Nebilox

Package Leaflet: Information for the User

NEBILOX 5 mg Tablets

Nebivolol
Please read this 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 other people, even if their symptoms are the same as yours, as it may 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:

1. What Nebilox is and what it is used for
2. What you need to know before taking Nebilox
3. How to take Nebilox
4. Possible side effects
5. How to store Nebilox
6. Contents of the pack and other information

1. What Nebilox is and what it is used for

Nebilox contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e. with selective action on the cardiovascular system). Nebilox prevents the increase in heart rate and controls the force of the heart's pumping action. In addition, it exerts a dilating effect on blood vessels, which contributes to lowering blood pressure. It is used to treat high blood pressure (hypertension). Nebilox is also used to treat mild to moderate chronic heart failure, in addition to other therapies, in elderly patients aged 70 years and older.

2. What you need to know before taking Nebilox

Do not take Nebilox

• If you are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6).
• If you have one or more of the following conditions:
  • Low blood pressure
  • Severe circulatory problems in the arms or legs
  • Very slow heart rate (less than 60 beats per minute)
  • Other serious heart rhythm disorders (e.g., second- or third-degree atrioventricular block and cardiac conduction disorders)
  • Recently developed or recently worsened heart failure, or if you are receiving intravenous therapy to treat circulatory shock due to acute heart failure to help support heart function
  • Asthma or wheezing (current or past)
  • Untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands)
  • Impaired liver function
  • Metabolic disorder (metabolic acidosis), such as diabetic ketoacidosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebilox.
Inform your doctor if you experience or develop any of the following symptoms:

• Abnormally slow heartbeat
• A type of chest pain caused by spontaneous spasm of the heart muscle known as Prinzmetal's angina
• Untreated chronic heart failure
• First-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
• Poor circulation in the arms and legs, for example Raynaud's disease or syndrome, or cramping pain while walking
• Prolonged breathing difficulties
• Diabetes: this medicine does not affect blood glucose levels, but it may mask warning signs of low blood sugar (e.g., palpitations, rapid heartbeat)
• Overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat caused by this condition
• Allergies: this medicine may intensify reactions to pollen or other substances to which you are allergic
• Psoriasis (a skin disease causing scaly, pink patches) or if you have previously suffered from psoriasis
• If you are undergoing surgery, always inform the anaesthetist that you are being treated with Nebilox before receiving anaesthesia.

Do not take Nebilox for the treatment of heart failure if you have severe kidney problems, and inform your doctor.
During the initial phase, treatment for chronic heart failure must be monitored by an experienced physician (see section 3).
Do not stop this treatment abruptly unless specifically instructed and evaluated by your doctor (see section 3).
For athletes: using this medicine without a 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 Nebilox is not recommended in these age groups.

Other medicines and Nebilox
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 have recently been given any of the following medicines in addition to Nebilox:

• Medicines for controlling blood pressure or heart conditions (e.g., amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).

• Sedatives and treatments for psychosis (a mental illness), e.g., barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea), and thioridazine.

• Medicines for depression, e.g., amitriptyline, paroxetine, fluoxetine.

• Medicines used for anaesthesia during surgery.

• Medicines for asthma, sinusitis, or certain eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation (enlargement).

• Baclofen (a muscle relaxant); amifostine (a protective agent used during anti-tumor treatment). All these medicines, like nebivolol, may affect blood pressure and/or heart function.

• Medicines for treating excess stomach acid or ulcers (antacids): take Nebilox with meals and take the antacid between meals.

Nebilox with food and drink
Refer to section 3.

Pregnancy and breastfeeding
Nebilox must not be used during pregnancy unless absolutely necessary.
Use during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine may cause dizziness or fatigue. If these occur, do not drive or operate machinery.

Nebilox contains lactose
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Nebilox

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Nebilox may be taken before, during, or after meals, or alternatively, independently of meals. It is preferable to swallow the tablet with water.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet daily. The dose should preferably be taken at the same time each day.
• In elderly patients and in patients with renal impairment, treatment is usually started with ½ (half) a tablet daily.
• The therapeutic effect on blood pressure becomes evident after 1–2 weeks of treatment. Sometimes the optimal effect is only achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be initiated and closely supervised by an experienced physician.
• Your doctor will start treatment with ¼ (one-quarter) of a tablet daily. After 1–2 weeks, the dose may be increased to ½ (half) a tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the appropriate dose required for your condition is reached. Your doctor will prescribe the appropriate dose for you at each stage of treatment, and you must follow their instructions carefully.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• You will need to be monitored by an experienced physician for the first 2 hours after starting treatment and after each dose increase.
• Your doctor may reduce the dose if necessary.
• Do not stop treatment abruptly, as this may worsen heart failure.
• This medicine must not be taken by patients with severe kidney problems.
• Take the medicine once daily, preferably at the same time each day.

