{"id":57098,"date":"2024-02-27T17:24:07","date_gmt":"2024-02-27T17:24:07","guid":{"rendered":"https:\/\/medsname.com\/sibelium\/"},"modified":"2026-05-01T10:49:13","modified_gmt":"2026-05-01T10:49:13","slug":"sibelium","status":"publish","type":"product","link":"https:\/\/medsbase.com\/cs\/product\/sibelium\/","title":{"rendered":"Sibelium"},"content":{"rendered":"<p><!-- medsbase-tldr-answer --><\/p>\n<div style=\"background:#fff8e1;border-left:4px solid #f5a623;padding:18px 22px;margin:0 0 24px 0;border-radius:4px;\">\n<h3 class=\"wp-block-heading\" style=\"margin:0 0 8px 0;font-size:16px;font-weight:700;\">&#9889; Quick Answer &mdash; What is Sibelium?<\/h3>\n<p style=\"margin:0;\"><strong>Sibelium<\/strong> obsahuje <strong>flunarizine 5 mg \/ 10 mg<\/strong> tablets from Janssen Pharmaceuticals &mdash; a <strong>selective calcium-channel blocker with antihistaminic and anti-dopaminergic activity<\/strong>, pou\u017e\u00edv\u00e1 se jako <strong>first-line preventive for episodic and chronic migraine<\/strong> in Europe, Asia, and South America (not FDA-approved in the US). Standard dose: <strong>10 mg nightly for adults, 5 mg nightly for patients &lt;40 kg or &gt;65 years<\/strong>. Full effect at 6-8 weeks. Reduces migraine frequency by 50-70% in responders &mdash; one of the most effective oral migraine preventives in head-to-head trials, matched only by topiramate. Particularly useful for: childhood and adolescent migraine (&ge;5 years), vertiginous \/ vestibular migraine, hemiplegic migraine, and cyclic vomiting syndrome. Main side effects: <strong>weight gain (in ~15%)<\/strong>, sedation, and &mdash; with long-term use &mdash; <strong>drug-induced parkinsonism and depression<\/strong> (dopaminergic blockade). Maximum recommended continuous duration <strong>6 m\u011bs\u00edc\u016f<\/strong>, with a planned washout.<\/p>\n<\/div>\n<div class=\"medsbase-trust-strip\" style=\"background:#f4f8fb;border:1px solid #d8e3eb;padding:12px 16px;margin:16px 0;border-radius:4px;font-size:14px;\">\n<strong>Co z\u00edsk\u00e1te s MedsBase:<\/strong> V\u00fdrobce certifikovan\u00fd WHO-GMP \u00b7 Diskr\u00e9tn\u00ed balen\u00ed \u00b7 Celosv\u011btov\u00e1 doprava \u00b7 V\u00edce ne\u017e 1 400 ov\u011b\u0159en\u00fdch <a href=\"https:\/\/medsbase.com\/cs\/reviews\/\">recenz\u00ed z\u00e1kazn\u00edk\u016f<\/a>\n<\/div>\n<h2 class=\"wp-block-heading\">What Is Sibelium?<\/h2>\n<p>Sibelium is an oral tablet of <strong>flunarizine 5 mg \/ 10 mg<\/strong> from Janssen Pharmaceuticals, supplied in 30-180 tablet packs. Flunarizine is a piperazine-derivative selective calcium-channel blocker with additional antihistaminic (H<sub>1<\/sub>) and weak anti-dopaminergic (D<sub>2<\/sub>) activity. It has been widely used in Europe since the 1980s as <strong>Sibelium<\/strong> (original Janssen brand) for migraine prophylaxis and vestibular disorders. Not FDA-approved in the US &mdash; hence unfamiliar to many US-trained physicians despite being first-line in European, Asian, and Latin American headache guidelines.<\/p>\n<h2 class=\"wp-block-heading\">How Flunarizine Prevents Migraine<\/h2>\n<p>Flunarizine&#8217;s migraine efficacy is thought to involve four mechanisms:<\/p>\n<ul>\n<li><strong>Selective calcium-channel blockade<\/strong> &mdash; reduces intracellular calcium overload in vulnerable neurons; inhibits cortical spreading depression (the pathophysiological substrate of migraine aura)<\/li>\n<li><strong>Vasomotor stabilisation<\/strong> &mdash; reduces both vasodilation and vasospasm of cranial arteries<\/li>\n<li><strong>Antihistaminic effect (H<sub>1<\/sub>)<\/strong> &mdash; explains the sedation and antivertigo action<\/li>\n<li><strong>Weak D<sub>2<\/sub> dopamine-receptor antagonism<\/strong> &mdash; explains both the efficacy in migraine (where dopamine dysregulation is implicated) and the long-term parkinsonism \/ depression side effects<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\">Schv\u00e1len\u00e9 a v\u011bdecky