FEATURE	DESCRIPTION
Pharmaceutical class	antiepileptics
Active substance (s)	for one tablet: caffeine (37.50 mg), phenobarbital (150 mg)
General medicine	no
Pharmaceutical form	compressed
Route (s) of administration	oral
Social security reimbursement rate	65%
Laboratory (s)	JUNIPER
Conditions of issue	available by simple prescription

Alepsal Dosage

The effectiveness of the drug can only be judged after 15 days of treatment.
The same will apply for any modification of the dosage.
When the clinic justifies it, control the barbitaemia by taking the sample preferably in the morning (in general 65 to 130 µmol / l in adults or 15 to 30 mg / l and 85 µmol / l or 20 mg / l in adults. child).

Children: by weight:

less than 20kg: 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 per day
Adults : 2 to 3 mg / kg per day.

Alepsal Contraindications

CONTRA-INDICATED

This medication should never be used in the following situations:

History of hypersensitivity to barbiturates.
Porphyrias.
Severe respiratory failure.
Treatment with Saquinavir and lfosfamide (phenobarbital used for prophylactic purposes).
In association with St. John’s Wort.

ADVISED AGAINST

This medication is generally not recommended in the following situations:

Breast-feeding: not recommended, because the possibility of sedation can lead to sucking difficulties causing a bad weight curve in the immediately neonatal period.
In association with alcohol and estrogen-progestogens and progestins used as contraceptives (see interactions).

How To Take Alepsal ?

Administration mode

Oral route. In children under 6 years old, the tablet will be crushed and mixed with food before administration.
IN ALL CASES STRICTLY COMPLY WITH THE ORDER OF YOUR DOCTOR.

Frequency of administration

One dose per day at bedtime.
IN ALL CASES STRICTLY COMPLY WITH THE ORDER OF YOUR DOCTOR.

Duration of treatment

Do not change the dosage or stop treatment without medical advice.
IN ALL CASES STRICTLY COMPLY WITH THE ORDER OF YOUR DOCTOR.

how does Alepsal work?

Pharmacotherapeutic group: ANTIEPILEPTIC; ATC code: N03AA02

ALEPSAL is made up of:

phenobarbital:

Phenobarbital is a barbiturate. It exhibits anticonvulsant, sedative and hypnotic properties.
Caffeine: reduces drowsiness at the start of treatment depending on the sensitivity of the subject.

How To Store Alepsal ?

Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
This medication should be stored in a dry place.
Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Alepsal Side Effects

Like all medicines, ALEPSAL 150 mg tablets can cause side effects, although not everybody gets them:

Drowsiness at the start of the day,
difficult to wake up with sometimes difficulties to speak,
coordination and balance disorders,
rarely dizziness with headache,
rash and severe skin disorders,
impaired liver function, rarely hepatitis,
generalized allergic reaction: fever, rash, impaired function of the
joint pain (shoulder-hand syndrome or “gardenal rheumatism),
mood disorders,
blood abnormalities (megaloblastic anemia due to folic acid deficiency),
dependence in case of prolonged intake.

Treatment should be stopped in the event of a generalized allergic reaction, rash, or changes in liver function.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Alepsal Interactions

Contraindicated associations

Saquinavir

Risk of decrease in the efficacy of saquinavir by increasing its hepatic metabolism by the inducer.
Ifosfamide (Phenobarbital for prophylaxis).
Risk of increased neurotoxicity by increased hepatic metabolism of ifosfamide by phenobarbital.

St. John’s Wort

Risk of decrease in plasma concentrations and the effectiveness of the anticonvulsant.

Not recommended associations

Alcohol

Alcohol enhancement of the sedative effect of phenobarbital. Impaired vigilance can make driving and using machines dangerous.
Avoid taking alcoholic drinks and drugs containing alcohol.

Estrogestogestins and progestins (contraceptives) (see section Fertility, pregnancy and lactation):

Decrease in contraceptive efficacy, by increased hepatic metabolism of the hormonal contraceptive by the inducer.
If the combination proves necessary, use an additional mechanical method for the duration of treatment with phenobarbital, and for two cycles after stopping the inducer.

Combinations subject to precautions for use

Valproic acid, valpromide

Increased plasma concentrations of phenobarbital, with signs of overdose, by inhibition of hepatic metabolism, most commonly in children. In addition, decrease in plasma concentrations of valproic acid by increasing its hepatic metabolism by phenobarbital.
Clinical monitoring during the first 15 days of the combination and immediate reduction of the doses of phenobarbital, as soon as signs of sedation appear; monitor the plasma concentrations of the two antiepileptics.

