Levetiracetam 100mgml oral solution sugar free

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Levetiracetam

Предлага се от:

Consilient Health Ltd

АТС код:

N03AX14

INN (Международно Name):

Levetiracetam

дозиране:

100mg/1ml

Лекарствена форма:

Oral solution

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04080100; GTIN: 5391512451585

Листовка

In this leaflet:
1. What Levetiracetam Synthon 100 mg/ml is and what it is
used for
2. What you need to know before you take Levetiracetam
Synthon 100 mg/ml
3. How to take Levetiracetam Synthon 100 mg/ml
4. Possible side effects
5. How to store Levetiracetam Synthon 100 mg/ml
6. Contents of the pack and other information
1. WHAT LeveTIrAceTAm SynTHon
100 mg/mL IS AnD WHAT IT IS USeD For
Levetiracetam is an antiepileptic medicine (a medicine used to
treat seizures in epilepsy).
Levetiracetam is used:
• on its own in patients 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 generalisation in
patients from one month of age
– myoclonic seizures in patients from 12 years of age with
juvenile myoclonic epilepsy
– primary generalised tonic-clonic seizures in patients from
12 years of age with idiopathic generalised epilepsy.
2. WHAT yoU neeD To knoW beFore yoU
TAke LeveTIrAceTAm SynTHon
100 mg/mL
Do not take Levetiracetam 100 mg/ml:
• If you are allergic (hypersenstive) to levetiracetam or
any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levetiracetam
100 mg/ml
• If you suffer from kidney problems, follow your doctor’s
instructions. He/she may decide if your dose should be
adjusted.
• If you notice any slow down in the growth or unexpected
puberty development of your child, please contact your
doctor.
• If you notice an increase in seizure severity (e.g.
increased number), please contact your doctor.
• A small number of people being treated with anti-epileptics
such as levetiracetam have had thoughts of harming or
killing themselves. If you have any symptoms of
depression and/or suicidal ideation, please contact
your doctor.
other medicines and Levetiracetam 100 mg/ml
Please tell your doctor or pharmacist if you are taking or
have rec

Данни за продукта

OBJECT 1
LEVETIRACETAM SYNTHON 100 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 23-May-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Levetiracetam Synthon 100 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 100 mg levetiracetam
Excipients with known effect:
Each ml contains 2.7 mg of methyl parahydroxybenzoate (E218), 0.3 mg
of propyl parahydroxybenzoate
(E216) and 300 mg of maltitol liquid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam is indicated as monotherapy in the treatment of partial
onset seizures with or without
secondary generalisation in patients from 16 years of age with newly
diagnosed epilepsy.
Levetiracetam is indicated as adjunctive therapy
• in the treatment of partial onset seizures with or without
secondary generalisation in adults, 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 c