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DESITREND 500 MG COATED GRANULES IN SACHET

Active substance(s): LEVETIRACETAM

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Format: 190 x 420 mm – Code: ohne

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® 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 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 development of your child,
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.
Children and adolescents
Desitrend® coated granules are not indicated in
children and adolescents below 16 years on its
own (monotherapy), and 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.
Other medicines and Desitrend®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for
one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before taking any medicine.

DesitrendMini-GB MOCKUP.indd 1

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
effects in animal studies at dose levels higher than
you would need to control your seizures.
Breast-feeding is not recommended during treatment.
Driving and using machines
Desitrend® may impair your ability to drive or operate 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
established 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.
Take the number of sachets following your doctor’s
instructions.
Levetiracetam Desitin must be taken twice a day,
once in the morning and once in the evening, at
about the same time each day.
Monotherapy:
Dose in adults and adolescents
(from 16 years of age):
• 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 (500 mg
each day) during 2 weeks before giving you the
lowest general dose of 1,000 mg.
Add-on therapy:
Dose in adults and adolescents
(12 to 17 years) weighing 50 kg or more
• General dose: between 1,000 mg and 3,000 mg
each day.
Dose in infants (1 month to 23 months), children
(2 to 11 years) and adolescents (12 to 17 years)
weighing less than 50 kg
Your doctor will prescribe the most appropriate
pharmaceutical form of Levetiracetam Desitin
according to the age, weight and dose.
Levetiracetam oral solution is a presentation more
appropriate to infants and children under the age of
6 years an d to children and adolescent (from 6 to 17
years) weighing less than 50 kg and when sachets
don’t allow accurate dosage.
Method of administration
1.

2.

3.

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. You may take Levetiracetam Desitin with or
without food.
The coated granules may also be suspended by
shaking for a minimum of 2 minutes in at least 10 ml

Format: 190 x 420 mm – Code: ohne

MOCKUP

– Schrift: 10 p

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.
If you take more Desitrend® than you should
The possible side effects of an overdose of Desitrend® are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and
coma. Contact your doctor if you took more sachets
than you should. Your doctor will establish the best
possible 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 forgotten dose.
®

If you stop taking Desitrend
If stopping treatment, Levetiracetam Desitin should
be discontinued gradually to avoid an increase of
seizures. Should your doctor decide to stop your
Levetiracetam Desitin treatment, he/she will instruct
you about the gradual withdrawal of Levetiracetam
Desitin.
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.

Rare: may affect 1 to 10 users in 10,000 people
• infection;
• decreased number of all blood cell types;
• severe allergic reactions (DRESS, anaphylactic
reaction [severe and important allergic reaction],
Quincke´s oedema [swelling of the face, lips,
tongue and throat]);
• decreased blood sodium concentration;
• suicide, personality disorders (behavioural problems),
• thinking abnormal (slow thinking, unable to concentrate);
• uncontrollable muscle spasms affecting the head,
torso and limbs, difficulty in controlling movements, hyperkinesias (hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• 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).
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: Website: 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 the month.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache,
fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over
time.

This medicine does not require any special storage
conditions.

Very common: may affect more than 1 user in 10
people
• nasopharyngitis;
• somnolence (sleepiness), headache.

6. Contents of the pack and other information

Common: may affect 1 to 10 users in 100 people
• anorexia (loss of appetite);
• depression,
hostility or aggression, anxiety,
insomnia, nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor
(involuntary trembling)
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1,000
people
• decreased number of blood platelets, decreased
number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
confusion, panic attack, emotional instability/
mood swings, agitation;
• amnesia (loss of memory), memory impairment
(forgetfulness), abnormal coordination/ataxia
(impaired coordinated movements), paraesthesia
(tingling), disturbance in attention (loss of concentration);
• diplopia (double vision), vision blurred;
• elevated/abnormal values in a liver function test;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

05/2016 DesitrendMini-GB

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.

What Desitrend® contains
The active substance is levetiracetam. Each sachet
contains 250 or 500 or 1000 mg of levetiracetam.
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® 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 05/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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