Nebilet hct

Package leaflet: Information for the user

NEBILET HCT, 5 mg + 25 mg, film-coated tablets
Nebivololum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for
the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm other people, even if their symptoms are the same.
• If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

NEBILET HCT contains as active substances nebivolol and hydrochlorothiazide.

• Nebivolol is a cardiovascular medicine belonging to the group of selective beta-adrenolytic agents (i.e. selectively acting on the cardiovascular system). It prevents the heart from beating too fast and controls the force of heart contractions. It also dilates blood vessels, which helps lower blood pressure.
• Hydrochlorothiazide is a diuretic (water pill) that works by increasing the amount of urine produced.

NEBILET HCT is a combination medicine containing nebivolol and hydrochlorothiazide in a single tablet, used for the treatment of high blood pressure (hypertension). It is used instead of two separate medicines in patients who have previously been treated with both of these medicines taken together.

2. Important information before using NEBILET HCT

When not to use NEBILET HCT

• If the patient is allergic to nebivolol or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• If the patient has an allergy (hypersensitivity) to other sulfonamide-derived drugs (medicines similar to hydrochlorothiazide, which is a sulfonamide derivative),
• If the patient has one or more of the following conditions:
  • very slow heart rate (less than 60 beats per minute),
  • certain other severe heart rhythm disorders (e.g. sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block),
  • heart failure that has recently developed or worsened, or if the patient is receiving intravenous therapy to support heart function due to cardiogenic shock in acute heart failure,
  • low blood pressure,
• severe circulatory disorders in the arms or legs,
• untreated phaeochromocytoma: a tumour located on top of the kidneys (in the adrenal glands),
• severe kidney disorders, complete absence of urine (anuria),
• metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis,
• asthma or wheezing (currently or in the past),
• liver function disorders,
• high calcium levels in blood, low potassium levels in blood, low sodium levels in blood, which persist and do not resolve with treatment,
• high uric acid levels with symptoms of gout.

Warnings and precautions
Before taking NEBILET HCT, consult a doctor or pharmacist.

• Inform the doctor if the patient has or develops any of the following conditions:
  • chest pain caused by spontaneous spasm of the coronary arteries (Prinzmetal’s angina),
  • first-degree heart block (a mild conduction disorder in the heart affecting heart rhythm),
  • abnormally slow heart rate,
  • untreated chronic heart failure,
  • systemic lupus erythematosus (an immune system disorder),
  • psoriasis (a skin disease characterized by scaly, pink patches) or history of psoriasis,
  • hyperthyroidism: NEBILET HCT may mask symptoms of abnormally fast heart rate associated with this condition,
  • circulatory disorders in hands or feet, e.g. Raynaud’s disease or syndrome, cramping pain while walking,
  • allergies: NEBILET HCT may worsen reactions to pollen or other allergens,
  • persistent breathing difficulties,
  • diabetes: NEBILET HCT may mask warning signs of low blood sugar (e.g. palpitations, rapid heartbeat) and may increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glimepiride, tolbutamide, glibenclamide, or glyquidone); the doctor may recommend more frequent blood sugar monitoring during treatment with NEBILET HCT, as dose adjustments of antidiabetic medicines may be necessary,
  • kidney function disorders: the doctor will monitor kidney function to ensure it does not worsen; NEBILET HCT should not be used in cases of severe kidney dysfunction (see section "When not to use NEBILET HCT"),
  • tendency to low potassium levels in blood, especially if the patient has long QT syndrome (an abnormal ECG pattern) or is taking digitalis glycosides (to support heart contraction); the risk of low potassium levels is higher in liver cirrhosis, rapid fluid loss due to intensive diuretic therapy, or insufficient potassium intake from food and drinks,
  • planned surgery – always inform the anaesthetist about taking NEBILET HCT before anaesthesia,
  • if the patient previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses and over a long period, may increase the risk of certain types of non-melanoma skin cancers and lip cancers. While taking Nebilet HCT, protect the skin from sunlight and UV radiation,
  • if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these may occur within hours or weeks after taking Nebilet HCT. This may lead to permanent vision loss if untreated. If

the patient previously had an allergy to penicillin or sulfonamides, they may be more susceptible to developing this
condition,

• if the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Nebilet HCT, seek immediate medical help.
  • NEBILET HCT may increase blood levels of fats and uric acid. It may affect blood levels of certain chemicals called electrolytes: the doctor will periodically monitor their levels through blood tests.
  • Hydrochlorothiazide, an ingredient in NEBILET HCT, may cause skin hypersensitivity to sunlight or artificial ultraviolet radiation. Discontinue NEBILET HCT and consult a doctor if rash, itchy spots, or skin hypersensitivity occur during treatment (see also section 4).
  • Anti-doping test: NEBILET HCT may cause a positive result in an anti-doping test.

