Sibelium 5 mg tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

SIBELIUM 5 mg Tablets

Flunarizine

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

• Keep this leaflet, as 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Sibelium is and what it is used for

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

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

2. What you need to know before taking Sibelium

Do not take Sibelium:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sibelium.

• If you experience a progressive increase in fatigue during treatment, contact your doctor immediately. In such a case, your doctor should discontinue the treatment.
• The treatment may worsen symptoms of depression and movement disorders such as tremor, slow and delayed movements, abnormal involuntary muscle movements, and/or muscle rigidity, especially in elderly patients. If these symptoms occur, contact your doctor immediately.
• If the effect of the medicine decreases, contact your doctor.
• If you take Sibelium continuously for several months, maintain regular contact with your doctor.

Other medicines and Sibelium

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

If you are taking Sibelium, alcohol, hypnotics, and tranquilizers may cause drowsiness and sedation more quickly. You should limit alcohol consumption and only take hypnotics and tranquilizers if prescribed by your doctor.

Taking Sibelium with food, drinks, and alcohol

If you take Sibelium together with alcohol, drowsiness and sedation may occur more quickly.

You should limit the amount of alcohol you consume.

Pregnancy and breastfeeding

Consult 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 using flunarizine during pregnancy.

It is unknown whether Sibelium passes into breast milk.

You must not continue breastfeeding if you are taking Sibelium. Consult your doctor.

Driving and using machines

At the beginning of treatment, Sibelium may cause drowsiness; therefore, you should exercise particular caution when driving or operating machinery.

Sibelium contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Sibelium

Follow exactly the instructions for taking this medicine as given 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 the prophylaxis of migraine and vertigo:

• Starting treatment in adults:

• if you are between 18 and 64 years old, take 2 Sibelium tablets (10 mg of flunarizine) daily before going to bed.

• Starting treatment in elderly patients:

  • if you are 65 years old or older, take 1 Sibelium tablet (5 mg of flunarizine) daily before going to bed.

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

• Continuing treatment in adults and elderly patients: After 1 or 2 months, your doctor will decide whether 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, daily before going to bed) for 5 consecutive days, then stop taking it for 2 consecutive days. Repeat this regimen (5 days on medication followed by 2 days off medication) throughout the duration of treatment.

Your doctor will assess the effectiveness of Sibelium treatment and decide on its continuation. Treatment with Sibelium should not last longer than 6 months. If you stop the treatment and your symptoms reappear, you should consult your doctor, who will decide whether to restart treatment with Sibelium.

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 disturbances, or, with very high doses, agitation or tachycardia.

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

Telephone (91) 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, Sibelium may produce adverse effects, although not everyone will experience them.

The frequency of the possible adverse 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 available data)

Very common adverse effects may include:

• Weight gain.

Common adverse effects may include:

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

Uncommon adverse effects may include:

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

Adverse effects with frequency not known may include:

• Inability to stay still, slow and delayed movements, rigid muscle movements like a cogwheel, difficulty moving, involuntary tremor, a group of symptoms known as extrapyramidal symptoms (EPS), which generally include abnormal involuntary muscle movements; Parkinson's syndrome or disease (a chronic and degenerative disorder affecting the nerves, causing progressive motor impairment "paralysis"), gait disturbance or altered walking pattern, drowsiness, tremor
• Redness or pinkish discoloration of the skin, severe allergic reaction causing swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing, itching
• Muscle rigidity
• Discharge of fluid from the nipples
• Increased liver transaminases

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sibelium

Keep this medicine out of 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 refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sibelium

• The active substance is flunarizine (as hydrochloride). Each tablet contains 5 mg of flunarizine.
• The other components are: monohydrate lactose, corn starch, polyvinylpyrrolidone, microcrystalline cellulose, talc and magnesium stearate.

Appearance of the product and contents of the pack

Sibelium are white, circular, flat, bevelled tablets, with the Sibelium anagram on one side.

Presented in blister packs. Pack sizes: 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 the most recent revision of this leaflet: August 2017

Other sources of information:

Detailed and up-to-date 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/