Ivineb

Package Leaflet: Information for the User

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

1. What is Ivineb and what is it used for

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

2. Important information before taking Ivineb

When not to take Ivineb

• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6),
• if you have low blood pressure (systolic blood pressure less than 90 mmHg),
• if you have severe circulation problems in your limbs,
• if you have a very slow heart rate (less than 60 beats per minute before starting treatment with this medicine),
• if you have been diagnosed with conduction problems in the heart (such as sick sinus syndrome or atrioventricular block) and you do not have a pacemaker,
• if you have acute heart failure or are being treated intravenously (through a drip) to support the heart,
• if you have difficulty breathing or wheezing (currently or in the past),
• if you have a tumor of the adrenal gland called phaeochromocytoma,
• if you have severe liver disease or liver function disorders,
• if you have metabolic acidosis (as in diabetic patients when blood sugar levels become too high and the blood becomes too acidic),
• if you are taking medicines containing floctafenine or sultopride.

Warnings and precautions

Before starting treatment with Ivineb, discuss it with your doctor or pharmacist.

• If you have or develop any of the following conditions:
• heart failure (when the heart is unable to pump enough blood to meet the body's needs)
• mild atrioventricular block (first degree) (a type of mild conduction disorder that affects the heart rhythm)
• 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 syndrome, or pain similar to cramps in the muscles when walking
• long-term breathing difficulties
• diabetes: because Ivineb may mask the 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, glibenclamide, glipizide, gliburide, or tolbutamide)
• hyperthyroidism, because Ivineb may mask the abnormal rapid heart rate associated with this condition
• allergy, because allergic reactions may be more severe
• skin changes called psoriasis, because Ivineb may worsen symptoms
• wearing contact lenses, because Ivineb may reduce tear production and cause dry eyes.

In such cases, your doctor may modify the treatment or monitor your condition more closely.

Children and adolescents

There are no data on the use of the product in children and adolescents. Therefore, the use of the product is not recommended in these age groups. If surgery is planned and anesthesia is required, it is important for the patient to inform the surgeon or dentist about taking Ivineb. Do not take Ivineb in heart failure if you have severe kidney problems; inform your doctor about this.

Ivineb and other medicines

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription. Always inform your doctor or pharmacist if you are taking any of the following medicines at the same time as Ivineb:

• diltiazem or verapamil (used to treat high blood pressure or other heart disorders); verapamil should not be administered intravenously during treatment with Ivineb
• other calcium channel blockers used to treat high blood pressure or other heart disorders, 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 irregular heart rhythms (arrhythmias), 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 digitalis glycosides (used to treat heart failure)
• non-steroidal anti-inflammatory medicines (NSAIDs) used for pain and inflammation - note that low daily doses of acetylsalicylic acid (e.g. 50 or 100 mg) used as an antiplatelet agent can be taken safely with Ivineb
• 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 Ivineb before undergoing anesthesia
• cimetidine (used to treat excessive stomach acid production) - Ivineb should be taken during meals, and antacids between meals
• medicines that affect the metabolism of nebivolol, 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 medicine with protective effects, used during chemotherapy or radiotherapy)
• baclofen (a muscle relaxant)
• mefloquine (an antimalarial medicine).

Ivineb with food and drink

Ivineb can be taken with or without food. The tablet or its parts should be swallowed with water or another liquid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyDo not take Ivineb during pregnancy unless it is strictly necessary. BreastfeedingBreastfeeding is not recommended when taking Ivineb. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. When driving vehicles or operating machinery, patients should take into account the possibility of occasional dizziness and fatigue. Their occurrence is more likely at the beginning of treatment or after increasing the dose (see also section 4). If you are unsure, consult your doctor or pharmacist.

Ivineb contains lactose

This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Ivineb

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) once daily. It is recommended to take the dose at the same time every day.
• For elderly patients and patients with kidney problems, the initial dose is usually 2.5 mg (1/2 tablet) once daily.
• The blood pressure-lowering effect becomes apparent after 1-2 weeks of treatment. Sometimes the optimal effect occurs only after 4 weeks.

