NEBIVOLOL TEVA-RATIOPHARM 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Nebivolol Teva-ratiopharm 5 mg Tablets EFG

nebivolol

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Nebivolol Teva-ratiopharm contains nebivolol, a medicine with cardiovascular action, belonging to the group of selective beta-blockers (i.e., with selective activity in the cardiovascular system). It prevents an increase in heart rate and controls the heart's pumping force. It also has a vasodilating action on blood vessels, which in turn helps to lower blood pressure.

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

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

2. What you need to know before you take 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 are receiving intravenous treatment to help the heart work after suffering a circulatory collapse due to acute heart failure.
• If you suffer from heart rhythm disorders (such as sick sinus syndrome including sinoatrial block).
• If you suffer from cardiac conduction disorders (such as second or third degree cardiac block and do not use a pacemaker).
• If you have asthma or have ever suffered from breathing difficulties or wheezing.
• If you have high blood pressure, hot flashes, or diarrhea produced by an untreated tumor of the adrenal medulla (pheochromocytoma).
• If you have a metabolic disorder where there is a change 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

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

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

• If you are going to undergo an operation that requires anesthesia, always inform your anesthesiologist that you are taking Nebivolol Teva-ratiopharm before being anesthetized.
• Untreated chronic heart failure
• Abnormally slow heart rate
• If you have circulation problems in your arms or legs (such as Raynaud's disease or syndrome, intermittent claudication), pain when walking similar to a cramp.

• If you have first-degree cardiac block.
• If you have chest pain at rest that occurs in cycles (Prinzmetal's angina).
• • If you are diabetic, as nebivolol may mask the symptoms produced by low blood sugar (hypoglycemia) and could increase the risk of severe hypoglycemia when used with certain types of antidiabetic medications called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
  • If you have thyroid problems, as nebivolol may mask the symptoms of increased heart rate (tachycardia).
  • • If you have thickened and irritated areas of the skin (psoriasis).
    • If you have allergic reactions, as nebivolol may increase the severity of those reactions.
    • In patients with chronic obstructive pulmonary disease, beta-adrenergic antagonists should be used with caution as they may worsen airway constriction.
    • If you have prolonged breathing difficulties.

If you have severe kidney problems, consult your doctor before taking Nebivolol Teva-ratiopharm to treat your heart failure.

At the start of treatment for chronic heart failure, you will need to be regularly monitored by an experienced doctor (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 notrecommend the use of Nebivolol Teva-ratiopharm in children and adolescents due to the lack of data on the use of this medicine in these patients.

Taking Nebivolol Teva-ratiopharm with other medicines

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

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

• Certain heart medicines or blood pressure control medicines (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 barbiturics (also used for epilepsy), phenothiazines (also used for vomiting and nausea), and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medicines used for anesthesia during an operation.
• Medicines for asthma, nasal decongestants, and some medicines for treating eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (a muscle relaxant); Amifostine (a protective medicine used during cancer treatment).
• Medicines for diabetes, such as insulin or oral antidiabetics.

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

Medicines to treat excess stomach acid or ulcers (antacids): you should take Nebivolol Teva-ratiopharm during meals, and the antacid between meals.

Taking Nebivolol Teva-ratiopharm with food and drinks

See section 3.

Pregnancy and breastfeeding

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

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.

Driving and using machines

Nebivolol Teva-ratiopharm may cause dizziness and fatigue. In these cases, do not drive or use machinery.

Nebivolol Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Nebivolol Teva-ratiopharm contains sodium

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

3. How to take Nebivolol Teva-ratiopharm

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Method of administration:

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

If your doctor has indicated that you should take ¼ (a quarter) or ½ (half) tablet daily, please follow the instructions below to split the 5 mg nebivolol tablets, scored in a cross shape.

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

Diagrams 1 and 2: easy breaking of the 5 mg nebivolol tablet, scored in a cross shape, into a half.

Diagrams 3 and 4: easy breaking of the half 5 mg nebivolol tablet, scored in a cross shape, into a quarter.

