BENAZEPRIL 10 mg /12.5 Mg Фильм-Coated Таблетки

Содержание инструкции

1. Benazepril Hydrochlorothiazide Sandoz 10 mg/12.5 mg film-coated tablets
   1. WHAT IS BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING BENAZEPRIL HYDROCHLOROTHIAZIDE
   3. HOW TO TAKE BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Benazepril Hydrochlorothiazide Sandoz 10 mg/12.5 mg film-coated tablets

Generic medicine

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

1. WHAT IS BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ AND WHAT IS IT USED FOR

Benazepril Idroclorotiazide Sandoz is used to treat:

• high blood pressure, which cannot be adequately reduced using other medicines containing only benazepril.

Benazepril Idroclorotiazide Sandoz contains two active ingredients. Benazepril, which belongs to the group
of medicines called ACE inhibitors, helps the heart by reducing blood pressure and widening the
blood vessels.
Hydrochlorothiazide is a diuretic, which increases urine production.

2. WHAT YOU NEED TO KNOW BEFORE TAKING BENAZEPRIL HYDROCHLOROTHIAZIDE

SANDOZ
Do not take Benazepril Hydrochlorothiazide Sandoz:

• If you are allergicto benazepril hydrochloride, to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergicto other ACE inhibitors, such as ramipril, or to sulfonamide derivatives (mostly antibiotics, such as sulfamethoxazole)
• If you are unable to produce urine
• If you suffer from severe kidney or liver problems
• 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
• If in the past you have suffered from swelling of the limbs, face, lips, throat, mouth or tongue (angioedema) when you were treated with other medicines belonging to a group of medicines called ACE inhibitors or in any other circumstance
• 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 suffer from a deficiency of potassium or sodiumin the blood
• if you have high levels of uric acidin the blood (gout)
• If you are pregnant for more than three months. (It is best to avoid Benazepril Hydrochlorothiazide Sandoz even in the early stages of pregnancy - see the Pregnancy section).

Warnings and precautions
Talk to your doctor before taking Benazepril Hydrochlorothiazide Sandoz:

• if you suffer from excessive fluid loss due to: medicines that increase urine production or dialysis or a low-salt diet or vomiting or diarrhea. You may experience a sharp drop in blood pressure at the beginning of treatment and feel faint or dizzy.
• if you suffer from heart problems, in addition to the one being treated. These include valve disorders, narrowing of blood vessels, or thickening of the heart muscle
• if you suffer from liver or kidney disordersor narrowing of blood vessels leading to the kidney. You should not take this medicine if you have severe kidney or liver problems. See also the section “Do not take Benazepril Hydrochlorothiazide Sandoz”
• if you are to undergo the following types of treatment: o dialysiswith high-flux membranes o cholesterol removalwith methods similar to dialysis o or therapies aimed at reducing the tendency to allergic reactions. Tell your doctor that you are taking Benazepril Hydrochlorothiazide Sandoz. They may want to change the treatment, in order to prevent a possible allergic reaction.
• if you suffer from a history of allergy
• if you suffer from a diseasethat causes the immune system to attack the skinand internal organs (systemic lupus erythematosus)
• if you are to undergo general anesthesia. Tell your doctor that you are taking Benazepril Hydrochlorothiazide Sandoz
• if you suffer from diabetes. It may be necessary to adjust the dosage of your antidiabetic medicine
• if you suffer from disordersof absorption, transformation and/or conversion of fats.
• 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 the section “Do not take Benazepril Hydrochlorothiazide Sandoz”.
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhea
• 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 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 certain types of skin cancer and of the

lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Benazepril Hydrochlorothiazide Sandoz
The doctor will regularly check your kidney function, salt and sugar levels and your blood count. This will happen even more frequently in case of kidney disorders, diabetes or a skin disease.
Tell your doctor if you notice worsening vision or if you have pain in one or both eyes. These could be a sign that you are developing glaucoma, an increase in pressure in your eye(s) and can occur within hours or weeks of taking the medicine. This could lead to permanent vision damage if not treated. You should stop taking this medicine and follow medical care.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Benazepril Hydrochlorothiazide Sandoz is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see the Pregnancy section).

Caution for those who play sports: the product contains substances prohibited for doping. Taking it in a manner different from the prescribed dosage and route of administration is prohibited.