podlo\u017een\u00e9 indikace<\/h2>\n<ul>\n<li><strong>Migraine prophylaxis in adults<\/strong> &mdash; reduces monthly migraine days by 50-70% (several randomised trials; meta-analysis NNT ~3)<\/li>\n<li><strong>Paediatric migraine prophylaxis<\/strong> (children 5+, adolescents) &mdash; particularly effective; often the first-line preventive in European paediatric neurology<\/li>\n<li><strong>Hemiplegic migraine prophylaxis<\/strong> (familial and sporadic)<\/li>\n<li><strong>Vestibular migraine<\/strong> &mdash; useful for both migraine and vertigo components<\/li>\n<li><strong>M\u00e9ni\u00e8rova choroba<\/strong> &mdash; vertigo reduction<\/li>\n<li><strong>Cyclic vomiting syndrome<\/strong> u d\u011bt\u00ed<\/li>\n<li><strong>Perifern\u00ed vestibul\u00e1rn\u00ed vertigo<\/strong> (non-migraine)<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\">Sibelium Dosage<\/h2>\n<ul>\n<li><strong>Adults (&lt;65 years, &gt;40 kg):<\/strong> 10 mg orally at bedtime<\/li>\n<li><strong>Adults &gt;65 years or &lt;40 kg body weight:<\/strong> 5 mg at bedtime<\/li>\n<li><strong>Children 5+ (off-label in some countries):<\/strong> 5 mg at bedtime<\/li>\n<li>Take at night &mdash; flunarizine is sedating, which helps sleep onset and reduces daytime drowsiness<\/li>\n<li>U\u017e\u00edvejte s j\u00eddlem nebo nala\u010dno<\/li>\n<li>Vyhodno\u0165te \u00fa\u010dinek po <strong>6-8 weeks<\/strong><\/li>\n<li><strong>Maximum continuous course: 6 months<\/strong>, then a planned washout of 1-3 months. Restart if migraines recur.<\/li>\n<\/ul>\n<p><strong>Why the 6-month limit?<\/strong> Flunarizine&#8217;s weak dopamine-receptor antagonism is cumulative. With &gt;6 months of continuous use, the risk of drug-induced extrapyramidal side effects (parkinsonian tremor, bradykinesia, akathisia) rises, particularly in older patients. Planned washouts of 1-3 months allow dopaminergic receptor recovery.<\/p>\n<h2 class=\"wp-block-heading\">Vedlej\u0161\u00ed \u00fa\u010dinky<\/h2>\n<p><strong>Velmi \u010dast\u00e9 (&gt;10 %):<\/strong><\/p>\n<ul>\n<li><strong>P\u0159ib\u00fdv\u00e1n\u00ed na v\u00e1ze<\/strong> (~15% of users; up to 5-10 kg over 6 months; mechanism: increased appetite via H<sub>1<\/sub> )<\/li>\n<li>Drowsiness, sedation (take at night; partially adapts over 2-4 weeks)<\/li>\n<li>Zv\u00fd\u0161en\u00e1 chu\u0165 k j\u00eddlu<\/li>\n<\/ul>\n<p><strong>B\u011b\u017en\u00e9 (1-10 %):<\/strong><\/p>\n<ul>\n<li>Mild depression, low mood (dopaminergic effect; more common in patients with history of depression)<\/li>\n<li>Lethargy, asthenia<\/li>\n<li>Gastric upset, dry mouth<\/li>\n<li>Galactorrhoea, hyperprolactinaemia (dopaminergic effect)<\/li>\n<li>Menstrual irregularities in women<\/li>\n<\/ul>\n<p><strong>Important long-term (months to years of continuous use):<\/strong><\/p>\n<ul>\n<li><strong>L\u00e9ky indukovan\u00fd parkinsonismus<\/strong> &mdash; tremor, rigidity, bradykinesia. Usually reversible within months of stopping. Risk rises steeply with continuous use &gt;6 months, particularly in elderly patients. This is why the 6-month cap exists.<\/li>\n<li><strong>Drug-induced depression<\/strong> &mdash; can be severe; mechanism dopaminergic. Most common in patients with a prior depression history.<\/li>\n<li><strong>Tardive dyskinesia<\/strong> &mdash; rare; involuntary movements of face, tongue, or limbs; can be irreversible even after stopping. Uncommon at 6-month durations.