NEBILOX 5 mg Tablet

Зміст інструкції

1. NEBILOX 5 mg Tablets
   1. What is Nebilox and what is it 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

NEBILOX 5 mg Tablets

Nebivolol
Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or 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 you take 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 is Nebilox and what is it used for

Nebilox contains nebivolol, a cardiovascular drug belonging to the group of selective beta-
blockers (i.e. with a selective action on the cardiovascular system). Nebilox prevents
an increase in heart rate, controls the strength of the heart pump. It also exerts
a dilating action on blood vessels which contributes to lowering blood pressure. It is
used to treat high blood pressure (hypertension). Nebilox is also used to
treat chronic heart failure of mild and moderate degree in addition to other therapies in
elderly patients aged 70 years or more.

2. What you need to know before taking Nebilox

Do not take Nebilox

• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from 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 and third degree atrioventricular block and disturbances of cardiac conduction).
• Heart failure, of recent onset or recent worsening, or if you are undergoing therapy to treat circulatory shock due to acute heart failure through intravenous administration to help the functioning of the heart
• Asthma or wheezing (current or previous)
• 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.
Tell your doctor if you notice or develop any of the following symptoms:

• Abnormally slow heartbeat
• A type of chest pain due to the spontaneous onset of a heart cramp called Prinzmetal's angina
• Untreated chronic heart failure
• First-degree heart block (a mild disturbance of cardiac conduction that affects heart rate)
• Poor circulation in the arms and legs, such as Raynaud's disease or syndrome, cramp-like pain while walking
• Prolonged difficulty breathing
• Diabetes: this medicine does not affect blood glucose levels, but it may mask the warning signs of low glucose levels (e.g. palpitations, rapid heartbeat)
• Hyperactive thyroid gland: this medicine can mask the signs of a rapidly abnormal heart rate caused by this condition
• Allergy: this medicine may intensify reactions to pollen or other substances to which you are allergic
• Psoriasis (a skin condition that causes scaly pink patches) or if you have suffered from psoriasis in the past
• If you are going to undergo surgery, always inform the anesthesiologist that you are being treated with Nebilox before undergoing anesthesia.

In case of severe kidney problems, do not take Nebilox for the treatment of heart failure and
inform your doctor.
During the initial phase, therapy for chronic heart failure must be monitored by a
doctor experienced in this field (see section 3).
Do not abruptly stop this therapy unless this is indicated and evaluated by
your doctor (see section 3).
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and
may still result in a positive doping test.

Children and adolescents
Due to the lack of data on the use of the product in children and adolescents, the use of Nebilox is not
recommended for these age groups.

Other medicines and Nebilox
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Always tell 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 problems (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 therapies for psychosis (a mental illness), for example barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea) and thioridazine.
• Medicines for depression, for example amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during a surgical operation.
• Medicines for asthma, sinusitis or some eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil.
• Baclofen (an antispastic drug); amifostine (a medicine with a protective action used during anti-cancer treatment). All these medicines, as well as nebivolol, can affect blood pressure and/or heart function.
• Medicines for the treatment of excess stomach acid or ulcers (antacids): take Nebilox during meals and the antacid medicine between meals.

Nebilox with food and drink
See section 3.

Pregnancy and breastfeeding
Nebilox should not be used during pregnancy unless absolutely necessary.
Use during breastfeeding is not recommended.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This medicine can cause dizziness or fatigue. If these conditions occur,

do notdrive or use machines.

Nebilox contains lactose
This product contains lactose. If your doctor has diagnosed you with intolerance to some
sugars, contact him/her beforetaking 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 following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Nebilox can be taken before, during or after meals, or, alternatively, also independently
of meals. It is preferable to swallow the tablet with some water.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet a day. The dose should be taken preferably always at the same time.
• In the elderly and patients with kidney disorders, therapy usually starts with ½ (half) a tablet a day.
• The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Sometimes the optimal effect is achieved only after 4 weeks.

