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Drugs Sibelium have composition Flunarizine hydrochloride. Sibelium therapeutic indications Prophylaxis of classic , vestibular vertigo , due to diagnosed functional disorder of the vestibular system.

Tanganil recommended in the treatment of dizziness

Dogmatil treat certain forms of anxiety in adults and certain behavioral disorders in adults

Description

Sibelium is  selective calcium antagonist available in red and grey capsules Each capsule  contains  5.9 mg flunarizine  hydrochloride equivalent to 5 mg flunarizine

List of excipients Lactose monohydrete. com starch, talcum magnesium stearate coolloidal silicon dioxide

sibelium

Therapeutic indications

Prophylaxis of classic   (with aura) or common (without aura) imgrame

Symptomatic treatment of vestibular vertigo, due to diagnosed functional disorder of the vestibular system

Dosage and method of administration (See also Special warnmgs and Special precautions for use)

a) Migrainee prophytaxis

– Starting dose:

Treament is started at 10 mg daily (at night) for patients younger than 65 years.ot aged« at 5mg dady tor patients older than 66 years If. dunng the treatment, depress   exeapyramidel or other unacceptable adverse experiences occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement observed, the patient should be considered a non-responder and administration should also be discontinued

Maintenance treatment

it pabent responds satisfactorily and it a maintenance treatment is needed, the dose should be decreased so that each week hefshe has 5 days treatment at the same daily dose with 2 successive drug-tree days

Even if the prophylactic maintenance treatment is successful and we» tolerated, it should be interrupted after 6 months and re-mniated only if the patient relapses

b) Vertigo

The same daify doses should be used as lor migraine, but the starting treatment staid not be grve longer than needed  symptom control, which genoralty takes less than two montir. ft. however, no significant improvement is observed after one month for chronic vertigo or after two months for paroxysmal vertigo, the patient should be considered a non-respond ‘ and edmmrsttaeon should be discontinued

Contraindications

Sibelium is  contraindicated in patients with u history of depressive. or with prexisting symptoms of Parkinson’s disease or other extrepyramtda disorders (see Spedu warnings and special precautions for use and Adverse reactions)

Special warnings and special precautions for use

This treatment may give nse of extra pyramidal and depressive symptoms and reveal Pariunsontsm. espeoaffy m predisposed patients such as the ofderfy Therefore it

In rare cases lattgue may increase progressively during Stbehum therapy In this event the foerapy staid be discontinued

The recommended dose should not be exceeded Patients should be seen at regulr intervals, especially dunng maintenance treatment, so that extrapyramkla) or depress   symptoms may be detected early end it so, treatment discontinued H during maintenance treatment the therapeutic effect wane, treatment should also be discontinued (tor duration of treatment, see also Dose and Administration)

Interactions

Excessive sedation can occur when alcohol, hypnotics or tranguikzers are taken simultaneously with Sibelium.

Sibelium is not contraindicated in patients who use betablocking agents.

The pharmacokinetics of fkmanzme were unaffected by topiramsle. Dunng Coadministration of Stortum with lopaamate 50 mg every 12 hours, a 16% Increase in fro system  exposure to hunanzwe m migraine patients was observed comparable to a 14% nersase n patients treated with flunanzme oofy The steady-state pharmacotanettes of lopramate were unaffected by flunarizme

Chronic administration ot ftunanzme did not affect the disposition of phanytoin carbamazepme. valproate or phenobartMtai Plasma concentrations of ftunarizine we generally lower r patients with epilepsy taking these anti-epileptic drugs (AEDs) compete to healthy subjects given smear doaee. The plasma protein binding of corbamazeptoo. valproate, and phenytom m not effected by co-adrmmstrabon with flunarizine.

Atroolnic medicines

Consideration should be taken that atroinic substances may addition their undesirable affects and cause more easily an urine acute exposition of giaucoma, constipation, dry mouth, etc…

The different efropasc mertiemes are represented by imiprammc antidepressants, most of H1 antihrstarvmcs. antichoimergrc anti pariunsoraan drug. Btroptmc antispasmodcdrugs, dtsopyramfoe phenotiaonc neuroleptics and clozapine

Sedative medicines

Consideration should be taken that many medones or instances may add on tuy depressant effects of the central nervous system and contribute to decrease vtgiance Such as denvwvee morpfwac (analgescs, anblussrves and substMon traetmanl). naurotepbci- barbdurtes. benzodiazepines. other anxioiytics that benzodiazepines(for example  meprobamate). hypnotics, sedative antidepressants (amitnptytote.,doxepine, mianserine, mirtazapine, trimipramine). sedative H1 antihstamescs, central snohypertentve drugs bedoian and thalidomide

Non recommended combinations:

Alcohol:

Alcohol  increases the sedative effect The depressed level of corisicaouenees may make ability to drive vehicles and use machinery dangerous Avoid taking alcohoac dnoka and medicines containing alcohol

Pregnancy and lactation

Use during pngnancy

The safety of Sibeffum for use in human pregnancy has not been established

An evaluation ol animal studies does not indicate deed or indeed harmful effects with reaped to reproduction, development of the embryo or letus, the course of gestation or pert-end postnatal development.

