Nebivolol and hydrochlorothiazide Teva Italia

Italy
Brand name Nebivolol and hydrochlorothiazide Teva Italia
Form tablets, film-coated
Active substance / Dosage
HYDROCHLOROTHIAZIDE
NEBIVOLOLO
Prescription type Prescription only
ATC code
C07BB12
Registration number 046511
Manufacturer TEVA B.V.

Table of Contents

Patient Information Leaflet

Nebivolol and Hydrochlorothiazide Teva Italia 5 mg / 12.5 mg film-coated tablets, 25 mg film-coated tablets

Nebivolol / Hydrochlorothiazide
Generic medicine
Please read this leaflet carefully before using this medicine because 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
What Nebivolol and Hydrochlorothiazide Teva Italia is and what it is used for
What you need to know before taking Nebivolol and Hydrochlorothiazide Teva Italia
How to take Nebivolol and Hydrochlorothiazide Teva Italia
Possible side effects
How to store Nebivolol and Hydrochlorothiazide Teva Italia
Contents of the pack and other information

1. What Nebivololo e Idroclorotiazide Teva Italia is and what it is used for

Nebivololo e Idroclorotiazide Teva Italia contains nebivolol and hydrochlorothiazide as active substances.

  • Nebivolol is a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and controls the force of the heartbeat. It also exerts a dilating effect on blood vessels, helping to lower blood pressure.
  • Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced. Nebivololo e Idroclorotiazide Teva Italia combines nebivolol and hydrochlorothiazide in a single tablet. It is used to treat high blood pressure (hypertension). It is used instead of the two separate products in patients who are already taking them together.

2. What you need to know before taking Nebivolol and Hydrochlorothiazide Teva Italia

Do not take Nebivolol and Hydrochlorothiazide Teva Italia:

  • if you are allergic to nebivolol, hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to other sulfonamide-derived substances (such as hydrochlorothiazide, which is a sulfonamide-derived drug);
  • if you have one or more of the following conditions:
  • very slow heart rate (less than 60 beats per minute);
  • other serious heart rhythm disorders (for example, sick sinus syndrome, sinoatrial block,

second- or third-degree atrioventricular block);

  • recently developed or recently worsened heart failure, or if you are being treated for circulatory shock due to acute heart failure with intravenous therapy to support heart function;
  • low blood pressure;
  • severe circulatory problems in the arms or legs;
  • untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands);
  • severe kidney problems, complete absence of urine (anuria);
  • a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis;
  • asthma or breathing difficulties (currently or in the past);
  • liver function disorders;
  • high levels of calcium in the blood, low levels of potassium and sodium in the blood (persistent levels resistant to treatment);
  • high levels of uric acid with symptoms of gout.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivolol and Hydrochlorothiazide Teva Italia.

  • Inform your doctor if you notice or develop any of the following conditions:
  • a type of chest pain caused by spontaneous spasm of blood vessels supplying the heart, called Prinzmetal's angina;
  • first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm);
  • abnormally slow heartbeat;
  • untreated chronic heart failure;
  • systemic lupus erythematosus (an immune system disorder, i.e. the body's defense system);
  • psoriasis (a skin disease causing scaly pink patches) or if you have previously suffered from psoriasis;
  • overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat caused by this condition;
  • poor circulation in arms or legs, for example Raynaud's disease or syndrome, cramp-like pain when walking;
  • allergy: this medicine may intensify your reactions to pollen or other substances you are allergic to;
  • prolonged breathing difficulties;
  • diabetes: this medicine may mask warning signs of low blood glucose (e.g. palpitations, rapid heartbeat); your doctor will also advise you to monitor your blood glucose more frequently while taking Nebivolol and Hydrochlorothiazide Teva Italia, as it may be necessary to adjust the dose of your antidiabetic medications;
  • kidney problems: your doctor will monitor your kidney function to ensure it does not worsen. Do not take Nebivolol and Hydrochlorothiazide Teva Italia if you have severe kidney problems (see section "Do not take Nebivolol and Hydrochlorothiazide Teva Italia");
  • if you tend to have low potassium levels in the blood, especially if you have long QT syndrome (a type of electrocardiographic abnormality) or are taking digitalis (to support heart pumping function); you are more likely to have low blood potassium levels if you have liver cirrhosis, have experienced rapid fluid loss after intensive diuretic therapy, or if your dietary and fluid intake of potassium is inadequate;
  • if you are undergoing surgery, always inform the anaesthetist that you are being treated with Nebivolol and Hydrochlorothiazide Teva Italia before receiving anaesthesia.
  • 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV radiation while taking Nebivolol and Hydrochlorothiazide Teva Italia.

