SILOSTAR 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is Silostar and what is it used for

Silostar 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 to treat high blood pressure (hypertension). Silostar is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, administered in combination with other medications.

2. What you need to know before you take Silostar

Do not take Silostar

• 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 Silostar.

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.
• Chronic heart failure without treatment.
• 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, fast heart rate).
• Hyperthyroidism: 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 Silostar 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 Silostar in children and adolescents due to the lack of data on the use of this medicine in these patients.

Using Silostar with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is important that you always inform your doctor or pharmacist if, in addition to Silostar, you are using 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, nasal 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 Silostar, can affect blood pressure and heart function.

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

Taking Silostar with food and drinks

See section 3.

Pregnancy and breastfeeding

Silostar 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine may cause dizziness or fatigue. If so, avoiddriving and using machinery.

Silostar 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 Silostar

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

Silostar 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 per day. It is preferable to take the dose always at the same time of day.
• In elderly patients and/or with kidney problems, it is recommended to start treatment with 1/2 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 must always be started under medical supervision.
• Your doctor will start your treatment with 1/4 (one quarter) of a tablet per day. The dose will be increased after 1-2 weeks to 1/2 (half) 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 must 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 performed under the supervision of an experienced doctor during a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• Do not interrupt 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 of day.

If your doctor has indicated that you should take 1/4 (one quarter) or 1/2 (half) tablet daily, follow these instructions 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 tablet of 5 mg nebivolol, scored in a cross shape, into a quarter.

• Your doctor will decide whether to combine Silostar with other medicines to treat your condition.
• Do not administer to children or adolescents.

If you take more Silostar than you should

If you have accidentally taken an overdose of this medicine, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 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 Silostar 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 Silostar

If you forget to take a dose of Silostar, but remember shortly after when you should have taken it, take the daily dose as usual. If a lot of time has passed (several hours), so that 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 the medication.

If you stop taking Silostar

Always consult your doctor before stopping treatment with Silostar, 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 other questions about 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 usedSilostar 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.
• Difficulty breathing / 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), gas in the stomach or intestine, vomiting.
• Skin rash, itching.
• Difficulty breathing 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 only a few isolated cases during treatment with Silostar:

• Allergic reactions, such as generalized skin rashes (hypersensitivity reactions).
• Sudden swelling of the lip, eyelid, and/or tongue area, which may be accompanied by acute difficulty breathing (angioedema).
• Skin rash characterized by pink, raised patches, which may 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 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. Storage of Silostar

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 indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silostar

• 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, sodium croscarmellose (E-468), microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551), magnesium stearate (E-572).

Appearance of the product and pack contents

Silostar 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:

Guidotti Farma, S.L.

C/Alfons XII, 587

08918 Badalona

(Barcelona) Spain

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.

Rijsweg 9, 2880 Bornem, Belgium

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Nomexor

Belgium: Hypoloc

Spain: Silostar

Greece: Hypoloc

Ireland: Nebilet

Italy: Lobivon

Netherlands: Hypoloc

United Kingdom (Northern Ireland): Nebilet

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/