Nebivolol and hydrochlorothiazide EG: detailed information

Package leaflet: Information for the patient

NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG 5 mg / 12.5 mg film-coated tablets, 25 mg film-coated tablets

Read this entire leaflet carefully before taking 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG is and what it is used for
What you need to know before taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG
How to take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG
Possible side effects
How to store NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG
Contents of the pack and other information

1. What NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG is and what it is used for

NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG 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 heart's pumping action. In addition, it dilates blood vessels, helping to lower blood pressure.
Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced.

NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG combines nebivolol and hydrochlorothiazide in a single tablet. It is used to treat high blood pressure (hypertension). It is used in place of the two separate medicines for patients who are already taking them together.

2. What you need to know before taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG

Do not take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG

if you are allergic to nebivolol or 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);
certain other serious heart rhythm disorders (e.g., sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block);
newly developed heart failure or recent worsening of 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 arms or legs;
untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal gland);
severe kidney problems, complete absence of urine (anuria);
a metabolic disorder (metabolic acidosis), such as diabetic ketoacidosis;
asthma or breathing difficulties (current or past);
liver problems;
persistently high levels of calcium in the blood, persistently low levels of potassium and sodium in the blood that are 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 EG.

Inform your doctor if you have or have had any of the following conditions:
a specific type of chest pain due to spontaneous cardiac spasms known as Prinzmetal's angina;
first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm);
abnormally slow heartbeat;
untreated chronic heart failure;
lupus erythematosus (an autoimmune disorder, i.e., a disorder of the body's immune defense system);
psoriasis (a skin disease characterized by 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 and legs, e.g., Raynaud's disease or syndrome, cramp-like pain while walking;
allergy: this medicine may intensify your reaction to pollen or other substances you are allergic to;
prolonged breathing difficulties;
diabetes: this medicine may mask warning signs of low blood sugar (e.g., palpitations, rapid heartbeat); your doctor will also advise you to monitor your blood glucose more frequently when taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG, as your antidiabetic medication dose may need adjustment;
kidney problems: your doctor will check your kidney function to ensure it does not worsen. Do not take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG if you have severe kidney problems (see section "Do not take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG");
if you tend to have low potassium levels in the blood, especially if you have long QT syndrome (a type of electrocardiographic abnormality) or if you are taking digitalis (to support heart pumping); you are more likely to have low 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 scheduled for surgery, always inform the anaesthetist that you are taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG before being anaesthetized.

During treatment

NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG may increase levels of fats in the blood and uric acid.
NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG may affect levels of certain electrolytes in the blood (such as magnesium, potassium, sodium, and chloride): your doctor may periodically check electrolyte levels through blood tests. This may cause symptoms such as dry mouth, thirst, weakness, fatigue, muscle pain or cramps, rapid heartbeat, dizziness, low blood pressure, restlessness, feeling unwell, and reduced urination. Inform your doctor if any of these symptoms occur.
The hydrochlorothiazide contained in NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG may make your skin hypersensitive to sunlight or artificial UV light. Stop taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG 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 experience any changes in vision or eye pain during treatment with NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG. This could indicate the development of glaucoma. Discontinue treatment with NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG and consult your doctor.

Laboratory tests

Anti-doping tests: NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG may cause a positive anti-doping test result.
NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG may alter results of parathyroid function tests. Inform your doctor or hospital staff that you are taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG before undergoing these tests. For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Due to lack of data on use in children and adolescents, the use of NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG is not recommended in these age groups.

