Quetra 1000mg film-coated Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

LEVETIRACETAM

Dostupné z:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC kód:

N03AX14

INN (Medzinárodný Name):

LEVETIRACETAM 100 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

LEVETIRACETAM 100 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTIEPILEPTICS

Prehľad produktov:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2019-11-01

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUETRA 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 Quetra is and what it is used for
2.
What you need to know before you take Quetra
3.
How to take Quetra
4.
Possible side effects
5.
How to store Quetra
6.
Contents of the pack and other information
1.
WHAT QUETRA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in
epilepsy).
Quetra 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
adu

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Quetra 250 mg film-coated tablets
Quetra 500 mg film-coated tablets
Quetra 750 mg film-coated tablets
Quetra 1000 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Quetra 250: each film-coated tablet contains 250 mg levetiracetam.
Quetra 500: each film-coated tablet contains 500 mg levetiracetam.
Quetra 750: each film-coated tablet contains 750 mg levetiracetam.
Quetra 1000: each film-coated tablet contains 1000 mg levetiracetam.
Excipients with known effect
750mg:
Quetra 750 film-coated tablets contain 0.36 mg Sunset Yellow Aluminium
Lake
(E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
250 mg: Blue, oval shaped film coated tablets scored on one side with
dimensions
12.9 × 6.1 mm. The tablet can be divided into equal doses.
500 mg: Yellow, oval shaped film coated tablets scored on one side
with dimensions
16.5 × 7.7 mm. The tablet can be divided into equal doses.
750 mg: Orange, oval shaped film coated tablets scored on one side
with dimensions
18.8 × 8.9 mm. The tablet can be divided into equal doses.
1000 mg: White, oval shaped film coated tablets scored on one side
with dimensions
19.2 × 10.2 mm. The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetra 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.
Quetra is indicated as adjunctive therapy
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•
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 seizures in adults and adolescents from
12 years of
age with Juvenile Myoclonic Epilepsy.
•
in
the
treatment
of
primary
generalised
tonic-clonic
seizures
in
adults
and
adolescents from 12 years of age with Idiopathic General