Silostar 5 mg tablets

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Silostar is and what it is used for

Silostar contains nebivolol, a cardiovascular agent belonging to the group of selective beta-blockers (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping force. It also exerts a blood vessel-dilating effect, which further contributes to lowering blood pressure.

It is used for the treatment of high blood pressure (hypertension). Silostar is also used for the treatment of mild to moderate chronic heart failure in patients aged 70 years or older, administered in combination with other medicinal products.

2. What you need to know before starting Silostar

Do not take Silostar

• If you are allergic to nebivolol or any of its components (listed in section 6).

• If you have one or more of the following conditions:

• Low blood pressure.

• Severe circulation problems in arms or legs.

• Very slow heart rate (less than 60 beats per minute).

• Other serious heart rhythm disorders such as second- or third-degree atrioventricular block or other cardiac conduction disorders.

• Recently experienced an episode of heart failure or worsening of heart failure, or are receiving intravenous treatment to support heart function after circulatory collapse due to acute heart failure.

• Asthma or breathing difficulties (currently or in the past).

• Phaeochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), which is not being treated.

• Liver function disorders.

• Metabolic disorders characterized by metabolic acidosis (e.g., diabetic ketoacidosis).

Warnings and precautions

Talk to your doctor before starting Silostar

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

• Abnormally slow heart rate.
• A type of chest pain caused by spontaneous spasm of the heart arteries, called Prinzmetal's angina.
• Chronic heart failure without treatment.
• First-degree heart block (a mild cardiac conduction disorder affecting heart rhythm).
• Poor circulation in arms or legs, such as Raynaud’s disease or syndrome, or pain when walking resembling cramps.
• Chronic respiratory problems.
• Diabetes: this medicine has no effect on blood sugar levels, but may mask warning signs of low blood sugar (such as palpitations, rapid heartbeat), and could increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Overactivity of the thyroid gland: this medicine may mask symptoms of this condition, such as abnormally high heart rate.
• Allergies: this medicine may intensify 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 are scheduled for surgery, always inform your anaesthetist that you are taking this medicine.

If you have severe kidney problems, consult your doctor before taking Silostar for treatment of heart failure.

At the beginning of treatment for chronic heart failure, you should 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

Silostar is not recommended for use in children and adolescents due to lack of data on its use in this patient group.

Taking Silostar with other medicines

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

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

• Certain medicines for the heart or blood pressure control (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), phenothiazines (also used for nausea and vomiting), and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medicines used for anaesthesia during surgery.
• Medicines for asthma, nasal decongestants, and some medicines used to treat eye conditions 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 Silostar, may affect blood pressure and heart function.

• Medicines for treating excess stomach acidity or ulcers (antacids): Silostar should be taken with food, and antacids should be taken between meals.

Taking Silostar with food and drink

See section 3.

Pregnancy and breastfeeding

Beta-blockers, including nebivolol, may affect pregnancy and harm the unborn baby. They may reduce blood flow to the placenta, which can lead to slower fetal growth, miscarriage, premature birth, or fetal death during pregnancy. Silostar should not be given during pregnancy unless your doctor considers it necessary.

If you need to take nebivolol during pregnancy, close monitoring is required. After birth, your baby should be monitored for signs of low blood sugar (hypoglycaemia) and slow heart rate (bradycardia), which may occur during the first three days of life.

Mothers receiving Silostar should not breast-feed.

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 this occurs, do not drive or operate machinery.

Silostar contains lactose

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

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

3. How to take Silostar

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist.

Silostar may be taken before, during, or after meals, or it may also be taken independently of meals. It is preferable to take the tablet with some water.

Treatment of high blood pressure (hypertension):

• The usual dose is 1 tablet daily. It is preferable to take the dose at the same time each day.
• In elderly patients and/or those with renal impairment, treatment should be initiated with 1/2 tablet daily.

The therapeutic effect on blood pressure is achieved after 1–2 weeks of treatment. Occasionally, optimal effect may not be reached until 4 weeks.

Treatment of chronic heart failure:

• Your treatment must always be initiated under medical supervision.
• Your doctor will start your treatment with ¼ (one-quarter) of a tablet daily. The dose will then be increased after 1–2 weeks to ½ (one-half) tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily until the optimal dose for you is reached. Your doctor will prescribe the correct dose for you at each stage, and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• The initiation of treatment and each dose increase must be carried out under the supervision of an experienced physician for a period of 2 hours.
• Your doctor may reduce your dose if necessary.
• You must not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems must not take this medicine.
• Take the medicine once daily, preferably at the same time each day.

If your doctor has instructed you to take ¼ (one-quarter) or ½ (one-half) tablet daily, follow the instructions below to split the 5 mg nebivolol tablets, which are cross-scored.

• 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 with the index fingers of both hands placed on either side of one of the scores (Figures 1 and 2).
• Repeat the same procedure to split the half tablet into quarters (Figures 3 and 4).

Figures 1 and 2: Easy splitting of the cross-scored 5 mg nebivolol tablet into halves.

Figures 3 and 4: Easy splitting of the half cross-scored 5 mg nebivolol tablet into quarters.

• Your doctor will decide whether Silostar should be combined 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

The most common symptoms and signs of Silostar overdose are very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), breathing difficulties as in 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 the time you were supposed to take it, take your daily dose as usual. If a long time has passed (several hours), so that it is almost time for your 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 repeatedly forgetting to take your medication.

If treatment with Silostar is interrupted

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

You should not stop the treatment abruptly, as this could temporarily worsen your heart failure. If it becomes necessary to discontinue treatment for chronic heart failure, the daily dose should be gradually reduced by halving the dose at weekly intervals.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When Silostar is used for the treatment of high blood pressure, the possible adverse effects are:

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

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Difficulty breathing / shortness of breath
• Sweating of hands and feet

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

• Slow heart rate or other cardiac disturbances
• Low blood pressure
• Pain when walking resembling cramps
• Abnormal vision
• Sexual impotence
• Feeling of depression
• Difficulty in digestion (dyspepsia), stomach or intestinal gas, vomiting
• Skin rash, itching
• Difficulty breathing as in asthma, due to sudden contraction of the muscles around the airways (bronchospasm)
• Nightmares

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

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

The following adverse 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 lips, eyelids and/or tongue, possibly accompanied by acute breathing difficulty (angioedema)
• Skin rash characterized by raised, itchy, pink welts, due to either allergic or non-allergic causes (urticaria)

In a clinical study for chronic heart failure, the following adverse effects were observed:

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

• Slow heart rate
• Dizziness

Frequent adverse 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 disturbance in cardiac conduction affecting heart rhythm (first-degree atrioventricular block)
• Swelling of the lower limbs (increased ankle volume)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the carton and blister after 'EXP':. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 components are: monohydrate lactose, 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-470b).

Appearance of the product and contents of the pack

Silostar is available as white, round, cross-scored tablets in packs containing 7, 14, 28, 30, 50, 56, 90, 100 and 500 tablets.

The tablets are packed 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 responsible

Berlin-Chemie AG

Glienicker Weg 125 - 12489 Berlin, Germany

or

Menarini-Von Heyden GmbH

Leipziger Strasse 7-13, 01097 – Dresden, Germany

or

Sanico

Veedijk 59, Turnhout, Antwerp, 2300 – Belgium

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Austria: Nomexor

Spain: Silostar

Greece: Hypoloc

Ireland: Nebilet

Italy: Lobivon

Netherlands: Hypoloc

United Kingdom (Northern Ireland): Nebilet

Date of the most recent review of this leaflet: October 2025

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