Children and adolescents
Not recommended for use in children and adolescents due to lack of data on use in this age group.
Other medicines and NEBILET HCT
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Always inform the doctor if any of the following medicines are taken simultaneously with NEBILET HCT:

• Medicines that, like NEBILET HCT, may affect blood pressure and/or heart function:
  • Medicines lowering blood pressure and those used in heart disorders (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 antipsychotics (used in psychiatric disorders) e.g. amisulpride, barbiturates (also used in epilepsy), chlorpromazine, carbamazepine, droperidol, haloperidol, levomepromazine, opioids, phenothiazines (also used for nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine
  • Antidepressants, e.g. amitriptyline, fluoxetine, paroxetine
  • Medicines used for anaesthesia during surgery
  • Medicines used in asthma, nasal congestion, or certain eye diseases such as glaucoma (increased eye pressure) or to dilate the pupil
  • Medicines used in diabetes, such as insulin or oral antidiabetics
  • Baclofen (a muscle relaxant)
  • Amifostine (a protective agent used during cancer treatment).
• Medicines whose effect or toxicity may be increased by NEBILET HCT:
  • Lithium salts, used as mood stabilizers
  • Cisapride (used for gastrointestinal disorders)
  • Bepridil (used in angina pectoris)
  • Difemanil (used for excessive sweating)
  • Medicines used in infections: erythromycin administered by infusion or injection, pentamidine, sparfloxacin, amphotericin and sodium penicillin G, halofantrine (used in malaria)
  • Vinpocetine (used in cerebral circulation disorders)
  • Mizolastine and terfenadine (used in allergies)
• Diuretics and laxatives
• Medicines used to treat acute inflammatory conditions: steroids (e.g. cortisone and prednisone), ACTH (adrenocorticotropic hormone), and salicylic acid derivatives (e.g. acetylsalicylic acid/aspirin and other salicylates)
• Carbenoxolone (used to treat heartburn and gastric ulcers)
• Calcium salts, used as supplements to increase bone mineralization
• Medicines used to relax muscles (e.g. tubocurarine)
• Diazoxide, used to treat low blood sugar and high blood pressure
• Amantadine, an antiviral medicine
• Cyclosporine, used to suppress the immune system
• Iodinated contrast agents, used as contrast media in X-ray examinations.
• Anticancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate).
  • Medicines whose effect may be reduced by NEBILET HCT:
• Medicines lowering blood sugar (insulin and oral antidiabetics, metformin)
• Medicines used in gout (e.g. allopurinol, probenecid, sulfinpyrazone)
• Medicines such as noradrenaline, used to treat low blood pressure and slow heart rate.
  • Painkillers and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs), as they may reduce the blood pressure-lowering effect of NEBILET HCT.
  • Medicines used for acidity and peptic ulcer disease (medicines reducing gastric acid secretion): NEBILET HCT should be taken with meals, and antacids should be taken between meals.

NEBILET HCT and alcohol
Exercise caution when consuming alcohol while taking NEBILET HCT, as fainting or dizziness may occur. In such cases, do not consume alcohol, including wine, beer, and carbonated alcoholic beverages.
Pregnancy and breastfeeding
The patient must inform her doctor if she is pregnant or suspects pregnancy.
In such cases, the doctor will usually prescribe an alternative medicine instead of Nebilet HCT, as Nebilet HCT is not recommended during pregnancy. This is because one of the active substances in Nebilet HCT – hydrochlorothiazide – crosses the placenta. Therefore, using Nebilet HCT during pregnancy may potentially harm the foetus and newborn.
Inform the doctor if the patient is breastfeeding or plans to start breastfeeding. Nebilet HCT is not recommended for breastfeeding mothers.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
NEBILET HCT may cause dizziness and fatigue. In such cases, do not drive or operate machinery.
NEBILET HCT contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use NEBILET HCT

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.
Take 1 tablet daily, with sufficient water, preferably at the same time each day.
NEBILET HCT may be taken before, during, or after meals, or independently of food intake.
Use in children and adolescents
NEBILET HCT must not be given to children and adolescents.
Taking more NEBILET HCT than recommended
In case of accidental overdose, you must inform your doctor or pharmacist immediately.
The most common subjective and objective symptoms of overdose include: very slow heart rate (bradycardia), low blood pressure which may lead to fainting, breathlessness similar to that occurring in bronchial asthma, acute heart failure, excessive urination leading to dehydration, nausea and drowsiness, muscle cramps, and cardiac arrhythmias (especially if glycosides of foxglove or antiarrhythmic drugs are taken concomitantly).
Missed dose of NEBILET HCT
If you miss a dose of NEBILET HCT but remember shortly afterwards, take the missed dose as planned for that day. However, if a significant delay has occurred (e.g. several hours) and it is nearly 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. Avoid repeatedly missing doses of this medicine.
Stopping NEBILET HCT treatment
Always consult your doctor before stopping treatment with NEBILET HCT.
If you have any further questions regarding use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

The following side effects have been reported during the use of nebivolol:

Common side effects (may affect up to 1 in 10 people):

• headaches
• dizziness
• feeling tired
• unusual sensations of burning, prickling, tingling or numbness
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling of the hands or feet.