<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\">Kontraindikace<\/h2>\n<ul>\n<li>Current or history of depression<\/li>\n<li>Parkinson&#8217;s disease or other extrapyramidal disorder<\/li>\n<li>Hypersensitivity to flunarizine or piperazines<\/li>\n<li>Pregnancy and breastfeeding (insufficient safety data; dopaminergic drugs not recommended)<\/li>\n<li>T\u011b\u017ek\u00e9 jatern\u00ed po\u0161kozen\u00ed<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\">Interakce s l\u00e9\u010divy<\/h2>\n<ul>\n<li><strong>Alcohol, benzodiazepines, opioids, sedating antihistamines<\/strong> \u2014 kumulativn\u00ed \u00fatlum CNS<\/li>\n<li><strong>Antipsychotika<\/strong> &mdash; additive dopamine blockade; avoid combination (extrapyramidal risk)<\/li>\n<li><strong>Metoklopramid, prochlorperazin<\/strong> &mdash; dopaminergic; avoid prolonged co-use<\/li>\n<li><strong>Beta-blok\u00e1tory<\/strong> &mdash; generally well-tolerated; can combine with <a href=\"https:\/\/medsbase.com\/cs\/inderal\/\">propranolol<\/a> for migraineurs needing combined prevention<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\">Skladov\u00e1n\u00ed<\/h2>\n<p>Skladujte p\u0159i teplot\u011b do 25\u00b0C. Uchov\u00e1vejte mimo dosah d\u011bt\u00ed.<\/p>\n<h2 id=\"faqs\">\u010casto kladen\u00e9 dotazy<\/h2>\n<h3 class=\"wp-block-heading\">How long until Sibelium starts working?<\/h3>\n<p>6-8 weeks at target dose. Reductions of 50-70% in monthly migraine days are typical in responders. If no response at 8 weeks on 10 mg, switch agent (<a href=\"https:\/\/medsbase.com\/cs\/topicon\/\">topiram\u00e1t<\/a>, <a href=\"https:\/\/medsbase.com\/cs\/inderal\/\">propranolol<\/a>, amitriptyline).<\/p>\n<h3 class=\"wp-block-heading\">Why only 6 months of continuous use?<\/h3>\n<p>Flunarizine weakly blocks dopamine receptors. With continuous use beyond 6 months, the risk of drug-induced parkinsonism (tremor, rigidity, slowness) and depression rises. A planned washout of 1-3 months every 6 months allows dopaminergic recovery. If migraines remain controlled after a washout, you may not need to restart; if they recur, restart with a new 6-month course.<\/p>\n<h3 class=\"wp-block-heading\">Will Sibelium make me gain weight?<\/h3>\n<p>Yes for about 15% of users &mdash; up to 5-10 kg over 6 months. Mechanism: antihistaminic appetite increase. If weight gain is concerning, <a href=\"https:\/\/medsbase.com\/cs\/topicon\/\">topiram\u00e1t<\/a> (causes weight loss) or <a href=\"https:\/\/medsbase.com\/cs\/inderal\/\">propranolol<\/a> (weight-neutral) are alternatives.<\/p>\n<h3 class=\"wp-block-heading\">Can I take Sibelium in pregnancy?<\/h3>\n<p>No &mdash; insufficient safety data and dopaminergic drugs are generally avoided in pregnancy. For pregnant migraineurs, <a href=\"https:\/\/medsbase.com\/cs\/inderal\/\">propranolol<\/a> is the preferred preventive; amitriptyline is a second option.<\/p>\n<h3 class=\"wp-block-heading\">Is Sibelium safe for children?<\/h3>\n<p>Yes &mdash; flunarizine is one of the preferred migraine preventives in European paediatric neurology (age 5+), typically 5 mg at bedtime. Paediatric trials have shown similar efficacy to adult data. Same 6-month course limit applies.<\/p>\n<h3 class=\"wp-block-heading\">Can Sibelium treat vertigo?<\/h3>\n<p>Yes &mdash; flunarizine is licensed for vestibular vertigo (M&eacute;ni&egrave;re&#8217;s, peripheral vertigo, vestibular migraine). The antihistaminic and calcium-channel-blocking actions reduce vestibular excitability. Dose is the same as for migraine.<\/p>\n<h3 class=\"wp-block-heading\">Why isn&#8217;t Sibelium available in the US?<\/h3>\n<p>Janssen never pursued FDA approval. It is widely available in Europe, Asia, Latin America, and Canada as a first-line migraine preventive. US patients sometimes access it via international pharmacies.<\/p>\n<h3 class=\"wp-block-heading\">Where can I buy Sibelium online?<\/h3>\n<p>You can buy Sibelium (flunarizine 5 mg \/ 10 mg, 30-180 tablet packs) from MedsBase with discreet packaging and worldwide shipping.