Patient Information Leaflet

Nebivor, 5 mg, tablets
Nebivololum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

What Nebivor is and what it is used for
Important information before taking Nebivor
How to take Nebivor
Possible side effects
How to store Nebivor
Contents of the pack and other information

1. What Nebivor is and what it is used for

Nebivor contains nebivolol, a selective beta-blocking agent (beta-adrenolytic) with vasodilating properties. This medicine is used for the treatment of high blood pressure (hypertension).
Nebivor is also used in the treatment of chronic heart failure in patients aged 70 years or older.

2. Important information before using Nebivor

When not to use Nebivor

if the patient is allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6)
in case of low blood pressure (systolic or "upper" blood pressure below 90 mmHg)
in case of poor blood circulation in the limbs
in case of very slow heart rate (less than 60 beats per minute before starting this medicine)
if the patient has been diagnosed with heart conduction disorders (such as sick sinus syndrome or atrioventricular block) and does not have a pacemaker implanted
in case of acute heart failure or intravenous treatment (via intravenous infusion) to support heart function
in case of severe breathing difficulties or wheezing
if the patient has a tumour of the adrenal gland called phaeochromocytoma
if the patient has severe liver disease or impaired liver function
in case of metabolic acidosis (as in diabetic patients when blood sugar levels become too high and blood pH becomes too acidic)
if the patient is taking medicines containing floctafenic or sultopride.

Warnings and precautions
Before starting treatment with Nebivor, consult your doctor or pharmacist
if the patient has or develops any of the following conditions:

heart failure (inability of the heart to pump enough blood to meet the body's needs)
mild (first-degree) atrioventricular heart block
chest pain caused by coronary artery spasm (so-called Prinzmetal's angina or nocturnal angina)
poor circulation in the limbs, e.g. Raynaud's disease or Raynaud's phenomenon, muscle cramp-like pain when walking
long-term breathing problems
if the patient has diabetes, because nebivolol may mask symptoms of low blood sugar (hypoglycaemia) and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glimepiride, tolbutamide, glibenclamide or glyquidone)
hyperthyroidism, because Nebivor may mask abnormally rapid heart rate associated with this condition
allergies, as allergic reactions may be more severe and a larger dose of medication may be needed to treat them
skin changes known as psoriasis, as Nebivor may worsen symptoms
wearing contact lenses, as Nebivor may reduce tear production and cause dry eyes.

In such cases, the doctor may adjust treatment or monitor the patient more frequently.
If surgery is planned and anaesthesia is required, it is important that
the patient informs the surgeon or dentist about taking this medicine.
In case of impaired kidney function, this medicine should not be used for the treatment
of heart failure. Inform your doctor about this.
Children and adolescents
Not recommended for use in children and adolescents under 18 years of age.
Nebivor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans to take, including
medicines available without prescription, herbal preparations, vitamins and mineral supplements
in high doses.
Always inform your doctor or pharmacist if the patient is taking any of
the following medicines together with Nebivor:

diltiazem or verapamil (used to treat high blood pressure or other heart conditions). Intravenous verapamil must not be administered during treatment with Nebivor
other medicines called calcium antagonists used to treat high blood pressure
or other heart conditions, such as amlodipine, felodipine, lacidipine, nifedipine,
nicardipine, nimodipine, nitrendipine
other antihypertensive medicines or organic nitrates used to treat chest pain
clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure
medicines used to treat heart rhythm disorders (irregular heartbeat), such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone
tricyclic antidepressants (used to treat depression), phenothiazines (used to treat psychosis) or barbiturates (used to treat epilepsy)
medicines for diabetes, such as insulin or oral antidiabetic medicines
digoxin or other medicines called cardiac glycosides (used to treat heart failure)
anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs - NSAIDs) used for pain and inflammation – note that low daily doses of acetylsalicylic acid (e.g. 50 or 100 mg) used for antithrombotic purposes can be safely taken with Nebivor
medicines used to treat asthma, nasal congestion or certain eye conditions such as glaucoma (increased eye pressure) or pupil dilation
anaesthetics: always inform the anaesthesiologist that you are taking Nebivor before undergoing anaesthesia
cimetidine (used to treat stomach acid overproduction) – Nebivor should be taken with food, and antacids should be taken between meals
medicines affecting nebivolol metabolism, i.e. terbinafine (used in fungal or candidiasis infections), bupropion (used to aid smoking cessation), chloroquine (used to treat malaria or rheumatoid arthritis), levomepromazine (used to treat psychosis), paroxetine, fluoxetine, thioridazine (used to treat depression)
amifostine (a protective agent used during chemotherapy or radiotherapy)
baclofen (a muscle relaxant)
mefloquine (an antimalarial medicine)