Oral anticoagulants

Decrease in the effect of the oral anticoagulant (increase in its hepatic metabolism).
More frequent monitoring of the prothrombin level and monitoring of the INR. Adjustment of the dosage of the oral anticoagulant, during treatment with phenobarbital and 8 days after stopping it.

Imipramine antidepressants

Imipramine antidepressants promote the onset of generalized seizures.
Clinical monitoring and possible increase in antiepileptic doses.

Ciclosporin, tacrolimus

(By extrapolation from rifampicin).

Decrease in plasma concentrations of the immunosuppressant and its efficacy by increasing its hepatic metabolism.
Increase in the dosage of the immunosuppressant under control of plasma concentrations. Decrease in dosage when the inducer is stopped.

Corticosteroids (gluco-, mineralo-)

(Systemic use) (except hydrocortisone used as a replacement therapy in Addison’s disease).
Decrease in plasma concentrations and in the efficacy of corticosteroids by increasing their hepatic metabolism: the consequences are particularly important in Addisonians and in cases of transplantation.
Clinical and biological monitoring; adjustment of the dosage of corticosteroids during treatment with the inducer and after its discontinuation.

Digitoxin

Decreased plasma concentrations and efficacy of digitoxin (increase in its hepatic metabolism).
Clinical monitoring, ECG and possibly control of digitoxinemia. If necessary, adjustment of the dosage of digitoxin during the combination and after stopping phenobarbital or else prefer digoxin, which is less metabolized by the liver.

Disopyramide

Decreased plasma concentrations and effectiveness of the antiarrhythmic (increased liver metabolism).
Clinical monitoring, ECG and possibly monitoring of plasma disopyramide concentrations. If necessary, dosage adjustment of disopyramide during treatment with phenobarbital and after its discontinuation.

Dihydropyridines

Decrease in plasma concentrations of dihydropyridine by increasing its hepatic metabolism.
Clinical monitoring and possible adjustment of the dosage of dihydropyridine during treatment with the inducer and after its discontinuation.

Doxycycline

Decrease in plasma concentrations of doxycycline by increasing its hepatic metabolism.
Clinical monitoring and possible adjustment of the dose of doxycycline.

Estrogens and progestins (non-contraceptives)

Decrease in the effectiveness of estrogen or progestin by increasing its hepatic metabolism.
Clinical monitoring and possible adjustment of the dosage of estrogen or progestin during treatment with the inducer and after its discontinuation.

Folates

Decrease in plasma concentrations of phenobarbital, by increasing its metabolism, of which folate is one of the cofactors.
Clinical monitoring, control of plasma concentrations, and adjustment, if necessary, of the dosage of phenobarbital during folic supplementation and after its discontinuation.

Thyroid hormones

Described for phenytoin, rifampicin, carbamazepine.
Risk of clinical hypothyroidism in hypothyroid patients, by increased metabolism of T3 and T4.
Monitoring of serum T3 and T4 concentrations and adjustment, if necessary, of the dosage of thyroid hormones during treatment with the inducer and after its discontinuation.

Hydroquinidine, quinidine

Decreased plasma concentrations and efficacy of quinidines (increased hepatic metabolism).
Clinical monitoring, ECG and monitoring of plasma concentrations; if necessary, adjustment of the dosage of the antiarrhythmic drug during treatment with the inducer and after its discontinuation.

Ifosfamide

Risk of increased neurotoxicity by increased hepatic metabolism of ifosfamide by phenobarbital.
In the event of treatment with phenobarbital prior to chemotherapy: clinical monitoring and adjustment of the dosage of the anticancer drug.

Itraconazole

Decreased plasma concentrations and efficacy of itraconazole.
Clinical monitoring and, if necessary, dosage of itraconazole in the plasma and possible adjustment of the dosage.

Methadone

Increased risk of respiratory depression, which may be fatal in case of overdose.
In addition, decrease in plasma concentrations of methadone with the risk of the onset of withdrawal syndrome by increasing its hepatic metabolism.
Regular clinical monitoring and adjustment of methadone dosage.

Progabid

Possible increase in plasma concentrations of phenobarbital.
Likely decrease in plasma progabid concentrations (not verified).
Clinical monitoring and control of plasma concentrations of phenobarbital.
Possible adjustment of dosages.

Theophylline (base and salts) and aminophylline

Decrease in plasma concentrations and theophylline activity by increasing its hepatic metabolism.
Clinical monitoring and, if necessary, theophyllinemia. Possible adjustment of the theophylline dosage during treatment with the inducer and after its discontinuation.