Other medicines and NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor if you are using or receiving any of the following medicines concurrently with NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG:

Medicines that, like NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG, may affect blood pressure and/or heart function:
Medicines for controlling blood pressure or heart problems (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 antipsychotic treatments (for psychosis, a mental illness), e.g., amisulpride, barbiturates (also used for epilepsy), chlorpromazine, carbamazepine, 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 disorders such as glaucoma (increased eye pressure) or pupil dilation (pupil enlargement);
Baclofen (a muscle relaxant);
Amifostine (a protective agent used during anti-tumour therapy);
Cholestyramine or colestipol (medicines used to lower cholesterol levels);
Medicines whose effect or toxicity may be increased by NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG:
Lithium (used as a mood stabilizer);
Cisapride (used for digestive problems);
Bepridil (used for angina);
Difemanil (used for excessive sweating);
Medicines used for infections: intravenous or injected erythromycin, 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: steroids (e.g., cortisone and prednisone), ACTH (adrenocorticotropic hormone), and medicines derived from salicylic acid (e.g., acetylsalicylic acid/aspirin and other salicylates);
Carbenoxolone (used for heartburn and gastric ulcers);
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;
Certain anticancer drugs (e.g., cyclophosphamide, fluorouracil, methotrexate);
Medicines whose effect may be reduced by NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG:
Medicines that lower blood glucose levels (insulin and oral antidiabetic medicines, metformin);
Medicines for gout (e.g., allopurinol, probenecid, sulfinpyrazone);
Medicines such as noradrenaline, used to treat low blood pressure or slow heart rate;
Non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation, as these may reduce the blood pressure-lowering effect of NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG.
Medicines for treating gastric hyperacidity or ulcers (antacids), e.g., cimetidine: take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG with a meal and the antacid between meals.

NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG with alcohol
Be cautious when consuming alcohol during treatment with NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG, as dizziness or fainting may occur. If this happens, do not consume any more alcohol, including wine, beer, or carbonated alcoholic beverages.

Pregnancy and breastfeeding
You must inform your doctor if you are or think you may be pregnant. Normally, your doctor will advise you to take another medicine instead of NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG, as NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG is not recommended during pregnancy. This is because the active substance hydrochlorothiazide crosses the placenta. The use of NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG during pregnancy may cause potentially harmful effects on the fetus and newborn.
Tell your doctor if you are breastfeeding or plan to breastfeed. NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG is not recommended for women who are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine may cause dizziness or fatigue. Do not drive or operate machinery if you experience these symptoms.

NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, please contact him/her before taking this medicine.

3. How to take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG

Take this medicine exactly as your doctor has told you. If you have any doubts, contact your doctor.
The recommended dose is 1 tablet daily, taken with some water, preferably always at the same time of day.
NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG may be taken before, during or after meals, or independently of meals.

For NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG 5 mg/12.5 mg film-coated tablets only:
The break line is intended solely to assist in splitting the tablet if you have difficulty swallowing it whole.

Use in children and adolescents
Do not administer NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG to children or adolescents.

If you take more NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG than you should
If you accidentally take too much of this medicine, contact your doctor or pharmacist immediately.
The most common symptoms and signs of overdose include 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 disturbances in heart rhythm (especially if you are also taking digitalis or medicines for heart rhythm disorders).

If you forget to take NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG
If you forget to take a dose of NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG but remember shortly afterwards, you may take the missed dose as usual. However, if you remember only after a longer period (e.g. several hours), such that you are already due to take the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for the forgotten dose. However, avoid missing too many doses.

If you stop taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG
You must always consult your doctor before stopping treatment with NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG.

If you have any doubts about how to use this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG and contact a doctor immediately if you experience any of the following reactions:

severe allergic reactions affecting the whole body, including widespread skin rash (hypersensitivity reactions); sudden swelling, especially around the lips, eyes, or tongue, possibly with 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 sensations of burning, tingling, itching, or pins and needles
diarrhoea
constipation
nausea
shortness of breath
swollen hands or feet

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

slow heartbeat or other heart problems
low blood pressure
cramp-like leg pain when walking
abnormal vision
impotence
feeling depressed
digestive problems, bloating, vomiting
skin rash, itching
breathlessness such as in asthma due to sudden spasms of the muscles surrounding the airways (bronchospasm)
nightmares

