Description
COMPOSITION :
Each tablet contains 5 mg and 10 mg Flunarizine ( as HCl )
ACTIONS :
Flunarizine is a selective calcium-entry blocker that has no effect on contractility and conduction of the heart.
It is well absorbed from the gut, reaching peak plasma levels within 2-4 hrs and reaching steady-state at 39-115 mcg/L after
re-administration use once a day. After extensive hepatic metabolism, the drug and its metabolites are excreted through the
faeces via the bile. The mean terminal elimination half-life is about 18 days. Plasma protein-binding is 90%. Controlled clinical
studies have shown that Siberid prevents attacks of migraine, depresses vestibular irritability and reduces the symptoms of
cerebral and peripheral vascular disorders. Siberid has a long duration of action and may therefore be administered on a once-
daily basis.
INDICATIONS :
Migraine prophylaxis.
Treatment of Vestibular Disturbances of Cerebral and Peripheral : Dizziness, tinnitus, vertigo, cramps when walking or when
lying down, paraesthesia, cold extremities and tropic disorders.
When necessary, usual hygienic measures, eg diet, non smoking and appropiate walking exercise will be prescribed with
Siberid.
DOSAGE & ADMINISTRATION :
The maximum dose of 5 mg daily can decrease occurrence of side effects.
Migraine Prophylaxis :
Starting Dose : 10 mg daily ( at night ) in patients < 65 years and 5 mg daily in patients older than 65 years. If during
this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be
discontinued. If after 2 months of this initial treatment, no significant improvement is observed, the patient should be
considered a non-responder and administration should also be discontinued.
Maintenance Treatment :
If patient is responding satisfactory and if maintenance treatment is needed, the dose should be decrease to 5 days
treatment a week (2 days a week without the drug). Even if the prophylactic maintenance treatment is successful and
well tolerated, it should be interrupted after 6 months and should be re-initiated only if patient relapses.
Treatment of Vestibular Disturbances Prophylaxis of Cerebral and Peripheral :
The same daily doses should be used as for migraine, but the starting treatment should not be given longer than
needed for symptom control, which generally takes < 2 months. Anyhow, if after 1 month for chronic vertigo or after 2
months for paroxymal vertigo, non-significant improvement is observed, the patient should be considered a non
responder and administration should be discontinued.
Siberid : The average daily use doses are 2 tabs taken both in the evening or 1 tab in the morning and another in the
evening.
OVERDOSAGE :
Symptoms : On the basis of the pharmacological properties of Siberid, sedation and asthenia can occur.
A few cases of acute overdosage ( up to 600 mg in one intake ) have been reported and observed symptoms were
sedation, agitation and tachycardia.
Extrapyramidal symptoms and depression in patient who take 10-40 mg daily for 3 weeks and 15 months.
Treatment : Consist of charcoal administration, induction of emesis or gastric lavage and supportive measures. No
specific antidote is known.
CONTRAINDICATION :
Patient with a history of depressive illness or with pre-existing symptoms of Parkinson’s disease or other extrapyramidal
disorder. Siberid is contraindicated in patients treated with beta-blocking agent.
WARNING :
This treatment may give rise to extrapyramidal and depressive symptoms and reveal parkinsonism, especially in predisposed
patients, eg elderly; therefore, it should be used with caution in such patients. Caution should be taken in hypotensive patient.
The effect of Siberid is gradual, so that the disorder improves gradually, too. In migraine, therefore, 3-4 months of treatment
may sometimes be required before a final assessment of the result can be given. If after such a period of time, no favorable
effect is observed, there is no point in continuing the therapy. In patients in whom, within that time period, a good result has
been established, the latter is maintained for at least a year with continued treatment.
Siberid is not suitable for terminating a migraine attack. Also on days in which such attacks occur, the prescribed dosage is to
be maintained. As depression may exacerbate migraine or sometimes occur concomitantly with it, treatment should be carried
out in view of the possibility of a depression before prophylactic treatment of migraine is started.
PRECAUTIONS :
In rare cases, fatigue may increase progressively during Siberid therapy : In the event, the therapy should not be
discontinued. The recommended dose should not be exceeded.
Patients should be seen at regularly intervals, especially during maintenance treatment, so that extrapyramidal or depressive
symptoms may be detected early and if so, treatment discontinued. If during maintenance treatment the therapeutic effects
wane, treatment should also be discontinued.
Galactorrhea was reported in a few female patients on oral contraceptives within the first 2 months of Siberid treatment.
Effect of Ability to Drive and Operate Machine : Since somnolence may occur, especially at the start of the treatment, caution
should be exercised during the activities, eg driving or operating machinery.
Use in pregnancy since the safety of Siberid use in human pregnancy has not been established.
An evaluation of animal studies does not indicate teratogenic effect. Although in experimental animals there is no evidence of
embryotoxic effects, the anticipated therapeutic benefits of flunarizine should be weighed against potential hazards before
administering the compound during pregnancy.
Studies in lactating dogs have shown that flunarizine is excreted in the milk and that the concentration in the milk greater than
in the plasma. No data are available on the excretion in human breast milk. Therefore, it is not recommended to breast feed
during treatment with Siberid.
Use in children : Safe use of Siberid in children is not known.
SIDE EFFECTS :
The most frequent adverse experiences are drowsiness and / or fatigue (20%), which are generally transient, as well as weight
gain ( and / or increased appetite ) 11%.
The following serious adverse experiences occur during chronic treatment : Depression, of which female patients with a history
of depressive illness may particularly be at risk.
Extrapyramidal symptoms ( eg, bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor ) or which elderly patients seem
particularly at risk.
Infrequently reported adverse experiences are : Gastrointestinal : Heartburn, nausea, gastralgia. Central Nervous System :
Insomnia, anxiety. Others : Galactorrhea, dry mouth, muscle ache, skin rash. Siberid : The recommended dose can
occasionally evoke somnolence and fatigue, but these side effects are usually transient and can be enhanced by alcoholic
beverages.
When somnolence does not subside spontaneously during the treatment or when it is very pronounced, caution is mandatory
in car drivers and the possibility of achieving sufficient activity at half the dosage should be examined.
In rare cases, however, fatigue may increase progressively and give rise to apathy or inertia. An extrapyramidal reaction or
depression may be the unwanted effect flunarizine. Investigations conducted so far do not readily permit an evaluation of the
frequency of such effects, and it is still unclear whether they occur mainly in predisposed persons or not. One should, in any
case, be on the look for their occurrence.
The occurrence of depression may constitute grounds for discontinuing the flunarizine treatment and starting on antidepressant
treatment. It is recommended, therefore, to first treat the depression when depression and migraine occur concomitantly ( see
Warnings ). Weight gain has occasionally been reported during the prophylactic treatment of migraine.
INTERACTIONS :
Excessive sedation can occur when alcohol, hypnotics or tranquilizers are taken simultaneously with Siberid.
STORAGE :
Store at room temperature.
PACKING :
Tablet 5 mg. Box of 5×10’s Reg.No. DKL9621010410A1
Tablet 10 mg. Box of 5×10’s. Reg.No. DKL9621010410B1
On medical prescription only.
