Matever 250mg film-coated tablets

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

levetiracetam

Beszerezhető a:

Pharmathen S.A.

INN (nemzetközi neve):

levetiracetam

Adagolás:

250mg

Gyógyszerészeti forma:

tablets film-coated

Recept típusa:

Prescription

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MATEVER 250 MG FILM-COATED TABLETS
MATEVER 500 MG FILM-COATED TABLETS
MATEVER 750 MG FILM-COATED TABLETS
MATEVER 1000 MG FILM-COATED TABLETS
Levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOUSTART 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 anyofthesideeffects,talk to your doctor
or pharmacist.
This includes any possible side effects not listed in
this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Matever is and what it is used for
2. What you need to know before you take Matever
3. How to take Matever
4. Possible side effects
5. How to store Matever
6. Contents of the pack and other information
1. WHAT MATEVER IS AND WHAT IT IS USED FOR
Matever is an antiepileptic medicine (a medicine
used to treat seizures in epilepsy).
Matever is used:
• on its own in adults and adolescents from 16
years of age with newly diagnosed epilepsy, to treat
partial onset seizures with or without secondary
generalisation.
• as an add-on to other antiepileptic medicines to
treat:
- partial onset seizures with or without generalisa-
tion in adults, adolescents, children and infantsfrom
one month of age
- myoclonic seizures in adults and adolescents from
12 years of age with juvenile myoclonic epilepsy
- primary generalised tonic-clonic seizures inadults
and adolescents from 12 years of age with
idiopathic generalised epilepsy
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MATEVER
DO NOT TAKE MATEVER
• if you are allergic (hypersensitive) to levetirace-
tam or any of the other ingredients of this medicine
(listed in Section 6).
WARNINGS AND PRECAUTIONS
• Talk to your doctor before taking MateverIf you
suffer from kidney problems, follow your doctor’s
instructions. He/she may

Termékjellemzők

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
Matever 250 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam.
Excipients
Each film-coated tablet contains 0.0025 mg sunset yellow FCF aluminium
lake (E110) and 0.6065 mg
propylene glycol (E1520).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, oblong, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Matever 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.
Matever is 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 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 Generalised Epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy for adults and adolescents from 16 years of age _
The recommended starting dose is 250 mg twice daily which should be
increased to an initial
therapeutic dose of 500 mg twice daily after two weeks. The dose can
be further increased by 250 mg
twice daily every two weeks depending upon the clinical response. The
maximum dose is 1500 mg
twice daily.
_Add-on therapy for adults (≥18 years) and adolescents (12 to 17
years) weighing 50 kg or more _
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of
treatment.
Depending upon the clinical response and tolerability, the daily dose
can be increased up to 1,500 mg
twice daily. Dose changes can be made in 500 mg twice daily increases
or decreases every two to four
weeks.