Sibelium

Sibelium, with the active ingredient flunarizine dihydrochloride, is a calcium channel blocker specifically indicated for the prophylaxis of migraine. It is not intended for the acute treatment of a migraine attack. This prescription medication works by stabilizing vascular tone and modulating neuronal calcium influx, which are key pathways implicated in the pathophysiology of migraine. Its targeted mechanism offers a preventive therapeutic option for patients suffering from frequent and debilitating migraine episodes, aiming to reduce the frequency, severity, and duration of attacks, thereby improving overall quality of life and functional capacity.

Features

• Active Ingredient: Flunarizine dihydrochloride
• Pharmacological Class: Selective calcium channel blocker with additional histamine (H1) blocking properties
• Standard Tablet Strength: 5 mg
• Administration: Oral
• Mechanism of Action: Inhibits calcium influx into vascular smooth muscle cells and neurons; also exhibits dopamine antagonism and calmodulin binding properties

Benefits

• Proven Reduction in Migraine Frequency: Clinical studies demonstrate a significant decrease in the number of monthly migraine attacks.
• Decreased Attack Severity: Helps lessen the pain intensity and associated symptoms of migraines, such as photophobia and phonophobia.
• Improved Functional Capacity: By preventing attacks, patients can experience fewer disruptions to daily activities, work, and social engagements.
• Potential Mood-Stabilizing Effect: Its dopaminergic activity may offer ancillary benefits for certain patients, though this is not a primary indication.
• Convenient Once-Daily Dosing: Supports patient adherence to the prescribed prophylactic regimen.

Common use

Sibelium (flunarizine) is primarily prescribed for the prophylactic (preventive) management of migraine headaches in patients who experience frequent and severe attacks. It is not effective for aborting an acute migraine episode once it has begun. Its use is considered when non-pharmacological strategies and other first-line preventatives are ineffective, poorly tolerated, or contraindicated. It may also be utilized off-label in some regions for the management of vertigo of peripheral origin, such as in Ménière’s disease, due to its vasoactive properties.

Dosage and direction

The dosage must be individualized by a physician based on patient response and tolerability. The typical adult starting dose for migraine prophylaxis is 10 mg (two 5 mg tablets) once daily, taken in the evening with food to minimize potential drowsiness. For elderly patients, a lower starting dose of 5 mg daily is often recommended. After an initial period (e.g., one month), the physician may adjust the maintenance dose based on therapeutic efficacy. The maintenance dose is typically 5 mg to 10 mg per day. Treatment duration is determined by the treating physician and should be periodically re-evaluated. The medication should be taken at the same time each day to maintain a consistent level in the bloodstream.

Precautions

• Extrapyramidal Symptoms: Flunarizine can rarely induce or exacerbate parkinsonian symptoms (tremor, rigidity, akinesia) or other extrapyramidal effects, particularly in the elderly. Patients should be monitored closely.
• Drowsiness and Sedation: This drug commonly causes drowsiness, which may impair mental and/or physical abilities required for hazardous tasks like driving or operating machinery. Patients should be cautioned accordingly.
• Weight Gain: A moderate increase in body weight has been frequently observed during long-term therapy. Dietary monitoring is advised.
• Depression: There have been reports of depression associated with flunarizine use. Patients with a history of depressive illness should be closely supervised.
• Use in Specific Populations: Use with caution in patients with liver impairment, as the drug is extensively metabolized by the liver. Caution is also advised in patients with hypotension.
• Pregnancy and Lactation: The safety of flunarizine during pregnancy and breastfeeding has not been established. Use is only recommended if the potential benefit justifies the potential risk to the fetus or infant.

Contraindications

Sibelium is contraindicated in patients with:

• Known hypersensitivity to flunarizine dihydrochloride, other piperazine derivatives, or any component of the formulation.
• History of depressive illness, or currently active depression.
• Pre-existing extrapyramidal disorders, such as Parkinson’s disease.
• Severe liver impairment.

Possible side effect

Like all medicines, Sibelium can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people) include:

• Drowsiness, sedation, tiredness
• Weight gain
• Dry mouth
• Nausea Uncommon side effects (may affect up to 1 in 100 people) include:
• Depression
• Insomnia, agitation
• Gastric pain
• Muscle aches Rare side effects (may affect up to 1 in 1,000 people) include:
• Extrapyramidal symptoms (e.g., tremor, rigidity, akathisia)
• Galactorrhea (inappropriate milk secretion)
• Skin reactions (e.g., rash)

Drug interaction

Flunarizine may interact with other medications. Patients should inform their doctor of all medicines they are taking, including prescription, over-the-counter, and herbal products.

• CNS Depressants: Concomitant use with alcohol, hypnotics, sedatives, anxiolytics (e.g., benzodiazepines), or neuroleptics may potentiate sedative effects.
• Antihypertensives: May potentiate the blood pressure-lowering effects of other antihypertensive drugs, potentially leading to hypotension.
• Drugs that Prolong QT Interval: Concurrent use with other agents known to prolong the QT interval (e.g., certain antiarrhythmics, antidepressants, antimicrobials) should be approached with caution due to a theoretical increased risk of arrhythmia.
• Dopamine Agonists/Antagonists: Its dopamine antagonist activity may interfere with drugs acting on the dopaminergic system (e.g., levodopa, antipsychotics).

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If it is nearly time for the next scheduled dose, the missed dose should be skipped. A double dose should not be taken to make up for a forgotten dose. Patients should resume their regular dosing schedule the following day.

Overdose

Symptoms of overdose are primarily an extension of the drug’s known pharmacological effects and may include severe drowsiness, sedation, coma, hypotension, bradycardia (slow heart rate), and agitation. In case of suspected overdose, immediate medical attention should be sought. Management is supportive and symptomatic, including gastric lavage if ingestion was recent, activated charcoal, and monitoring of vital signs. There is no specific antidote for flunarizine overdose.

Storage

• Store below 30°C (86°F).
• Keep the blister strips in the outer carton to protect from light and moisture.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
• Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the typical properties of the drug and may not cover all possible uses, directions, precautions, interactions, or adverse effects.

Reviews

• “After six months on Sibelium, my chronic migraines have reduced from weekly to maybe one mild one a month. The drowsiness was significant at first but subsided after a few weeks. Life-changing.” – Patient A, 42
• “Effective for prevention, but the weight gain side effect has been a real struggle for me. Working with my doctor to manage diet and exercise alongside the medication.” – Patient B, 35
• “Prescribed for vestibular migraine and vertigo. It has provided remarkable stability and drastically reduced my episodes of dizziness. I take it in the evening to sleep through the drowsiness.” – Patient C, 58
• “I had to discontinue use due to experiencing symptoms of depression and significant lethargy, which I did not have prior to starting the medication. It’s important to be aware of this potential side effect.” – Patient D, 29