Nebilenin

Package Leaflet: Information for the Patient

Nebilenin, 5 mg, Tablets

Nebivolol

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Nebilenin and what is it used for

Nebilenin contains nebivolol, which is a selective beta-adrenergic blocker with vasodilating properties. This medication is used to treat high blood pressure (hypertension).
Nebilenin is also used to treat chronic heart failure in patients aged 70 or older.
Nebilenin may also be used to treat symptomatic, stable angina pectoris.

2. Important information before taking Nebilenin

When not to take Nebilenin

• if the patient has been diagnosed with an allergy (hypersensitivity) to nebivolol or any other component of Nebilenin (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 to take this medication),
• if the patient has been diagnosed with conduction disorders in the heart (such as sick sinus syndrome or atrioventricular block) and the patient does not have a pacemaker,

in case of acute heart failure or intravenous treatment (through a drip) to support heart function,

• in case of breathing difficulties or wheezing,
• if the patient has a adrenal gland tumor called phaeochromocytoma,
• if the patient has 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 the blood reaction is too acidic),
• if the patient is taking medications containing floctafenine or sultopride.

Warnings and precautions

Before starting to take Nebilenin, the patient should discuss it with their doctor or pharmacist,
if the patient has or develops any of the following conditions:

• heart failure (the heart's inability to pump enough blood to meet the body's needs)
• mild atrioventricular block in the heart (first degree)
• chest pain caused by coronary artery spasm (so-called Prinzmetal's angina or nocturnal angina)
• poor circulation in the limbs, such as Raynaud's disease or muscle cramps while walking
• long-term breathing problems
• diabetes: Nebilenin does not affect blood sugar levels, but may mask the symptoms of low blood sugar (e.g. trembling, rapid heartbeat)
• hyperthyroidism, as Nebilenin may mask the symptoms of an abnormally fast heart rate associated with this condition
• allergy, as allergic reactions may be more severe and may require more medication to treat
• skin changes known as psoriasis, as Nebilenin may exacerbate symptoms
• wearing contact lenses, as Nebilenin may reduce tear production and cause dry eyes.

In such cases, the doctor may adjust the treatment or monitor the patient more frequently.

Children and adolescents

There is no data on the use of the product in children and adolescents. Therefore, it is not recommended to use the product in these age groups.
In case of planned surgery and the need for anesthesia, it is essential for the patient to inform the surgeon or dentist about taking this medication.
In case of kidney function disorders, this medication should not be taken to treat heart failure. The patient should inform their doctor about this.

Nebilenin and other medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription.
The patient should always inform their doctor or pharmacist if they are taking any of the following medications at the same time as Nebilenin:

• diltiazem or verapamil (used to treat high blood pressure or other heart disorders); during treatment with Nebilenin, verapamil should not be administered intravenously
• other calcium antagonists used to treat high blood pressure or other heart disorders, such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine
• other antihypertensive medications or organic nitrates used to treat chest pain
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure
• medications 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)
• medications used to treat diabetes (insulins or oral medications)
• digoxin or digitalis glycosides (used to treat heart failure)
• non-steroidal anti-inflammatory pain medications (NSAIDs) used for pain and inflammation - it should be remembered that small daily doses of acetylsalicylic acid (e.g. 50 or 100 mg) used as an antiplatelet agent can be safely taken with Nebilenin
• medications used to treat asthma, nasal congestion or certain eye disorders, such as glaucoma (increased eye pressure) or pupil dilation
• anesthetics: the patient should always inform the anesthesiologist about taking Nebilenin before being anesthetized
• cimetidine (used to treat stomach acid excess) - Nebilenin should be taken during meals, and antacids between meals
• medications that affect nebivolol metabolism, i.e. terbinafine (used to treat 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, thioridazine (used to treat depression)
• amifostine (a protective medication used during chemotherapy or radiotherapy)
• baclofen (a muscle relaxant)
• mefloquine (an antimalarial medication)

Nebilenin with food and drink

Nebilenin can 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, breastfeeding, and fertility

Pregnancy
Nebilenin should not be taken during pregnancy, unless the doctor has decided otherwise.
Breastfeeding
It is not recommended to breastfeed while taking Nebilenin.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

