Nebilet Hct

Package Leaflet: Information for the User

NEBILET HCT, 5 mg + 12.5 mg, film-coated tablets
Nebivolol + Hydrochlorothiazide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you; do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is NEBILET HCT and what is it used for
• 2. Important information before taking NEBILET HCT
• 3. How to take NEBILET HCT
• 4. Possible side effects
• 5. How to store NEBILET HCT
• 6. Contents of the pack and other information

1. What is NEBILET HCT and what is it used for

NEBILET HCT contains the active substances nebivolol and hydrochlorothiazide.

• Nebivolol is a medicine that acts on the cardiovascular system, belonging to the group of selective beta-adrenergic blocking agents (i.e., selectively affecting the cardiovascular system). It prevents the acceleration of heart rate and controls the force of heart contractions. It also dilates blood vessels, which helps lower blood pressure.
• Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced.

NEBILET HCT is a combination medicine containing nebivolol and hydrochlorothiazide in one tablet and is used to treat high blood pressure (hypertension). It is used instead of two separate medicines, for patients who have already been taking these two medicines simultaneously.

2. Important information before taking NEBILET HCT

When not to take NEBILET HCT

• If you are allergic to nebivolol or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• If you are allergic (hypersensitive) to other sulfonamide derivatives (medicines similar to hydrochlorothiazide, which is a sulfonamide derivative),
• If you have one or more of the following disorders:
• very slow heart rate (less than 60 beats per minute),
• certain other severe heart rhythm disorders (e.g., sick sinus syndrome, atrioventricular block, second- or third-degree atrioventricular block),
• heart failure that has recently occurred or worsened or if you are receiving intravenous treatment to support heart function due to cardiogenic shock in acute heart failure,
• low blood pressure,
• severe circulatory disorders in the arms or legs,
• untreated pheochromocytoma: a tumor located on the top of the kidney (in the adrenal gland),
• severe kidney disorders, complete lack of urine (anuria),
• metabolic disorders (metabolic acidosis), such as diabetic ketoacidosis,
• asthma or wheezing (currently or in the past),
• liver function disorders,
• high calcium levels in the blood, low potassium levels in the blood, low sodium levels in the blood, which persist and do not improve with treatment,
• high uric acid levels in the blood with symptoms of gout.

Warnings and precautions

Before starting to take NEBILET HCT, consult your doctor or pharmacist.

• Tell your doctor if you have or develop any of the following conditions:
• chest pain caused by spontaneous coronary artery spasm (Prinzmetal's angina),
• first-degree atrioventricular block (mild conduction disorder in the heart that affects heart rhythm),
• abnormally slow heart rate,
• untreated chronic heart failure,
• systemic lupus erythematosus (a disorder of the immune system, i.e., the body's defense system),
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past,
• hyperthyroidism: NEBILET HCT may mask symptoms of abnormally fast heart rate occurring in this disease,
• circulatory disorders in the hands or feet, such as Raynaud's disease or intermittent claudication,
• allergy: NEBILET HCT may increase the reaction to pollen or other substances you are allergic to,
• persistent breathing difficulties,
• diabetes: NEBILET HCT may mask warning signs of low blood sugar (e.g., palpitations, fast heart rate) and may increase the risk of severe hypoglycemia when used with certain types of oral antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glibenclamide, glimepiride, or tolbutamide); your doctor will recommend more frequent blood sugar testing while taking NEBILET HCT, as it may be necessary to adjust the dose of your antidiabetic medicines,
• kidney function disorders: your doctor will monitor your kidney function to ensure it does not worsen; in case of severe kidney function disorders, you should not take NEBILET HCT (see "When not to take NEBILET HCT"),
• tendency to low potassium levels in the blood, especially in cases of prolonged QT interval (abnormal ECG recording) or when taking digitalis glycosides (to support heart contractions); the risk of low potassium levels in the blood is higher in cases of liver cirrhosis, excessive fluid loss due to intense diuretic treatment, or insufficient potassium intake with food and drinks,
• planned surgery - before anesthesia, always inform the anesthesiologist about taking NEBILET HCT,
• NEBILET HCT may cause increased fat and uric acid levels in the blood. It may affect the levels of certain chemicals in the blood, called electrolytes: your doctor will periodically check their levels by ordering blood tests.
• Hydrochlorothiazide, a component of NEBILET HCT, may cause skin sensitivity to sunlight or artificial ultraviolet radiation. You should stop taking NEBILET HCT and consult your doctor if you experience a rash, itchy patches, or skin sensitivity during treatment (see also section 4).
• Doping test: NEBILET HCT may cause a positive doping test result.

Children and adolescents
Do notrecommend NEBILET HCT for children and adolescents due to a lack of data on the use of the medicine in this age group.

