Levetiracetam 1g tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Levetiracetam

Предлага се от:

Actavis UK Ltd

АТС код:

N03AX14

INN (Международно Name):

Levetiracetam

дозиране:

1gram

Лекарствена форма:

Tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04080100; GTIN: 5012617022431

Листовка

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 Actavis is and what it is used for
2.
What you need to know before you take Levetiracetam
Actavis
3.
How to take Levetiracetam Actavis
4.
Possible side effects
5.
How to store Levetiracetam Actavis
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM ACTAVIS IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used
to treat seizures in epilepsy).
Levetiracetam Actavis 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 the 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 thereafter 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 seizures (short, shock-like jerks of a muscle
or group of muscles) in adults and adolescents from
12 years of age with juvenile myoclonic epilepsy;
-
primary generalised tonic-clonic seizures (major
fits, including loss of consciousness) in adults and
adolescents from 12 years of age wi

Данни за продукта

OBJECT 1
LEVETIRACETAM ACTAVIS 250 MG, 500MG, 750MG
AND 1000MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 03-Oct-2016 | Accord-UK Ltd
1. Name of the medicinal product
Levetiracetam Actavis 250 mg film-coated tablets
Levetiracetam Actavis 500 mg film-coated tablets
Levetiracetam Actavis 750 mg film-coated tablets
Levetiracetam Actavis 1,000 mg film-coated tablets
2. Qualitative and quantitative composition
Levetiracetam Actavis 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Actavis 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam.
Levetiracetam Actavis 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam.
Excipient with known effect:
Each film-coated tablet contains 0.156 mg sunset yellow E110.
Levetiracetam Actavis 1,000 mg film-coated tablets
Each film-coated tablet contains 1,000 mg levetiracetam.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Levetiracetam Actavis 250 mg film-coated tablets
Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and
“250” on the other side.
Levetiracetam Actavis 500 mg film-coated tablets
Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and
“500” on the other side.
Levetiracetam Actavis 750 mg film-coated tablets
Oval, orange 19.0 x 9.3 mm marked with “L” on one side and
“750” on the other side.
Levetiracetam Actavis 1,000 mg film-coated tablets
Oval, white, 19.0 x 10.0 mm marked with “L” on one side and
“1000” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam Actavis is 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 Actavis is indicated as adjunctive therapy
• in the treatment of partial onset seizures with or without
secondary generalisation in adults, adolescents,