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

• slow heart rate or other heart-related disorders
• low blood pressure
• cramping leg pain when walking
• visual disturbances
• impotence
• depressive disorders
• digestive disorders, bloating, vomiting
• skin rash, itching
• asthma-like shortness of breath caused by sudden contraction of the airway muscles (bronchospasm)
• nightmares.

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

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

The following side effects have been reported in individual cases only:

• whole-body allergic reactions with widespread skin changes (hypersensitivity reactions)
• rapidly developing swelling, particularly around the mouth, eyes or tongue, possibly accompanied by sudden breathing difficulties (angioedema)
• a type of skin rash appearing as pale red, raised, itchy lumps, either due to allergy or non-allergic causes (urticaria).

The following side effects have been reported during the use of hydrochlorothiazide:
Frequency not known: skin and lip cancers (non-melanoma skin cancers).

Allergic reactions

• systemic allergic reaction (anaphylactic reaction)

Heart and circulatory system

• heart rhythm disorders, palpitations
• changes in electrocardiogram (ECG)
• sudden fainting in the upright position, blood clot formation in veins (thrombosis), embolism, circulatory collapse (shock).

Blood

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

Stomach and intestines

• loss of appetite, dryness of the oral mucosa, nausea, vomiting, stomach discomfort, abdominal pain, diarrhoea, reduced intestinal peristalsis (constipation), absence of intestinal peristalsis (paralytic ileus), bloating
• inflammation of salivary glands, pancreatitis, increased blood amylase activity (pancreatic enzyme)
• yellowing of the skin (jaundice), inflammation of the gallbladder.

Chest

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

Nervous system

• dizziness (sensation of spinning)
• seizures, disturbances of consciousness, coma, headache, dizziness
• apathy, confusion, depression, nervousness, anxiety, sleep disturbances
• unusual sensations of burning, prickling, tingling or numbness
• muscle weakness (paresis).

Skin and hair

• itching, purple spots on the skin (purpura), urticaria, increased sensitivity of the skin to sunlight, rash, facial rash and/or red patches which may lead to scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue necrosis (necrotising vasculitis), skin peeling, redness, skin layer separation and blister formation (toxic epidermal necrolysis).

Eyes and ears

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

Joints and muscles

• muscle cramps, muscle pain.

Urinary system

• kidney function disorders, acute kidney failure (reduced urine production and accumulation of fluid and metabolic waste products in the body), inflammation of renal connective tissue (interstitial nephritis), presence of glucose in urine.

Genital organs

• erectile dysfunction.

General/other

• general weakness, fatigue, fever, excessive thirst.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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 helps provide more information on the safety of this medicine.

5. How to store the medicine NEBILET HCT

Keep the medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use the medicine NEBILET HCT after the expiry date stated on the carton and blisters following
the abbreviation "EXP". The expiry date refers to the last day of the specified month.
Medicines must 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 are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride: 2.5 mg d-nebivolol and 2.5 mg l-nebivolol) and 25 mg of hydrochlorothiazide.
• Other components are:
  • tablet core: monohydrate lactose, polysorbate 80, hypromellose 15 mPa•s, corn starch, sodium croscarmellose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate;
  • coating: polyglycol stearate (type I), titanium dioxide (E171), carmine (carmine acid, E120), lacquer, hypromellose 6 cps, microcrystalline cellulose.

What NEBILET HCT looks like and contents of the pack
NEBILET HCT is a violet-coloured, round, slightly biconvex coated tablet with the imprint "5/25" on one side.
Pack sizes: 7, 14, 28 coated tablets.
The tablets are contained in blisters made of PP/COC/PP/Aluminium, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Nobiretic
Cyprus: Lobivon-plus
Czech Republic: Nebilet Plus H 5 mg / 25 mg coated tablets
Denmark: Hypoloc Comp
Estonia: Nebilet Plus
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 / 25 mg
Slovenia: Co-Nebilet
Slovakia: Nebilet HCTZ
Spain: Lobivon plus
Netherlands: Nebiretic

Date of latest revision of the leaflet: 04/2025