Nebilet

Patient Information Leaflet

NEBILET, 5 mg, tablets
Nebivolol
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Nebilet is and what it is used for

Nebilet contains the active substance nebivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of medicines called selective beta-blockers (i.e. drugs that selectively affect the cardiovascular system). It prevents the heart from beating too fast and reduces the force of heart contractions. It also dilates blood vessels, which helps lower blood pressure.
Nebilet is used to treat high blood pressure (hypertension).
It is also used in the treatment of mild to moderate chronic heart failure as an addition to standard therapy in patients aged 70 years and older.

2. Important information before using Nebilet

When not to use Nebilet

• if the patient is allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has any of the following conditions:
  • low blood pressure,
  • severe circulatory disorders in the arms or legs,
  • very slow heart rate (less than 60 beats per minute),
  • certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders),
  • heart failure which has recently developed or worsened, or if the patient is receiving intravenous medicines to support heart function due to cardiogenic shock in acute heart failure,
  • asthma or wheezing (currently or in the past),
  • untreated phaeochromocytoma – a tumour located in the upper part of the kidney (adrenal gland),
• liver function disorders,
• metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis.

Warnings and precautions
Before starting to take Nebilet, discuss this with your doctor or pharmacist.
Inform your doctor if any of the following conditions are present or develop in the patient:

• abnormally slow heart rate,
• chest pain caused by spontaneous spasm of the coronary arteries (Prinzmetal's angina),
• untreated chronic heart failure,
• first-degree heart block (a mild conduction disorder affecting heart rhythm),
• circulatory disorders in the hands or feet, e.g. Raynaud's disease or syndrome, cramping pains while walking,
• persistent breathing difficulties,
• diabetes – Nebilet does not affect blood sugar levels, but may mask warning symptoms of low blood sugar (e.g. palpitations, rapid heartbeat) and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glimepiride, glipizide, glyburide, tolbutamide or gliquidone),
• hyperthyroidism – Nebilet may mask symptoms of abnormally rapid heartbeat associated with this condition,
• allergies – Nebilet may worsen reactions to pollen or other allergens,
• psoriasis (a skin disease characterised by scaly, red patches) or history of psoriasis,
• planned surgical procedure – before anaesthesia, inform the anaesthetist that Nebilet is being taken.
  In case of severe kidney function impairment, Nebilet should not be used for the treatment of heart failure and this should be discussed with the doctor.

The patient's condition with chronic heart failure will be monitored by an experienced physician at the start of treatment (see section 3).
Do not stop treatment suddenly unless clearly instructed by your doctor (see section 3).

Children and adolescents
Nebilet is not recommended for use in children and adolescents due to lack of data on use in this age group.

Nebilet and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Inform your doctor if any of the following medicines are being taken at the same time as Nebilet:

• Medicines used to treat high blood pressure or heart conditions (such as 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 antipsychotics (used in psychiatric disorders), e.g. barbiturates (also used in epilepsy), phenothiazines (also used for nausea and vomiting), thioridazine.
• Antidepressants, e.g. amitriptyline, paroxetine, fluoxetine.
• Medicines used for anaesthesia during surgery.
• Medicines used for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased pressure in the eye) or to dilate the pupil.
• Baclofen (a medicine that reduces muscle tension), amifostine (a protective agent used during cancer treatment).
• Medicines used in diabetes, such as insulin or oral antidiabetic medicines. All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart function.
• Medicines used for acid reflux or peptic ulcer disease (medicines that reduce stomach acid secretion) – Nebilet should be taken with food, and antacids should be taken between meals.

Nebilet with food and drink
See section 3.

Pregnancy and breastfeeding
Beta-blockers, including nebivolol, may affect pregnancy and may harm the unborn child.
They may reduce blood flow through the placenta, which may lead to growth retardation, miscarriage, premature delivery or fetal death during pregnancy. Nebilet should not be used during pregnancy unless its use is necessary.
If treatment with nebivolol is necessary during pregnancy, close monitoring is required. After birth, the newborn must be monitored for symptoms of low blood sugar (hypoglycaemia) and slow heart rate (bradycardia), which may occur within the first three days of life.
Women taking Nebilet should not breast-feed.
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
This medicine may cause dizziness and fatigue. In such cases, do not drive or operate machinery.

Nebilet contains lactose
If the patient has previously been diagnosed with 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 tablet; i.e. the medicine is considered "sodium-free".

