Label: information for the user

SIBELIUM 5 mg tablets

Flunarizine

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Sibelium and what is it used for

2. What you need to know before starting to take Sibelium

3. How to take Sibelium

4. Possible adverse effects

5. Storage of Sibelium

6. Contents of the pack and additional information

Sibelium contains flunarizine, and belongs to a group of medications 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 alleviate symptoms of vestibular vertigo (when due to alterations of the vestibular system of the ear) in adults.

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

Consult your doctor or pharmacist before starting to take Sibelium.

• If you experience progressive fatigue during treatment, contact your doctor immediately. In this case, your doctor will need to suspend treatment.
• Treatment may increase symptoms of depression and movement disorders such as tremor, slow movements, and involuntary abnormal muscle movements and/or muscle rigidity, especially in elderly patients. If these symptoms appear, contact your doctor immediately.
• If the medication's effect decreases, contact your doctor.
• If you take Sibelium for several months in a row, stay in contact with your doctor.

Other medications and Sibelium

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

Taking Sibelium with food, drinks, and alcohol

If you take Sibelium with alcohol, drowsiness and drowsiness may appear more quickly.

You should limit the amount of alcohol you consume.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There are no data on the use of flunarizine in pregnant women. As a precaution, it is recommended to avoid using flunarizine during pregnancy.

It is unknown whether Sibelium passes into breast milk.

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

Driving and operating machinery

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

Sibelium contains Lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will tell you for 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:

• If you are between 18 and 64 years old, take 2 Sibelium tablets (10 mg of flunarizine) per day before going to sleep.

• Start of treatment in elderly patients:
• • If you are 65 years old or more, take 1 Sibelium tablet (5 mg of flunarizine) per day before going to sleep.

You may experience some benefits within the first month, but you might need another month before feeling the full effect of the medication.

• 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 follows:

• Take the same dose you were taking (1 or 2 Sibelium tablets, that is, 5 or 10 mg of flunarizine, per day before going to sleep) for 5 consecutive days, and stop taking them for 2 consecutive days. Repeat this schedule (5 days with medication followed by 2 days without medication) while the treatment lasts.

Your doctor will evaluate the effectiveness of Sibelium treatment and decide on its maintenance. A Sibelium treatment lasts a maximum of 6 months. If you interrupt treatment but your symptoms reappear, you should consult your doctor, who will decide whether to start treatment with Sibelium again.

Like all medicines, Sibelium can cause side effects, although not everyone will experience them.

The frequency of 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 available data)

The very common side effects may include:

• Weight gain.

The common side 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

The uncommon side effects may include:

• Allergic reaction
• Depression symptoms, difficulty falling asleep, feeling indifferent, 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 muscle contractions of the neck (torticollis), weakness
• Perception of heartbeats (palpitations)
• Low blood pressure (hypotension), redness
• Intestinal obstruction, dry mouth, digestive system alterations, indigestion and vomiting
• Excessive sweating, urticaria, skin rash
• Muscle cramps, muscle contractions
• Heavy and prolonged menstrual flow, menstrual irregularities (irregular or absent periods), infrequent or light 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, complete weakness or lack of energy (asthenia)

The side effects of unknown frequency may include:

• Inability to remain still, slow and delayed movements, rigid muscle movements like a cogwheel, difficulty moving, involuntary tremor, a group of symptoms known as extrapyramidal symptoms (EPS) that generally include abnormal involuntary muscle movements; Parkinson's disease (a chronic and degenerative disease that affects the nerves and causes progressive inability to move), alteration in gait or way of walking, feeling of sleep, tremor
• Redness or pink color of the skin, severe allergic reaction that causes swelling in the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, itching
• Muscle stiffness

• Fluid secretion from the nipples
• Increased liver transaminases

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store above 25 °C.

Do not use Sibelium after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sibelium

- The active ingredient is flunarizine (in the form of hydrochloride). Each tablet contains 5 mg of flunarizine.

- The other components are: lactose monohydrate, cornstarch, polyvinylpyrrolidone, microcrystalline cellulose, talc, and magnesium stearate.

Appearance of the product and contents of the packaging

Sibelium are white, circular, flat, bisected tablets with the Sibelium logo on one face.

It is presented in a blister pack. Packaging with 30 and 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

c/ de San Martí, 75-97

08107 Martorelles (Barcelona)

Last review date of this leaflet: August 2017

Other sources of information:

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