WP GABAPENTIN gabapentin 600 mg film coated tablets blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

gabapentin, Quantity: 600 mg

Pieejams no:

MedTAS Pty Ltd

Zāļu forma:

Tablet, film coated

Kompozīcija:

Excipient Ingredients: magnesium stearate; hyprolose; purified talc

Ievadīšanas:

Oral

Vienības iepakojumā:

10, 20, 30, 45, 50, 60, 84, 90 or 100 tablets.

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

GABAPENTIN B&B 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 B&B is indicated for the treatment of neuropathic pain.

Produktu pārskats:

Visual Identification: White to off white, oval, biconvex, film coated tablets approx.18.00 mm long and 9.20 mm wide, engraved with '600' on one face and plain on the other; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorizācija statuss:

Registered

Autorizācija datums:

2017-12-05

Lietošanas instrukcija

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
WP Gabapentin.
WP GABAPENTIN
2
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 Gab

Produkta apraksts

PRODUCT INFORMATION
GABAPENTIN B&B
600 MG /800 MG TABLETS
NAME OF THE MEDICINE
Gabapentin B&B (gabapentin) 600 mg and 800 mg Tablets
Gabapentin B&B contains the active ingredient gabapentin. The
structural formula of
gabapentin is shown below:
Chemical name
: 1-(aminomethyl) cyclohexaneacetic acid
Molecular formu1a
: C
9
H
17
NO
2
Molecular weight
: 171.24
CAS Registry Number
: 60142-96-3
DESCRIPTION
Gabapentin is a white to off-white crystalline powder. It is freely
soluble in water and both
basic and acidic aqueous solutions.
It has values for LogP of -1.10, and values for pKa of
3.68 and 10.70.
Gabapentin B&B tablets also contain the following inactive
ingredients: hyprolose,
magnesium stearate and Opadry white YS-1-18111 (ARPING No.
3289).
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism by which gabapentin exerts its anticonvulsant action is
unknown.
Gabapentin is structurally related to the neurotransmitter GABA
(gamma-aminobutyric acid)
but its mechanism of action is different from that of several other
drugs that interact with
GABA synapses including valproate, barbiturates, benzodiazepines, GABA
transaminase
inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs.
_In vitro _
studies
with radiolabelled gabapentin have characterised a novel peptide
binding site in rat brain
tissues including neocortex and hippocampus that may relate to
anticonvulsant activity of
gabapentin and its structural derivatives. However, the identification
and function of the
gabapentin
binding
site
remains
to
be
elucidated.
Gabapentin
at
relevant
clinical
concentrations does not bind to other common drug or neurotransmitter
receptors of the brain
including GABA
A
, GABA
B
, benzodiazepine, glutamate, glycine or
_N_
-methyl-d-aspartate
receptors.
Gabapentin does not interact with sodium channels
_in vitro_
and so differs from phenytoin and
carbamazepine. Several test systems ordinarily used to assess activity
at the NMDA receptor
complex have been examined. Results are contradictory. Accordingly no
general statement
about