Sibelium 5mg Tablet (30 Tab)

SIBELIUM 5MG TABLET

SIBELIUM 5MG TABLET is a medication primarily prescribed for the prevention and management of migraine headaches. It works by improving blood flow and dilating blood vessels in the brain, which helps to reduce the frequency and severity of migraine attacks.

Composition

• Active Ingredient: Each tablet contains 5mg of flunarizine, present as flunarizine dihydrochloride.
• Other Ingredients: Lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silica, hypromellose, polysorbate 20, microcrystalline cellulose, and croscarmellose sodium.

Uses SIBELIUM is indicated for:

• Migraine Prophylaxis: Prevention of classic (with aura) or common (without aura) migraine headaches. It is not intended for the treatment of an acute migraine attack.
• Vestibular Disorders: Symptomatic treatment of vestibular vertigo, dizziness, and balance problems, including Meniere's disease.

Dosage and Administration

• Adults (18-64 years): The typical starting dose is two 5mg tablets (10mg) taken once daily in the evening.
• Elderly (65 years and older): The recommended dose is one 5mg tablet daily in the evening.
• General Guidance: Take the tablets orally with water, preferably after a meal to avoid stomach irritation. It is important to take SIBELIUM at the same time each day to maintain consistent drug levels. Do not skip doses or stop treatment abruptly without consulting your doctor.
• Maintenance Treatment: Your doctor may recommend a maintenance schedule, such as taking the medicine for 5 consecutive days each week, followed by 2 medicine-free days. Treatment should be reviewed periodically, and if no significant improvement is observed after a specified duration (e.g., 2 months for migraine), discontinuation may be considered.

Side Effects Common side effects include:

• Drowsiness, fatigue, and lethargy.
• Weight gain and increased appetite.
• Nausea, constipation, stomach discomfort, and heartburn.
• Insomnia or difficulty sleeping.
• Runny or blocked nose, dry mouth, muscle aches, and breast pain. More serious, though less frequent, side effects can include:
• Depression, especially in individuals with a history of depressive illness or in elderly patients.
• Extrapyramidal symptoms such as tremors, muscle stiffness (rigidity), slow movements (bradykinesia), or involuntary muscle movements.

Precautions

• Contraindications: Do not take SIBELIUM if you are allergic to flunarizine or any of its ingredients, have a depressive illness or a history of recurrent depression, or have Parkinson's disease or other extrapyramidal disorders.
• Warnings:
  • Inform your doctor if you experience progressive fatigue, as treatment may need to be adjusted or discontinued.
  • Elderly patients are at a higher risk of developing depressive illness or Parkinson's-like symptoms.
  • Pregnancy and Breastfeeding: SIBELIUM is generally not recommended during pregnancy or breastfeeding. Consult your doctor if you are pregnant, planning to conceive, or breastfeeding.
  • Alcohol and CNS Depressants: Avoid consuming alcohol while on SIBELIUM, as it can increase drowsiness. Concomitant use with hypnotics, tranquilizers, or other CNS depressants may enhance sedative effects.
  • Driving and Machinery: SIBELIUM may cause dizziness or drowsiness, especially at the beginning of treatment. Exercise caution when driving or operating machinery until you know how the medicine affects you.
  • Interactions: Inform your doctor about all other medications you are taking, including antidepressants, antihypertensives, and anti-seizure medications, as interactions may occur.
  • Weight Management: Maintain a healthy and balanced diet to manage potential weight gain.
  • Lactose Intolerance: SIBELIUM contains lactose monohydrate.

Storage

• Store SIBELIUM 5MG TABLET in a cool, dry place, typically below 25°C or 30°C.
• Protect the medicine from direct sunlight, heat, and moisture.
• Keep out of sight and reach of children.
• Always keep the tablets in their original packaging.
• Do not use the medicine beyond its expiry date.

Frequently Asked Questions about Sibelium 5mg Tablet

What is Sibelium 5mg Tablet used for?

Sibelium 5mg Tablet is primarily used for the prevention and management of migraine headaches. It helps reduce the frequency and severity of migraine attacks in adults. Additionally, it is used for the symptomatic treatment of vestibular vertigo, which is dizziness due to a functional disorder of the ear's vestibular system, and can also address other vestibular disorders affecting balance.

How does Sibelium 5mg Tablet work?

Sibelium 5mg Tablet contains flunarizine, which is a selective calcium channel blocker. It works by preventing the narrowing of blood vessels and reducing the excessive influx of calcium into cells. By inhibiting calcium channels, it helps to dilate blood vessels and improve blood flow in the brain, thereby preventing migraine headaches and managing symptoms associated with vestibular disorders.

What is the usual dosage of Sibelium 5mg Tablet?

For adults aged 18 to 64 years, the recommended starting dose is two 5mg tablets (10mg of flunarizine) taken in the evening. For elderly patients aged 65 years and older, the recommended starting dose is one 5mg tablet daily in the evening. It is advised to take Sibelium Tablets after a meal whenever possible to avoid stomach irritation and to swallow them whole with water. Your doctor may also recommend a maintenance schedule of 5 consecutive days of treatment followed by 2 medicine-free days each week.

What are the possible side effects of Sibelium 5mg Tablet?

Common side effects include drowsiness, fatigue, weight gain, increased appetite, nausea, constipation, stomach pain, muscle aches, breast pain, and menstrual problems. Some individuals may also experience a blocked or runny nose, insomnia (difficulty sleeping), and feeling low or depressed. If you experience persistent or concerning side effects, it is important to consult your doctor.

Is Sibelium 5mg Tablet safe during pregnancy or breastfeeding?

Sibelium 5mg Tablet is generally not recommended during pregnancy. It is also not recommended for breastfeeding mothers, as small amounts of the medicine could pass into breast milk. If you are pregnant, planning to become pregnant, or breastfeeding, you should consult your doctor before taking this medicine.

Can Sibelium 5mg Tablet be taken with other medications?

It is important to inform your doctor or pharmacist about all other medicines you are taking, including over-the-counter and herbal products. Sibelium 5mg Tablet can interact with certain medications. For example, taking it with medicines for anxiety or to help you sleep (tranquillizers, sedatives, hypnotics) or alcohol can increase drowsiness. Caution is also advised when taken with medicines for high blood pressure, as your doctor may need to adjust the dosage.

What precautions should be taken while using Sibelium 5mg Tablet?

Inform your doctor if you have a history of depressive illness, Parkinson's disease, or similar movement disorders, as Sibelium is not recommended in these cases and can worsen symptoms. If you experience progressive fatigue during treatment, tell your doctor, as treatment may need to be discontinued or the dose reduced. Since Sibelium can cause drowsiness, especially at the start of treatment, avoid driving or operating machinery until you know how the medicine affects you. This medicine contains lactose, so if you have an intolerance to some sugars, consult your doctor.

What happens if a dose of Sibelium 5mg Tablet is missed?

If you forget to take a dose, do not take the missed dose. Simply wait and take your next dose as usual, then continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.

How should Sibelium 5mg Tablet be stored?

Sibelium 5mg Tablets should be stored below 30°C (or not above 25°C), in a cool and dry place, protected from moisture, direct sunlight, and heat. Keep the medicine out of the sight and reach of children and pets, and always keep the tablets in their original packaging.