Treatment of chronic heart failure

• Treatment will be initiated and monitored by an experienced doctor.
• The doctor will start treatment with a dose of 1.25 mg (1/4 tablet) once daily. This dose may be increased after 1-2 weeks to a dose of 2.5 mg (1/2 tablet) once daily, then to a dose of 5 mg (1 tablet) once daily, and finally to a dose of 10 mg (2 tablets) once daily, until the optimal dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets once daily).
• An experienced doctor will monitor the patient's condition for 2 hours after starting treatment and after each dose increase.
• If necessary, the doctor may reduce the dose; do not stop treatment abruptly as it may worsen heart failure.
• Patient with severe kidney problems should not take this medicine.

The medicine should be taken once daily, preferably at the same time every day. The doctor may recommend taking another medicine at the same time, depending on the patient's condition. Do not take Ivineb in children and adolescents.

Taking a higher dose of Ivineb than recommended

If you accidentally take too many tablets (overdose), the following may occur: slow heart rate, low blood pressure, or other heart problems, breathing difficulties or wheezing. Seek immediate medical attention at the nearest hospital or contact your doctor. Take the package with the remaining tablets with you.

Missing a dose of Ivineb

If you forget to take a dose 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 or a larger dose to make up for the missed dose. Avoid repeatedly missing doses.

Stopping treatment with Ivineb

Do not stop taking Ivineb without consulting your doctor first. Abrupt withdrawal of the medicine may lead to a worsening of symptoms. This is especially true for patients with angina. If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ivineb can cause side effects, although not everybody gets them. The following side effects may occur when taking Ivineb for high blood pressure: Common side effects (occurring in more than 1 in 100 patients but less than 1 in 10):

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

Uncommon side effects (occurring in more than 1 in 1,000 patients but less than 1 in 100):

• Slow heart rate or other heart problems
• Low blood pressure
• Cramping leg pain when walking
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Depressive feelings
• Digestive problems (indigestion), gas in the stomach or intestines, vomiting
• Skin rash, itching
• Shortness of breath similar to that experienced in asthma, caused by sudden constriction of the airway muscles (bronchospasm)
• Nightmares

Rare side effects (occurring in less than 1 in 10,000 patients):

• Fainting
• Worsening of psoriasis (a skin disease - scaly, pink patches)

The following side effects have been observed only in isolated cases during treatment with Ivineb:

• allergic reactions affecting the whole body, with generalized skin rashes (hypersensitivity reactions).
• sudden swelling, especially around the lips, eyes, or tongue, with possible sudden difficulty breathing (angioedema).
• hives (a type of rash characterized by pale red, raised, itchy bumps)

In a clinical study on chronic heart failure, the following side effects were observed: Very common side effects (occurring in more than 1 in 10 patients):

• Slow heart rate
• Dizziness

Common side effects (occurring in more than 1 in 100 patients but less than 1 in 10):

• worsening of heart failure
• low blood pressure (e.g. feeling of fainting when standing up quickly)
• intolerance to the medicine
• mild conduction problems in the heart that affect the heart rhythm (first-degree atrioventricular block)
• swelling of the lower limbs (e.g. swelling of 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 181C, 02-222 Warsaw; Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309; e-mail: [email protected]

5. How to store Ivineb

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that 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. Other information

What Ivineb 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 Ivineb looks like and contents of the pack

Ivineb tablets are white, round, biconvex, with a cross-shaped groove on one side, approximately 9 mm in diameter. The tablet can be divided into equal doses. 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.

Marketing Authorization Holder

BIOTON S.A. ul. Starościńska 5 02-516 Warsaw

Manufacturer

PharmaPath S.A. 28is Oktovriou 1 Agia Varvara, 12351 Greece

Date of approval of the leaflet: March 2025