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DESITREND 750 MG COATED GRANULES IN SACHET

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Format: 190 x 420 mm



Code: 258



MOCKUP

Schrift: 10 p

Package Leaflet: Information for the patient

Desitrend® 250 mg coated granules in sachet
Desitrend® 500 mg coated granules in sachet
Desitrend® 750 mg coated granules in sachet
Desitrend® 1000 mg coated granules in sachet
Levetiracetam
Read all of this leaflet carefully before you 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
Desitrend® is an antiepileptic medicine (a medicine
used to treat seizures in epilepsy).
Desitrend® is used alone in the treatment of partial
seizures in adults and adolescents from 16 years of
age with newly diagnosed epilepsy.
Desitrend® is used in patients who are already taking
another antiepileptic medicine:
• in the treatment of partial seizures in adults, ado­
lescents, children and infants from one month of
age;
• in the treatment of myoclonic (brief, shock­like
muscle jerks) seizures in adults and adolescents
from 12 years of age with Juvenile Myoclonic Epi­
lepsy;
• in the treatment of primary generalised tonic­
clonic seizures (grand mal seizures) in adults and
adolescents from 12 years of age with Idiopathic
Generalised Epilepsy.
2. What you need to know before you take
Desitrend®
Do not take Desitrend®
• if you are allergic (hypersensitive) to levetiracetam
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.
Contact your doctor immediately:
• if you notice an increase in seizure severity (e.g.
increased number);
• if you have thoughts of harming or killing your­
self. A small number of people being treated with
anti­epileptics such as levetiracetam have had
thoughts of harming or killing themselves.
Children
Desitrend® coated granules are not recommended
in children under the age of 6 years as well as in
the initial treatment of children weighing less than
25 kg.
If you notice any slow down in the growth or unex­
pected puberty development of your child, please
contact your doctor.
Other medicines and Desitrend®
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Desitrend® with food, drink and alcohol

effects in animal studies at dose levels higher than
you would need to control your seizures.
Breast­feeding is not recommended during treat­
ment.
Driving and using machines
Desitrend® may impair your ability to drive or ope­
rate any tools or machinery, as Desitrend® may make
you feel sleepy. This is more likely at the beginning
of treatment or after an increase in the dose. You
should not drive or use machines until it is estab­
lished that your ability to perform such activities is
not affected.
3. How to take Desitrend®
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Monotherapy:
Dosage in adults and adolescents
(from 16 years of age):
Take the number of sachets with coated granules
according to your doctor’s instructions.
• General dose: between 1,000 mg and 3,000 mg
each day.
• When you will first start taking Desitrend®, your
doctor will prescribe you a lower dose during
2 weeks before giving you the lowest usual dose.
• Desitrend® must be taken twice a day, half of the
daily dose in the morning and half of the daily
dose in the evening, at about the same time each
day.
Add­on therapy:
Dosage in adults and adolescents
(12 to 17 years) weighing 50 kg or more
Take the number of sachets with coated granules
according to your doctor’s instructions.
• General dose: between 1,000 mg and 3,000 mg
each day.
• Desitrend® must be taken twice a day, half of the
daily dose in the morning and half of the daily dose
in the evening, at about the same time each day.
Dosage in infants (6 to 23 months), children
(2 to 11 years) and adolescents (12 to 17 years)
weighing less than 50 kg
Take / give to your child the dosage as instructed by
your doctor.
• General dose: between 20 mg/kg and 60 mg/kg
each day.
• Levetiracetam oral solution is a presentation more
appropriate to infants and children under the age
of 6 years.
• Desitrend® must be taken twice a day, half of the
daily dose in the morning and half of the daily dose
in the evening, at about the same time each day.
Dosage in infants (1 month to less than 6 months)
Levetiracetam oral solution is a presentation more
appropriate to infants.
Administration
1.

2.

3.

You may take Desitrend® with or without food.
As a safety precaution, do not take Desitrend® with
alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant or if you think you may be preg­
nant, please inform your doctor.
Desitrend® should not be used during pregnancy
unless clearly necessary. A risk of birth defects for
your unborn child cannot be completely excluded.
Levetiracetam has shown unwanted reproductive

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1. Hold sachet above arrow and shake content
downwards.
2. Tear off at incision (arrowhead) or cut off at dotted
line.
3. Pour content directly into the mouth and swallow
the granules immediately with a sufficient quantity
of liquid (e.g. a glass of water). Do not chew the
coated granules, as they may be of bitter taste.