During treatment

  • Nebivolol and Hydrochlorothiazide Teva Italia may increase levels of fats and uric acid in the blood.
  • Nebivolol and Hydrochlorothiazide Teva Italia may affect levels of certain electrolytes in the blood (such as magnesium, potassium, sodium, and chloride): your doctor may perform periodic blood tests to monitor electrolyte levels. This may cause symptoms such as dry mouth, thirst, weakness, fatigue, muscle weakness, muscle pain or cramps, rapid heartbeat, dizziness, low blood pressure, restlessness, nausea or vomiting, and reduced urine output. Inform your doctor if you experience any of these symptoms.
  • The hydrochlorothiazide contained in Nebivolol and Hydrochlorothiazide Teva Italia may make your skin hypersensitive to sunlight or artificial UV light. Stop taking Nebivolol and Hydrochlorothiazide Teva Italia and consult your doctor if you develop a skin rash, itchy spots, or skin sensitivity during treatment (see also section 4).
  • Inform your doctor if you notice changes in vision or eye pain while taking Nebivolol and Hydrochlorothiazide Teva Italia. This could be a sign that you are developing glaucoma. You must stop treatment with Nebivolol and Hydrochlorothiazide Teva Italia and see your doctor.

Laboratory tests

  • Anti-doping tests: Nebivolol and Hydrochlorothiazide Teva Italia may cause a positive result in anti-doping tests.
  • Nebivolol and Hydrochlorothiazide Teva Italia may alter the results of parathyroid function tests. Inform your doctor or hospital staff that you are taking Nebivolol and Hydrochlorothiazide Teva Italia before undergoing these tests.
  • For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test. Children and adolescents Due to lack of data on the use of this product in children and adolescents, the use of Nebivolol and Hydrochlorothiazide Teva Italia is not recommended in these age groups.

Other medicines and Nebivolol and Hydrochlorothiazide Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Always inform your doctor if you are using or have recently been given any of the
following medicines in addition to Nebivolol and Hydrochlorothiazide Teva Italia.

  • Medicines that, like Nebivolol and Hydrochlorothiazide Teva Italia, may affect blood pressure and/or heart function:
  • medicines for controlling blood pressure or heart conditions (e.g. amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecainide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine, mexiletine, methyldopa, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, sotalol, verapamil);
  • sedatives and treatments for psychosis (a mental illness), e.g. amisulpride, barbiturates (also used for epilepsy), chlorpromazine, cyamemazine, droperidol, haloperidol, levomepromazine, narcotics, phenothiazines (also used for nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine;
  • medicines for depression (e.g. amitriptyline, fluoxetine, paroxetine);
  • medicines used for anaesthesia during surgery;
  • medicines for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased eye pressure) or pupil dilation (enlargement);
  • baclofen (a muscle relaxant);
  • amifostine (a protective agent used in cancer treatment);
  • cholestyramine or colestipol (medicines used to lower cholesterol levels).
  • Medicines whose effect or toxicity may be increased by Nebivolol and Hydrochlorothiazide Teva Italia:
  • lithium (used as a mood stabilizer);
  • cisapride (used for digestive problems);
  • bepridil (used for angina);
  • difenamizine (used for excessive sweating);
  • medicines used for infections: erythromycin administered by infusion or injection, pentamidine, sparfloxacin, amphotericin, sodium penicillin G, halofantrine (used for malaria);
  • vincamine (used for cerebral circulation problems);
  • mizolastine and terfenadine (used for allergies);
  • diuretics and laxatives;
  • medicines used to treat acute inflammation: corticosteroids (e.g. cortisone and prednisone), ACTH (adrenocorticotropic hormone), and salicylic acid derivatives (e.g. acetylsalicylic acid/aspirin and other salicylates);
  • carbenoxolone (used for heartburn and gastric ulcer);
  • calcium salts (used as bone health supplements);
  • medicines used to relax muscles (e.g. tubocurarine);
  • diazoxide (used to treat hypoglycemia and hypertension);
  • amantadine (an antiviral drug);
  • cyclosporine (used to suppress the body's immune response);
  • iodinated contrast agents (used as contrast media in X-rays);
  • anticancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate).
  • Medicines whose effect may be reduced by Nebivolol and Hydrochlorothiazide Teva Italia:
  • medicines that lower blood glucose levels (insulin and oral antidiabetics, metformin);
  • medicines for gout (e.g. allopurinol, probenecid, sulfinpyrazone);
  • medicines such as noradrenaline (used to treat low blood pressure or slow heart rate).
  • Medicines for pain and inflammation (non-steroidal anti-inflammatory drugs), because these may reduce the blood pressure-lowering effect of Nebivolol and Hydrochlorothiazide Teva Italia.
  • Medicines for treating excess stomach acid or ulcers (antacids), for example cimetidine, omeprazole: the use of these medicines together with Nebivolol and Hydrochlorothiazide Teva Italia is not recommended due to possible undesirable interactions. Nebivolol and Hydrochlorothiazide Teva Italia and alcohol Be cautious if you drink alcohol while taking Nebivolol and Hydrochlorothiazide Teva Italia, as dizziness or weakness may occur. If this happens, do not drink alcohol, including wine, beer, or low-alcohol beverages. Pregnancy and breastfeeding If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You must inform your doctor if you are or think you may be pregnant. Generally, your doctor will advise you to take another medicine instead of Nebivolol and Hydrochlorothiazide Teva Italia, as Nebivolol and Hydrochlorothiazide Teva Italia is not recommended during pregnancy. This is because the active substance hydrochlorothiazide crosses the placenta. The use of Nebivolol and Hydrochlorothiazide Teva Italia during pregnancy may cause potentially harmful effects on the fetus and newborn.

