NEURONTIN 400 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

GABAPENTIN

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

N03AX12

الشكل الصيدلاني:

CAPSULES

تركيب:

GABAPENTIN 400 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

المجموعة العلاجية:

GABAPENTIN

المجال العلاجي:

GABAPENTIN

الخصائص العلاجية:

Epilepsy :- Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents ( age 12 and up ) with epilepsy.- Treatment of neuropathic pain- Gabapentin is indicated for the treatment of neuropathic pain in diabetic neuropathy or postherpetic neuropathy(neuralgia) in adults.

تاريخ الترخيص:

2022-03-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
NEURONTIN
® 300 MG
CAPSULES
NEURONTIN
® 400 MG
CAPSULES
COMPOSITION
COMPOSITION
Each capsule contains:
Each capsule contains:
gabapentin 300 mg
gabapentin 400 mg
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this medicine’s ingredients’ and section
6
‘Further
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if it seems to you that their medical condition
is similar to yours.
THIS MEDICINE IS INDICATED FOR THE TREATMENT OF EPILEPSY IN ADULTS
AND ADOLESCENTS OVER 12 YEARS OF AGE. THIS MEDICINE IS INDICATED
FOR THE TREATMENT OF NEUROPATHIC PAIN IN ADULTS OVER 18 YEARS OF
AGE.
1. WHAT IS THIS MEDICINE INTENDED FOR?
EPILEPSY:
As adjunctive therapy in the treatment of partial seizures, with and
without secondary generalization, in adults and adolescents (age 12
and up) with epilepsy.
NEUROPATHIC PAIN:
For the treatment of neuropathic pain in diabetic neuropathy or
postherpetic neuropathy (neuralgia) in adults.
THERAPEUTIC GROUP: Anticonvulsant.
Your doctor will prescribe Neurontin for you to help treat epilepsy
when the current treatment is not fully controlling your condition.
Your
doctor
will
prescribe
Neurontin
to
treat
neuropathic
pain
(chronic pain due to damage to the nerves) following shingles or
diabetes in adults.
Pain sensations may be described as:
hot, burning, throbbing, shooting, stabbing, sharp, cramping,
tingling,
numbness, pins and needles, etc.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to the active ingredient (gabapentin)
or to any of the other ingredients in this medicine (see section 6).
SPECIAL W

خصائص المنتج

Neurontin 300mg_ 400mg, Capsules LPD CC 27 Sep 2023
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8
NEURONTIN
®
300 MG
NEURONTIN
®
400 MG
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Neurontin 300 mg capsules
Neurontin 400 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
300 mg: Each capsule contains 300 mg of gabapentin.
400 mg: Each capsule contains 400 mg of gabapentin.
Excipients with known effect:
300 mg: Each capsule contains 42.75 mg lactose monohydrate.
400 mg: Each capsule contains 57 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
300 mg:
A two-piece, yellow opaque hard gelatin capsule, imprinted with
'Neurontin 300 mg' and 'PD'
and containing a white to off-white powder.
400 mg:
A two-piece, orange opaque hard gelatin capsule, imprinted with
'Neurontin 400 mg' and 'PD'
and containing a white to off-white powder.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and
without secondary generalization in adults and adolescents (age 12 and
up) with epilepsy (see
section 5.1).
Treatment of neuropathic pain
Gabapentin is indicated for the treatment of neuropathic pain in
diabetic neuropathy or post-
herpetic neuropathy (neuralgia) in adults.
4.2
Posology and method of administration
Posology
Neurontin 300mg_ 400mg, Capsules LPD CC 27 Sep 2023
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8
For all indications a titration scheme for the initiation of therapy
is described in Table 1,
which is recommended for adults and adolescents aged 12 years and
above.
Table 1
DOSING CHART – INITIAL TITRATION
Day 1
Day 2
Day 3
300 mg once a day
300 mg two times a day
300 mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is
recommended this should be done gradually over a minimum of 1 week
independent of the
indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by
the treating physician
according to indi