Zidovudine

(By extrapolation from rifampicin).
Risk of reduction in the efficacy of zidovudine by acceleration of its hepatic metabolism.
Regular clinical monitoring.

Associations to take into account

Alprenolol, metoprolol, propranolol

(Beta-blockers)

Decrease in plasma concentrations of these beta blockers with reduction of their clinical effects (acceleration of their hepatic metabolism).
To be taken into account, for these beta-blockers eliminated mainly by hepatic biotransformation.

Other CNS antidepressants:

Morphine derivatives (analgesics, cough suppressants and substitution treatments); benzodiazepines; anxiolytics other than benzodiazepines: carbamates, captodiam, etifoxine; hypnotics; sedative antidepressants; neuroleptics; sedative H1 antihistamines; central antihypertensive drugs; baclofen; thalidomide.
Increase in central depression. Impaired vigilance can make driving and using machines dangerous.

Carbamazepine

Progressive decrease in plasma concentrations of carbamazepine and its active metabolite with no apparent change in anticomitial efficacy.
To be taken into account, in particular for the interpretation of plasma concentrations.

Methotrexate

Increased haematological toxicity by additive inhibition of dihydrofolate reductase.

Morphine drugs (analgesics), benzodiazepines

Increased risk of respiratory depression, which may be fatal in case of overdose.

Phenytoin

In the event of previous treatment with phenobarbital and addition of phenytoin, increase in plasma concentrations of phenobarbital which may cause toxic signs (inhibition of metabolism by competition).
If previous treatment with phenytoin and phenobarbital addition, unpredictable variations:
- the plasma concentrations of phenytoin are most often reduced (increased metabolism) without this decrease adversely affecting the anticonvulsant activity. On discontinuation of phenobarbital, possibility of toxic effects of phenytoin;
- Sometimes phenytoin concentrations may be increased (inhibition of metabolism by competition).

Procarbazine

Increased hypersensitivity reactions (eosinophilia, rash) by increased metabolism of procarbazine.

Effects on ability to Drive and use machines

Due to the risk of drowsiness, caution should be exercised in drivers of motor vehicles or mechanical machinery.

Warnings and Precautions

Special warnings

This medicine is not effective in some forms of epilepsy.

If the frequency of seizures increases or the appearance of seizures of a different type, CONSULT YOUR DOCTOR IMMEDIATELY.

Do not suddenly stop treatment. Indeed, a sudden stop can cause the reappearance of the attacks.

Precautions for use

Alcohol intake is strongly discouraged during treatment.

Get regular monitoring from your doctor. Treatment should be stopped in the event of a generalized allergic reaction, rash, or changes in liver function.

NEVER LEAVE WITHIN THE REACH OF CHILDREN.

Use this medication WITH CAUTION in case of:

Liver disease,
Kidney disease,
Respiratory problems.

If you must be hospitalized, tell the medical staff that you are taking this medicine.

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & FERTILITY

Women of childbearing potential / Contraception

Phenobarbital should not be used in women of childbearing potential and pregnant women, except in the absence of a less teratogenic therapeutic alternative. If treatment is initiated in a woman of childbearing age, ensure that pregnancy is not present and that she is informed of the risk in the event of exposure during pregnancy. Women of childbearing potential should use effective contraception during treatment and for up to 2 months after stopping treatment. Due to the enzyme inducing nature of phenobarbital, treatment with ALEPSAL may reduce the effectiveness of oral contraceptives containing estrogen and / or progesterone. If the association proves necessary, use an additional mechanical method.
If pregnancy is planned, discontinuation of treatment should be considered except in the absence of a less teratogenic therapeutic alternative.

Pregnancy

Risk associated with epilepsy and antiepileptics in general :

Specialist medical advice should be given to women of childbearing age, with regular re-evaluation of treatment, by a specialist doctor. They must be informed, before the start of treatment, of the need to anticipate a pregnancy plan. When a woman plans to become pregnant, the need for antiepileptic treatment should be reassessed and appropriate follow-up put in place. Combination antiepileptic therapy may be associated with a higher risk of birth defects than monotherapy; this risk varies depending on the antiepileptics co-administered and is, in particular, greater if the combination therapy includes valproate.
In women being treated for epilepsy, abrupt discontinuation of antiepileptic therapy should be avoided as this may result in the recurrence of seizures, the consequences of which for the mother and the fetus may be serious.

Risk associated with phenobarbital :

In humans, phenobarbital can lead to a risk of malformations approximately 3 times greater than that of the general population which is 2-3%, in particular cleft lip and / or palate, heart defects and hypospadias. Facial dysmorphias, microcephaly, and hypoplasia of the fingernails and fingers have also been reported. Published data suggest a dose-effect relationship, but this remains to be confirmed. Studies on neurodevelopmental disorders in children exposed in utero to phenobarbital are contradictory, but they do not rule out a risk.
Phenobarbital crosses the placenta and maternal and neonatal concentrations are similar.
In view of these data, phenobarbital should not be used in women of childbearing potential and pregnant women, except in the absence of a less teratogenic therapeutic alternative.

In women of childbearing age :

· It is recommended to use less teratogenic therapeutic alternatives;

– In case of initiation of treatment with phenobarbital:

Make sure that the woman of childbearing age is not pregnant

Patients must be informed of the risks of using phenobarbital during pregnancy and of the need to anticipate a planned pregnancy;
Patients should use effective contraception during treatment and up to 2 months after stopping treatment. Due to the enzymatic inducing nature of phenobarbital, treatment with ALEPSAL may lead to failure of oral contraceptives containing estrogen and / or progesterone. If the association proves necessary, use an additional mechanical method.

If a woman is planning to become pregnant and the pregnant woman :

A preconception visit is recommended
Discontinuation of therapy should be considered except in the absence of therapeutic alternative less teratogenic
The patient should be fully informed of the risks
If, after reassessment, phenobarbital treatment should absolutely be maintained during pregnancy:
- the minimum effective dosage should be administered. Regular monitoring of plasma concentrations is recommended to adjust the dosage.
- The efficacy of folic acid supplementation has not yet been substantiated in women exposed to phenobarbital. However, given its beneficial effect in other situations, it can be offered at a dosage of 5 mg / day 1 month before and 2 months after conception.
- Specialized prenatal surveillance focused on the malformations described above should be instituted.
- Screening for malformations will be the same whether or not the patient has received folic acid.

Before childbirth / In the newborn :

Enzyme-inducing antiepileptics can sometimes cause in the newborn of treated mothers:

Haemorrhagic syndrome can occur during childbirth or in the first days of life. Prevention with oral vitamin K1 in the mother in the month preceding childbirth and the administration of vitamin K1 by parenteral route (IM or slow IV) at birth in the newborn seem effective. A normal hemostasis test in the mother does not rule out hemostasis abnormalities in the newborn.
Disturbances of phosphocalcic metabolism and bone mineralization, which vitamin D supplementation of the mother during the 3rd trimester seems to be able to prevent.
Symptoms related to the impregnation of the newborn with phenobarbital, including sedation, hypotonia and poor suck.
Rarely: mild withdrawal syndrome (abnormal movements, sucking ineffective).

Post-natal follow-up / In children : in the event of exposure during pregnancy, close monitoring of the child’s neurobehavioural development should be instituted and appropriate treatment should be implemented as soon as possible if necessary.

Feeding with milk

Not recommended, because the possibility of sedation can lead to sucking difficulties causing a bad weight curve in the immediately neonatal period.

What happens if I overdose from Alepsal ?

Notify your doctor or hospital.

What should I do if I miss a dose?

If you forget to take a dose, take it as soon as you remember, but if you remember when it is time for your next dose, do not take a double dose. Then continue as before.

What happens if you stop taking Alepsal ?

If you stop taking ALEPSAL 150 mg tablet:

Stopping treatment should be done gradually; in fact, abrupt stopping of treatment (or a significant reduction in the doses) may lead to the recurrence of seizures.

What is Forms and Composition ?

Appearance and shape

Compressed.
30 tablets in blister packs (PVC – Aluminum).

Other shapes

ALEPSAL 50 mg, tablet, box of 500
ALEPSAL 50 mg, tablet, box of 2000
ALEPSAL 15 mg, tablet, box of 30
ALEPSAL 50 mg, tablet, box of 30
ALEPSAL 100 mg, tablet, box of 30

Composition

Active ingredient Compressed

Phenobarbital 150 mg *

Caffeine 37.5 mg *

* per unit dose

Active ingredients: Phenobarbital , Caffeine

Excipients: Carboxymethylcellulose Sodium polymer (ACDISOL) , Polysorbate 80 , Povidone (PLASDONE KW 29-32) , Magnesium stearate , Microcrystalline cellulose (EMCOCELL) , Caramel , Copper chlorophyll 100%

No excipient with known effect ?

is not present in the composition of this drug

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Caffeine Phenobarbital