GABAPENTIN TEVA 800 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GABAPENTIN

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

N03AX12

Pharmaceutical form:

TABLETS

Composition:

GABAPENTIN 800 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

GABAPENTIN

Therapeutic area:

GABAPENTIN

Therapeutic indications:

Epilepsy :- Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents ( age 12 and up ) with epilepsy.- Treatment of neuropathic pain- Gabapentin is indicated for the treatment of neuropathic pain in diabetic neuropathy or postherpetic neuropathy(neuralgia) in adults.

Authorization date:

2016-07-31

Patient Information leaflet

GABA TAB PL SH 251216
GABA TAB PL SH 251216
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
GABAPENTIN TEVA
® 600 MG
TABLETS
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains:
Gabapentin 600 mg
GABAPENTIN TEVA
® 800 MG
TABLETS
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains:
Gabapentin 800 mg
For the list of inactive ingredients, please see
section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you.
Do not pass it on to others. It may harm them
even if it seems to you that their medical condition
is similar.
THIS MEDICINE IS INTENDED FOR TREATMENT OF
EPILEPSY IN ADULTS AND ADOLESCENTS ABOVE 12
YEARS OF AGE.
THIS MEDICINE IS INTENDED TO TREAT NEUROPATHIC
PAIN IN ADULTS FROM 18 YEARS OF AGE AND
ABOVE.
1. WHAT IS THE MEDICINE INTENDED
FOR?
∙ For treatment of various forms of epilepsy
(seizures that are initially limited to certain parts
of the brain, whether they spread to other parts
of the brain or not). The doctor will prescribe
gabapentin for you to help treat your epilepsy
when your current treatment does not provide
full control of your condition.
∙ For treatment of neuropathic pain (prolonged
pain caused by nerve damage) after herpes
or due to diabetes. Pain sensations may be
described as hot, burning, throbbing, shooting,
stabbing, sharp, cramping, tingling, numbing,
pins and needles and the like.
THERAPEUTIC GROUP:
Anticonvulsants.
2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF:
∙ There is a known sensitivity to gabapentin
or to any of the other ingredients (see
section 6: “Further Information”).
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE:
∙ A small number of people being treated with
anti-epileptics, such as gabapentin, had
suicidal thoughts or thoughts

Summary of Product characteristics

Neurontin 600mg_ 800mg, Tablets SmpC Notification New 112020
1
GABAPENTIN TEVA 600 MG
GABAPENTIN TEVA 800 MG
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Teva 600 mg Tablets
Gabapentin Teva 800 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
600 mg: Each tablet contains 600 mg of gabapentin.
800 mg: Each tablet contains 800 mg of gabapentin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
600 mg:
White to off white, oval shaped, beveled edge, tablet. On one side
engraved "7173" and on the
other engraved "93".
800 mg:
White to off white, oval shaped, beveled edge, tablet. On one side
engraved "7174" and on the
other engraved "93".
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and
without secondary generalization in adults and adolescents (age 12 and
up) with epilepsy (see
section 5.1).
Treatment of neuropathic pain
Gabapentin is indicated for the treatment of neuropathic pain in
diabetic neuropathy or post-
herpetic neuropathy (neuralgia) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all indications a titration scheme for the initiation of therapy
is described in Table 1, which
is recommended for adults and adolescents aged 12 years and above.
Neurontin 600mg_ 800mg, Tablets SmpC Notification New 112020
2
Table 1
DOSING CHART - INITIAL TITRATION
Day 1
Day 2
Day 3
300 mg once a day
300 mg two times a day
300 mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be
discontinued it is
recommended this should be done gradually over a minimum of 1 week
independent of the
indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by
the treating physician
according to individual tolerance and efficacy.
_Adults and adolescents:_
In clinical trials, the effective dosing range was 900 to 3600 mg/day.
Therapy may be initiated
by titrating the