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Format: 190 x 420 mm  –  Code: 258   –  Schrift: 10 p

The coated granules may also be suspended by
shaking for a minimum of 2 minutes in at least 10 ml
of water and administered via a feeding tube that
should be rinsed twice with 10 ml of water each
immediately after administration. If this method of
administration is used, the suspension should be
prepared immediately before administration.
Each sachet is for single use only.
Duration of treatment
• Desitrend® is used as chronic treatment. You
should continue Desitrend® treatment for as long
as your doctor has told you.
• Do not stop your treatment without your
­doctor’s advice as this could increase your
seizures. Should your doctor decide to stop your
Desitrend® treatment, he/she will instruct you
about the gradual withdrawal of Desitrend®.
If you take more Desitrend® than you should
The possible side effects of an overdose of Desi­
trend® are sleepiness, agitation, aggression, de­­
crease of alertness, inhibition of breathing and
coma. Contact your doctor if you took too much
Desitrend®. Your doctor will establish the best pos­
sible treatment of overdose.
®

If you forget to take Desitrend
Contact your doctor if you have missed one or more
doses.
Do not take a double dose to make up for a forgot­
ten dose.
If you stop taking Desitrend®
Never alter the dose without consulting the doctor.
Do not stop using your medication without first con­
sulting your doctor, or else you may put the success
of therapy at risk.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common: may affect more than 1 user in 10
• sleepiness, headache;
• nasopharyngitis (nose or throat inflammation).
Common: may affect 1 to 10 users in 100
• dizziness, convulsion, lethargy;
• involuntary trembling, balance disorder;
• inability to sleep, nervousness;
• depression, anxiety, hostility, aggression, irritabil­
ity;
• tiredness, feeling of weakness;
• abdominal pain, dyspepsia (indigestion), diar­
rhoea;
• vomiting, nausea;
• anorexia (loss of appetite);
• vertigo (sensation of rotation);
• cough;
• rash.
Uncommon: may affect 1 to 10 users in 1,000
• decreased number of blood platelets, decreased
number of white blood cells;
• paraesthesia (a skin sensation, such as burning,
prickling, itching, or tingling, with no apparent
physical cause);
• ataxia (impaired movement coordination);
• amnesia (loss of memory), forgetfulness, impaired
ability to concentrate;
• abnormal behaviour, anger, confusion;
• panic attack, emotional instability, mood swings,
agitation;
• hallucination, psychotic disorder (abnormal
thoughts and perceptions);
• suicide attempt and suicidal ideation;
• liver function test abnormal;
• weight loss; weight increase;
• double vision, blurred vision;
• muscle weakness, muscle pain;
• injury;
• hair loss, eczema, pruritus.
Rare: may affect 1 to 10 users in 10,000
• decreased number of a certain type of white
blood cells (neutrophil granulocytes), or all types
of blood cells;
• severe hypersensitivity reactions (DRESS)
• decreased blood sodium concentration

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• uncontrollable muscle spasms affecting the head,
torso and limbs, difficulty in controlling move­
ments;
• hyperkinesia (increased movements and inability
to keep still);
• suicide, personality disorders (changes in
thoughts, feelings and behaviour);
• difficulty in thinking (e.g. slow thinking);
• inflammation of the pancreas;
• liver failure, liver inflammation;
• infection;
• skin rash, which may form blisters and looks like
small targets (central dark spots surrounded by
a paler area, with a dark ring around the edge)
(erythema multiforme), a widespread rash with
blisters and peeling skin, particularly around the
mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing
skin peeling in more than 30% of the body surface
(toxic epidermal necrolysis).
Some of the side effects like sleepiness, tiredness
and dizziness may be more common at the begin­
ning of the treatment or at dosage increase. These
effects should however decrease over time.
Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme: Web­
site: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.
5. How to store Desitrend®
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date stated
on the carton box and sachet after EXP:. The expiry
date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Desitrend® contains
The active substance is levetiracetam. Each sachet
contains 250 or 500 or 750 or 1000 mg of leveti­
racetam.
The other ingredients are:
Povidone K30
Cellulose, microcrystalline
Silica, colloidal anhydrous
Magnesium stearate
Poly(vinyl alcohol)
Titanium dioxide (E171)
Macrogol 3350
Talc
What Desitrend® looks like and contents of the
pack
Coated granules in sachets; the coated granules are
white or almost white and round (diameter approx.
2 mm).
Desitrend® 250 mg coated granules in sachet
Pack size of 20, 30, 50, 60, 100, 200 sachets
Desitrend® 500 mg coated granules in sachet
Pack size of 20, 30, 50, 60, 100, 200 sachets
Desitrend® 750 mg coated granules in sachet
Pack size of 20, 30, 50, 60, 100, 200 sachets
Desitrend® 1000 mg coated granules in sachet
Pack size of 20, 30, 50, 60, 100, 200 sachets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Desitin Arzneimittel GmbH
Weg beim Jaeger 214
22335 Hamburg
Germany
E-mail: medinfo@desitin.co.uk
This leaflet was last revised in 03/2014

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