Nebispes

Package Leaflet: Information for the User

Nebispes, 5 mg, Tablets

Nebivolol

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed for your specific use. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Nebispes and what is it used for

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

2. Important information before taking Nebispes

When Not to Take Nebispes

• if you are allergic to nebivolol or any of the other ingredients of this medication (listed in section 6),
• in case of low blood pressure (systolic or "upper" blood pressure is less than 90 mm Hg),
• in case of poor blood circulation in the upper or lower limbs,
• in case of very slow heart rate (less than 60 beats per minute before starting this medication),
• 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 an untreated adrenal gland tumor, called pheochromocytoma,
• if you have severe liver disease or liver function disorders,
• in case of metabolic acidosis (as in diabetic patients, when blood sugar levels become too high and blood pH becomes too acidic),
• if you are taking medications containing floctafenine or sultopride

Warnings and Precautions

Before starting Nebispes, discuss it 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 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 upper or lower limbs, such as Raynaud's disease or symptom, or muscle cramps while walking
• long-term breathing problems
• diabetes: Nebispes does not affect blood sugar levels, but may mask symptoms of low blood sugar levels (e.g., tremors, rapid heartbeat)
• hyperthyroidism, as Nebispes may mask abnormally rapid 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 Nebispes may exacerbate symptoms
• wearing contact lenses, as Nebispes may reduce tear secretion and cause dry eyes.

Use in children and adolescents under 18 years of age is not recommended. In such cases, the doctor may adjust the treatment or monitor the patient more closely. If surgery is planned and anesthesia is required, it is essential for the patient to inform the surgeon or dentist about taking this medication. In case of kidney function disorders, do not take this medication for heart failure treatment. Inform your doctor about this.

Nebispes and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take. Always inform your doctor or pharmacist if you are taking any of the following medications with Nebispes:

• diltiazem or verapamil (used to treat high blood pressure or other heart disorders); during Nebispes treatment, do not administer verapamil intravenously
• other medications, known as 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 medications called cardiac glycosides (used to treat heart failure)
• non-steroidal anti-inflammatory pain medications (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 safely taken with Nebispes
• medications 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 Nebispes before undergoing anesthesia
• cimetidine (used to treat stomach acid excess) - take Nebispes with food, and antacids between meals
• medications that affect nebivolol metabolism, such as 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, thioridazine (used to treat depression)
• amifostine (a protective medication used during chemotherapy or radiotherapy)
• baclofen (a muscle relaxant)
• mefloquine (an antimalarial medication)

Nebispes with Food and Drink

Nebispes can be taken before, during, or after a meal, and can also be taken without food. The tablet or its parts should be swallowed with water or another liquid.

Pregnancy and Breastfeeding

Pregnancy
Do not take Nebispes during pregnancy, unless your doctor decides otherwise.
Breastfeeding
Do not breastfeed while taking Nebispes.
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 medication.

Driving and Using Machines

No studies have been conducted on the effects on the ability to drive or use machines. The medication lowers blood pressure, which may cause dizziness or fainting. If these occur, 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).

Nebispes Contains Lactose

The medication contains lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medication.

3. How to Take Nebispes

Always take Nebispes exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Treatment of High Blood Pressure (Hypertension)

• The usual 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.

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

• Treatment will be started 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 appropriate dose for the patient 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 medication; do not stop treatment abruptly, as this may worsen heart failure.
• Patients with severe kidney function disorders should not take this medication.

Take the medication once a day, preferably at the same time each day. The doctor may decide to take the tablets with another medication indicated for the patient. Nebispes is not recommended for use in children and adolescents.

Taking More Than the Recommended Dose of Nebispes

If you accidentally take too many tablets (overdose), you may experience: slow heart rate, low blood pressure, and other heart disorders, breathing difficulties or wheezing. Contact the nearest hospital emergency department or inform your doctor or pharmacist immediately.

Missing a Dose of Nebispes

If you forget to take the medication, but remember soon after, take the next tablet at a time close to your usual dosing schedule. 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 repeatedly missing doses.

Stopping Nebispes Treatment

Do not stop taking Nebispes without consulting your doctor first. Abruptly stopping the medication may cause dangerous worsening of symptoms in the patient. If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Nebispes can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking Nebispes and tell your doctor or go to the emergency department of the nearest hospital:

• Feeling of pressure in the chest and difficulty breathing or wheezing (uncommon, may affect up to 1 in 100 people)
• Swelling of the face, lips, throat, or tongue (angioedema), hypersensitivity (allergy), itchy rash (urticaria) (frequency not known, cannot be estimated from the available data)

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

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

Common side effects (may affect up to 1 in 10 people) in the treatment of chronic heart failure:

• In a clinical trial for chronic heart failure, the following side effects were observed: slow heart rate, dizziness

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
• Onset or worsening of pain in the feet/legs while walking due to narrowed arteries and poor blood circulation (intermittent claudication)
• Abnormal vision
• Impotence (difficulty achieving erection)
• Feeling depressed
• Indigestion, gas in the stomach or intestine
• Vomiting
• Skin rash
• Itching
• Nightmares

Uncommon side effects (may affect up to 1 in 100 people) in the treatment of chronic heart failure:

• In a clinical trial for chronic heart failure, the following side effects were observed: worsening of heart failure, low blood pressure (e.g., feeling faint when standing up quickly), intolerance to the medication, irregular heartbeat, swelling (e.g., swelling around the ankles).

Very rare side effects (may affect up to 1 in 10,000 people):

• Fainting
• Worsening of psoriasis

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, 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 181C, 02-222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Nebispes

Store the medication 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 after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Medications should not be disposed of via wastewater or household waste. Ask your 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 Nebispes Contains

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

What Nebispes Looks Like and Contents of the Pack

Nebispes tablets are white, round, biconvex, with a cross-shaped groove on one side, approximately 9 mm in diameter. The 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: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer

PharmaPath S.A. 28is Octovriou 1 Agia Varvara 123 51 Greece

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

DK: Nebispes 5 mg tablets HU: Nebispes 5 mg tablet PL: Nebispes, 5 mg, tablets SI: Nebispes 5 mg tablets CZ: Nebispes 5 mg tablets EE: Nebispes 5 mg tablets LT: Nebispes 5 mg tablets Date of Revision of the Leaflet:March 2022