Desitrend 100mg/ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levetiracetam

Available from:

Desitin Pharma Ltd

ATC code:

N03AX14

INN (International Name):

Levetiracetam

Dosage:

100mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 4031649002366

Patient Information leaflet

Format: 154 x 420 mm
–
Laetus-Code: ohne
MOCKUP
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 medi-
cine 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 generalisa-
tion). 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 generali-
sation
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
adults and adolescents from 12 years of age
with idiopathic generalised epilepsy (the type
of epilepsy that is thought to have a genetic
cause).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DESITREND
DO NOT TAKE DESITREND
• if you are allergic to levetiracetam, pyrrolidone
derivatives or any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Desitrend
• 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 de

Summary of Product characteristics

OBJECT 1
DESITREND ORAL SOLUTION 100MG/ML
Summary of Product Characteristics Updated 02-May-2018 | Desitin
Pharma Ltd
1. Name of the medicinal product
Desitrend 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 liquid.
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 generalization 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 from12 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 twi