Treatment of chronic heart failure

• The treatment will be initiated and strictly supervised by an experienced doctor.
• The doctor will start the treatment with ¼ (one quarter) of a tablet a day. After 1-2 weeks the dosage may be increased to ½ (half) a tablet a day, then to 1 tablet a day and subsequently to 2 tablets a day until the appropriate dose required for your condition is reached. The doctor will prescribe the appropriate dose for you at each stage of the treatment and you must follow their instructions carefully.
• The maximum recommended dose is 2 tablets (10 mg) a day.
• You should be monitored by an experienced doctor for the 2 hours following the start of treatment and at each increase in the drug dose.
• The doctor may reduce the dose if necessary.
• Do not stop treatment abruptlyas this may worsen heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take the medicine once a day, preferably always at the same time.

If your doctor has prescribed you to take ¼ (one quarter) or ½ (half) a tablet a day, refer to the
instructions below which specify the method for dividing the tablet with
double fracture bar of Nebilox 5 mg.

• Place the tablet on a flat, rigid surface (e.g. a table or worktop) with the fracture bars facing upwards.
• Divide the tablet by pressing with the index fingers of both hands positioned along a fracture bar (Figures 1 and 2).
• Divide the half of the tablet in the same way to obtain the quarters (Figures 3 and 4).

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

• Do not use in children and adolescents.

If you take more Nebilox than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or
pharmacist immediately. The most frequent symptoms and signs of a Nebilox overdose
are a very slow heartbeat (bradycardia), low blood pressure with possible
fainting (hypotension), shortness of breath as in asthma (bronchospasm) and acute
heart failure.
You can take activated charcoal (available at the pharmacy) while waiting for the doctor to arrive.

If you forget to take Nebilox
If you forget to take a dose of Nebilox, but remember shortly afterwards that you should
have taken it, take the daily dose as usual. In the event of a longer delay
(i.e. several hours), close to the time you should take the next dose, do not take the
forgotten dose and take the normal dosenext scheduled, at the scheduled time. Do not
take a double dose. However, avoid repeatedly skipping taking the medicine.

If you stop taking Nebilox
You should always consult your doctor before stopping therapy with Nebilox, whether you are
taking it for high blood pressure or for chronic heart failure.
You should not stop treatment with Nebilox abruptly as this may temporarily
worsen heart failure. If it is necessary to stop treatment for heart failure with Nebilox, the daily dose must be gradually decreased ,halving the dose
at weekly intervals.
If you have any doubts about the use of this product, ask 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 for the treatment of high blood pressure, the possible side effects are:

• headache
• dizziness
• fatigue
• 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):

• slowed heart rate or other heart problems
• low blood pressure
• cramp-like leg pain while walking
• abnormal vision
• impotence
• feeling of depression
• difficulty in digestion (dyspepsia), gas in the stomach or intestines ,vomiting
• skin rashes ,itching
• shortness of breath as in asthma, due to sudden cramps 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 that causes scaly pink patches).

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

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

In a clinical study on chronic heart failure,the following side effects were detected:
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 a feeling of fainting when getting up quickly)
• inability to tolerate this medicine
• a mild disturbance of cardiac conduction that affects the heart rate (AV block of 1st degree)
• swelling of the lower limbs (swollen ankles).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 which is stated on the box and on the blister after
“EXP”. The expiry date refers to the last day of the month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nebilox contains

• The active ingredient 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 ingredients are: lactose monohydrate, polysorbate 80 (E433), hypromellose (E464), corn 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 in the form of tablets with a double fracture line, white in color and round,
available in packs of 7, 14, 28, 30, 50, 56, 90, 100, 500 tablets. The tablets are
packaged in blisters (in PVC/aluminum).
(Not all pack sizes may be marketed).

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Menarini International Operations Luxembourg S.A.
Avenue de la Gare 1
L 1611-Luxembourg.

Distributor for sales
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 authorised in the Member States of the European Economic Area under the
following denominations:
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
Netherlands: Nebilet
Great Britain: Hypoloc
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