LOBIVON 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

LOBIVON 5 mg Tablets

(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:

1. What is Lobivon and what is it used for
2. What you need to know before you take Lobivon
3. How to take Lobivon
4. Possible side effects
5. Storing Lobivon
6. Contents of the pack and other information

1. What is Lobivon and what is it used for

Lobivon contains nebivolol, a medicine with cardiovascular action, 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 heart's pumping force. It also has a vasodilating action on blood vessels, which in turn helps to lower blood pressure.

It is used for the treatment of high blood pressure (hypertension). Lobivon is also used for the treatment of mild and moderate chronic heart failure in patients aged 70 or over, administered in combination with other medicines.

2. What you need to know before you take Lobivon

Do not take Lobivon

• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).

• If you have any of the following conditions:

• Low blood pressure.
• Severe circulation problems in your arms or legs.
• Very slow heart rate (less than 60 beats per minute).
• Other severe heart rhythm disorders such as second- or third-degree atrioventricular block or other cardiac conduction disorders.
• You have recently had a heart attack or your heart failure has worsened, or you are receiving intravenous treatment to help your heart work after suffering a circulatory collapse due to acute heart failure.
• Asthma or difficulty breathing (currently or in the past).
• Pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), that is not being treated.
• Liver function disorders.
• Metabolic disorders characterized by metabolic acidosis (e.g., diabetic ketoacidosis).

Warnings and precautions

Consult your doctor before starting to take Lobivon

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

• Abnormally slow heart rate.
• A type of chest pain due to a spontaneous spasm of the heart arteries, called Prinzmetal's angina.
• Untreated chronic heart failure.
• First-degree heart block (mild cardiac conduction disorder affecting heart rhythm).
• Poor circulation in your arms or legs, such as Raynaud's disease or pain when walking similar to a cramp.
• Chronic respiratory problems.
• Diabetes: this medicine has no effect on blood sugar levels, but it can mask the warning signs of low blood sugar levels (palpitations, rapid heartbeat).
• Overactive thyroid gland: this medicine can mask the signs of this condition, such as abnormally high heart rate.
• Allergies: this medicine can increase your reaction to pollen or other substances you are allergic to.
• If you have or have had psoriasis, a skin disease characterized by scaly pink patches.
• If you need to undergo surgery, always inform your anesthesiologist that you are taking this medicine.

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

At the start of treatment for chronic heart failure, you will need to be regularly monitored by a 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 Lobivon in children and adolescents due to the lack of data on the use of this medicine in these patients.

Using Lobivon with other medicines

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

It is important to inform your doctor or pharmacist if, in addition to Lobivon, you are taking any of the following medicines:

• Some 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 psychosis (mental illness), such as barbiturates (also used for epilepsy), phenothiazine (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, decongestants, and some medicines for treating eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (an antispastic medicine); Amifostine (a protective medicine used during cancer treatment).

All these medicines, like Lobivon, can affect blood pressure and heart function.

• Medicines to treat excess stomach acid or ulcers (antacids): you should take Lobivon during meals, and the antacid between meals.

Taking Lobivon with food and drinks

See section 3.

Pregnancy and Breastfeeding

Lobivon should not be taken during pregnancy unless your doctor considers it necessary.

It is not recommended 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

This medicine may cause dizziness or fatigue. If this happens, do notdrive or use machines.

Lobivon contains Lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consultthem before taking this medicine.

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

3. How to take Lobivon

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

Lobivon can be taken before, during, or after meals, but it can also be taken independently of them. It is preferable to take the tablet with a little water.

Treatment of high blood pressure (hypertension):

• The normal dose is 1 tablet a day. It is preferable to take the dose at the same time every day.
• In elderly patients and/or those with kidney problems, it is recommended to start treatment with 1/2 tablet a 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 must always be started under medical supervision.
• Your doctor will start your treatment with 1/4 (a quarter) of a tablet a day. The dose will be increased after 1-2 weeks to 1/2 (half) a tablet a day, then to 1 tablet a day, and finally to 2 tablets a day to achieve the optimal dose for you. Your doctor will prescribe the correct dose for you at each time and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) a 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.
• Do not stop treatment abruptly, as this could 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 every day.