Other medicines and NEBILET HCT

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Always inform your doctor about taking any of the following medicines with NEBILET HCT:

• Medicines that, like NEBILET HCT, may affect blood pressure and/or heart rate:
• Medicines that lower blood pressure and medicines used in heart disorders (such as amiodarone, amlodipine, cybenzoline, 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 antipsychotic medicines (used in mental disorders) such as amisulpride, barbiturates (also used in epilepsy), chlorpromazine, cyanemazine, droperidol, haloperidol, levomepromazine, opioid medicines, phenothiazine (also used for nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine
• Antidepressant medicines, such as amitriptyline, fluoxetine, paroxetine
• Anesthetics used during surgery
• Medicines used for asthma, stuffy nose, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils
• Medicines used in diabetes, such as insulin or oral antidiabetic medicines
• Baclofen (a muscle relaxant)
• Amifostine (a protective medicine used during cancer treatment)
• Medicines whose effects or toxicity may be increased by NEBILET HCT:
• Lithium salts, used as mood stabilizers
• Cisapride (used in gastrointestinal disorders)
• Bepridil (used in angina pectoris)
• Difemanil (used in excessive sweating)
• Medicines used in infections: erythromycin given by infusion or injection, pentamidine, and sparfloxacin, amphotericin, and sodium penicillin G, halofantrine (used in malaria)
• Vincamine (used in cerebral circulation disorders)
• Mizolastine and terfenadine (used in allergies)
• Diuretics and laxatives
• Medicines used in acute inflammatory conditions: corticosteroids (e.g., cortisone and prednisone), ACTH (adrenocorticotropic hormone), and salicylate derivatives (e.g., acetylsalicylic acid/aspirin and other salicylates)
• Carbenoxolone (used in the treatment of heartburn and stomach ulcers)
• Calcium salts, used as supplements to increase bone calcification
• Medicines used to relax muscles (e.g., tubocurarine)
• Diazoxide, used in the treatment of low blood sugar and high blood pressure
• Amantadine, an antiviral medicine
• Cyclosporine, used to weaken the immune system
• Iodine-based contrast agents, used as contrast agents in X-ray examinations.
• Anticancer medicines (e.g., cyclophosphamide, fluorouracil, methotrexate).
• Medicines whose effects may be reduced by NEBILET HCT:
• Medicines that lower blood sugar levels (insulin and oral antidiabetic medicines, metformin)
• Medicines used in gout (e.g., allopurinol, probenecid, and sulfinpyrazone)
• Medicines such as noradrenaline, used in the treatment of low blood pressure and slow heart rate.
• Pain and anti-inflammatory medicines (non-steroidal anti-inflammatory medicines), as they may reduce the blood pressure-lowering effect of NEBILET HCT.
• Medicines used in acidity and stomach ulcers (medicines that reduce stomach acid production): NEBILET HCT should be taken during meals, and antacids between meals.

NEBILET HCT with alcohol

Be cautious when consuming alcohol while taking NEBILET HCT, as fainting or dizziness may occur. In such cases, do not consume alcohol, including wine, beer, and alcoholic fizzy drinks.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, inform your doctor.
In this case, your doctor will usually prescribe a different medicine instead of NEBILET HCT, as NEBILET HCT is not recommended during pregnancy. This is because one of the active substances of NEBILET HCT, hydrochlorothiazide, passes through the placenta. Therefore, taking NEBILET HCT during pregnancy may potentially harm the fetus and the newborn.
Tell your doctor if you are breastfeeding or plan to breastfeed. NEBILET HCT is not recommended for breastfeeding mothers.
If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

NEBILET HCT may cause dizziness and fatigue. In such cases, do notdrive vehicles or operate machines.

NEBILET HCT contains lactose and sodium

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take NEBILET HCT

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Take one tablet a day, with a sufficient amount of water, preferably at the same time every day.
NEBILET HCT can be taken before, during, or after meals, as well as independently of meals.

Use in children and adolescents

Do not give NEBILET HCT to children and adolescents.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.

What to do if you take more NEBILET HCT than you should

If you accidentally take too much of the medicine, immediatelytell your doctor or pharmacist. The most common subjective and objective symptoms of overdose are: very slow heart rate (bradycardia), low blood pressure that can lead to fainting, shortness of breath similar to that in asthma, acute heart failure, excessive urination leading to dehydration, nausea and drowsiness, muscle cramps, and heart rhythm disorders (especially when taking digitalis glycosides or antiarrhythmic medicines).

What to do if you miss a dose of NEBILET HCT

If you miss a dose of NEBILET HCT but remember soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and close to the time for the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose of the medicine. Avoid missing multiple doses of the medicine.

What to do if you stop taking NEBILET HCT

Before stopping treatment with NEBILET HCT, always consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, NEBILET HCT can cause side effects, although not everybody gets them.
The following side effects have been reported during treatment with nebivolol:
Common side effects (may affect up to 1 in 10 people):

• headache
• dizziness
• fatigue
• unusual sensation of burning, prickling, itching, or tingling
• diarrhea
• constipation
• nausea
• shortness of breath
• swelling of hands or feet.

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

• slow heart rate or other heart disorders
• low blood pressure
• cramping leg pain when walking
• vision disorders
• impotence
• depressive disorders
• gastrointestinal disorders, gas accumulation in the stomach or intestines, vomiting
• skin rash, itching
• shortness of breath similar to that in asthma, caused by sudden constriction of airway muscles (bronchospasm)
• nightmares.

