Sibelium, with the active ingredient flunarizine dihydrochloride, is a selective calcium channel blocker specifically indicated for the prophylaxis of migraine. It represents a cornerstone in preventive neurological therapy, designed to reduce the frequency and severity of migraine attacks in susceptible patients. By modulating vascular smooth muscle and neuronal calcium influx, it addresses the pathophysiological mechanisms believed to underpin migraine, offering a targeted approach to chronic management. This prescription medication is intended for use under strict medical supervision as part of a comprehensive treatment plan.

Features

• Active Ingredient: Flunarizine dihydrochloride
• Pharmacological Class: Selective calcium entry blocker with calmodulin binding properties
• Formulation: Standard oral tablets
• Mechanism of Action: Inhibits calcium influx into vascular smooth muscle cells and neurons
• Half-life: Approximately 18 days, allowing for once-daily dosing
• Bioavailability: High oral absorption, with peak plasma concentrations reached within 2-4 hours

Benefits

• Significantly reduces the frequency of migraine attacks, leading to fewer disrupted days
• Decreases the intensity and duration of migraine episodes when they occur
• May reduce the need for acute migraine abortive medications, minimizing associated side effects and medication-overuse headaches
• Improves overall quality of life by allowing for better daily planning and reduced anxiety about attack occurrence
• Exhibits vasodilatory effects without significant reflex tachycardia, offering a favorable cardiovascular profile
• Provides prophylactic benefits that can be sustained with long-term therapy under medical guidance

Common use

Sibelium (flunarizine) is primarily prescribed for the prophylactic treatment of migraine. It is not intended for the acute relief of a migraine attack already in progress. Its use is considered in patients experiencing frequent or severe migraines (typically defined as four or more migraine days per month) where the impact on quality of life is significant, or where acute medications are ineffective, poorly tolerated, or contraindicated. It may also be considered for patients with certain types of vertigo of vestibular origin, as per a neurologist’s assessment.

Dosage and direction

The dosage must be individualized based on patient response and tolerance. The typical adult starting dose for migraine prophylaxis is 10 mg (one tablet) taken orally in the evening, with or without food. For elderly patients or those with low body weight, a starting dose of 5 mg may be recommended. Clinical response is usually evaluated after one month of therapy. If satisfactory control is achieved with good tolerance, treatment may be continued for several months. The duration of therapy should be reassessed periodically by the treating physician, and attempts to withdraw treatment should be made every 6 months. Do not crush or chew the tablet; swallow it whole with a glass of water.

Precautions

Patients should be closely monitored, especially at the beginning of treatment. Sibelium can cause drowsiness and somnolence, which may impair the ability to drive or operate machinery; patients should be cautioned until their individual response is known. It may also cause weight gain and/or depression in some individuals, necessitating regular weight checks and mood assessment. Use with caution in patients with a history of depressive illness, Parkinson’s disease, or extrapyramidal disorders. Liver function tests are advisable during prolonged therapy. It is not recommended for use during pregnancy or breastfeeding unless clearly necessary and under direct medical supervision.

Contraindications

Sibelium is contraindicated in patients with known hypersensitivity to flunarizine dihydrochloride or any of the tablet’s excipients. Its use is also contraindicated in patients with a history of depressive illness, especially with suicidal ideation, or pre-existing symptoms of Parkinson’s disease. It should not be used in patients with severe liver impairment (Child-Pugh Class C). Concomitant use with other drugs that cause significant CNS depression or extrapyramidal symptoms is generally contraindicated.

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, fatigue, weight gain, and nausea. Uncommon side effects (may affect up to 1 in 100 people) include depression, muscle stiffness (extrapyramidal symptoms such as tremor, akathisia), dry mouth, and gastrointestinal disturbances. Rare side effects (may affect up to 1 in 1,000 people) include skin reactions like rash or pruritus, galactorrhea, and increased appetite. Any sudden changes in mood or the emergence of suicidal thoughts require immediate medical attention.

Drug interaction

Sibelium can potentiate the effects of other CNS depressants, including alcohol, barbiturates, opioids, tranquilizers, and sedative antihistamines, leading to increased sedation. Concomitant use with other drugs that cause extrapyramidal symptoms (e.g., antipsychotics, metoclopramide) may increase the risk of such effects. It may interact with antihypertensive drugs, potentially enhancing their blood pressure-lowering effect. Caution is advised when administering with drugs that inhibit liver enzymes (e.g., cimetidine), as this may increase flunarizine plasma concentrations. Always inform your physician of all medications you are taking, including over-the-counter drugs and herbal supplements.

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, skip the missed dose and resume the usual dosing schedule. Do not take a double dose to make up for a forgotten one. Maintaining a consistent daily schedule is important for therapeutic efficacy.

Overdose

Symptoms of overdose are primarily related to extensions of its pharmacological effects and may include severe drowsiness, profound sedation, coma, hypotension, bradycardia, and extrapyramidal symptoms. In case of suspected overdose, seek immediate medical attention or contact a Poison Control Center. Treatment is supportive and symptomatic; there is no specific antidote. Gastric lavage may be considered if presented early. Vital signs and ECG should be monitored closely.

Storage

Store in the original package below 25°C (77°F) to protect from light and moisture. Keep the container tightly closed. Do not use after the expiration date printed on the blister and carton. Keep all medicines out of the sight and reach of children. Do not dispose of medications via wastewater or household waste; return any unused product to a pharmacy for proper disposal.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. It 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 product’s Summary of Product Characteristics and may not be exhaustive.

Reviews

“After struggling with chronic migraines for over a decade and trying numerous preventatives, Sibelium has been a game-changer. The reduction in frequency from weekly attacks to maybe one a month has given me my life back. The initial drowsiness was noticeable but subsided after a few weeks.” — Verified Patient, 42

“Prescribed Sibelium for vestibular migraine and vertigo. The difference in stability and reduction in vertigo episodes has been significant. Requires careful monitoring for mood changes, but under neurologist supervision, it’s been very effective.” — Verified Patient, 38

“As a neurologist, I find Sibelium to be a valuable tool in the prophylactic arsenal, particularly for patients who have not responded to beta-blockers. Its long half-life supports adherence. Monitoring for weight gain and depressive symptoms is a key part of the management protocol.” — Dr. A. Sharma, Neurologist