Phenytoin sodium 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenytoin sodium

Available from:

Dowelhurst Ltd

ATC code:

N03AB02

INN (International Name):

Phenytoin sodium

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04080100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENYTOIN SODIUM MILPHARM 100 MG
FILM-COATED TABLETS
phenytoin sodium
Black
PHENYTOIN SODIUM
P15XXXXX
PHENYTOIN SODIUM
P15XXXXX
Pharmacode position may change as per Supplier’s m/c requirement &
additional
small pharma code may appear on the front / back panel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Phenytoin Milpharm tablets are and what they are used
for
2.
What you need to know before you take Phenytoin Milpharm
tablets
3.
How to take Phenytoin Milpharm tablets
4.
Possible side effects
5.
How to store Phenytoin Milpharm tablets
6.
Contents of the pack and other information
1.
WHAT PHENYTOIN MILPHARM TABLETS ARE AND WHAT THEY ARE
USED FOR
The name of your medicine is Phenytoin Sodium Milpharm 100 mg
film-coated tablets (referred to as Phenytoin tablets or as Phenytoin
throughout this leaflet).
Phenytoin is one of a group of medicines called anti-epileptic drugs;
these medicines are used to treat epilepsy.
Phenytoin tablets can be used to control a variety of epileptic
conditions (tonic-clonic seizures and partial seizures), to control or
prevent seizures during or after brain surgery or severe head injury.
Phenytoin can also be used to treat trigeminal neuralgia (facial
nerve pain).
You should ask your doctor if you are unsure why you have been
given Phenytoin tablets.
Note: Phenytoin sodium is not effective in absence status
epilepticus or in the prophylaxis and treatment of febrile
convulsions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENY

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenytoin sodium Milpharm 100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of phenytoin sodium
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval shaped, film-coated tablets debossed with
‘C’ on one side
and ‘70’ on the other side. The size is 11.6 mm X 6.5 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenytoin sodium 100 mg tablets are indicated for the following:
•
Control of tonic-clonic seizures (grand mal epilepsy), partial
seizures (focal
including temporal lobe) or a combination of these
•
Prevention and treatment of seizures occurring during or following
neurosurgery
and/or severe head injury.
Phenytoin sodium has also been employed in the treatment of trigeminal
neuralgia
but it should only be used as second line therapy if carbamazepine is
ineffective
or patients are intolerant to carbamazepine.
Note:
Phenytoin sodium is not effective in absence status epilepticus or in
the
prophylaxis and treatment of febrile convulsions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dosage: _
Dosage should be individualised as there may be wide interpatient
variability in
phenytoin serum levels with equivalent dosage. Phenytoin should be
introduced in
small dosages with gradual increments until control is achieved or
until toxic effects
appear. In some cases serum level determinations may be necessary for
optimal
dosage adjustments - the clinically effective level is usually
10-20mg/l (40-80
micromoles/l) although some cases of tonic-clonic seizures may be
controlled with
lower serum levels of phenytoin. With recommended dosage a period of
seven to ten
days may be required to achieve steady state serum levels with
Phenytoin and
changes in dosage should not be carried out at intervals shorter than
seven to ten days.
Maintenance of treatment should be the lowest dose of anticonvulsant
consistent with
c