Nebivolol Teva-Ratiopharm 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nebivolol Teva-ratiopharm 5 mg tablets EFG

nebivolol

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Nebivolol Teva-ratiopharm is and what it is used for
2. What you need to know before taking Nebivolol Teva-ratiopharm
3. How to take Nebivolol Teva-ratiopharm
4. Possible side effects
5. How to store Nebivolol Teva-ratiopharm
6. Contents of the pack and other information

1. What Nebivolol Teva-ratiopharm is and what it is used for

Nebivolol Teva-ratiopharm contains nebivolol, a medicine with cardiovascular action, belonging to the group of selective beta-blocking agents (that is, with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's force of contraction. It also exerts a vasodilating effect on blood vessels, which further contributes to lowering blood pressure.

Nebivolol Teva-ratiopharm is used in the treatment of patients with:

• High blood pressure (hypertension)
• Mild to moderate chronic heart failure in patients aged 70 years or older, in addition to other treatments.

2. What you need to know before taking Nebivolol Teva-ratiopharm

Do not take Nebivolol Teva-ratiopharm

• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems.
• If you have heart failure that has just occurred or has recently worsened, or if you are receiving intravenous treatment to help your heart function, following circulatory collapse due to acute heart failure.
• If you have heart rhythm disorders (such as sick sinus syndrome including sinoatrial block).
• If you have heart conduction disorders (such as second- or third-degree heart block and you do not have a pacemaker).
• If you have asthma or have ever experienced difficulty breathing or wheezing.
• If you have high blood pressure, flushing, or diarrhea caused by an untreated adrenal medulla tumor (pheochromocytoma).
• If you have a metabolic disorder involving an imbalance in the body's acid/base balance (metabolic acidosis).
• If you have a slow heart rate (less than 60 beats per minute before starting treatment with this medicine).
• If you have low blood pressure (systolic blood pressure less than 90 mmHg).
• If you have poor blood circulation in your arms or legs.

Warnings and precautions

Talk to your doctor before starting to take Nebivolol Teva-ratiopharm.

Inform your doctor if you have any of the following conditions:

• If you are due to undergo surgery requiring anesthesia, always inform your anesthetist that you are taking Nebivolol Teva-ratiopharm before being anesthetized.
• Chronic heart failure without treatment.
• Abnormally slow heartbeat.
• If you have circulation problems in your arms or legs (such as Raynaud's disease or syndrome, intermittent claudication), cramp-like pain when walking.
• If you have first-degree heart block.
• If you have chest pain at rest that occurs in cycles (Prinzmetal's angina).
  • If you are diabetic, as nebivolol may mask symptoms of low blood sugar (hypoglycemia) and could increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g., repaglinide, gliclazide, glyburide, glipizide, glimepiride, or tolbutamide).
  • If you have thyroid problems, as nebivolol may mask symptoms of increased heart rate (tachycardia).
    • If you have thickened, irritated skin areas (psoriasis).
    • If you suffer from allergic reactions, as nebivolol may increase the severity of such reactions.
    • In patients with chronic obstructive pulmonary disorders, beta-adrenergic blockers should be used with caution as they may worsen airway constriction.
    • If you have long-term breathing problems.

If you have severe kidney problems, consult your doctor before taking Nebivolol Teva-ratiopharm for treatment of heart failure.

At the start of treatment for chronic heart failure, you should be regularly monitored by an experienced physician (see section 3). This treatment should not be stopped abruptly unless clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

Do not use Nebivolol Teva-ratiopharm in children and adolescents due to lack of data on the use of this medicine in this patient group.

Taking Nebivolol Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking any of the following:

• Certain medicines for the heart or for blood pressure control (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and medicines for mental illness (psychosis), such as barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting), and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines for asthma, nasal decongestants, and certain medicines used to treat eye conditions such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (a muscle relaxant); Amifostine (a protective agent used during cancer treatment).
• Medicines for diabetes, such as insulin or oral antidiabetics.

All of these medicines, like Nebivolol Teva-ratiopharm, may affect blood pressure and heart function.

Medicines for treating excess stomach acid or ulcers (antacids): Nebivolol Teva-ratiopharm should be taken with food, and antacids should be taken between meals.

Taking Nebivolol Teva-ratiopharm with food and drink

See section 3.

Pregnancy and breastfeeding

Nebivolol Teva-ratiopharm should not be used during pregnancy unless your doctor considers it necessary. Its use during breastfeeding is not recommended.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Nebivolol Teva-ratiopharm may cause dizziness and fatigue. If this occurs, do not drive or operate machinery.

Nebivolol Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Nebivolol Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially "sodium-free".

3. How to take Nebivolol Teva-ratiopharm

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration:

The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water). The tablet may be taken with or without food. The tablet can be divided into equal halves and quarters.

If your doctor has instructed you to take ¼ (one-quarter) or ½ (one-half) tablet daily, please follow the instructions below to split the 5 mg nebivolol tablets, which are cross-scored.

• Place the tablets on a flat, hard surface (e.g., table or countertop), with the cross-shaped score facing upwards.
• Break the tablet by pressing with the index fingers of both hands placed on either side of one of the scores (Figures 1 and 2).
• Proceed similarly to split the half tablet into quarters (Figures 3 and 4).

Figures 1 and 2: Easy splitting of the 5 mg cross-scored nebivolol tablet into halves.

Figures 3 and 4: Easy splitting of the half tablet of 5 mg cross-scored nebivolol into quarters.

