Gabapentin 100mg capsules

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Gabapentin

Pieejams no:

Dowelhurst Ltd

ATĶ kods:

N02BF01

SNN (starptautisko nepatentēto nosaukumu):

Gabapentin

Deva:

100mg

Zāļu forma:

Oral capsule

Ievadīšanas:

Oral

Klase:

Schedule 3 (CD No Register Exempt Safe Custody)

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04080100

Lietošanas instrukcija

121XXXX
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Gabapentin Noumed is and what it is used for
2. What you need to know before taking Gabapentin Noumed
3. How to take Gabapentin Noumed
4. Possible side effects
5. How to store Gabapentin Noumed
6. Contents of the pack and other information
1. WHAT GABAPENTIN NOUMED IS AND WHAT IT IS USED FOR
Gabapentin Noumed 100mg, 300mg or 400mg Capsules (called gabapentin
throughout this leaflet)
belongs to a group of medicines used to treat epilepsy and peripheral
neuropathic pain (long lasting
pain caused by damage to the nerves)
GABAPENTIN NOUMED 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 Noumed
for you to help treat your epilepsy when your current treatment is not
fully controlling your
condition. You should take Gabapentin Noumed in addition to your
current treatment unless told
otherwise. Gabapentin Noumed 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
occurring in the legs and/or
arms), such as diabetes or shingles. Pain sensations may be described
as hot, burning, throbbing,
shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins
and needles etc.
2. WHAT YOU

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gabapentin Medreich 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100mg hard capsule contains 100mg of gabapentin.
Excipient with known effect:
Each 100mg hard capsule contains 16.83 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
‘Capsule, hard’.
Size ‘3’ white/white hard gelatin capsule marked ‘MG 100’
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 generalisation 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
300mg once a day
300mg two times a day
300mg 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 dose as described in Table 1 or