If your doctor has prescribed you to take ¼ (one-quarter) or ½ (half) a tablet daily, refer to the instructions below detailing how to split the Nebilox 5 mg tablet with double score lines.

• Place the tablet on a flat, hard surface (e.g. a table or countertop), with the score lines facing upwards.
• Break the tablet by pressing with the index fingers of both hands placed along one of the score lines (Figures 1 and 2).
• Break the half tablet in the same way to obtain quarters (Figures 3 and 4).

Your doctor may decide to combine Nebilox with other medicines to treat your condition.

• Not to be used in children and adolescents.

If you take more Nebilox than you should
If you accidentally take too much of this medicine, inform your doctor or pharmacist immediately. The most common symptoms and signs of Nebilox overdose are very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), difficulty breathing as in asthma (bronchospasm), and acute heart failure.
You may take activated charcoal (available from pharmacies) while waiting for medical help to arrive.

If you forget to take Nebilox
If you forget to take a dose of Nebilox but remember shortly afterwards, take your daily dose as usual. If a significant delay has occurred (i.e. several hours) and it is close to the time for your next scheduled dose, do not take the missed dose and take your next regular dose at the usual time. Do not take a double dose. However, avoid repeatedly missing doses of this medicine.

If you stop taking Nebilox
You must always consult your doctor before stopping treatment with Nebilox, whether you are taking it for high blood pressure or for chronic heart failure.
Do not stop treatment with Nebilox abruptly, as this may temporarily worsen heart failure. If discontinuation of Nebilox treatment for heart failure is necessary, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any questions about the 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 gets them.

When Nebilox is used to treat high blood pressure, possible side effects are:

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

• headache
• dizziness
• tiredness
• unusual sensation of itching or tingling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling of the hands and feet

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

• slow heart rate or other heart problems
• low blood pressure
• cramp-like pain in the legs when walking
• abnormal vision
• impotence
• feeling of depression
• difficulty in digestion (dyspepsia), stomach or intestinal gas, vomiting
• skin rashes, itching
• shortness of breath as in asthma, due to sudden cramping 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 causing scaly pink patches)

During treatment with Nebilox, the following side effects have been reported only in a few isolated cases:

• widespread allergic reactions, including generalized skin rashes (hypersensitivity reactions)
• rapidly developing swelling, especially around the lips, eyes or tongue, possibly with sudden breathing difficulties (angioedema)
• a type of skin rash characterized by itchy, raised, pale red wheals, either allergic or non-allergic in nature (urticaria)

In a clinical study on chronic heart failure, the following side effects were observed:

Very common side effects (may affect more than 1 in 10 people):

• slow heartbeat
• dizziness

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

• worsening of heart failure
• low blood pressure (with feeling of faintness upon standing up quickly)
• inability to tolerate this medicine
• a mild heart conduction disorder affecting heart rhythm (first-degree AV block)
• swelling of the lower limbs (swollen ankles)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebilox

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 the 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 Nebilox contains

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride): 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
• The other components are: monohydrate lactose, polysorbate 80 (E433), hypromellose (E464), maize starch, sodium croscarmellose (E468), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572).

Description of the appearance of Nebilox and contents of the pack
Nebilox is presented as white, round tablets with two score lines,
available in packs of 7, 14, 28, 30, 50, 56, 90, 100, and 500 tablets. The tablets are
packaged in blisters (PVC/aluminum).
(Not all pack sizes may be marketed.)

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A.
Avenue de la Gare 1
L-1611 Luxembourg
Distribution Licensee
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l’Ema, 7 - Bagno a Ripoli (FI)
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125, 12489 Berlin, Germany
or
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13, 01097 Dresden, Germany
or
Qualiphar N.V.
Rijksweg 9, 2880 Bornem, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Hypoloc
Belgium: Nobiten
Cyprus: Lobivon
Denmark: Hypoloc
Finland: Hypoloc
France: Temerit
Germany: Nebilet
Greece: Nebilox
Ireland: Hypoloc
Italy: Nebilox
Iceland: Hypoloc
Luxembourg: Nobiten
Norway: Hypoloc
Portugal: Nebilet
Spain: Lobivon
Sweden: Hypoloc
The Netherlands: Nebilet
United Kingdom: Hypoloc

This leaflet was last updated on: