Composition- Sodium Phenytoin, Lactose and
Information for the User- Recommended for
crises involving Grand Mal, temporal lobe epilepsy and other colvulsive
Directions- The average dosage for adults and
children over the age of six is 0.10 gram (one capsule) three times per day
before meals. Should an additional dose of 0.10 grams be necessary, this may be
taken at bedtime. the total adult dosage should not exceed 0.60 grams per day.
Children between the age of four and six should initially take a dose of 0.10
grams twice daily. For younger children and nursing mothers, the initial dose is
0.05 grams twice daily. to order
Guidelines for the Correct Use of this Product-
Following every dose of Epanutin®, the patient should drink at least half a glass
of water. Should he suffer from nausea or gastric distress, these doses may be
taken during or after meals. Contraindications- Epanutin® is not recommended for
patients with a history of hypersensitivity to hydantoins. Because the safety of
this product during pregnancy has not been proven, it's use should be evaluated
not only according to the benefits involved, but also the possible danger to the
foetus. Recent studies suggest an increased risk of birth defects when the
mother receives treatment for epilepsy during pregnancy. Caution- This product
contains Lactose. Cases have been reported of poor tolerance to this product in
children and adolescents. Although the amount of Lactose in this product is
probably not sufficient to cause intolerance symptoms. Consult a doctor in the
case of diarrhea. Pregnant Women and Nursing Mothers- With Epilepsy and it's
treatment there is a 4% risk of birth defects in new-borns (approximately double
that of the general population).
We recommend the following guidelines-
1. Plan your pregnancies with the help of your specialist.
2. If you are already pregnant, do not interrupt treatment and consult your
3. If you are breast-feeding, consult your pediatrician.
Interaction- Epanutin® should not be taken with
barbiturates, coumarinic anticoagulants, Disulfiram, Phenylbutazone and
Sulphaphenazol, Isoniazid, tricyclic antidepressants, Methopyrone and
Central Nervous System- Nystagmus-
Ataxia, slurring and speech alterations, mental confusion, dizziness, insomnia,
temporary nervousness and headaches. The effects will most likely disappear with
continued use of the product, although a weaker dose is recommended.
System- Possible nausea, vomiting and constipation. Taking this product during
or immediately after meals may prevent gastrointestinal symptoms.
Effects- Rash, Morbiliform or scarlatiniform types have been seen in children
and young adults. Hematological alterations, Thrombocytopenia, leucopenia,
granulcytosis, agranulcytosis and pancytopenia. Frequent cases of gingival
hyperplasia have appeared but this problem may be avoided with good oral
hygiene, including gum massage, frequent cleaning and proper dental care.
Intoxication and its Treatment- Intoxication is treated by stomach pumping.
Oxygen therapy, vasopressors and assisted ventilation may be necessary in the
case of depression of the central nervous, respiratory and cardiovascular
systems. Blood replacement therapy has been employed in cases of severe
intoxication in children.
Storage Conditions- Keep in a cool dry place.