Nebivor

Package Leaflet: Information for the Patient

Nebivor, 5 mg, Tablets

Nebivolol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet:

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

1. What is Nebivor and what is it used for

Nebivor contains nebivolol, which is a selective beta blocker (beta-adrenergic blocker) that dilates blood vessels. This medicine is used to treat high blood pressure (hypertension).
Nebivor is also used to treat chronic heart failure in patients aged 70 or older.

2. Important information before taking Nebivor

When not to take Nebivor

• if you are 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 is less than 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 treatment with this medicine)
• if you have been diagnosed with conduction disorders in the heart (such as sick sinus syndrome or atrioventricular block) and you do not have a pacemaker
• in case of acute heart failure or intravenous treatment (through a drip) to support heart function
• in case of severe breathing difficulties or wheezing
• if you have a tumor of the adrenal gland called phaeochromocytoma
• if you have severe liver disease or liver function disorders
• in case of metabolic acidosis (such as in diabetic patients, when blood sugar levels become too high and blood pH is too acidic)

and

• if you are taking medicines containing floctafenine or sultopride.

Warnings and precautions

Before starting treatment with Nebivor, discuss with your doctor or pharmacist if you have or develop any of the following conditions:

• heart failure (inability of the heart to pump blood in sufficient quantities for the body's needs)
• mild (first-degree) atrioventricular block in the heart
• 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 muscle cramps during walking
• long-term breathing problems
• if you have diabetes, as nebivolol may mask symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain types of oral antidiabetic medicines called sulfonylureas (such as gliclazide, glimepiride, or tolbutamide)
• hyperthyroidism, as Nebivor may mask abnormal rapid heart rate in this condition
• allergy, as allergic reactions may be more severe and may require more medication to treat
• skin changes called psoriasis, as Nebivor may exacerbate symptoms
• wearing contact lenses, as Nebivor may reduce tear secretion and cause dry eyes.

In such cases, your doctor may adjust the treatment or monitor you more closely.
In case of planned surgery and the need for anesthesia, it is essential to inform the surgeon or dentist that you are taking this medicine.
In case of kidney function disorders, do not take this medicine for heart failure treatment. Inform your doctor about this.

Children and adolescents

Nebivor is not recommended for children and adolescents under 18 years of age.

Nebivor and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription, herbal preparations, vitamins, and minerals in high doses.
Always inform your doctor or pharmacist if you are taking any of the following medicines with Nebivor:

• diltiazem or verapamil (used to treat high blood pressure or other heart conditions). Do not administer verapamil intravenously 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

and

• 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, cybenzoline, 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)
• non-steroidal anti-inflammatory painkillers (NSAIDs) used for pain and inflammation - note that small daily doses of acetylsalicylic acid (e.g. 50 or 100 mg) used as an antiplatelet agent can be taken safely with Nebivor
• medicines used to treat asthma, nasal congestion, or certain eye disorders, such as glaucoma (increased eye pressure) or pupil dilation
• anesthetics: always inform the anesthesiologist about taking Nebivor before undergoing anesthesia
• cimetidine (used to treat stomach acid excess) - take Nebivor with food, and antacids between meals
• medicines that affect nebivolol metabolism, i.e. terbinafine (used for fungal or yeast infections), bupropion (used to help quit smoking), chloroquine (used to treat malaria or rheumatoid arthritis), levomepromazine (used to treat psychosis), paroxetine, fluoxetine, tiordiazine (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 can be taken before, during, or after a meal, and can also be taken without food.
Swallow the tablet or its parts with water or another liquid.

Pregnancy and breastfeeding

Pregnancy
Do not take Nebivor during pregnancy unless your doctor decides otherwise.
Breastfeeding
Do not breastfeed while taking Nebivor.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies have been conducted on the effect on the ability to drive or use machines.
The medicine may cause dizziness, fatigue, or fainting due to low blood pressure. If you experience these symptoms, DO NOT drive or operate machines. The occurrence of these symptoms is more likely at the beginning of treatment or when the dose is increased (see also section 4).

Nebivor contains lactose

Nebivor contains 81.66 mg of lactose (in the form of lactose monohydrate). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Nebivor

Always take this medicine exactly as your doctor or pharmacist has told you.
In case of doubts, ask your doctor or pharmacist.
Treatment of high blood pressure (hypertension)

• The recommended dose is 1 tablet per day.
• For elderly patients and patients with kidney function disorders, the initial dose is usually 1/2 tablet per day.
• It may take up to 4 weeks for the medicine to start working fully.

Treatment of chronic heart failure

• The patient's treatment will be initiated and monitored by an experienced doctor.
• Treatment starts with an initial dose of 1/4 tablet per day. This dose may be increased after 1-2 weeks to 1/2 tablet per day, then to 1 tablet per day, and then to 2 tablets per day, until the individual dose is reached.
• The maximum recommended dose is 10 mg (2 tablets per day).
• The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose is increased.
• Depending on the need, the doctor may reduce the dose of the medicine; do not stop treatment abruptly, as this may worsen heart failure.
• Patients with severe kidney function disorders should not take this medicine.

Take the medicine once a day, preferably at the same time every day.
Your doctor may decide to take the tablets with another medicine prescribed for you.

Use in children and adolescents

Nebivor is not recommended for children and adolescents.

Overdose of Nebivor

In case of accidental ingestion of too many tablets (overdose), the patient may experience: slow heart rate, low blood pressure, and other heart disorders, breathing difficulties, or wheezing. Contact the nearest hospital or inform your doctor or pharmacist immediately.

Missed dose of Nebivor

If you forget to take the medicine, but remember soon after, take the next tablet at a time close to the usual time. However, if a long time has passed (e.g. a whole day), skip the missed dose and take the next dose at the usual time the next day. Do not take a double dose to make up for the missed dose. Avoid repeated missed doses.

Stopping treatment with Nebivor

Do not stop taking Nebivor without consulting your doctor first.
Sudden withdrawal of the medicine may cause dangerous worsening of symptoms in the patient. This applies especially to patients with angina pectoris.
In case of doubts related to the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebivor can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) in the treatment of high blood pressure:

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

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

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

Rare side effects (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 study on chronic heart failure, the following side effects were observed: slow heart rate, dizziness, worsening of heart failure, low blood pressure (e.g. feeling of fainting when standing up suddenly), intolerance to the medicine, irregular heartbeat, swelling (e.g. swelling around the ankles).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivor

Keep the medicine out of the 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 month.
Do not store above 30°C.
Medicines should 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 Nebivor contains

• The active substance is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of nebivolol.
• The 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 a cross-shaped groove on one side, approximately 9 mm in diameter.
The Nebivor tablet can be divided into equal doses.
Pack sizes: 30, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
kontakt@orionpharma.info.pl

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 03/2025