Other medicines and Benazepril Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines in particular can influence or be influenced by Benazepril Hydrochlorothiazide Sandoz:

• medicines used to treat high blood pressure, such as: o medicines used to widen blood vessels o methyldopa o guanethidine o drugs with active ingredients whose name ends with the suffix “-olol” o calcium antagonists such as nifedipine and verapamil
• Potassium supplements (including salt substitutes), potassium-sparing diuretics(medicines used to increase urine production such as triamterene, amiloride and spironolactone) and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazolefor treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent clots)
• lithium: a medicine used to treat depression
• some medicines used to reduce inflammationor to prevent rejection of organs after a transplant, such as prednisolone
• adrenocorticotropic hormone: a medicine used to control the function of the adrenal gland
• amphotericin B: a medicine used to treat fungal infections
• carbenoxolone: a medicine used to treat ulcers and inflammation of the throat
• medicines used to treat heart failure, such as digoxin
• medicines used to treat diabetes, such as insulin, gliclazide, metformin.
• The doctor may need to adjust the dosage of these medicines
• Non-steroidal anti-inflammatory drugs used to relieve pain and inflammation (e.g. ibuprofen, indometacin)
• Acetylsalicylic acid when used to relieve pain and inflammation (benazeprilcan be used with acetylsalicylic acid when it is taken to prevent heart attacks and strokes)
• medicines used to reduce blood fat levels, such as colestyramine, colestipol. If used together, they must be taken several hours apart
• allopurinol: a medicine used to treat gout
• diazoxide: a medicine used to increase blood sugar levels
• medicines for cancer treatment, such as cyclophosphamide, methotrexate
• amantadine: a medicine for treating influenza, Parkinson's disease or similar disorders
• medicines that act against acetylcholine, a substance produced by the body. These medicines are used for various disorders, such as abdominal cramps, muscle and bladder spasms, dizziness, Parkinson's disease and preparation for anesthesia. Some examples are atropine and biperidene.
• calcium and vitamin D
• goldfor the treatment of rheumatoid arthritis
• carbamazepine(mainly used for the treatment of epilepsy and bipolar disorder)
• medicines used to prevent organ rejection and for cancer (example temsirolimus, sirolimus, everolimus).

The 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 the section “Do not take Benazepril Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

Benazepril Hydrochlorothiazide Sandoz with alcohol
Drinking alcohol is not recommended, as it may increase the risk of a sharp drop in blood pressure.

Pregnancy and breastfeeding
Ask your doctor for advice before taking this medicine if you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding.

Pregnancy
Tell your doctor if you think you may be (or could become) pregnant. As a rule, your doctor will advise you to stop taking Benazepril Hydrochlorothiazide Sandoz before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Benazepril Hydrochlorothiazide Sandoz.
Benazepril Hydrochlorothiazide Sandoz is not recommended during pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding.
Benazepril Hydrochlorothiazide Sandoz is not recommended in women who are breastfeeding.

Driving and using machines
Some people taking Benazepril Hydrochlorothiazide Sandoz have experienced dizziness and fatigue. If any of these effects occur, do not drive or operate machinery (see section 4, “Possible side effects”).

Benazepril Hydrochlorothiazide Sandoz contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ

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

Dosage in adults

• Usual starting dose: ½ tablet once a day. Your doctor will adjust the dosage based on your response to treatment. Your doctor may increase the dose to one tablet once a day after 3-4 weeks and subsequently up to 2 tablets a day, if necessary.
• Maximum dose: 2 tablets twice a day

Patients with kidney problems or patients 65 years and older
Your doctor will adjust the dosebased on your response to treatment.
Patients with severe kidney problems undergoing treatment with medicines intended to increase urine
production should take benazepril in combination with other substances. See also paragraph 2, “Do not take Benazepril Hydrochlorothiazide Sandoz”.

Use in children and adolescents
This medicine is not recommended in children and adolescents under the age of 18, due to
insufficient experience of use in this age group.

Instructions for dividing the tablet
The tablet can be divided into two equal doses.
Place the tablet on a solid surface, with the fracture line facing upwards.
Divide the tablet by applying gentle pressure with your thumb.

Method of administration
Take Benazepril Hydrochlorothiazide Sandoz at the same time each day, preferably in the morning,
with a glass of water.

Duration of therapy
Your doctor will decide the duration of therapy.

If you take more Benazepril Hydrochlorothiazide Sandoz than you should
Contact your doctor immediately, who will decide what further measures to take.
Symptoms of overdose are:

• sudden drop in blood pressure
• water and mineral imbalance
• heart rhythm disturbances
• muscle cramps
• dizziness
• nausea
• drowsiness.

If you forget to take Benazepril Hydrochlorothiazide Sandoz
Do not take a double dose to make up for a missed dose. Continue to take
Benazepril Hydrochlorothiazide Sandoz as prescribed, at the usual time.

If you stop taking Benazepril Hydrochlorothiazide Sandoz
Do not stop taking Benazepril Hydrochlorothiazide Sandoz without your doctor's permission, because the
sudden discontinuation of Benazepril Hydrochlorothiazide Sandoz may increase blood pressure.
If you have any doubts about 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. The side effects listed below refer to Benazepril Idroclorotiazide Sandoz and the medicinal groups of both active ingredients.

Stop taking Benazepril Idroclorotiazide Sandoz and immediately inform your doctor or go to the emergency room of the nearest hospital if you experience any of the following serious side effects

• skin rash, itching, swelling of the extremities, face, lips, mouth or throat

rare: may affect up to 1 in 1,000 people

• skin rash, skin redness, blisters on the lips, eyes or mouth, peeling skin (the frequency cannot be defined based on available data)
• severe decrease in urine (an uncommon side effect: may affect up to 1 in 100 people)
• purple spots on the skin (possible signs of leukopenia, purpura) (a rare side effect: may affect up to 1 in 1,000 people)
• fever, sore throat, more frequent infections or mouth ulcers due to infections (possible signs of agranulocytosis and leukopenia - very rare side effects: may affect up to 1 in 10,000 peopleor of neutropenia - the frequency cannot be defined based on available data)
• weakness, bruising and frequent infections (possible signs of aplastic anemia - the frequency cannot be defined based on available dataor bone marrow depression - very rare side effect: may affect up to 1 in 10,000 people)
• pale skin, fatigue, shortness of breath, dark urine (possible signs of hemolytic anemia - very rare side effect: may affect up to 1 in 10,000 people
• decreased vision and eye pain (possible signs of acute myopathy and closed-angle glaucoma - the frequency cannot be defined based on available data)

Side effects can occur with the following frequencies
Common, may affect up to 1 in 10 people

• palpitations
• low blood pressure when getting up quickly, causing dizziness and lightheadedness
• gastric and intestinal disorders
• skin rash
• flushing (e.g. on the face)
• itching
• increased sensitivity to light
• frequent urination
• cough
• difficulty breathing
• headache
• dizziness
• fatigue
• urticaria and other forms of skin rash
• loss of appetite
• mild nausea
• impotence
• vomiting.

Rare, may affect up to 1 in 1,000 people

• low blood pressure
• chest pain
• diarrhea
• constipation
• nausea
• abdominal pain
• low levels of potassium in the blood
• increased urea in the blood

muscle tissue

• increased concentrations of uric acid in the blood
• drowsiness
• insomnia
• nervousness
• feeling of fainting
• anxiety
• abnormal sensations, such as tingling, prickling and itching on arms or legs
• joint pain or inflammation
• muscle pain
• pain in skeletal muscles
• lack of blood and oxygen to the heart muscle, due to narrowing of the blood vessels
• irregular heartbeat
• inflammation of the liver, particularly due to reduced bile drainage
• yellowing of the skin, internal organs and/or whites of the eyes, caused by reduced bile drainage
• severe skin disease with blisters, not caused by any apparent reason
• depression
• visual disturbances, especially during the first few weeks of treatment
• decreased platelet count in the blood, causing bruising and a tendency to bleed.
• vomiting
• headache
• irregular heartbeat

Very rare, may affect up to 1 in 10,000 people

• low levels of sodium in the blood
• tinnitus
• loss of taste
• heart attack
• inflammation of the pancreas
• reduced kidney function
• serious skin diseases: or rash with fever and blisters or a potentially fatal condition due to which the upper layer of the skin dies and peels off or diseases that cause the immune system to attack the skin and internal organs
• deficiency of red blood cells, caused by an increase in their breakdown
• deficiency of white blood cells
• deficiency of certain white blood cells, accompanied by sudden high fever, severe sore throat and mouth ulcers
• bone marrow damage, causing a reduction in bone marrow and blood cells
• inflammation of blood vessels with tissue damage
• allergic reactions
• difficulty breathing, including inflammation of the lungs and swelling caused by excess fluid.

Not known:the frequency cannot be defined based on available data

• low concentrations of red pigment in the blood
• muscle spasms
• fever
• feeling of weakness
• skin and lip cancer (non-melanoma skin cancer)

Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals are required to report any suspected adverse reaction through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

5. HOW TO STORE BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ

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 blister and the packaging after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Benazepril Idroclorotiazide Sandoz contains
The active ingredientsare benazepril hydrochlorideand hydrochlorothiazide.
Each film-coated tablet contains 10 mg of benazepril hydrochloride and 12.5 mg of
hydrochlorothiazide.
The other ingredients are: crospovidone, hydrogenated castor oil, hypromellose, lactose monohydrate,
macrogol 4000, microcrystalline cellulose, pregelatinized starch (corn), highly dispersed silica,
titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Benazepril Idroclorotiazide Sandoz and package contents
Benazepril Idroclorotiazide Sandoz tablets are round, pink, film-coated, convex,
with a fracture line on one side.
Benazepril Idroclorotiazide Sandoz is available in packs containing 14, 28, 42, 50 and 98
film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA)

Manufacturer
SALUTAS Pharma GmbH
Otto-von-Guericke-Allee, 1
39179 Barleben (Germany)

This medicinal product is authorised in the Member States of the EEA with the following denominations:
Germany: Benazepril HEXAL comp 10 mg/12,5 mg Filmtabletten
Benazepril HEXAL® comp 20 mg / 25 mg Filmtabletten
Italy: Benazepril Idroclorotiazide Sandoz
Netherlands: Benazepril HCl/Hydrochloorthiazide 10/12.5, filmomhulde tabletten 10
mg/12,5 mg
Benazepril HCl/Hydrochloorthiazide 20/25, filmomhulde tabletten 20 mg/25 mg