Rare side effects (may affect up to 1 in 1,000 people):

• fainting
• worsening of psoriasis (a skin disease characterized by scaly, pink patches).

The following side effects have been reported in individual cases:

• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions);
• rapidly developing swelling, especially around the mouth, eyes, or tongue, with possible difficulty breathing (angioedema);
• a type of skin rash characterized by pale red, raised, itchy patches, which may be due to an allergic reaction or not (urticaria).

The following side effects have been reported during treatment with hydrochlorothiazide:
Frequency not known: malignant skin tumors and lip tumors (non-melanoma skin cancer).
Allergic reactions

• systemic allergic reaction (anaphylactic reaction)

Heart and blood vessels

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

Blood

• changes in blood cell count, such as decreased white blood cell count, decreased platelet count, decreased red blood cell count, impaired production of new blood cells in the bone marrow
• changes in body fluid volume and blood chemical levels, especially decreased potassium levels, decreased sodium levels, decreased magnesium levels, decreased chloride levels, and increased calcium levels
• increased uric acid levels, gout, increased blood glucose levels, diabetes, metabolic alkalosis (a metabolic disorder), increased cholesterol and/or triglyceride levels in the blood.

Stomach and intestines

• loss of appetite, dry mouth, nausea, vomiting, discomfort in the stomach, abdominal pain, diarrhea, weakened intestinal peristalsis (constipation), absent intestinal peristalsis (paralytic ileus), bloating,
• inflammation of the salivary glands, pancreatitis, increased amylase activity in the blood (a pancreatic enzyme)
• jaundice, inflammation of the gallbladder.

Chest

• breathing difficulties, pneumonia, formation of fibrous tissue in the lungs (interstitial lung disease), fluid accumulation in the lungs (pulmonary edema).
• very rarely: acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Nervous system

• dizziness (feeling of spinning)
• seizures, impaired consciousness, coma, headache, dizziness
• apathy, confusion, depression, nervousness, anxiety, sleep disorders
• unusual sensation of burning, prickling, itching, or tingling
• muscle weakness (paresis).

Skin and hair

• itching, purple spots on the skin (purpura), urticaria, increased skin sensitivity to sunlight, rash, rash on the face and/or red patches that can cause scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue necrosis (necrotizing vasculitis), peeling, redness, scaling, and blistering of the skin (toxic epidermal necrolysis).

Eyes and ears

• yellow vision, blurred vision, worsening of myopia, decreased tear production
• vision loss or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma).

Joints and muscles

• muscle cramps, muscle pain.

Urinary system

• kidney function disorders, acute kidney failure (decreased urine production and fluid accumulation in the body), interstitial nephritis (inflammation of the kidney tissue), presence of sugar in the urine.

Genital organs

• erectile dysfunction.

General/other

• general weakness, fatigue, fever, increased thirst.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store NEBILET HCT

Keep the medicine out of the sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the carton and blister packs after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What NEBILET HCT contains

• The active substances of the medicine are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol (as 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol) and 12.5 mg of hydrochlorothiazide.
• Other ingredients are:
• tablet core: lactose monohydrate, polysorbate 80, hypromellose 15 mPa•s, cornstarch, croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate;
• coating: magnesium stearate (type I), titanium dioxide (E171), carmine (carmic acid, E120), lacquer, hypromellose 6 cps, microcrystalline cellulose.

What NEBILET HCT looks like and contents of the pack

NEBILET HCT is a pink, round, slightly convex film-coated tablet with "5/12.5" embossed on one side and a score line on the other side of the tablet.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Pack sizes: 7, 14, 28 film-coated tablets.
Tablets are packaged in PP/COC/PP/Aluminum blisters in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer

Berlin-Chemie AG
Glienicker Weg 125, 12489 Berlin, Germany
or
Menarini - von Heyden GmbH
Leipziger Strasse 7-13, 01097 – Dresden
Germany
or

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Sette Santi 3, 50131 Florence Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Nobiretic
Bulgaria:
Nebilet Plus
Cyprus:
Lobivon-plus
Czech Republic:
Nebilet Plus H 5 mg / 12.5 mg film-coated tablets
Denmark:
Hypoloc Comp
Estonia:
Nebilet Plus
Finland:
Hypoloc Comp
France:
TEMERITDUO
Greece:
Lobivon-plus
Hungary:
Nebilet Plus
Ireland:
Hypoloc Plus
Italy:
Aloneb
Latvia:
Nebilet Plus
Lithuania:
Nebilet Plus
Luxembourg:
Nobiretic
Malta:
Nebilet Plus
Poland:
Nebilet HCT
Portugal:
Nebilet Plus
Romania:
Co-Nebilet 5 mg / 12.5 mg
Slovakia:
Nebilet HCTZ
Slovenia:
Co-Nebilet
Spain:
Lobivon plus
Netherlands:
Nebiretic
Date of last revision of the leaflet:04/2025