Phenytoin sodium 50mg capsules

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Phenytoin sodium

থেকে পাওয়া:

Flynn Pharma Ltd

এটিসি কোড:

N03AB02

INN (আন্তর্জাতিক নাম):

Phenytoin sodium

ডোজ:

50mg

ফার্মাসিউটিকাল ফর্ম:

Oral capsule

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Caution - AMP level prescribing advised

পণ্য সারাংশ:

BNF: 04080100; GTIN: 5060106551269

তথ্য লিফলেট

EPANUTIN
® 50MG HARD CAPSULES
(phenytoin sodium)
Your medicine is known by the above name but will be referred to as
Epanutin Hard Capsules throughout this:
PATIENT INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET:
1)
What Epanutin Hard Capsules are and what they are used for
2)
What you need to know before you take Epanutin Hard Capsules
3)
How to take Epanutin Hard Capsules
4)
Possible side effects
5)
How to store Epanutin Hard Capsules
6)
Contents of the pack and other information
1)
WHAT EPANUTIN HARD CAPSULES ARE AND WHAT THEY ARE USED
FOR
Epanutin Hard Capsules are one of a group of medicines called anti-
epileptic drugs; these medicines are used to treat epilepsy.
Epanutin Hard Capsules can be used to control a variety of epileptic
conditions, to control or prevent seizures during or after brain
surgery or
severe head injury. Epanutin Hard Capsules 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
Epanutin Hard Capsules.
2)
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPANUTIN HARD
CAPSULES
DO NOT TAKE EPANUTIN HARD CAPSULES
•
if you are allergic to Phenytoin, or any of the other ingredients of
this
medicine (listed in section 6).
•
if you are allergic to other medicines with a similar chemical
structure to
Phenytoin (e.g. hydantoins).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Epanutin Hard
Capsules.
Medicines are not always suitable for everyone.
Your doctor needs to know before you take Epanutin Hard Capsules if
you
suffer from or have suffered in the past from any of the following
conditions:
•
Liver disease.
•
Kidney disease.
•
Porphyria (an inherited disease that affects haemoglobin
biosynthesis).
The following symptoms have been reported in some people treated with
phenytoin at recommended doses:
•
shortness of breath, becoming unconscious, or unresponsive. All
can be the symptoms of the sudden, unexpected stopping of the
heart (known as cardiac arrest). If you or someone you know is

পণ্য বৈশিষ্ট্য

OBJECT 1
PHENYTOIN SODIUM FLYNN HARD CAPSULES 25MG
Summary of Product Characteristics Updated 13-Mar-2018 | Flynn Pharma
Ltd
1. Name of the medicinal product
Phenytoin Sodium Flynn 25 mg Hard Capsules
Phenytoin Sodium Flynn 50 mg Hard Capsules
Phenytoin Sodium Flynn 100 mg Hard Capsules
Phenytoin Sodium Flynn 300 mg Hard Capsules
2. Qualitative and quantitative composition
Each capsule contains 25 mg phenytoin sodium.
Each capsule also contains 66.857 mg lactose monohydrate
Each capsule contains 50mg phenytoin sodium
Each capsule also contains 90.71 mg lactose monohydrate
Each capsule contains 100mg phenytoin sodium
Each capsule also contains 96.15 mg lactose monohydrate
Each capsule contains 300mg phenytoin sodium
Each capsule also contains 61.88 mg lactose monohydrate
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Capsules, hard
Phenytoin Sodium Flynn 25 mg Hard Capsules
A white powder in a No 4 hard gelatin capsule with a white opaque body
and blue-violet cap, radially
printed 'EPANUTIN 25'.
Phenytoin Sodium Flynn 50 mg Hard Capsules
A white powder in a No 4 hard gelatin capsule with a white opaque body
and a flesh-coloured transparent
cap, radially printed 'EPANUTIN 50'
Phenytoin Sodium Flynn 100 mg Hard Capsules
A white powder in a No 3 hard gelatin capsule with a white opaque body
and orange cap, radially printed
'EPANUTIN 100'
Phenytoin Sodium Flynn 300 mg Hard Capsules
A white powder in a No 1 hard gelatin capsule with a white opaque body
and green cap, radially printed
'EPANUTIN 300'
4. Clinical particulars
4.1 Therapeutic indications
Phenytoin Sodium Flynn Hard Capsules are indicated for control of
tonic-clonic seizures (grand mal
epilepsy), partial seizures (focal including temporal lobe) or a
combination of these, and for the
prevention and treatment of seizures occurring during or following
neurosurgery and/or severe head
injury.
Phenytoin Sodium Flynn Hard Capsules has also been employed in the
treatment of trigeminal neuralgia
but it should only be used as second line ther