SIBELIUM 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

SIBELIUM 5 mg tablets

Flunarizine

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Sibelium and what is it used for

Sibelium contains flunarizine and belongs to a group of medicines called calcium channel blockers. It acts as a selective blocker of calcium entry into the cell.

It is indicated for the prevention of migraine and to relieve the symptoms of vestibular vertigo (when it is due to alterations of the vestibular system of the ear) in adults.

2. What you need to know before you take Sibelium

Do not take Sibelium:

• if you are allergic to flunarizine or any of the other ingredients of Sibelium (listed in section 6.1).
• if you currently have symptoms of depression or have had them in the past.
• if you already have symptoms of Parkinson's disease or other extrapyramidal disorders (movement or coordination disorders).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Sibelium.

• If you experience progressive fatigue during treatment, contact your doctor immediately. In this case, your doctor should stop the treatment.
• Treatment may increase symptoms of depression and movement disorders such as tremors, slow and delayed movements, abnormal involuntary muscle movements, and/or muscle stiffness, especially in elderly patients. If these symptoms appear, contact your doctor immediately.
• If the effect of the medicine decreases, contact your doctor.
• If you take Sibelium for several months in a row, stay in touch with your doctor.

Other medicines and Sibelium

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought without a prescription.

If you are taking Sibelium, alcohol, hypnotics, and tranquilizers may cause you to become drowsy and sleepy more quickly. You should limit your alcohol intake and only take hypnotics and tranquilizers if your doctor prescribes them.

Taking Sibelium with food, drinks, and alcohol

If you take Sibelium with alcohol, you may become drowsy and sleepy more quickly.

You should limit the amount of alcohol you drink.

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before using any medicine.

There are no data on the use of flunarizine in pregnant women. As a precautionary measure, it is preferable to avoid the use of flunarizine during pregnancy.

It is not known whether Sibelium passes into breast milk.

You should not continue breastfeeding if you take Sibelium. Consult your doctor.

Driving and using machines

At the beginning of treatment, Sibelium may cause drowsiness, so you should be especially careful when driving or using machinery.

Sibelium contains lactose

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

3. How to take Sibelium

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how long you need to take Sibelium.

Swallow the tablets with a little water.

Never take more tablets than you need.

Recommended dose for migraine and vertigo prophylaxis:

• Start of treatment in adults:

• Start of treatment in elderly patients:

You will probably experience some benefits within the first month, but you may need another month before you feel the full effect of the medicine.

• Continuation of treatment in adults and elderly patients: After 1 or 2 months, your doctor will tell you if you need to continue treatment with Sibelium.

The dose will be as described below:

• Take the same dose you have been taking (1 or 2 Sibelium tablets, i.e., 5 or 10 mg of flunarizine, per day before going to bed) for 5 consecutive days, and then stop taking them for 2 consecutive days. Repeat this pattern (5 days with medicine followed by 2 days without medicine) for the duration of the treatment.

Your doctor will assess the effectiveness of the treatment with Sibelium and decide whether to maintain it. Treatment with Sibelium should not last more than 6 months. If you interrupt it but your symptoms reappear, you should consult your doctor, who will decide whether you should start treatment with Sibelium again.

If you take more Sibelium than you should

Contact your doctor if you have taken too much Sibelium. You may experience sedation, fatigue, movement or coordination disorders, or, with very high amounts, agitation or tachycardia.

In case of overdose or accidental ingestion, consult the Toxicology Information Service.

Phone (91) 562 04 20 indicating the medicine and the amount ingested.

4. Possible side effects

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

The frequency of the possible side effects listed below is defined using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

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

Frequency not known (cannot be estimated from the available data)

Very commonside effects may include:

• Weight gain.

Commonside effects may include:

• Itching, nasal congestion, or runny nose.
• Increased appetite
• Depression, difficulty sleeping or staying asleep
• Drowsiness
• Constipation, stomach discomfort, nausea.
• Muscle pain
• Irregular menstrual periods, breast pain
• Fatigue

Uncommonside effects may include:

• Allergic reaction
• Symptoms of depression, difficulty falling asleep, feeling of indifference, anxiety
• Abnormal muscle movements, disorientation, weakness or unusual calmness, abnormal sensation of tingling in arms and legs, restlessness or concern, ringing in the ears, involuntary and prolonged contraction of the neck muscles (torticollis), weakness
• Perception of heartbeat (palpitations)
• Low blood pressure (hypotension), flushing
• Intestinal obstruction, dry mouth, digestive disorders, indigestion, and vomiting
• Excessive sweating, hives, skin rash
• Muscle cramps, muscle contractions
• Heavy and prolonged menstrual flow, menstrual disorders (irregular or absent periods), scarce or infrequent menstruation, breast enlargement, loss of sexual desire
• Swelling due to fluid accumulation in tissues, in legs and feet or in other parts of the body, feeling of complete weakness or lack of energy (asthenia)

Side effects of unknown frequencymay include:

• Inability to remain still, slow and delayed movements, stiff muscle movement like a cogwheel, difficulty moving, involuntary tremorous movement, a set of symptoms known as extrapyramidal symptoms (EPS) that usually include abnormal involuntary muscle movements; Parkinson's disease (a chronic and degenerative disease that affects the nerves and causes progressive movement disability), gait disturbance or abnormal gait, feeling of sleep, tremor
• Redness or pink coloration of the skin, severe allergic reaction that causes swelling in the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing, itching
• Muscle stiffness

• Fluid secretion from the nipples
• Increased liver transaminases

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sibelium

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

Do not store above 25°C.

Do not use Sibelium after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, 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 further information

Composition of Sibelium

• The active substance is flunarizine (in the form of hydrochloride). Each tablet contains 5 mg of flunarizine.
• The other ingredients are: lactose monohydrate, cornstarch, povidone, microcrystalline cellulose, talc, and magnesium stearate.

Appearance of the product and pack contents

Sibelium are white, circular, flat, beveled tablets with the Sibelium anagram on one face.

They come in blister packs. Packs of 30 and 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

c/ de San Martí, 75-97

08107 Martorelles (Barcelona)

Date of last revision of this package leaflet: August 2017

Other sources of information:

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