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Nebivolol and Hydrochlorothiazide
Teva Italia is not recommended for women who are breastfeeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive and do not use
machinery.
Nebivolol and Hydrochlorothiazide Teva Italia contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact
them before taking this medicine.

3. How to take Nebivolol and Hydrochlorothiazide Teva Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
The recommended dose is 1 tablet daily with some water, always at the same time of day.
Nebivolol and Hydrochlorothiazide Teva Italia must be taken at least 30 minutes before meals on an empty stomach.
Only for the film-coated tablets of Nebivolol and Hydrochlorothiazide Teva Italia 5 mg/12.5 mg:
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

Use in children and adolescents
Do not administer Nebivolol and Hydrochlorothiazide Teva Italia to children or adolescents.

If you take more Nebivolol and Hydrochlorothiazide Teva Italia than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or pharmacist immediately.
The most common symptoms and signs of overdose are very slow heartbeat (bradycardia), low blood pressure with possible fainting, shortness of breath as in asthma, acute heart failure, excessive urination leading to dehydration, nausea and drowsiness, muscle cramps, and heart rhythm disturbances (especially if you are also taking digitalis or medicines for heart rhythm problems).

If you forget to take Nebivolol and Hydrochlorothiazide Teva Italia
If you forget to take a dose of Nebivolol and Hydrochlorothiazide Teva Italia but remember shortly afterwards, you may take the missed dose as usual. However, if a long time has passed (for example, several hours), and it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose. Nevertheless, avoid repeatedly missing doses.

If you stop taking Nebivolol and Hydrochlorothiazide Teva Italia
Always consult your doctor before stopping treatment with Nebivolol and Hydrochlorothiazide Teva Italia.

If you have any further questions 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.
Stop taking Nebivolol and Hydrochlorothiazide Teva Italia and consult your doctor immediately if you experience any of the following reactions:

  • Allergic reactions affecting the whole body, with generalized skin rash (hypersensitivity reactions); sudden swelling, especially around the lips, eyes or tongue, possibly causing sudden breathing difficulties (angioedema). Frequency unknown (frequency cannot be estimated from the available data)

The following side effects have been reported with nebivolol:
Common (may affect up to 1 in 10 people):

  • headache
  • dizziness
  • tiredness
  • unusual burning, tingling, pricking or numbness sensation
  • diarrhoea
  • constipation
  • nausea
  • shortness of breath
  • swelling of hands and feet.

Uncommon (may affect up to 1 in 100 people):

  • slow heartbeat or other heart problems
  • low blood pressure
  • cramp-like pain in the legs when walking
  • vision disorders
  • impotence
  • feeling of depression
  • indigestion, gas in the stomach or intestines, vomiting
  • skin rash, itching
  • shortness of breath as in asthma, due to sudden cramps of the airway muscles (bronchospasm)
  • nightmares.

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

  • fainting
  • worsening of psoriasis (a skin disease causing scaly pink patches).

Not known (frequency cannot be estimated from the available data):
The following side effects have been reported only in isolated cases:

  • skin rash appearing as raised, light red, itchy patches, either allergic or non-allergic in nature (urticaria);
  • seeing or hearing things that are not real (hallucinations);
  • loss of contact with reality (psychosis);
  • circulation problems in fingers of hands and feet, arms or legs, which may present as paleness, bluish discoloration or tingling in fingers of hands and feet (Raynaud's syndrome);
  • dry eyes, lesions or thickening of eyelids or the white part of the eye.

