WP GABAPENTIN gabapentin 400 mg capsule blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

gabapentin, Quantity: 400 mg

Dostupno od:

MedTAS Pty Ltd

INN (International ime):

Gabapentin

Farmaceutski oblik:

Capsule, hard

Sastav:

Excipient Ingredients: maize starch; purified talc; titanium dioxide; purified water; iron oxide red; iron oxide yellow; Gelatin; sodium lauryl sulfate

Administracija rute:

Oral

Jedinice u paketu:

PVC/ PVDC-Aluminium blister pack of 100 capsules (10x10C in carton)

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Gabapentin is indicated for the 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 anti-epileptic drugs.,Gabapentin is indicated for the treatment of neuropathic pain.

Proizvod sažetak:

Visual Identification: Orange-Orange colour size'0' hard gelatin capsule contains free flowing white crystalline powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

2017-04-28

Uputa o lijeku

WP GABAPENTIN
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1. WHY AM I USING WP GABAPENTIN?
2. WHAT SHOULD I KNOW BEFORE I USE WP GABAPENTIN?
3. WHAT IF I AM TAKING OTHER MEDICINES?
4. HOW DO I USE WP GABAPENTIN?
5. WHAT SHOULD I KNOW WHILE USING WP GABAPENTIN?
WP GABAPENTIN
The full CMI on the next page has more details. If you are worried
about using this medicine,
speak to your doctor or pharmacist.
WP Gabapentin contains the active ingredient gabapentin. WP Gabapentin
is used to
control epilepsy.
For more information, see Section 1. Why am I using WP Gabapentin? in
the full CMI.
Do not use if you have ever had an allergic reaction to WP Gabapentin
or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR
ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
WP Gabapentin? in
the full CMI.
Some medicines may interfere with WP Gabapentin and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
•
Your doctor will decide what dose of WP Gabapentin you will receive.
The dosage will
depend on your condition.
More instructions can be found in Section 4. How do I use WP
Gabapentin? in the full
CMI.
THINGS YOU SHOULD DO
•
If you are about to be started on any new medicine, remind
your doctor and pharmacist that you are taking Gabapentin
WP GABAPENTIN
2
B&B.
THINGS YOU SHOULD NOT
DO
•
Do not take WP Gabapentin to treat any other
complaints unless your doctor tells you to.
•
Do not give WP Gabapentin to anyone else, even if their
symptoms seem similar to yours or they have the same
condition as you.
•
Do not stop taking WP Gabapentin or lower the dose
without checking with your doctor.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know
how WP Gabapentin affects you.
DRINKING ALCOHOL
•
Be careful when drinking alcohol while you are taking
WP Gaba

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN B&B
(GABAPENTIN)
1. NAME OF THE MEDICINE
Gabapentin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin B&B 100 mg capsules contains 100 mg, of gabapentin.
Gabapentin B&B 300 mg capsules contains 300 mg, of gabapentin
Gabapentin B&B 400 mg capsules contains 400 mg, of gabapentin
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
GABAPENTIN CAPSULES, 100MG:
Size ‘3’ hard gelatin capsule with white body and white cap,
containing 100 mg of gabapentin.
GABAPENTIN CAPSULES, 300MG:
Size ‘1’ hard gelatin capsule with yellow body and yellow
cap, containing 300 mg of gabapentin.
GABAPENTIN CAPSULES, 400MG:
Size ‘0’ hard gelatin capsule with orange body and orange
cap, containing 400 mg of gabapentin.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gabapentin is indicated for the 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 anti-epileptic
drugs.
Gabapentin is indicated for the treatment of neuropathic pain.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE _
Initiation of treatment should be as add-on therapy. Gabapentin B&B
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 of Gabapentin B&B
three times a day on
Day 1, as 300 mg capsules, or by titrating the dose as described
below.
Titration to an effective dose can take place rapidly, over a few
days, giving 300 mg
Gabapentin B&B on Day 1, 300 mg Gabapentin B&B twice a day on Day 2,
300 mg
Gabapentin B&B three times a day on Day 3, as 300 mg capsules.
Titration may be preferable
for patients with renal impairment, patients with encephalopathy,
patients on more than 2
othe