Benazepril hydrochlorothiazide Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ IS AND WHAT IT IS USED FOR

Benazepril Hydrochlorothiazide Sandoz is used to treat:

• high blood pressure that cannot be adequately controlled using medicines containing only benazepril.

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING BENAZEPRIL HYDROCHLOROTHIAZIDE

SANDOZ
Do not take Benazepril Hydrochlorothiazide Sandoz:

• If you are allergic to benazepril hydrochloride, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to other ACE inhibitors, such as ramipril, or to sulfonamide derivatives (mostly antibiotics, such as sulfamethoxazole)
• If you are unable to produce urine
• If you have severe kidney or liver problems
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• If you have previously experienced swelling of the limbs, face, lips, throat, mouth, or tongue (angioedema) when treated with other medicines belonging to a group called ACE inhibitors, or under any other circumstances
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat)
• if you have a deficiency of potassium or sodium in the blood
• if you have elevated levels of uric acid in the blood (gout)
• If you are more than three months pregnant. (It is better to avoid Benazepril Hydrochlorothiazide Sandoz even in the early stages of pregnancy – see section Pregnancy).

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

• if you suffer from excessive fluid loss due to: diuretic medicines (which increase urine production), dialysis, low-salt diet, vomiting, or diarrhea. At the beginning of treatment, you may experience a significant drop in blood pressure, with symptoms such as fainting or dizziness.
• if you have heart problems other than the one being treated. These include valve disorders, narrowing of blood vessels, or thickening of the heart muscle
• if you have liver or kidney problems or narrowing of the blood vessels leading to the kidneys. You must not take this medicine if you have severe kidney or liver problems. See also section “Do not take Benazepril Hydrochlorothiazide Sandoz”
• if you are due to undergo the following treatments:
  • dialysis with high-flux membranes
  • cholesterol removal using methods similar to dialysis
  • or therapies aimed at reducing the tendency to allergic reactions. Inform your doctor that you are taking Benazepril Hydrochlorothiazide Sandoz. Your doctor may wish to change your treatment to prevent a possible allergic reaction.
• if you have a history of allergy
• if you have a disease causing the immune system to attack the skin and internal organs (systemic lupus erythematosus)
• if you are scheduled for surgery with general anesthesia. Inform your doctor that you are taking Benazepril Hydrochlorothiazide Sandoz
• if you have diabetes. The dose of your antidiabetic medicine may need to be adjusted
• if you have disorders affecting absorption, metabolism, and/or conversion of fats.
• 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 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 previously had skin cancer or if you 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 skin cancer and of the lips (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays during treatment with Benazepril Hydrochlorothiazide Sandoz.

Your doctor will regularly monitor your kidney function, levels of salts and sugars, and your blood count. This monitoring will be even more frequent if you have kidney disease, diabetes, or a skin condition.

Tell your doctor if you notice worsening vision or if you experience pain in one or both eyes. These could be signs that you are developing glaucoma, an increase in pressure in your eye(s), which may occur within hours or weeks of taking the medicine. This could lead to permanent vision damage if not treated. You must stop treatment with this medicine and seek medical care.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
Benazepril Hydrochlorothiazide Sandoz is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).

Caution for athletes: This product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is forbidden.

Other medicines and Benazepril Hydrochlorothiazide Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines in particular may affect or be affected by Benazepril Hydrochlorothiazide Sandoz:

• Medicines used to treat high blood pressure, such as:
  • medicines used to widen blood vessels
  • methyldopa
  • guanethidine
  • medicines whose active ingredients end in the suffix “-olol”
  • medicines such as nifedipine and verapamil, known as calcium antagonists
• 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 potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation)
• Lithium: a medicine used to treat depression
• Some medicines used to reduce inflammation or to prevent organ rejection after transplantation, such as prednisolone
• Adrenocorticotropic hormone: a medicine used to regulate adrenal gland function
• Amphotericin B: a medicine used to treat fungal infections
• Carbenoxolone: a medicine used to treat ulcers and throat inflammation
• Medicines used to treat heart weakness, such as digoxin
• Medicines used to treat diabetes, such as insulin, gliclazide, metformin.
  Your doctor may need to adjust the dosage of these medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation (e.g., ibuprofen, indomethacine)
• Acetylsalicylic acid when used to relieve pain and inflammation (benazepril may be used with acetylsalicylic acid when the latter is taken to prevent heart attacks and strokes)
• Medicines used to reduce fat levels in the blood, such as cholestyramine, colestipol. If used together, they should be taken several hours apart
• Allopurinol: a medicine used to treat gout
• Diazoxide: a medicine used to increase blood sugar levels
• Medicines used to treat cancer, such as cyclophosphamide, methotrexate
• Amantadine: a medicine used to treat influenza, Parkinson’s disease, or similar disorders
• Medicines acting against acetylcholine, a substance produced by the body. These medicines are used for various conditions such as abdominal cramps, muscle and bladder spasms, dizziness, Parkinson’s disease, and anesthesia preparation. Examples include atropine and biperiden.
• Calcium and vitamin D
• Gold used to treat rheumatoid arthritis
• Carbamazepine (mainly used to treat epilepsy and bipolar disorder)
• Medicines used to prevent organ transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus).

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Benazepril Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

Benazepril Hydrochlorothiazide Sandoz and alcohol
Alcohol consumption is not recommended, as it may increase the risk of a significant drop in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Benazepril Hydrochlorothiazide Sandoz before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine.

