Prospecto:information for the user

Nebivolol ratiopharm 5 mg tablets EFG

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhavethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenifthey are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting totake Nebivolol ratiopharm

3.How to take Nebivolol ratiopharm

4.Possible adverse effects

5.Storage of Nebivolol ratiopharm

6.Contents of the package and additional information

Nebivolol ratiopharmcontains nebivolol, a cardiovascular medication, belonging to the group of selective beta-blockers (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 on blood vessels, which in turn contributes to lowering blood pressure.

It is used for the treatment of high blood pressure (hypertension).

Nebivololis also used for the treatment of mild to moderate chronic heart failure in patients aged 70 or older, administered in combination with other medications.

Do not take Nebivolol ratiopharm

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• if you have one or more of the following conditions:

• low blood pressure
• serious circulation problems in arms or legs
• slow heart rate (less than 60 beats per minute)
• other serious heart rhythm disorders (such as second- and third-degree atrioventricular block or other conduction disorders)
• you have recently had a heart failure episode or worsening of the same, or are receiving intravenous treatment to help your heart work after suffering a circulatory collapse due to acute heart failure
• asthma or breathing difficulties (current or past)
• pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), that is not being treated
• liver function disorders
• metabolic disorders (metabolic acidosis), for example, diabetic ketoacidosis

Warnings and precautions

Consult your doctor or pharmacist before starting to take nebivolol.

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

• abnormally slow heart rate,
• a type of chest pain, due to spontaneous spasm of the heart arteries, called Prinzmetal's angina,
• untreated chronic heart failure,
• first-degree heart block (mild conduction disorder affecting heart rhythm),
• poor circulation in arms or legs, such as Raynaud’s disease or pain while walking similar to a cramp,
• chronic respiratory problems,
• diabetes: This medicine has no effect on blood sugar levels, but may mask warning signs of a decrease in these levels (e.g., palpitations, rapid heart rate),
• hyperthyroidism: This medicine may mask signs due to this condition, such as abnormally high heart rate,
• allergies: This medicine may intensify your reaction to pollen or other substances to which you are allergic,
• if you have or have had psoriasis (a skin disease characterized by pink scaly patches),
• if you are undergoing surgery, inform your anesthetist that you are taking Nebivolol ratiopharm.

If you have severe kidney problems, consult your doctor before taking nebivolol to treat heart failure.

You will need to be regularly monitored by a doctor (see section 3) at the start of treatment for chronic heart failure.

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 ratiopharm in children and adolescents due to the lack of data on the use of this medicine in this type of patient.

Taking Nebivolol ratiopharm with other medicines

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

It is essential to inform your doctor if, in addition to nebivolol, you are taking any of the following medicines:

• Some heart or blood pressure 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 psychoses medicines (mental illness), such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
• Depression medicines, such as amitriptyline, paroxetine, and fluoxetine.
• Anesthesia medicines used during surgery.
• Asthma medicines, nasal decongestants, or some medicines for eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (an antispasmodic medicine); Amifostine (a protective medicine used during cancer treatment).

All these medicines, like nebivolol, may affect blood pressure and heart function.

Medicines for treating excess stomach acid or ulcers (antacids): Take nebivolol with food, and the antacid between meals.

Taking Nebivolol ratiopharm with food and drinks

See section 3.

Pregnancy and breastfeeding

Nebivolol ratiopharm should not be administered during pregnancy unless your doctor considers it necessary.

It is not recommended to use this medicine during breastfeeding.

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 operating machinery

This medicine may cause dizziness or fatigue. If so, do not drive or operate machinery.

Nebivolol ratiopharm contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

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

Nebivolol can be taken before, during, or after meals, but it can also be taken regardless of meals. It is recommended to take the tablet with a little water.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet per day. It is recommended to take the dose at the same time every day.
• In elderly patients and patients with renal impairment, it is recommended to start treatment with ½ (half) tablet per day.
• The therapeutic effect on blood pressure is achieved after 1-2 weeks of treatment. Occasionally, the optimal effect is not achieved until 4 weeks.

Treatment of chronic heart failure

• Your treatment will be initiated and supervised by an experienced doctor.
• 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 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 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.
• Patients with severe kidney problems should not take this medication.
• Take the medication once a day, preferably at the same time every day.

If your doctor has indicated that you take ¼ (quarter) or ½ (half) tablet per day, follow the instructions below to split the Nebivolol ratiopharm 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 upwards.
• Break the tablet by pressing it with your index fingers from both hands placed on either side of one of the scores (Figures 1 and 2).
• Proceed in the same way to split the half-tablet into quarters (Figures 3 and 4).

Figures 1 and 2: Easy breaking of the Nebivolol 5 mg tablet scored in a cross shape into a half.

Figures 3 and 4: Easy breaking of the half-tablet of Nebivolol 5 mg scored in a cross shape into quarters.

• Your doctor will decide whether you should combine nebivolol with other medications to treat your condition.
• Do not administer to children or adolescents.

If you take more Nebivolol ratiopharm than you should

If you have accidentally taken an overdose of this medication, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken. The most frequent symptoms and signs of a nebivolol overdose are a very slow heart rate (bradycardia), low blood pressure with a risk of fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

You can take activated charcoal (available at your pharmacy) while waiting for the doctor to arrive.

If you forget to take Nebivolol ratiopharm

If you forget to take a dose of nebivolol, but remember shortly after when you should have taken it, take the daily dose as usual. However, if a lot of time has passed (several hours), so that you are close to the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose. However, you should try to avoid repeated missed doses of the medication.

If you interrupt treatment with Nebivolol ratiopharm

Always consult your doctor before stopping treatment with Nebivolol 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Whennebivololis used for the treatment of high blood pressure, the possible side effects are:

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

• headache,
• dizziness,
• fatigue,
• unusual itching or tingling sensation,
• diarrhea,
• constipation,
• nausea,
• difficulty breathing,
• inflammation of the hands or feet

Rare side effects (may affect up to 1 in 100 people)

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

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

• syncope,
• worsening of psoriasis (a skin disease characterized by scaly pink patches).

The following side effects have been reported in isolated cases during treatment with Nebivolol ratiopharm:

• allergic reactions, such as generalized skin rash (hypersensitivity reactions),
• sudden swelling, especially around the lips, eyes, and/or tongue, which may be accompanied by acute difficulty breathing (angioedema),
• skin rash characterized by pink, raised patches that cause itching, of allergic or non-allergic cause (urticaria).

In a clinical study for chronic 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)

• worsening of heart failure,
• low blood pressure (as a feeling of fainting when standing up quickly),
• intolerance to this medication,
• mild alteration of cardiac conduction affecting heart rhythm (first-degree atrioventricular block).
• swelling of the lower extremities (increase in volume of the ankles).

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and in the blisterafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. In case of doubt,please ask your pharmacisthow to dispose ofthe packaging and medications that you no longerneed.

Composition ofNebivolol ratiopharm

• The active ingredient is nebivolol.

Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.

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

Appearance of the product and contents of the packaging

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

The tablets can be divided intohalves and quartersof equal size.

Packaging sizes:

Blister: 10, 14, 28, 30, and 90 tablets.

HDPE bottle: 10, 14, 28, 30, and 90 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Responsible manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

or

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last review date of thisleaflet:November 2019

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