Levetiracetam 250mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Levetiracetam

から入手可能:

Lupin Healthcare (UK

ATCコード:

N03AX14

INN（国際名）:

Levetiracetam

投薬量:

250mg

医薬品形態:

Tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04080100; GTIN: 8901107021269

情報リーフレット

450 mm
225 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM-LUPIN 250MG FILM-COATED TABLETS
LEVETIRACETAM-LUPIN 500 MG FILM-COATED TABLETS
LEVETIRACETAM-LUPIN 750 MG FILM-COATED TABLETS
LEVETIRACETAM-LUPIN 1000 MG FILM-COATED TABLETS
LEVETIRACETAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 Levetiracetam-Lupin is and what it is used for
2.
What you need to know before you take Levetiracetam-Lupin
3.
How to take Levetiracetam-Lupin
4.
Possible side effects
5.
How to store Levetiracetam-Lupin
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM-LUPIN IS AND WHAT IT IS USED FOR
Levetiracetam-Lupin contains the active substance levetiracetam, which
is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).
Levetiracetam-Lupin is used:
·
on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to treat a
certain form of epilepsy. Epilepsy is a condition where patients have
repeated fits (seizures).
Levetiracetam is used for the epilepsy form in which the fits
initially affect only one side of the brain,
but could then extend to larger areas on both sides of the brain
(partial onset seizure with or without
secondary generalisation). Levetiracetam has been given to you by your
doctor to reduce the number
of fits.
·
as an add-on to other antiepileptic medicines to treat:
-
partial onset seizures with or without generalisation in adults,
adolescents, children and infants
from one month of age;
-
myoclonic se

製品の特徴

OBJECT 1
LEVETIRACETAM-LUPIN FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Jan-2018 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Levetiracetam-Lupin 250 mg film-coated tablets
Levetiracetam-Lupin 500 mg film-coated tablets
Levetiracetam-Lupin 750 mg film-coated tablets
Levetiracetam-Lupin 1000 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 250 mg levetiracetam.
Each film-coated tablet contains 500 mg levetiracetam.
Each film-coated tablet contains 750 mg levetiracetam.
Each film-coated tablet contains 1000 mg levetiracetam.
Excipients with known effect (750mg only)
Each film-coated tablet contains 0.13 mg E110 sunset yellow FCF
aluminium lake (E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Blue, oblong shaped, biconvex film coated tablet debossed with
“250” on one side and score line on the
other side. The tablets can be divided into equal doses.
Yellow, oblong shaped, biconvex film coated tablet debossed with
“500” on one side and score line on
the other side. The tablets can be divided into equal doses.
Peach coloured, oblong shaped, biconvex film coated tablet debossed
with “750” on one side and score
line on the other side. The tablets can be divided into equal doses.
White to off white, oblong shaped, biconvex film coated tablet
debossed with “1000” on one side and
score line on one side. The tablets can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam tablets are indicated as monotherapy in the treatment of
partial onset seizures with or
without secondary generalisation in adults and adolescents from 16
years of age with newly diagnosed
epilepsy.
Levetiracetam tablets are indicated as adjunctive therapy
• in the treatment of partial onset seizures with or without
secondary generalisation in adults, adolescents,
children and infants from 1 month of age with epilepsy.
• in the treatment of myoclonic seizu