Driving and using machines

No studies have been conducted on the effect on the ability to drive or operate machinery.
When driving vehicles or operating machinery, patients should take into account the possibility of occasional dizziness and fatigue.
The occurrence of these symptoms is more likely at the beginning of treatment or when the dose is increased (see also section 4).
Nebilenin contains lactose.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

3. How to take Nebilenin

This medication should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (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 medication 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 patient's appropriate 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 medication dose is increased.
• Depending on the need, the doctor may reduce the medication dose; the treatment should not be stopped abruptly, as this may worsen heart failure. Patients with severe kidney function disorders should not take this medication.

Treatment of symptomatic, stable angina pectoris

• 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 (1.25 mg). This dose may be increased, depending on the patient's tolerance, after 1-2 weeks to 1/2 tablet (2.5 mg) per day, then to 1 tablet (5 mg) per day, and then to 2 tablets (10 mg) per day, until the patient's appropriate dose is reached.
• The maximum recommended dose is 10 mg (2 tablets per day).

The medication should be taken once a day, preferably at the same time every day.
The doctor may decide to take the tablets with another medication indicated for the patient.

Use in children and adolescents

Nebilenin is not recommended for use in children and adolescents.

Taking a higher dose of Nebilenin than recommended

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. The patient should immediately contact the nearest hospital or inform their doctor or pharmacist.

Missing a dose of Nebilenin

If the patient forgets to take the medication but remembers soon after, they should take the next tablet at a time close to the usual time. However, if a long time has passed (e.g. a whole day), the patient should skip the missed dose and take the next dose at the usual time the next day. The patient should not take a double dose to make up for the missed dose. The patient should avoid repeatedly missing doses.

Stopping treatment with Nebilenin

The patient should not stop taking Nebilenin without consulting their doctor first.
Abruptly stopping the medication may cause a dangerous worsening of symptoms in the patient. This applies especially to patients with angina pectoris.
In case of any further doubts related to the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Nebilenin can cause side effects, although not everybody gets them.
During treatment with Nebilenin for high blood pressure, the following side effects have been observed:
Common side effects (may occur in less than 1 in 10 people):

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swelling of hands or feet

Uncommon side effects (may occur in less than 1 in 100 people):

• Slow heart rate or other heart disorders
• Low blood pressure
• Cramping leg pain while walking
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Depressive feelings
• Indigestion, gas in the stomach or intestine, vomiting
• Skin rash
• Chest tightness, breathing difficulties, or wheezing
• Nightmares

Very rare side effects (may occur in less than 1 in 10,000 patients):

• Fainting/Fainting spells
• Exacerbation of psoriasis

Frequency not known (frequency cannot be estimated from the available data):
Swelling of the skin of the face or limbs, lips, tongue, mucous membranes of the throat and airways, causing shortness of breath or difficulty swallowing
Allergic reactions with skin rash (allergic reactions)
In a clinical study on chronic heart failure, the following side effects were observed:
Very common side effects (may occur in more than 1 in 10 people):
slow heart rate,
dizziness.
Common side effects (may occur in less than 1 in 10 people):
worsening of heart failure,
low blood pressure (e.g. feeling of fainting when standing up suddenly),
intolerance to the medication,
irregular heartbeat,
swelling (e.g. swelling in the ankle area).
If any of the side effects worsen or if any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Nebilenin

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the outer packaging and the immediate packaging. The expiry date refers to the last day of the given month.
Do not store above 30°C.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nebilenin contains

The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
The other ingredients are:
Lactose monohydrate
Crospovidone type A
Poloxamer 188
Povidone K-30
Microcrystalline cellulose
Magnesium stearate

What Nebilenin looks like and contents of the pack

Nebilenin tablets are white, round, biconvex, with crossed, double-scored lines on one side and a diameter of approximately 9 mm.
The Nebilenin tablet can be divided into four equal parts.
The tablets are packaged in PVC/PE/PVDC/Aluminum blisters (containing 7, 10, or 14 tablets).
Pack sizes: 28, 30, 56, 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

{Poland} {Nebilenin}
{Denmark} {Nebilenin}
Date of last revision of the leaflet:10.2019