High blood pressure (hypertension)

Adults

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

The blood pressure lowering effect is achieved after 1-2 weeks of treatment. Occasionally, the optimal effect is only achieved after 4 weeks.

Patient with kidney problems

If you have kidney problems, the initial recommended dose is 2.5 mg per day (half a tablet). If necessary, your doctor will increase your daily dose to 5 mg.

Elderly patients

If you are over 65 years old, the initial recommended dose is 2.5 mg per day (half a tablet). If necessary, your doctor will 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 should always be started under medical supervision.
• Your doctor will start your treatment with ¼ (a quarter) of a tablet per day. The dose will be increased after 1-2 weeks to ½ (half) a tablet per day, then to 1 tablet per day, and finally to 2 tablets per day until the optimal dose for you is achieved. Your doctor will prescribe the correct dose for you at each time and you should follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) per day.
• The start of treatment and each dose increase will be done under the supervision of an experienced doctor for a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• You should not stop treatment abruptly, as this could temporarily worsen your heart failure.
• Patient with severe kidney problems should not take this medicine.
• Take the medicine once a day, 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 frequent symptoms and signs of nebivolol overdose are very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

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

If you forget to take Nebivolol Teva-ratiopharm

If you have forgotten a dose of nebivolol, but remember it shortly after, take the next tablet normally. However, if there is a long delay (i.e., several hours), so that the next dose is near, skip the missed dose and take the next dose at the usual time. Do not take a double dose. However, repeated forgetting of the medicine 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 it is necessary to stop treatment for chronic heart failure, the daily dose should be gradually reduced, starting by halving the dose, at intervals of one week.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When usedNebivolol Teva-ratiopharm for the treatment of high blood pressure, the possible side effects are:

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

• headache
• dizziness
• fatigue
• unusual itching or tingling sensation
• diarrhea
• constipation
• nausea
• breathing difficulties
• swollen hands or feet.

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

• slow heart rate or other heart disorders
• low blood pressure
• pain when walking similar to a cramp
• abnormal vision
• impotence (erectile dysfunction)
• breathing difficulties like 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

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

• fainting.
• worsening of psoriasis (skin rash).

The frequency of the following side effects is not known:

• allergic reactions, such as generalized skin rashes (hypersensitivity reactions).
• sudden swelling of the lips, eyelids, or tongue, which may be accompanied by difficulty breathing (angioedema)
• skin rash characterized by pink, raised patches, which can be itchy, of allergic or non-allergic origin (urticaria).

In a clinical study for chronic heart failure, the following side effects were seen:

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

• slow heart rate
• dizziness

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

• worsening of heart failure
• low blood pressure (such as a feeling of fainting when standing up quickly)
• intolerance to this medicine
• mild alteration of heart conduction affecting heart rate (first-degree atrioventricular block)
• swelling of the lower limbs (increased volume of the ankles).

Reporting of side effects:

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

5. Storage of Nebivolol Teva-ratiopharm

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and on the carton. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Container Content and Additional Information

Composition of Nebivolol Teva-ratiopharm

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

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

Appearance of the Product and Container Content

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

The tablets are provided in PVC/PE/PVdC//Al or transparent and colorless unidose PVC/PE/PVdC//Al blisters. Package sizes: 7, 8, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500, and 50 x 1 unidose blisters (hospital packaging).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

Anabel Segura Street, nº 11, Albatros Building 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 authorized in the Member States of the European Economic Area under the following names:

Belgium: Nebivolol Teva 5 mg tablets

Bulgaria: Nebivolol Teva 5 mg tablets

Spain: Nebivolol Teva-ratiopharm 5 mg EFG tablets

Estonia: NEBIPHAR

Hungary: Nebivolol-Teva 5 mg tablet

Ireland: Nebivolol Teva 5 mg Tablets

Italy: Nebivololo Teva Italia 5 mg tablets

Netherlands: Nebivolol Teva 5mg, tablets

Date of the Last Revision of this Leaflet:June 2021

Other Sources of Information

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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