Desitrend 500mg granules sachets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-06-2018
Summary of Product characteristics
(SPC)
20-06-2018
Active ingredient:
Levetiracetam
Available from:
Desitin Pharma Ltd
ATC code:
N03AX14
INN (International Name):
Levetiracetam
Dosage:
500mg
Pharmaceutical form:
Oral granules
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04080100; GTIN: 4031649002229
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESITREND 250 MG COATED GRANULES IN SACHET
DESITREND 500 MG COATED GRANULES IN SACHET
DESITREND 1000 MG COATED GRANULES IN SACHET
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 Desitrend is and what it is used for
2.
What you need to know before you take Desitrend
3.
How to take Desitrend
4.
Possible side effects
5.
How to store Desitrend
6.
Contents of the pack and other information
1.
WHAT DESITREND IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Desitrend 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 generalization in adults,
adolescents, children and infants
from one month of age;
•
myoclonic seizures (short, shock-like jerks of a muscle group or
muscles) in adults and
adolescents from 12 years of age with Juvenile Myoclonic Epilepsy;
•
primary generalised
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Summary of Product characteristics
OBJECT 1
DESITREND 500MG
Summary of Product Characteristics Updated 16-Jan-2017 | Desitin
Pharma Ltd
1. Name of the medicinal product
Desitrend 500 mg coated granules in sachet
2. Qualitative and quantitative composition
_Desitrend 500 mg coated granules in sachet_
Each sachet contains 500 mg levetiracetam.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated granules in sachet
Sachets with white or almost white, round, coated granules (diameter
approx. 2 mm).
4. Clinical particulars
4.1 Therapeutic indications
Desitrend 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.
Desitrend 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 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
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