If your doctor has told you to take 1/4 (a quarter) or 1/2 (half) a tablet a day, follow these instructions to split the 5 mg nebivolol tablets, which are scored in a cross shape:

• Place the tablets on a flat, hard surface (e.g., table or countertop), with the cross-shaped score line facing up.
• Break the tablet by pressing it with the index fingers of both hands on either side of one of the score lines (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 tablet of 5 mg nebivolol scored in a cross shape into a quarter.

• Your doctor will decide whether you should combine Lobivon with other medicines to treat your condition.
• Do not give to children or adolescents.

If you take more Lobivon than you should

If you have accidentally taken an overdose of this medicine, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

The most frequent symptoms and signs of an overdose of Lobivon are very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

If you forget to take Lobivon

If you forget to take a dose of Lobivon, but remember soon after when you should have taken it, take the daily dose as usual. If it has been a long time (several hours) and it is close to the next dose, skip the missed dose and take the next scheduled doseat the usual time. Do not take a double dose. However, you should try to avoid repeatedly forgetting to take your medication.

If you stop taking Lobivon

Always consult your doctor before stopping treatment with Lobivon, whether you are taking it for high blood pressure or chronic heart failure.

Do 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 product, ask your doctor or pharmacist.

4. Possible side effects

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

When usedLobivon for the treatment of high blood pressure, the possible side effects are:

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

• Headache.
• Dizziness.
• Fatigue.
• Unusual itching or tingling sensation.
• Diarrhea.
• Constipation.
• Nausea.
• Breathing difficulties / feeling of shortness of breath.
• Sweating of hands and feet.

Uncommon side effects (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.
• Feeling of depression.
• Difficulty digesting (dyspepsia), stomach or intestinal gas, vomiting.
• Skin rash, itching.
• Breathing difficulties like asthma, due to sudden contraction of the muscles around the airways (bronchospasm).
• Nightmares.

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

• Fainting.
• Worsening of psoriasis, a skin disease characterized by scaly pink patches.

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

• Allergic reactions, such as generalized skin rashes (hypersensitivity reactions).
• Sudden swelling of the lips, eyelids, and/or tongue, which may be accompanied by difficulty breathing (angioedema).
• Skin rash characterized by pink, raised patches, which may cause itching, 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 feeling faint when standing up quickly).
• Intolerance to this medicine.
• Mild cardiac conduction disorder affecting heart rhythm (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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lobivon

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

No special storage conditions are required.

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

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

6. Contents of the pack and other information

Composition of Lobivon

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride): 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
• The other ingredients are: lactose monohydrate, polysorbate 80 (E-433), hypromellose (E-464), corn starch, croscarmellose sodium (E-468), microcrystalline cellulose (E-460), colloidal anhydrous silica (E-551), magnesium stearate (E-572).

Appearance and packaging

Lobivon is presented in the form of white, round, cross-scored tablets and is available in packs of 7, 14, 28, 30, 50, 56, 90, 100, and 500 tablets.

The tablets are packaged in PVC/aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A.,

1, Avenue de la Gare L-1611, Luxembourg

Local representative:

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

Manufacturer

Berlin-Chemie AG

Glienicker Weg 125 - 12489 Berlin, Germany

or

Menarini – Von Heyden GmbH

Leipziger Strasse 7-13, 01097 – Dresden, Germany

or

Qualiphar N.V.

Rijksweg 9, 2880 Bornem, Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Nebilet

Austria: Hypoloc

Belgium: Nobiten

Cyprus: Lobivon

Denmark: Hypoloc

Spain: Lobivon

Finland: Hypoloc

France: Temerit

Greece: Lobivon

Ireland: Hypoloc

Iceland: Hypoloc

Italy: Nebilox

Luxembourg: Nobiten

Norway: Hypoloc

Netherlands: Nebilet

Portugal: Nebilet

United Kingdom: Hypoloc

Sweden: Hypoloc

Date of last revision of this leaflet:August 2018

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