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

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

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

a type of skin rash characterized by raised, itchy, pale red welts of allergic or non-allergic origin (urticaria)
seeing or hearing things that are not real (hallucinations)
loss of contact with reality (psychosis)
blood circulation problems in the fingers and toes, arms and legs, which may cause paleness, bluish discoloration, or tingling in the fingers and toes (Raynaud's syndrome)
dry eyes, scarring or thickening of the eyelids or the white part of the eye

The following side effects have been reported with hydrochlorothiazide:
Allergic reactions

severe allergic reactions affecting the whole body (anaphylactic reaction)

Heart and circulation

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

Blood

changes in blood cell counts, such as: reduced white blood cells, reduced platelets, reduced red blood cells; decreased production of new blood cells by the bone marrow
disturbances in 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 discomfort, abdominal pain, diarrhoea, reduced bowel movements (constipation), absence of bowel movements (paralytic ileus), flatulence
inflammation of the salivary glands, inflammation of the pancreas, increased levels of blood amylase (a pancreatic enzyme)
yellowing of the skin (jaundice), inflammation of the gallbladder

Chest

breathing difficulties, lung inflammation (pneumonia), fibrous tissue formation in the lungs (interstitial pneumonitis), fluid accumulation 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 disturbances
unusual sensations of burning, tingling, itching, or pins and needles
muscle weakness (paresis)

Skin and hair

itching, purple spots or patches on the skin (purpura), urticaria, increased sensitivity of the skin to sunlight, skin rashes (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 blistering of the skin (toxic epidermal necrolysis)

Eyes and ears

yellow vision, blurred vision, worsening of myopia, reduced tear production, reduced vision and eye pain (possibly indicating acute myopia or acute angle-closure glaucoma)

Joints and muscles

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 the connective tissue within the kidneys (interstitial nephritis), sugar in the urine

Sexual function

erectile dysfunction

General/Other

general weakness, fatigue, 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 the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEBIVOLOL AND HYDROCHLOROTHIAZIDE EG

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 packaging and blister after the word EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 EG contains

The active substances are 5 mg nebivolol (as nebivolol hydrochloride) and 12.5 mg hydrochlorothiazide.
The active substances are 5 mg nebivolol (as nebivolol hydrochloride) and 25 mg hydrochlorothiazide.
The other components are:
Core of the tablet: lactose monohydrate, polysorbate 80 (E433), hypromellose (E15), maize starch, microcrystalline cellulose (PH 102), citric acid monohydrate, colloidal anhydrous silica (E551), magnesium stearate (E572). Coating: Opadry® white 03A 580004 [only 5/12.5 mg], Opadry® yellow 03A520012 [only 5/25 mg], hypromellose (E464), titanium dioxide (E171), polyoxyl (Macrogol) stearate, microcrystalline cellulose (E460), yellow iron oxide (E172) [only 5/25 mg].

Description of the appearance of NEBIVOLOLO E IDROCLOROTIAZIDE EG and the contents of the pack
NEBIVOLOLO E IDROCLOROTIAZIDE EG 5 mg/12.5 mg film-coated tablets are available as
film-coated tablets of 9.2 mm, white to off-white, round, biconvex, with "515" engraved on one side and a break line on the other side.
NEBIVOLOLO E IDROCLOROTIAZIDE EG 5 mg/25 mg film-coated tablets are available as
film-coated tablets of 9.2 mm, light yellow, round, biconvex, with "525" engraved on one side.
Pack sizes: 10, 28, 30, 98 and 100 film-coated tablets.
The tablets are supplied in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitza 2600 – Bulgaria
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel – Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
BE Nebivolol/HCT EG 5mg/12.5mg filmomhulde tabletten
Nebivolol/HCT EG 5mg/25mg filmomhulde tabletten
DE Nebivolol/HCT STADA Arzneimittel AG 5mg / 12.5 mg Filmtabletten
Nebivolol/HCT STADA Arzneimittel AG 5mg / 25 mg Filmtabletten
IT Nebivololo e Idroclorotiazide EG
LU Nebivolol/HCT EG 5mg/12.5mg comprimés pelliculés
Nebivolol/HCT EG 5mg/25mg comprimés pelliculés