Levetiracetam 100mgml oral solution sugar free

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Levetiracetam

Dostupno od:

Actavis UK Ltd

ATC koda:

N03AX14

INN (International ime):

Levetiracetam

Doziranje:

100mg/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04080100; GTIN: 5012617022509

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LEVETIRACETAM ORAL SOLUTION 100 MG/ML WITH A 10 ML SYRINGE PIL CENTRAL
PROCEDURE GROUP - UK
Black
Profile info
BBBA0462
C.Grant
23/01/17
31/01/17
C.Grant
160x440
9pts
Balkanpharma
23/01/17
24/01/2017
03
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 Group is and what it is used for
2.
What you need to know before you take Levetiracetam
Actavis Group
3.
How to take Levetiracetam Actavis Group
4.
Possible side effects
5.
How to store Levetiracetam Actavis Group
6.
Contents of the pack and other information
1. WHAT LEVETIRACETAM ACTAVIS GROUP IS AND WHAT IT IS USED
FOR
Levetiracetam is an antiepileptic medicine (a medicine used to
treat seizures in epilepsy).
Levetiracetam Actavis Group 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 th

Svojstava lijeka

OBJECT 1
LEVETIRACETAM ACTAVIS GROUP 100MG/ML ORAL
SOLUTION
Summary of Product Characteristics Updated 22-Feb-2017 | Accord-UK Ltd
1. Name of the medicinal product
Levetiracetam Actavis Group 100 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 100 mg levetiracetam.
Excipients with known effect:
Each ml contains 1.50 mg of methyl parahydroxybenzoate (E218), 0.15 mg
of propyl
parahydroxybenzoate (E216), 290 mg of maltitol liquid (E965) and 0.25
mg of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear, faint yellowish-brown solution.
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam Actavis Group 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 Group 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 1,500 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 respons