<\/p>\n<h2 class=\"wp-block-heading\">Souvisej\u00edc\u00ed l\u00e9\u010dba migr\u00e9ny na MedsBase<\/h2>\n<ul>\n<li><a href=\"https:\/\/medsbase.com\/cs\/zolmist-nasal-spray\/\">Zolmist nosn\u00ed sprej \u2014 Zolmitriptan 5 mg (rychlej\u0161\u00ed n\u00e1stup \u00fa\u010dinku)<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/zolitas-ods\/\">Zolitas ODS \u2014 Zolmitriptan 2,5\/5 mg orodispergovateln\u00e9 tablety<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/maxtan\/\">Maxtan \u2014 Rizatriptan 5\/10 mg<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/rizatop\/\">Rizatop \u2014 Rizatriptan 10 mg<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/rizact\/\">Rizact \u2014 Rizatriptan (Cipla)<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/sumitop\/\">Sumitop \u2014 Sumatriptan 25\/50\/100 mg<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/anti-migraine\/\"><strong>Prohl\u00e9dnout v\u0161echny l\u00e9ky proti migr\u00e9n\u011b<\/strong><\/a><\/li>\n<\/ul>\n<div style=\"background:#fff3f3;border-left:4px solid #d9534f;padding:16px 20px;margin:24px 0;border-radius:4px;\"><strong>\u2695 L\u00e9ka\u0159sk\u00e9 upozorn\u011bn\u00ed.<\/strong> Tato str\u00e1nka slou\u017e\u00ed pouze pro informa\u010dn\u00ed \u00fa\u010dely a nenahrazuje odbornou l\u00e9ka\u0159skou pomoc. P\u0159ed zah\u00e1jen\u00edm, zm\u011bnou nebo ukon\u010den\u00edm jak\u00e9hokoli l\u00e9\u010den\u00ed migr\u00e9ny se v\u017edy pora\u010fte se sv\u00fdm l\u00e9ka\u0159em.<\/div>\n<h3>Pro\u010d objedn\u00e1vat z MedsBase<\/h3>\n<p class=\"medsbase-reship-line\" style=\"font-size:14px;color:#444;margin:8px 0 18px;\">\ud83d\udce6 Ka\u017ed\u00e1 objedn\u00e1vka je pokryta na\u0161\u00ed <a href=\"https:\/\/medsbase.com\/cs\/medsbase-re-shipment-assurance-policy\/\"><strong>Z\u00e1rukou op\u011btovn\u00e9ho odesl\u00e1n\u00ed<\/strong><\/a> \u2014 pokud va\u0161e z\u00e1silka nedoraz\u00ed do 20 pracovn\u00edch dn\u016f, p\u0159epos\u00edl\u00e1me ji.<\/p>\n<p><!-- medsbase-related-alts-v1 --><\/p>\n<h3 class=\"wp-block-heading\">Souvisej\u00edc\u00ed alternativy<\/h3>\n<p>Dal\u0161\u00ed produkty v <strong>Chronick\u00e1 onemocn\u011bn\u00ed<\/strong> kter\u00e9 z\u00e1kazn\u00edci tak\u00e9 prohl\u00ed\u017eej\u00ed:<\/p>\n<ul>\n<li><a href=\"https:\/\/medsbase.com\/cs\/placentrex-injection\/\">Placentrex Injekce<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/methycobal-injection\/\">Methycobal Injekce<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/frusenex\/\">Frusenex<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/syndopa\/\">Syndopa<\/a><\/li>\n<li><a href=\"https:\/\/medsbase.com\/cs\/losatec-h\/\">Losatec H<\/a><\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Sibelium is flunarizine 5 mg \/ 10 mg oral tablets from Janssen \u2014 selective calcium-channel blocker with antihistaminic and anti-dopaminergic action. First-line migraine preventive in European, Asian, and Latin American guidelines (not FDA-approved in US). Standard dose 10 mg at bedtime for adults under 65; 5 mg for elderly or paediatric. Particularly effective for paediatric migraine, vestibular migraine, and hemiplegic migraine. Maximum continuous course 6 months.<\/p>","protected":false},"featured_media":57099,"comment_status":"open","ping_status":"open","template":"","meta":[],"product_brand":[],"product_cat":[3553,3141,3223,3342,3554],"product_tag":[4231,4232],"class_list":{"0":"post-57098","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-anti-migraine","7":"product_cat-category-overview","8":"product_cat-chronic-conditions","9":"product_cat-general-health","10":"product_cat-migraine-treatment","11":"product_tag-flunarizine-dihydrochloride","12":"product_tag-sibelium","14":"first","15":"instock","16":"shipping-taxable","17":"purchasable","18":"product-type-variable","19":"has-default-attributes"},"acf":[],"_links":{"self":[{"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/product\/57098","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/comments?post=57098"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/media\/57099"}],"wp:attachment":[{"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/media?parent=57098"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/product_brand?post=57098"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/product_cat?post=57098"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/medsbase.com\/cs\/wp-json\/wp\/v2\/product_tag?post=57098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}