Phenytoin sodium 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenytoin sodium

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N03AB02

INN (International Name):

Phenytoin sodium

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04080100

Patient Information leaflet

Phenytoin Sodium 100 mg capsules PIL - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. Pharmacode
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAI7813
6
25.02.16
DR
02.06.16
DR
IL/Apex Laboratories Pvt Ltd
180 x 240
8.5pt
25.02.16
20.05.16
SPACE FOR
PHARMA-
CODE
PHENYTOIN SODIUM NRIM
100MG CAPSULES
PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
• 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. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Phenytoin Capsules are and what they are used for
2.
Before you take Phenytoin Capsules
3.
How to take Phenytoin Capsules
4.
Possible side effects
5.
How to store Phenytoin Capsules
6.
Further Information
1. WHAT PHENYTOIN CAPSULES ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Phenytoin sodium NRIM 100mg Capsules
(referred to as Phenytoin Capsules or as Phenytoin throughout this
leaflet).
Phenytoin belongs to a group of medicines called anti-epileptic drugs;
these
medicines are used to treat epilepsy.
Phenytoin can be used to control a variety of epileptic conditions, 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 capsules.
2. BEFORE YOU TAKE PHENYTOIN CAPSULES
You should not take Phenytoin until you are sure it is safe for you to
do so.
DO NOT TAKE PHENYTOIN
-
if you are allergic (hypersensitive) to phe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenytoin Sodium NRIM 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100mg of phenytoin sodium.
Each capsule also contains 85.50 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, Hard (capsules)
Size “3” Hard gelatin capsule with orange transparent coloured cap
printed with
“146” and white coloured body, containing white granular powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenytoin Sodium NRIM 100mg Capsules are indicated for the following:
-
Control of tonic-clonic seizures (grand mal epilepsy), partial
seizures (focal
including temporal lobe) or a combination of these
-
The
prevention
and
treatment
of
seizures
occurring
during
or
following
neurosurgery and/or severe head injury.
Phenytoin Sodium NRIM 100mg Capsules have also been employed in the
treatment
of
trigeminal
neuralgia
but
should
only
be
used
as
second
line
therapy
if
carbamazepine is ineffective or patients are intolerant to
carbamazepine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Phenytoin Sodium NRIM Capsules contain phenytoin sodium. Although
100mg of
phenytoin sodium is equivalent to 92mg of phenytoin on a molecular
weight basis,
these molecular equivalents are not necessarily biologically
equivalent. Physicians
should therefore exercise care in those situations where it is
necessary to change the
dosage form and serum level monitoring is advised.
Posology
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 rec