- Pharmaceutical Form : Capsules
- Composition : Flunarizine HCl 5.9 mg Eq. Flunarizine base 5 mg /Caps
- Active Substance : Flunarizine HCl
Flunarizine HCl has histamine H1 receptor and calcium channel blocking activity ,it prevents Cellular calcium overload by reducing excessive transmembrane calcium influxes .
Flunarizine is well Absorbed from the gastro intestinal tract . After extensive hepatic metabolism , Flunarizine and its meta-bolites are excreted through the faeces via the bile,The mean terminal elimination half- life is about 18 days.
Sebbal is used for :
* prophylaxis of migraine .
* symptomatic treatment of vestibular vertigo
Contra Indications :
Sebbal is contra-indicated in patients with a history of depressive illness , or with pre-existing symptoms of Parkinson’s disease or other extrapyramidal disorders , hypersensitivity to Flunarizine .
Adverse reactions :
Drowsiness , fatigue , weight gain , insomnia , gastro intestinal disturbances , headache , and skin raches . the following side effects have been reported during chronic treatment with Sebbal : depression , extrapyramidal symptoms .
Drug Interactions :
– Galactorrhoea in few woman on oral contraceptives with in the first two months Of Sebbal treatment .Hepatic enzyme inducers such as carbamazepine and phenytoin may interact with Flunarizine
by increasing its metabolism . An increase in dosage of Flunarizine may be required .
The sedative and inhibited effect for the product increases with CNS inhibitors and alcohol .
Sebbal should be used with care in patients with depression or those being prescribed other agents , such as phenothiazine, concurrently , which may cause extrapyramidal side effects.
Fatigue may increase progressively during Sebbal therapy , in this event therapy should be discontinued. Sebbal is not suited for aborting a migraine attack . This treatment may give rise to extrapyramidal and depressive symptoms and reveal parkinsonism , Especially elderly patients .
Patients sould be cautioned against driving motor vehicles or performing other potentially hazardous Tasks .
Should not be administered to pregnant women unless the anti cipated benefits outweigh the potential risks .
During lactation , breast feeding should be discouraged in women taking Flunarizine .
Dosage and Administration :
Migraine prophylaxist : The starting dose is two capsules ( 10 mg. ) at night in patients less than 65 years of age , and one Capsule ( 5 mg ) daily in patients older than 65 years , if after 2 months of this initial treatment , no significant improvement is observed , the patient should be considered a non-responder and administration should be discontinued.
Maintenance treatment :
If a patient is responding satisfactory and if a maintenance treatment is needed the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week .
Even if the prophylactic maintenance treatment is successful and well tolerated , it should be interrupted After 6 months and it should be re-initiated only if the patient relapses .
Vertigo : the same dosage should be used as for migraine , but the starting treatment should not be
given longer than needed for symptom control , which generally takes less than two months .
After one month of treatment for chronic vertigo or after two months treatment for paroxysmal
Vertigo , no significant improvement is observed , the patient should be considered a non- responder
And administration should be discontinued .
Storage conditions : store up to 20 oC
Packing : 20 capsules .