Gabapentin Ascend 100 mg capsules, hard

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Prieinama:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC kodas:

N03AX12

INN (Tarptautinis Pavadinimas):

GABAPENTIN 100 mg

Vaisto forma:

HARD CAPSULE

Sudėtis:

GABAPENTIN 100 mg

Recepto tipas:

POM

Gydymo sritis:

ANTIEPILEPTICS

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2022-08-30

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Gabapentin Ascend 100 mg hard capsules
Gabapentin Ascend 300 mg hard capsules
Gabapentin Ascend 400 mg hard capsules
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.
WHAT IS IN THIS LEAFLET:
1.
What Gabapentin Ascend is and what it is used for
2.
What you need to know before you take Gabapentin Ascend
3.
How to take Gabapentin Ascend
4.
Possible side effects
5.
How to store Gabapentin Ascend
6.
Contents of the pack and other information
1.
WHAT GABAPENTIN ASCEND IS AND WHAT IT IS USED FOR
Gabapentin Ascend 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).
Epilepsy:
Gabapentin Ascend 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 this medicine for you to help treat your epilepsy when your
current treatment is not fully
controlling your condition. You should take Gabapentin Ascend in
addition to your current treatment
unless told otherwise. This medicine can also be used on its own to
treat adults and children over 12
years of age.
Peripheral neuropathic pain:
Gabapentin Ascend is used to treat long lasting pain caused by damage
to the nerves. A variety of
different diseases can cause peripheral (primarily occurring in the
legs and/or arms) neuropathic pain,
such as diabetes or shingles.

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gabapentin Ascend
100 mg capsules, hard
Gabapentin Ascend
300 mg capsules, hard
Gabapentin Ascend
400 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of gabapentin.
Excipient with known effect:
Each capsule contains 7.462 mg of lactose.
Each capsule contains 300 mg of gabapentin.
Excipient with known effect:
Each capsule contains 22.386 mg of lactose.
Each capsule contains 400 mg of gabapentin.
Excipient with known effect:
Each capsule contains 29.848 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
White to off white crystalline powder filled in size "4" white hard
gelatin capsule imprinted "216" on body
with blue ink.
White to off white crystalline powder filled in size "1" yellow
coloured hard gelatin capsule imprinted "215"
on body with blue ink.
White to off white crystalline powder filled in size "0" Orange
coloured hard gelatin capsule imprinted "214"
on body with blue ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy
Gabapentin Ascend 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 Ascend 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 Ascend 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 