNIPRILDIUR 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)

• Rash with or without swelling
• Hot flushes, fainting, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, prickling or creeping sensation (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness or tremor than usual
• Blocked nose, inflammation of the sinuses (sinusitis), shortness of breath
• Inflammation of the gums (gingivitis), swelling of the mouth
• 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 feeling more 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 males
• Decreased number of red blood cells, white blood cells and platelets in the blood or hemoglobin concentration, revealed by blood tests
• Changes in liver, pancreas or kidney function revealed by blood tests
• Blood tests show a lower than normal potassium level.

Very rare(affect less than 1 in 10,000 patients)

• Feeling unwell, causing diarrhea or heartburn
• Swollen and red tongue or dry mouth
• Blood tests show a higher than normal potassium level.
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion). Not known(frequency cannot be estimated based on available data)
• Skin cancer and cancer of the lips (non-melanoma skin cancer)
• Rapid onset of distant vision impairment (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.

Other side effects reported:
Inform your doctor if any of the following conditions becomes serious or persists for a time
longer than a few days:

• Difficulty concentrating, feeling restless or confused
• Fingers of the 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
• Less moist eyes than usual
• Objects appear yellow, transient visual disturbance, severe eye pain accompanied by redness and sudden blurred vision. Patients who experience red eyes with acute pain should see a doctor immediately; if left untreated, this
  condition could lead to permanent vision loss
• Dehydration
• Swelling, pain and pallor 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, lumpy 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)
• Greater amount of sugar in the urine than normal
• Increased number of certain white blood cells in the blood (eosinophilia) detected during blood tests
• Too low number of blood cells detected by blood tests (pancytopenia)
• Change in the level of salts such as sodium, calcium, magnesium and chlorine in the blood detected by blood tests
• Slowed or altered reactions
• Change in the perception of smells
• Difficulty breathing or worsening of asthma.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. 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 UNIPRILDIUR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp) which is reported on the blister and on the packaging. The
expiry date refers to the last day of that month.
Store this medicine in the original packaging to protect the contents from light.
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 UNIPRILDIUR contains

• The active ingredients are ramipril and hydrochlorothiazide
• The other ingredients are: hypromellose, microcrystalline cellulose, pregelatinized corn starch, sodium stearylfumarate.

Description of the appearance of UNIPRILDIUR and contents of the pack
2.5 mg + 12.5 mg tablets: white, oblong tablets, 8x4.4 mm in size with a fracture line
on both sides, with “HNV/HNV” imprinted on one side.
5 mg + 25 mg tablets: white, oblong tablets, 10x5.6 mm in size with a fracture line
on both sides, with “HNW/marketing authorisation holder logo” imprinted on one side and “marketing authorisation holder logo/HNW” on the other.
UNIPRILDIUR is available in packs containing blisters of 14, 20, 28, 50 and 100 tablets.
Packs containing 28 blisters may also be available with the days of the
week marked
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Global Pharmacies Partners S.r.l.
Via Cesare Battisti 1, 20122 Milano

Manufacturer
Sanofi-aventis S.p.A.
S.S. n. 17, km. 22 – 67019 Scoppito (AQ)

This medicinal product is authorised in the Member State of the European Economic Area with the
following designation:
Italy:
Uniprildiur 2.5 mg/12.5 mg tablets, Uniprildiur 5 mg/25 mg tablets
if you are not sure about something, ask your doctor or pharmacist.

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian
Medicines Agency.