Nebivor with food and drink
Nebivor may be taken before, during or after a meal, or without food.
The tablet or its parts should be swallowed with water or another liquid.
Pregnancy and breastfeeding
Pregnancy
Do not use Nebivor during pregnancy unless otherwise directed by a doctor.
Breastfeeding
Breastfeeding is not recommended while taking Nebivor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this
medicine.
Driving and using machines
No studies have been conducted on the effect on the ability to drive or
operate machinery.
This medicine may cause dizziness, fatigue or fainting due to low blood
pressure. If these symptoms occur, DO NOT drive or
operate machinery. These symptoms are more likely to occur at the beginning
of treatment or after increasing the dose (see also section 4).
Nebivor contains lactose
Nebivor contains 81.66 mg of lactose (as lactose monohydrate). If intolerance to certain sugars has been diagnosed, the patient should contact their doctor before taking this medicine.

3. How to use Nebivor

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Treatment of high blood pressure (hypertension)

The recommended dose is 1 tablet daily.
For elderly patients and patients with impaired kidney function, the initial dose is usually 1/2 tablet daily.
It may take up to 4 weeks before the medicine starts to work fully.

Treatment of chronic heart failure

Treatment will be initiated and monitored by an experienced physician.
Treatment starts with an initial dose of 1/4 tablet daily. This dose may be increased after 1–2 weeks to 1/2 tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the appropriate dose for the patient is reached.
The maximum recommended dose is 10 mg (2 tablets daily).
The patient will require monitoring by an experienced physician for 2 hours after starting treatment and each time the dose is increased.
Depending on the clinical situation, the doctor may reduce the dose. Do not stop treatment suddenly, as this may worsen heart failure.
Patients with severe kidney function impairment should not take this medicine.

The medicine should be taken once daily, preferably at the same time each day.
Your doctor may decide to use this medicine together with another medicine appropriate
for the individual patient.
Use in children and adolescents
Nebivor is not recommended for use in children and adolescents.
If you take more Nebivor than you should
If too many tablets are accidentally taken (overdose), symptoms may include slow heart rate, low blood pressure, other heart-related disturbances, breathing difficulties, or wheezing. Seek immediate medical attention at the nearest hospital or contact your doctor or pharmacist immediately.
If you forget to take Nebivor
If you forget to take your dose but remember shortly afterwards, take the next tablet at the usual time. However, if a significant delay has occurred (e.g. a full day), skip the missed dose and take the next dose at the usual time the following day. Do not take a double dose to make up for a missed dose. Avoid repeatedly missing doses.
Stopping Nebivor
Do not stop taking Nebivor without first consulting your doctor.
Suddenly stopping the medicine may cause a dangerous worsening of symptoms, particularly in patients with angina pectoris.
If you have any doubts about how to use 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.

Common adverse reactions (may affect up to 1 in 10 people) in the treatment of high blood pressure:

headache
dizziness
fatigue
unusual itching or tingling sensation
diarrhoea
constipation
nausea
shortness of breath
swelling of hands or feet.

Uncommon adverse reactions (may affect up to 1 in 100 people) in the treatment of high blood pressure:

slow heart rate or other heart-related disorders
low blood pressure
vision abnormalities
impotence (difficulty achieving erection)
depressive feelings
indigestion, gas in the stomach or intestines
vomiting
skin rash
chest tightness, breathing difficulties or wheezing
nightmares.

Very rare adverse reactions (may affect up to 1 in 10,000 people) in the treatment of high blood pressure:

fainting
worsening of psoriasis.

Unknown frequency (cannot be estimated from the available data):

angioedema
hypersensitivity
urticaria.

In a clinical trial investigating chronic heart failure, the following adverse reactions were observed: slow heart rate, dizziness, worsening of heart failure, low blood pressure (e.g. feeling faint upon sudden standing), drug intolerance, irregular heart rate, oedema (e.g. swelling around the ankles).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nebivor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nebivor contains

The active substance is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of nebivolol.
Other ingredients are: lactose monohydrate, crospovidone type A, poloxamer 188, povidone K30, microcrystalline cellulose, magnesium stearate.

What Nebivor looks like and contents of the pack
Nebivor tablets are white, round, biconvex, with crossed dividing grooves on one side, approximately 9 mm in diameter.
Nebivor tablets can be divided into equal doses.
Pack sizes: 30, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Nebivolol Orion 5 mg Tablets
Finland: Nebivolol Orion 5 mg Tablets
Latvia: Nebivolol Orion 5 mg Tablets
Poland: Nebivor 5 mg Tablets