3. How to take Nebilet

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Nebilet may be taken before, during, or after meals, or independently of meals.
Swallow the tablet with a sufficient amount of water.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet daily. Try to take the dose at the same time each day.
• In elderly patients and in patients with renal impairment, treatment is usually initiated at ½ (half) tablet once daily.
• The effect on blood pressure becomes apparent after 1–2 weeks of treatment. In rare cases, optimal effect may only be achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be initiated and monitored by an experienced physician.
• Your doctor will start treatment at ¼ (one-quarter) of a tablet daily. After 1–2 weeks of treatment, the dose may be increased to ½ (half) a tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the optimal dose for the patient is reached. Your doctor will determine the appropriate dose at each stage of treatment, and the patient must strictly follow the doctor's instructions.
• The maximum recommended dose is 2 tablets daily (10 mg nebisolol).
• The patient requires close monitoring by an experienced physician for 2 hours after starting treatment and each time the dose is increased.
• If necessary, your doctor may reduce the dose of the medicine.
• Do not stop taking the medicine suddenly, as this may worsen heart failure.
• Patients with severe renal impairment should not take this medicine.
• Use in patients with hepatic impairment is contraindicated.
• The medicine should be taken once daily, preferably at the same time each day.

If your doctor has prescribed ¼ (one-quarter) or ½ (half) tablet daily, please follow the tablet-splitting instructions provided below.

• Place the tablet on a flat, hard surface (e.g., a table or countertop), with the scored side facing up.
• Break the tablet along the vertical score line by pressing down with the index fingers of both hands, as shown in Figures 1 and 2.
• To obtain quarters, break each half in the same manner, as shown in Figures 3 and 4.

Figures 1 and 2: Dividing a Nebilet tablet into 2 halves.

Figures 3 and 4: Dividing a half Nebilet tablet into 2 halves (to obtain ¼ tablet).

• Your doctor may prescribe Nebilet in combination with other medicines appropriate for treating the patient's condition.
• Nebilet should not be used in children and adolescents.

Taking more Nebilet than prescribed
In case of accidental overdose, immediately consult a doctor or pharmacist. The most common subjective and objective symptoms of Nebilet overdose include very slow heart rate (bradycardia), low blood pressure that may cause fainting (hypotension), asthma-like shortness of breath, and acute heart failure.
The patient may take activated charcoal (available from pharmacies) while waiting for medical assistance.

If you forget to take Nebilet
If you forget to take your dose but remember shortly afterwards, take the missed dose as soon as you remember. However, if a significant delay has occurred (e.g., 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.
Avoid repeatedly missing doses.

Stopping Nebilet
Always consult your doctor before stopping Nebilet, regardless of whether it is being used to treat high blood pressure, chronic heart failure, or stable angina.
Do not stop taking this medicine suddenly, as this may lead to a temporary worsening of heart failure symptoms.
If treatment with Nebilet for chronic heart failure must be discontinued, the dose should be reduced gradually by half every week.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported during treatment with nebivolol for high blood pressure:

Common (may affect up to 1 in 10 patients):

• headache,
• dizziness,
• fatigue,
• unusual sensations of itching or tingling,
• diarrhoea,
• constipation,
• nausea,
• shortness of breath,
• swelling, e.g. of hands or feet.

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

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

Rare (may affect up to 1 in 10,000 patients):

• fainting,
• worsening of psoriasis (a skin disease with scaly, red patches).

The following adverse reactions have been reported only in individual cases during treatment with Nebilet:

• systemic allergic reactions involving the whole body, with generalized skin lesions (hypersensitivity reactions);
• rapidly developing swelling, particularly around the lips, eyes or tongue, possibly accompanied by sudden breathing difficulties (angioedema);
• a type of skin rash characterized by raised, pale-red, itchy wheals, resulting from allergy or occurring without allergic basis (urticaria).

In a clinical trial in which Nebilet was used in chronic heart failure, the following adverse reactions were observed:

Very common (may affect more than 1 in 10 patients):

• slowing of heart rate,
• dizziness.

Common (may affect up to 1 in 10 patients):

• worsening of heart failure,
• low blood pressure (e.g. feeling faint when standing up quickly),
• drug intolerance,
• mild disturbance of electrical conduction in the heart affecting heart rhythm (first-degree atrioventricular block),
• swelling of the lower limbs (e.g. swelling around the ankles).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further collection of information on the safety of the medicine.

5. How to store Nebilet

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the blisters and the outer carton,
following the abbreviation "EXP". The expiry date refers to the last day of the stated 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 contains
The active substance is nebilolol. 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 ingredients are: monohydrate lactose, corn starch, sodium croscarmellose (E468), hypromellose (E464), polysorbate 80 (E433), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), magnesium stearate (E470b), purified water.

What Nebilet looks like and contents of the pack
White, round tablets with cross-scored lines allowing division into four equal parts.
Tablets can be divided into four equal parts.
Pack sizes of 7 or 28 tablets.
Blister packs made of PVC/aluminium foil in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin, Germany

Manufacturer
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin, Germany
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13
01097 – Dresden
Germany

For further information, please contact the Marketing Authorisation Holder's representative:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: (22) 566 21 00
Fax: (22) 566 21 01