Benazepril Hydrochlorothiazide Sandoz is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.

Benazepril Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding.

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

Benazepril Hydrochlorothiazide Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE BENAZEPRIL HYDROCHLOROTHIAZIDE SANDOZ

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Dosage in adults

• Usual starting dose: ½ tablet once daily. Your doctor will adjust the dosage according to your response to treatment. Your doctor may increase the dose to 1 tablet once daily after 3–4 weeks and subsequently up to 2 tablets daily, if necessary.
• Maximum dose: 2 tablets twice daily

Patients with renal problems or patients aged 65 years and over
Your doctor will adjust the dose according to your response to treatment.
Patients with severe renal impairment currently treated with medicines designed to increase urine
production must take benazepril in combination with other substances. See also section 2, “Do not take Benazepril Hydrochlorothiazide Sandoz”.
Use in children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age due to insufficient experience of use in this age group.
Instructions for splitting the tablet
The tablet may be divided into two equal doses.
Place the tablet on a firm surface with the score line facing upwards.
Divide the tablet by applying gentle pressure with your thumb.

Method of administration
Take Benazepril Hydrochlorothiazide Sandoz at the same time every day, preferably in the morning,
with a glass of water.
Duration of treatment
Your doctor will decide how long you should take this medicine.
If you take more Benazepril Hydrochlorothiazide Sandoz than you should
Contact your doctor immediately. The doctor will decide what further steps are needed.
Symptoms of overdose include:

• sudden drop in blood pressure
• fluid and electrolyte 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 the forgotten dose. Continue taking Benazepril Hydrochlorothiazide Sandoz as prescribed, at your usual time.
If you stop taking Benazepril Hydrochlorothiazide Sandoz
Do not stop taking Benazepril Hydrochlorothiazide Sandoz without your doctor’s permission, as abruptly stopping Benazepril Hydrochlorothiazide Sandoz may increase blood pressure.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects listed below refer to Benazepril Hydrochlorothiazide Sandoz and to the medicinal groups of both active substances.

Stop taking Benazepril Hydrochlorothiazide Sandoz and contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following serious adverse effects

• Rash, itching, swelling of the extremities, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing (angioedema) (uncommon effect: may affect up to 1 in 1,000 people)
• Skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling (frequency cannot be determined from available data)
• Severe decrease in urine output (an uncommon adverse effect: may affect up to 1 in 100 people)
• Purple spots on the skin (possible signs of leukopenia, purpura) (a rare adverse 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 adverse effects: may affect up to 1 in 10,000 people or neutropenia – frequency cannot be determined from available data)
• Weakness, bruising, and frequent infections (possible signs of aplastic anemia – frequency cannot be determined from available data or bone marrow depression – very rare adverse 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 adverse effect: may affect up to 1 in 10,000 people)
• Decreased vision and eye pain (possible signs of acute myopia and angle-closure glaucoma – frequency cannot be determined from available data)

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

• Palpitations
• Drop in blood pressure when standing up quickly, causing dizziness and lightheadedness
• Gastrointestinal and intestinal disturbances
• Rash
• Flushing (e.g., of the face)
• Itching
• Increased sensitivity to light
• Frequent urination
• Cough
• Breathing difficulties
• 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 potassium levels in the blood
• Increased blood urea
• Increased serum creatinine concentrations, a breakdown product from muscle tissue
• Increased blood uric acid concentrations
• Drowsiness
• Insomnia
• Nervousness
• Feeling faint
• Anxiety
• Abnormal sensations, such as tingling, prickling, and itching in arms or legs
• Joint pain or inflammation
• Muscle pain
• Pain in skeletal muscles
• Insufficient blood and oxygen supply to the heart muscle due to narrowing of blood vessels
• Heart rhythm disturbances
• Liver inflammation, 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, particularly in the first 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 sodium levels in the blood
• Tinnitus or ringing in the ears
• Loss of taste
• Heart attack
• Inflammation of the pancreas
• Reduced kidney function
• Severe skin diseases: either rash with fever and blisters, or a potentially fatal disorder in which the top layer of skin dies and peels off, or diseases causing the immune system to attack the skin and internal organs
• Red blood cell deficiency due to increased breakdown
• White blood cell deficiency
• Deficiency of certain white blood cells, accompanied by sudden high fever, severe sore throat, and mouth ulcers
• Bone marrow damage, leading to reduced bone marrow and blood cells
• Inflammation of blood vessels with tissue damage
• Allergic reactions
• Breathing difficulties, including lung inflammation and swelling due to fluid accumulation

Not known: frequency cannot be determined from 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 suspected adverse reactions after a medicine has been authorized is important, as it allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are encouraged to report any suspected adverse reactions via 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 stated on the blister and packaging following
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Benazepril Hydrochlorothiazide Sandoz contains
The active substances are benazepril hydrochloride and hydrochlorothiazide.
Each film-coated tablet contains 10 mg of benazepril hydrochloride and 12.5 mg of
hydrochlorothiazide.
The other components are: crospovidone, hydrogenated castor oil, hypromellose, lactose monohydrate,
macrogol 4000, microcrystalline cellulose, pregelatinized maize starch, highly dispersed silica,
titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Benazepril Hydrochlorothiazide Sandoz and pack contents
Benazepril Hydrochlorothiazide Sandoz tablets are round, pink, film-coated, convex tablets with a break line on one side.
Benazepril Hydrochlorothiazide 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 EEA Member States under the following names:
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