Animal studies have not indicated any teratogenous effect in the absence of any teratogenous effed in animals, malformation is not expected In humans In fact, to date, substances responsible lor malformations in humans have revealed themselves to be temtogenous mammals during studies property earned out on two epedes

Clinically, there is not currentiy any sufficiently relevant data to assess a possible malformation or toetotoxtc effed of fiurwtzine administered durtng pregnancy Conseousntly, as a precaution, flunartzme should preferably not be taken during pregnancy

Use during lactation

Studies in lactating dogs have shown that flunarizene is excreted in the milk and that the concentration tn the milk is greater than tn the plasma No data are available on the excretion tn human breast milk Nursing should therefore be discouraged In woman taking Sibelium

Effects on driving ability and use of machinery

Since somnolence may occur, especially at the start of the treatment, caution should be exercised dunng activities such as driving or operation dangerous machinery.

Undesirable effects

Clinical trial Data

The safety of Sibelium (5 to 10 mg/day) was evaluated in 500 subjects (of which 247 were treated with Sibekum. 253 were given placebo) who partiopeied in two placebo-conirotted. doubfe-bfmd parcel ctiracai trials, one In the treatment of migraine and the other m the treatment of vertigo

Psychiatric Disorders

Depressive Symptom

Sleep disorder

Apetfry

Nervous System Disorders

Torticollis

Tinnitus

Lethargy

Paraestheeia

Sluggishness

Restlessness

Coordnation Abnormal

Disorientation

Cardiac Disorders

Palpitations

Gastrointestinal Disorders

Intestinal obebucbon

Gastrointestinal disorder

Dry Mouth

Skin end Subcutaneous Tissue Disorders

Hyperhidrosis

Musculoskeletal and Connective Tissue Disorders

Muscle Spasms

Muscle Twitching

Reproductive System and Breast Disorders

Oligomenorthoea

Menontiagi

Hypertrophy Breast

Menstrual Disorder

Libido Decreased

General Disorders and Administration Site Conditions

Generalised Oedema

Asthenia

Oedema Peripheral

Overdosage

Symptom

On the basic of the pharmacological properties of the drug. sedation and asthenia expected to occur A few cases of  acute overdoeege (up to 600 mg in one intake) have been reported end the observed symptoms were sedation, agnation and tachycenfca

Treatment

There is no specific antidote. Within the first hour efter ingestion, gaetnc lavage mey be performed Activated charcoal mey be prve it considered appropnete

Pharmacology Propertes

ATC Code. N2C Anti-Migraine Preps

Pharmacodynamics

Flunartzine is a selective calcium antagonist ft prevents cellular calcium overtoed by reducing excessive transrmembrane calcium influx. Flunanzme has no effect on contractility of conduction ol the heart

Pharmacokinetics

The drug is wefl absorbed reaching peak plasma concentrations within 2-4 hours and reaching steady state at 5-6 weeks

Absorption

Flunartzine is wefl absorbed (>80%) from the gastrointestinal tract, reaching peak plasma concentrations within 2 lo 4 hours after oral dosaig Under conditions of reduced gastric acidity (higher gastric pH). bioavailability may be moderately lower

Distribution

Flunarizine  is >99% bound to plasma proteins. It has a large volume of of distribution appronmnteiy 78l/kg in healthy subjects and approximately  207 L/kg  in epileptic patients indicating extensive distribution into The drug croeae the blood bram barner; concentrations m the or am oie approximately 10 times higher than those in plasma.

Metabolism

Flunanzino is metabolized m the liver into at least 15 metabolites. The primary metabolic pathway is CYP206

Elimination

Flunarizine Is primarily eliminatednas parent drug and metabofctes through the feces via bile. We Within 24 to 48 hours alter admanstrabon. approximately 3% to 5% ol the admewterod dose of flunanzme is eliminated In the laces as parent drug and metaboWee and less <1% is excreted as unchanged drug m urine. Ns terminal semination haif-flfle ts h&ty variable ranging from 5 to 15 hours In most Individual subjects after a setQSe dose Some subjects show measurable plasma concentrations ol flunertzme (>0 5 ngftnL) lor a prolonged time period (up to 30 days), possibly due to redistribution ol the drug from other tissues. Multiple-Dose

Plasma concentrations ol flunanzme reach steady-stale after sppranmattiy 6 weeks ol once-deily multiple dosmg and are about 3-fold higher than those observed titer a single dose. Steady-state fiunarizlne concentrations are proportional over a dose range ol 5 mg to 30 mg.

Preclinical Safety Data

Preclinical effects of a CNS nature (e.g.. sedation, sefcvatton. ataxia) were observed only at exposures considered sufficiently in excess ol the maximum human exposure indicating little relevance to clinical use.

How supplied

Foil packs 50×10’s and 10×10’s

Storage conditions

Store between 15 and 30°C.

Keep out of reach of children

Shell life: 2 years from manufacturing date

Do not use drug beyond the expiry date printed on the peek.

Reed leaflet carefully before using. For more Information, please ask for your doctor’s advice.

This drug is used only by doctor’s preecriptfon.

Some drugs have composition  Flunarizine  :  Reinal , Hagizin , Fluzinstad , Flumigra

Reinal-10mg

Reinal-10mg

Fluzinstad 5mg

Flumigra-10mg

 

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