GABAPENTIN GENERICHEALTH gabapentin 300 mg capsule blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

gabapentin, Quantity: 300 mg

Dostupné z:

Generic Health Pty Ltd

INN (Medzinárodný Name):

Gabapentin

Forma lieku:

Capsule

Zloženie:

Excipient Ingredients: lactose monohydrate; maize starch; purified talc; Gelatin; purified water; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Spôsob podávania:

Oral

Počet v balení:

500, 100, 20, 300, 1000, 50, 10, 150, 30

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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.

Prehľad produktov:

Visual Identification: Yellow/Yellow colored size 0 with cap M and body 300 printed with black ink, hard gelatin capsules, filled with white to off-white blend; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2016-12-19

Príbalový leták

CONSUMER MEDICINE INFORMATION
GABAPENTIN GENERICHEALTH
(GABAPENTIN) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Gabapentin generichealth. 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 Gabapentin generichealth
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 GABAPENTIN
GENERICHEALTH IS USED FOR
_WHAT GABAPENTIN _
_GENERICHEALTH DOES _
Gabapentin generichealth 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.
Gabapentin generichealth 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 GABAPENTIN _
_GENERICHEALTH WORKS _
This medicine is thought to work
by controlling brain chemicals
which send signals to nerves to
help control seizures or
neuropathic pain.
Gabapentin generichealth also
has pain relieving effects.
Your doctor may have
prescribed Gabapentin
generichealth 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 Gabapentin
generichealth for another
reason.
Gabapentin generichealth may
lead to dependence on this
medicine.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
GABAPENTIN GENERICHEALTH 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
GABAPENTIN
G

Súhrn charakteristických

AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN GENERICHEALTH
(GABAPENTIN) CAPSULES
1
NAME OF THE MEDICINE
Gabapentin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg, 300 mg or 400 mg of gabapentin as the
active ingredient.
List of excipients with known effect: sugars as lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Gabapentin generichealth capsules are intended for oral
administration.
100 mg capsules: White/White coloured size ‘3’ hard gelatin
capsules, filled with white to off-white
blend.
300 mg capsules: Yellow/Yellow colored size ‘0’ with cap ‘M’
and body ‘300’ printed with black ink, hard
gelatin capsules, filled with white to off-white blend.
400 mg capsules: Orange/Orange colored size ‘0el’ with cap ‘M’
and body ‘400’printed with black ink,
hard gelatin capsules, filled with white to off-white blend.
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.
WARNINGS:
ABUSE POTENTIAL OR DEPENDENCE
Gabapentin is a potential drug of abuse and dependence. Gabapentin
poses risks of abuse and
dependence which can lead to overdose and death especially when used
concomitantly with opioids and
other CNS depressants. Assess the patient’s risk of abuse or
dependence before prescribing and monitor
the patient regularly during treatment, particularly amongst patients
with current or past abuse or
dependence of opioids and/or benzodiazepines (see SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR
USE).
Gabapentin generichealth v6
Page 2 of 21
(gabapentin) capsules
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Epilepsy Dosage for Adults and Children Older than 12 Years of Age
Initiation