High blood pressure (hypertension)

Adults

The recommended dose is 5 mg (one tablet) once daily, preferably at the same time each day.

The antihypertensive effect is achieved within 1–2 weeks of treatment. Occasionally, the optimal effect is only achieved after 4 weeks.

Patients with kidney problems

If you have kidney problems, the recommended starting dose is 2.5 mg daily (half a tablet). If necessary, your doctor may increase your daily dose up to 5 mg.

Elderly patients

If you are over 65 years of age, the recommended starting dose is 2.5 mg daily (half a tablet). If necessary, your doctor may increase your daily dose to 5 mg.

Use in children and adolescents

Nebivolol is not recommended for use in children and adolescents under 18 years of age.

Chronic heart failure

Adults

• Your treatment must always be initiated under medical supervision.
• Your doctor will start your treatment with ¼ (one-quarter) of a tablet daily. The dose will be increased after 1–2 weeks to ½ (one-half) tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily, until the optimal dose for you is reached. Your doctor will prescribe the correct dose at each stage, and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• Initiation of treatment and each dose increase must be supervised by an experienced physician for a period of 2 hours.
• Your doctor may reduce your dose if necessary.
• You should not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take the medicine once daily, preferably at the same time each day.

Use in children and adolescents

Nebivolol is not recommended for use in children and adolescents under 18 years of age.

Combination with other medicines

Your doctor may decide to combine Nebivolol Teva-ratiopharm with other medicines to treat your condition.

If you take more Nebivolol Teva-ratiopharm than you should

The most common symptoms and signs of nebivolol overdose are very slow heart rate (bradycardia), low blood pressure possibly leading to fainting (hypotension), breathing difficulties such as in asthma (bronchospasm), and acute heart failure.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Nebivolol Teva-ratiopharm

If you forget a dose of nebivolol but remember shortly afterwards, take the missed dose as usual. However, if a long delay has occurred (i.e., several hours) and the next dose is due soon, skip the missed dose and take the next dose at the usual scheduled time. Do not take a double dose. However, repeated missed doses should be avoided.

If you stop taking Nebivolol Teva-ratiopharm

Always consult your doctor before stopping treatment with Nebivolol Teva-ratiopharm, whether you are taking it for high blood pressure or chronic heart failure. You should not stop treatment abruptly, as this could temporarily worsen your heart failure. If discontinuation of treatment for chronic heart failure is necessary, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When Nebivolol Teva-ratiopharm is used for the treatment of high blood pressure, the possible adverse effects are:

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• fatigue
• unusual itching or tingling sensation
• diarrhoea
• constipation
• nausea
• difficulty breathing
• swollen hands or feet

Uncommon (may affect up to 1 in 100 people):

• slow heart rate or other heart problems
• low blood pressure
• cramp-like pain when walking
• abnormal vision
• impotence (erectile dysfunction)
• difficulty breathing as in asthma, due to sudden contraction of the muscles around the airways (bronchospasm)
• indigestion, stomach or intestinal gas, vomiting
• itching, skin rash
• nightmares
• feeling of depression

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

• fainting
• worsening of psoriasis (skin rash)

Frequency of the following adverse effects is not known:

• allergic reactions, such as widespread skin rashes (hypersensitivity reactions)
• sudden swelling of the lips, eyelids or tongue, possibly accompanied by acute breathing difficulty (angioedema)
• skin rash characterized by raised, itchy, pink welts, due to allergic or non-allergic causes (urticaria)

In a clinical study for chronic heart failure, the following adverse effects were observed:

Very common adverse effects (may affect more than 1 in 10 people):

• slow heartbeat
• dizziness

Common adverse effects (may affect up to 1 in 10 people):

• worsening of heart failure
• low blood pressure (such as feeling faint when standing up quickly)
• intolerance to this medicine
• mild disturbance in heart conduction affecting heart rhythm (first-degree atrioventricular block)
• swelling of the lower limbs (increased ankle volume)

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nebivolol Teva-ratiopharm

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and container. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Nebivolol Teva-ratiopharm

The active substance is nebivolol (as hydrochloride). Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.

The other components are: monohydrate lactose, sodium croscarmellose, anhydrous colloidal silica, macrogol 6000 and magnesium stearate.

Appearance of the product and contents of the container

Round, white, biconvex tablet with a diameter of 9 mm, with a cross-shaped score on one side and marked with "N 5" on the other side.

The tablets are supplied in PVC/PE/PVdC//Al blisters or in transparent colourless PVC/PE/PVdC//Al single-dose blisters. Package sizes: 7, 8, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500 and 50 x 1 single-dose blister (hospital pack).

Only certain package sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma S.L.U.

C/ Anabel Segura nº 11, Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid

Manufacturer

Balkanpharma Dupnitsa AD,

3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

or

Actavis Ltd,

BLB 015-016, Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:

Belgium: Nebivolol Teva 5 mg tabletten

Bulgaria: Nebivolol Teva 5 mg tablets

Spain: Nebivolol Teva-ratiopharm 5 mg comprimidos EFG

Estonia: NEBIPHAR

Hungary: Nebivolol-Teva 5 mg tabletta

Ireland: Nebivolol Teva 5 mg Tablets

Italy: Nebivololo Teva Italia 5 mg compresse

Netherlands: Nebivolol Teva 5mg, tabletten

Date of the most recent revision of this leaflet: June 2021

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72140/P_72140.html

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