SIBELIUM Tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Sibelium 5 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 5 mg of flunarizine as flunarizine dihydrochloride. <u>Excipients with known effect:</u> Each tablet also contains 57.42 mg lactose monohydrate. For the full list of excipients see ...
Pharmaceutical form
Tablet. White, oblong tablet inscribed J-C on one side and FL 5 on the other side.
Therapeutic indications
In the prophylaxis of migraine. The limited information available for periods longer than 12 months has shown flunarizine to continue to be effective. Patients should be regularly reviewed to assess their ...
Posology and method of administration
Adults and elderly (18 years of age and older) Starting Dose Treatment is started at 10 mg daily (at night) for adult patients aged 18 to 64 years and at 5 mg daily (at night) for elderly patients aged ...
Contraindications
Use in patients with current depressive illness or with a history of recurrent depression (see Sections 4.4 and 4.8). Use in patients with pre-existing symptoms of Parkinsons Disease or other extrapyramidal ...
Special warnings and precautions for use
Flunarizine may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in elderly patients. Therefore, it should be used with caution in such patients. The recommended ...
Interaction with other medicinal products and other forms of interaction
When used in conjunction with anti-hypertensive drugs, dosage of the latter may need adjustment. Galactorrhoea has been reported in some female patients on oral contraceptives within the first two months ...
Pregnancy and lactation
Pregnancy There are no data from the use of flunarizine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition ...
Effects on ability to drive and use machines
Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities such as driving or operating dangerous machinery.
Undesirable effects
The safety of Sibelium (5 to 10mg/day) was evaluated in 247 flunarizine-treated subjects who participated in two placebo-controlled clinical trials in the treatment of vertigo and migraine, and in 476 ...
Overdose
Symptoms and signs On the basis of the pharmacological properties of the drug, sedation and asthenia may be expected to occur. Cases of acute overdosage (up to 600 mg in one intake) have been reported ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-vertigo Preparations <b>ATC Code:</b> N07CA03 Class IV selective calcium entry blocker, which reduces arterial and arteriolar smooth muscle spasm.
Pharmacokinetic properties
The drug is well absorbed reaching peak plasma concentrations within 2-4 hours, and reaching steady state at 5-6 weeks. Absorption Flunarizine is well absorbed (>80%) from the gastrointestinal tract, reaching ...
Preclinical safety data
Preclinical effects of a CNS nature (e.g. sedation, salivation, ataxia) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical ...
List of excipients
Lactose monohydrate Maize starch Magnesium stearate Colloidal anhydrous silica Hypromellose Polysorbate 20 Microcrystalline cellulose Croscarmellose sodium
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
The tablets are supplied in PVC/Aluminium blister packs in a carton containing 20 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, Cork, P43 FA46, Ireland
Marketing authorization number(s)
PA22612/011/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 30<sup>th</sup> January 2009 Date of last renewal: 29<sup>th</sup> January 2014
Date of revision of the text
August 2020
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