Neurontin

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Gabapentin 800mg; Gabapentin 800mg

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Alþjóðlegt nafn):

Gabapentin 800 mg

Skammtar:

800 mg

Lyfjaform:

Film coated tablet

Samsetning:

Active: Gabapentin 800mg Excipient: Candelilla wax Crospovidone Magnesium stearate Maize starch Nitrogen Opacode Orange NS-78-13026 Opadry white YS-1-18111 Poloxamer 407 Purified water Active: Gabapentin 800mg Excipient: Candelilla wax Crospovidone Magnesium stearate Maize starch Nitrogen Opadry white YS-1-18111 Poloxamer 407 Purified water

Einingar í pakka:

Blister pack, PVC/PVDC/Al, 100 dose units

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Hikal Limited

Ábendingar:

NEURONTIN is indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures, in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 100 dose units - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Al - 100 dose units - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 100 dose units - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 500 dose units - 24 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2000-01-05

Upplýsingar fylgiseðill

NEURONTIN
®
1
NEURONTIN
(NEW-RON-TIN)
_gabapentin (gab-a-pen-tin) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Neurontin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Neurontin
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NEURONTIN IS
USED FOR
_WHAT NEURONTIN DOES _
Neurontin is used to control epilepsy.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of seizures,
ranging from mild to severe.
Neurontin is also used to treat
neuropathic pain, a type of pain
caused by damage to the nerves.
This medicine belongs to a group of
medicines called anticonvulsants.
_HOW NEURONTIN WORKS _
This medicine is thought to work by
controlling brain chemicals which
send signals to nerves to help control
seizures or neuropathic pain.
Neurontin also has pain relieving
effects.
Your doctor may have prescribed
Neurontin in addition to other
medicines that you may be taking.
This may be necessary if your current
treatment is no longer working as
well.
Your doctor may have prescribed
Neurontin for another reason.
Neurontin may lead to dependence
on this medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NEURONTIN HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
There is not enough information to
recommend the use of this medicine
in children:
•
under the age of 3 years to control
epilepsy, or
•
under the age of 18 years to treat
neuropathic pain.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NEURONTIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
gabapentin, the active ingredient
in Neurontin
•
any of the ingre

Vara einkenni

NEURONTIN – data sheet
Page 1 of 23
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
NEURONTIN 100 mg, 300 mg and 400 mg capsules
NEURONTIN 600 mg and 800 mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg capsule contains 100 mg of gabapentin.
Each 300 mg capsule contains 300 mg of gabapentin.
Each 400 mg capsule contains 400 mg of gabapentin.
Each 600 mg tablet contains 600 mg of gabapentin.
Each 800 mg tablet contains 800 mg of gabapentin.
Excipient(s) with known effect:
Each 100 mg capsule contains 13 mg lactose (as monohydrate).
Each 300 mg capsule contains 41 mg lactose (as monohydrate).
Each 400 mg capsule contains 54 mg lactose (as monohydrate).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3. PHARMACEUTICAL FORM
100 mg capsules: Size C capsules with white opaque body and cap, blue
imprint “Neurontin
100” and “PD”.
300 mg capsules: Size B capsules with yellow opaque body and cap, grey
imprint “Neurontin
300” and “PD”.
400 mg capsules: Size A capsules with orange opaque body and cap, grey
imprint “Neurontin
400” and “PD”.
600 mg tablets: White, elliptical film-coated tablets with bisecting
score on both sides and
debossed with “NT” and “16” on one side.
800 mg tablets: White, elliptical film-coated tablets with bisecting
score on both sides and
debossed with “NT” and “26” on one side.
NEURONTIN – data sheet
Page 2 of 23
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NEURONTIN is indicated for the treatment of partial seizures with or
without secondarily
generalised tonic-clonic seizures, in adults and children age 3 years
and above who have not
achieved adequate control with standard anti-epileptic drugs (see
SECTION 4.2 DOSE AND METHOD
OF ADMINISTRATION
).
NEURONTIN is indicated for the treatment of neuropathic pain (see
SECTION 4.2 DOSE AND
METHOD OF ADMINISTRATION
).
4.2 DOSE AND METHOD OF ADMINISTRATION
EPILEPSY
_Adults and Children Older than 12 Years of Age _
Initiation of treatment should be as add-on therapy.