Medicinal Products

ALEPSAL 50 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Phenobarbital, Caffeine
laboratory: Genevrier

Compressed
Box of 30
All forms

Indication

AT THE ADULT:
. in monotherapy,
. in combination with another anti-epileptic treatment:
- Treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures.
- Treatment of partial epilepsies: partial seizures with or without secondary generalization.
IN THE CHILD:
. in monotherapy,
. in combination with another anti-epileptic treatment:
- Treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures.
- Treatment of partial epilepsies: partial seizures with or without secondary generalization.

Dosage ALEPSAL 50 mg Tablet Box of 30

The efficacy of the drug can only be judged after 15 days of treatment.
It will be the same for any change in dosage.
When the clinic warrants it, check the barbititia by taking the sample preferably in the morning (usually 65 to 130 μmol / L in adults or 15 to 30 mg / L in adults and 85 μmol / L or 20 mg / L in children).
- Children by weight:
. less than 20 kg: 5 mg / kg per day.
. between 20 and 30 kg: 3 to 4 mg / kg per day.
. above 30 kg: 2 to 3 mg / kg daily.
In children under 6 years, the tablet will be crushed and mixed with food before administration because of the risk of miscarriage.
- Adults: 2 to 3 mg / kg per day or, for a subject of 70 kg:
3 tablets dosed at 50 mg,
2 tablets dosed at 100 mg,
1 tablet dosed at 150 mg.
One dose per day (see pharmacokinetic properties) at bedtime.

Against indications

CONTRAINDICATED:
This medicine should never be used in the following situations:
- History of hypersensitivity to barbiturates.
- Porphyries.
- Severe respiratory failure.
- Treatment with Saquinavir and lfosfamide (phenobarbital used prophylactically).
- In combination with St. John's wort.
NOT RECOMMENDED :
This drug is generally not recommended in the following situations:
- Breast-feeding: not recommended, because sedation can lead to sucking difficulties that lead to an incorrect weight curve in the immediately neonatal period.
- In combination with alcohol and estrogens and progestins used as contraceptives (see interactions).

Alepsal side effects

- sleepiness at the beginning of the day,
- Difficult awakening with sometimes difficulties to articulate,
- disorders of coordination and balance,
- rarely vertigo with headache,
- cutaneous reactions most often in the form of maculopapular eruptions morbiliform or scarlatiniform,
- possibility of serious skin reactions including very rare cases of Lyell syndrome, Stevens-Johnson syndrome,
Hepatic effects: An isolated increase of gamma-glutamyltranspeptidase, related to hepatic enzymatic inducing effect of phenobarbital, can be observed. As a rule, this increase is of no clinical significance. An isolated and moderate elevation of a transaminase and / or alkaline phosphatase is very occasionally observed. Very rare cases of hepatitis.
- hypersensitivity syndrome: multisystemic hypersensitivity reactions with mostly fever, rash, eosinophilia and hepatic involvement have been reported. The rare occurrence of cross reactions between phenobarbital, phenytoin and carbamazepine should make it prudent to replace phenobarbital with either molecule.
- arthralgia (shoulder-hand syndrome or "rheumatism gardénalique"),
- mood disorders,
- megaloblastic anemia due to folic acid deficiency,
- prolonged intake of phenobarbital (100 mg daily for 3 months) may lead to the appearance of a dependence syndrome.
Serious effects affecting the hepatic and / or dermatological systems as well as hypersensitivity reactions require discontinuation of treatment .

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