Gabapentin Thame 50mg/ml Oral Solution

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

GABAPENTIN

Disponibbli minn:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

Kodiċi ATC:

N02BF01

INN (Isem Internazzjonali):

GABAPENTIN 50 mg/ml

Għamla farmaċewtika:

ORAL SOLUTION

Kompożizzjoni:

GABAPENTIN 50 mg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANALGESICS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2019-03-12

Fuljett ta 'informazzjoni

1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
GABAPENTIN THAME 50MG/ML ORAL SOLUTION
gabapentin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Gabapentin Thame 50mg/ml Oral Solution
but it will be
referred to as Gabapentin throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN
3. HOW TO TAKE GABAPENTIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE GABAPENTIN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR
Gabapentin contains the active substance gabapentin which belongs to a
group of medicines
used to treat epilepsy and peripheral neuropathic pain (long-lasting
pain caused by damage to
the nerves).
You must talk to a doctor if you do not feel better or if you feel
worse.
GABAPENTIN IS USED TO TREAT:

Various forms of epilepsy (seizures that are initially limited to
certain parts of the brain,
whether the seizure spreads to other parts of the brain or not). Your
doctor will prescribe
Gabapentin for you to help treat your epilepsy when your current
treatment is not fully
controlling your condition. You should take Gabapentin in addition to
your current
treatment unless told otherwise. Gabapentin can also be used on its
own to treat adults and
children over 12 years of age.

Peripheral neuropathic pain (long-lasting pain caused by damage to the
nerves). A variety
of different diseases can cause peripheral neuropathic pain (primarily
occurr

Karatteristiċi tal-prodott

VAR/IB-017
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Thame 50mg/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 50mg gabapentin.
_Excipients with known effect:_
Each ml of oral solution contains 1.2mg methyl parahydroxybenzoate
(E218), 0.12mg ethyl
parahydroxybenzoate (E214), 17.2mg propylene glycol (E1520) and
0.949mg sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Clear, colourless solution
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 children aged 6 years
and above (see section
5.1).
Gabapentin is indicated as monotherapy in the treatment of partial
seizures with and without
secondary generalization in adults and adolescents aged 12 years and
above.
Treatment of peripheral neuropathic pain
Gabapentin is indicated for the treatment of peripheral neuropathic
pain such as painful
diabetic neuropathy and post-herpetic 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. Dosing
instructions for children under 12 years of age are provided under a
separate sub-heading later
in this section.
Table 1: DOSING CHART – INITIAL TITRATION
Day 1
Day 2
Day 3
300 mg (6ml) once a day
300 mg (6ml) two times a day
300 mg (6ml) three times a day
VAR/IB-017
Page 2 of 14
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:_
I