Nupentin

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Gabapentin 400mg

थमां उपलब्ध:

Viatris Limited

INN (इंटरनेशनल नाम):

Gabapentin 400 mg

डोज़:

400 mg

फार्मास्यूटिकल फॉर्म:

Capsule

रचना:

Active: Gabapentin 400mg Excipient: Gelatin Iron oxide red Iron oxide yellow Lactose monohydrate Maize starch Purified talc Sunset yellow FCF Titanium dioxide

पैकेज में यूनिट:

Blister pack, Clear PVC/PE/PVDC-Al, 100 capsules

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Zhejiang Chiral Medicine Chemicals Co. Limited

चिकित्सीय संकेत:

Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard antiepileptic drugs.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Blister pack, Clear PVC/PE/PVDC-Al - 100 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, Blue HDPE with blue wadded PP child resistant cap - 100 capsules - 36 months from date of manufacture stored at or below 25°C

प्राधिकरण की तारीख:

2005-05-02

सूचना पत्रक

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
NUPENTIN
®
_GABAPENTIN 100MG, 300MG & 400MG CAPSULES_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nupentin.
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 Nupentin
against the benefits they expect it
will 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 NUPENTIN IS
USED FOR
Nupentin is used to control certain
types of epilepsy. Epilepsy is a
condition where you have repeated
seizures (fits). There are many
types of seizures, ranging from mild
to severe.
Nupentin is also used in the
treatment of neuropathic pain, a
type of pain caused by damage to
the nerves.
Nupentin contains the active
ingredient gabapentin. Gabapentin
belongs to a group of medicines
called anticonvulsants. These
medicines work by controlling brain
chemicals which send signals to
nerves to help control seizures or
neuropathic pain.
Your doctor may prescribe Nupentin
in addition to your current therapy
when your treatment is no longer
working as well.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
Some people may become
dependent on Nupentin.
This medicine is available only with
a doctor’s prescription.
_USE IN CHILDREN_
Nupentin is not recommended for
use in children under the age of:
•
3 years to control epilepsy
•
18 years for the treatment of
neuropathic pain.
The safety and effectiveness of
Nupentin in children of these age
groups have not been established.
BEFORE YOU TAKE
NUPENTIN
_WHEN YOU MUST NOT TAKE _
_IT:_
DO NOT TAKE NUPENTIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
gabapentin
•
any of the ingredients listed at
the end of this leaflet.
Some of the sympt

उत्पाद विशेषताएं

Page 1 of 19
NEW ZEALAND DATA SHEET
NUPENTIN
®
1. PRODUCT NAME
NUPENTIN, 100 mg, 300 mg & 400 mg capsules.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
Excipient with known effect: Lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nupentin 100 mg: size 3 capsule with white body and white cap,
“GP100” printed in black ink on the
body and “G” on the cap.
Nupentin 300 mg: size 1 capsule with yellow body and yellow cap,
“GP300” printed in black ink on
the body and “G” on the cap.
Nupentin 400 mg: size 0 capsule with orange body and orange cap,
“GP400” printed in black ink on
the body and “G” on the cap.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
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).
Indicated for the treatment of neuropathic pain (see section 4.2).
_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. Gabapentin can be
given orally with or without
food.
In controlled clinical trials, the effective dose range was 900 mg/day
to 1800 mg/day given in divided
doses (three times a day).
Therapy may be initiated by administering 300 mg gabapentin three
times a day on Day 1 or by
titrating the dose as described: titration to an effective dose can
take place rapidly, over a few days
Page 2 of 19
by giving 300 mg on day 1, 300 mg twice a day on day 2, then 300 mg
three times a day on day 3.
Titration may be preferable for patients with renal impairment,
patients with encephalopathy, patients
on more than two other antiepileptic medications and patients with
multiple other medical problems.
To minimise potential side effects, especially somnolence, dizziness,
fatigue and ataxia, the first
dose