Leaflet: information for the user

Nebivolol Teva-ratiopharm 5 mg tablets EFG

nebivolol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to 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 additional information

Nebivolol Teva-ratiopharm contains nebivolol, a cardiovascular medication, 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 force of heart pumping. It also exerts a vasodilatory action, which in turn contributes to reducing blood pressure.

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

• High blood pressure (hypertension)
• Chronic mild to moderate heart failure in patients 70 years of age or older, in addition to other treatments.

Do not take Nebivolol Teva-ratiopharm

• If you are allergic to nebivolol or any of the other components of this medication (listed in section 6).
• If you have liver problems.
• If you have heart failure, which has recently 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 conduction disorders of the heart (such as second- or third-degree heart block and do not use a pacemaker).
• If you have high blood pressure, hot flashes, or diarrhea caused by an untreated adrenal gland tumor (pheochromocytoma).
• If you have a metabolic disorder where there is a change in the acid-base balance of the body (metabolic acidosis).
• If you have a slow heart rate (less than 60 beats per minute before starting treatment with this medication).
• If you have low blood pressure (systolic blood pressure less than 90 mmHg).
• If you have poor blood circulation in the arms or legs.

Warnings and precautions

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

Inform your doctor if you suffer from any of the following conditions:

• If you are to undergo an operation that requires anesthesia, always inform your anesthesiologist that you are taking Nebivolol Teva-ratiopharm before being anesthetized.
• Chronic heart failure without treatment
• Abnormally slow heart rate
• If you suffer from circulatory problems in the arms or legs (such as Raynaud's disease, intermittent claudication), or walking pain similar to a cramp

• If you suffer from first-degree heart block.
• If you suffer from chest pain at rest that occurs in cycles (Prinzmetal's angina).
• • If you are diabetic, as nebivolol may mask the symptoms of low blood sugar (hypoglycemia).
  • If you suffer from thyroid problems, as nebivolol may mask the symptoms of high heart rate (tachycardia)
  • • If you have thickened and irritated skin patches (psoriasis).
    • If you suffer from 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 suffer from prolonged breathing problems.

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

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

Children and adolescents

Nebivolol Teva-ratiopharm is not recommended for use in children and adolescents due to the lack of data on the use of this medication in this type of patient.

Taking Nebivolol Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Some medications for the heart or to control blood pressure (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 medications for mental illness (psychosis), such as barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea), and thioridazine.
• Medications used for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medications used for anesthesia during an operation.
• Medications used for asthma, nasal decongestants, and some medications used to treat eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (an antispasmodic medication); Amifostine (a protective medication used during cancer treatment).

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

Medications used to treat excess stomach acid or ulcers (antacids): take Nebivolol Teva-ratiopharm with 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 administered during pregnancy unless your doctor considers it necessary. It is not recommended for use during breastfeeding.

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

Driving and operating machinery

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

Nebivolol Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Nebivolol Teva-ratiopharm contains sodium

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

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

Administration form:

The tablet should be taken 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 halves and quarters.

If your doctor has instructed you to take ¼ (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 scored surface facing upwards.
• Break the tablet by pressing it with your index fingers from both hands placed on either side of one of the scores (diagrams 1 and 2).
• Proceed in the same manner 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.

Hypertension

Adults

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

The hypotensive effect is achieved after 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 initial dose is 2.5 mg per day (half tablet). If necessary, your doctor will increase your daily dose to 5 mg.

Older adults

If you are over 65 years old, the recommended initial dose is 2.5 mg per day (half 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 old.

Chronic heart failure

Adults

• Your treatment should always be initiated under medical supervision.
• Your doctor will start your treatment with ¼ (quarter) tablet per day. The dose will be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and then to 2 tablets per day until you achieve the optimal dose for you. 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 initiation of treatment and each dose increase will be performed 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 worsen your heart failure temporarily.
• Patients with severe kidney problems should not take this medication.
• Take the medication once a day, preferably at the same time of day.

Use in children and adolescents

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

Combination with other medications

Your doctor may decide to combine Nebivolol Teva-ratiopharm with other medications 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 a risk of fainting (hypotension), difficulty breathing like in 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, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Nebivolol Teva-ratiopharm

If you have forgotten a dose of nebivolol, but remember it shortly, 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 normally, scheduled at the usual time. Do not take a double dose. However, repeated missed doses should be avoided.

If you interrupt treatment with Nebivolol Teva-ratiopharm

Always consult your doctor before interrupting treatment with Nebivolol Teva-ratiopharm, whether you take it for high blood pressure or chronic heart failure. Do not stop treatment abruptly, as this could worsen your heart failure temporarily. If necessary, the daily dose should be gradually reduced, starting with half the dose, at intervals of one week.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

When usingNebivolol Teva-ratiopharmfor the treatment of high blood pressure, the possible side effects are:

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

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

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

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

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

• syncope.
• worsening of psoriasis (skin eruption).

The frequency of the following side effects is unknown:

• allergic reactions, such as generalized skin eruptions (hypersensitivity reactions).
• sudden swelling of the lips, eyelids, or tongue, possibly accompanied by acute difficulty breathing (angioedema)
• skin eruption characterized by pink, raised patches that produce itching, of allergic or non-allergic cause (urticaria).

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

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

• slow heart rate
• dizziness

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

• aggravation of heart failure
• low blood pressure (as a sensation of fainting when standing up quickly)
• intolerance to this medication
• slight alteration of cardiac conduction affecting heart rhythm (first-degree atrioventricular block)
• swelling of the lower extremities (increased volume of the ankles).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

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

Appearance of the product and contents of the package

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

The tablets are provided in a blister of PVC/PE/PVdC//Al or a single-dose blister of transparent and colourless PVC/PE/PVdC//Al.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 some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

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

Alcobendas 28108 Madrid

Responsible 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 EEA Member States with the following names:

Belgium: Nebivolol Teva 5 mg tablets

Bulgaria: Nebivolol Teva 5 mg tablets

Spain: Nebivolol Teva 5 mg tablets EFG

Estonia: NEBIPHAR

Hungary: Nebivolol-Teva 5 mg tablet

Ireland: Nebivolol Teva 5 mg Tablets

Italy: Nebivololo Teva Italia 5 mg tablets

Lithuania: Nebiphar 5 mg tablets

Netherlands:Nebivolol Teva 5mg, tablets

Last review date of this leaflet:June 2021

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/