Apo-Gabapentin

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Gabapentin 600mg;  

Pieejams no:

Apotex NZ Ltd

SNN (starptautisko nepatentēto nosaukumu):

Gabapentin 600 mg

Deva:

600 mg

Zāļu forma:

Film coated tablet

Kompozīcija:

Active: Gabapentin 600mg   Excipient: Copovidone Hyprolose Hypromellose Macrogol 8000 Magnesium stearate Titanium dioxide

Vienības iepakojumā:

Blister pack, Al/Al blister, 100 tablets

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Zhejiang Chiral Medicine Chemicals Co. Limited

Ārstēšanas norādes:

Gabapentin is indicated for the treatment of neuropathic pain in adults over 18 years of age

Produktu pārskats:

Package - Contents - Shelf Life: Blister pack, Al/Al blister - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al blister - 500 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE bottle - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE bottle - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Autorizācija datums:

2008-11-21

Lietošanas instrukcija

New Zealand Consumer Medicine Information
APO-GABAPENTIN
_GABAPENTIN _
100mg, 300mg & 400mg Capsules and 600mg & 800mg Tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Gabapentin.
This leaflet answers some common questions about Apo-Gabapentin. 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 using
Apo-Gabapentin against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT APO-GABAPENTIN IS USED FOR
The name of your medicine is Apo-Gabapentin. It contains the active
ingredient
gabapentin.
Apo-Gabapentin is used to:
•
Control epilepsy, a condition that causes repeated seizures (fits).
There are
many different types of seizures, ranging from mild to severe
•
Treat neuropathic pain (pain due to nerves being damaged or affected).
_HOW IT WORKS _
Gabapentin belongs to a group of medicines called anticonvulsants.
It is thought to work by controlling brain chemicals which send
signals to nerves to
help control seizures or neuropathic pain.
This medicine helps to relieve pain.
Your doctor may prescribe gabapentin in addition to your current
treatment when
your current treatment is no longer working as well.
Your doctor may have prescribed Apo-Gabapentin for another reason.
2
Ask your doctor if you have any questions about why Apo-Gabapentin has
been
prescribed for you.
This medicine is available only with a doctor's prescription.
THERE IS EVIDENCE THAT THIS MEDICINE CAN LEAD TO DEPENDENCE.
_USE IN CHILDREN _
Gabapentin is not recommended for use in children under the age of:
•
3 years to control epilepsy
•
18 years for the treatment of neuropathic pain.
BEFORE YOU USE APO-GABAPENTIN
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Gabapentin if:
•
YOU ARE HYPERSENSITIVE TO,

Produkta apraksts

NEW ZEALAND DATA SHEET
APO-GABAPENTIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 24
1. APO-GABAPENTIN (100MG, 300MG & 400MG CAPSULES AND 600MG
& 800MG FILM COATED TABLETS)
APO-GABAPENTIN 100mg capsules
APO-GABAPENTIN 300mg capsules
APO-GABAPENTIN 400mg capsules
APO-GABAPENTIN 600mg film coated tablets
APO-GABAPENTIN 800mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100mg capsule contains 100mg of gabapentin
Each 300mg capsule contains 300mg of gabapentin
Each 400mg capsule contains 400mg of gabapentin
Each 600mg tablet contains 600mg of gabapentin
Each 800mg capsule contains 800mg of gabapentin
Chemical Structure:
EXCIPIENT(S) WITH KNOWN EFFECT
Apo-Gabapentin is gluten free and lactose free
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Apo-Gabapentin 100mg are hard gelatin capsules with a white opaque
body and a white
opaque cap. Each is imprinted with “Apo 112” in black ink.
Apo-Gabapentin 300mg are hard gelatin capsules with a white opaque
body and a yellow
opaque cap. Each is imprinted with “Apo 113” in black ink.
Apo-Gabapentin 400mg are hard gelatin capsules with a white opaque
body and an
orange opaque cap. Each is imprinted with “Apo 114” in black ink.
APO-GABAPENTIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 24
Apo-Gabapentin 600 mg tablets are white, oval biconvex tablets;
engraved “GAB” over
partial bisect “600” on one side and “APO” on the other side.
Apo-Gabapentin 800 mg tablets are white, oval biconvex tablets;
engraved “GAB” over
European bisect “800” on one side and “APO” on the other side.
The tablets can be divided into equal doses
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPILEPSY
Gabapentin is indicated for the treatment of partial seizures with or
without secondarily
generalized tonic-clonic seizures, in adults and children age 3 years
and above who have
not achieved adequate control with standard