The following side effects have been reported with hydrochlorothiazide:
Benign, malignant and unspecified abnormal growths (including cysts and polyps)
Not known (frequency cannot be estimated from the available data):

  • cancer of the skin and lips (non-melanoma skin cancer)

Allergic reactions

  • generalized allergic reaction (anaphylactic reaction).

Heart and circulation

  • heart rhythm disorders, palpitations
  • changes in electrocardiogram
  • sudden fainting upon standing, formation of blood clots in veins (thrombosis) and embolism, circulatory collapse (shock).

Blood

  • changes in blood cell counts, such as: decrease in white blood cells, decrease in platelets, decrease in red blood cells; reduced production of new blood cells by the bone marrow
  • altered levels of body fluids (dehydration) and blood electrolytes, particularly decreased potassium, sodium, magnesium, chloride, and increased calcium
  • increased levels of uric acid, gout, increased blood glucose, diabetes, metabolic alkalosis (a metabolic disorder), increased cholesterol and/or triglycerides.

Stomach and intestine

  • loss of appetite, dry mouth, nausea, vomiting, stomach upset, abdominal pain, diarrhoea, reduced bowel movements (constipation), absence of bowel movements (paralytic ileus), flatulence
  • inflammation of the glands producing saliva, inflammation of the pancreas, increased levels of amylase in blood (a pancreatic enzyme)
  • yellowing of the skin (jaundice), inflammation of the gallbladder.

Chest

  • breathing difficulties, inflammation of the lungs (pneumonia), formation of fibrous tissue in the lungs (interstitial pneumonitis), accumulation of fluid in the lungs (pulmonary edema).

Nervous system

  • dizziness (sensation of spinning)
  • seizures, reduced level of consciousness, coma, headache, dizziness
  • apathy, confusion, depression, nervousness, restlessness, sleep disorders
  • unusual burning, tingling, pricking or numbness of the skin
  • muscle weakness (paresis).

Skin and hair

  • itching, purple spots or patches on the skin (purpura), skin rash (urticaria), increased sensitivity of the skin to sunlight, skin eruptions (including erythema multiforme), facial rash and/or blotchy redness that may lead to scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue death (necrotizing vasculitis), skin peeling, redness, looseness and blisters (toxic epidermal necrolysis).

Eyes and ears

  • yellow vision, blurred vision, worsening of myopia, reduced tear production, decreased vision and eye pain (possible signs of acute myopia or acute angle-closure glaucoma).

Muscles and joints

  • muscle cramps, muscle pain.

Urinary system

  • kidney dysfunction, acute kidney failure (reduced urine production and accumulation of fluids and waste in the body), inflammation of connective tissue within the kidneys (interstitial nephritis), sugar in urine.

Sexual organs

  • erectile dysfunction.

General/Other

  • general weakness, tiredness, fever, thirst.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivolol and Hydrochlorothiazide Teva Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
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. Package contents and other information

What Nebivololo e Idroclorotiazide Teva Italia contains
Nebivololo e Idroclorotiazide Teva Italia 5 mg/12.5 mg film-coated tablets

  • The active substances are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride) and 12.5 mg of hydrochlorothiazide.

Nebivololo e Idroclorotiazide Teva Italia 5 mg/25 mg film-coated tablets

  • The active substances are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride) and 25 mg of hydrochlorothiazide.

The other components are:

  • tablet core: monohydrate lactose, polysorbate 80, hypromellose (13.6 mPas), corn starch, microcrystalline cellulose, monohydrate citric acid, anhydrous colloidal silica, magnesium stearate
  • tablet coating: Opadry White 03A 580004 [only 5/12.5 mg], Opadry Yellow 03A520012 [only 5/25 mg], hypromellose (6 mPas), titanium dioxide (E171), polyoxyl (macrogol) stearate, microcrystalline cellulose, yellow iron oxide (E172) [only 5/25 mg].

Description of the appearance of Nebivololo e Idroclorotiazide Teva Italia and contents of the pack
The film-coated tablets of Nebivololo e Idroclorotiazide Teva Italia 5 mg/12.5 mg are white to off-white, 9.2 mm in diameter, round, biconvex, with "515" engraved on one side and a score line on the other.
The breaking line is intended only to facilitate tablet splitting for ease of swallowing and is not intended to divide the tablet into equal doses.
The film-coated tablets of Nebivololo e Idroclorotiazide Teva Italia 5 mg/25 mg are pale yellow, 9.2 mm in diameter, round, biconvex, with "525" engraved on one side.

Pack sizes:
28, 30, 50 and 100 film-coated tablets.
The tablets are supplied in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitza 2600, Bulgaria
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren, Baden-Wuerttemberg 89143, Germany