Skip to Content

DESITREND 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

View full screen / Print PDF » Download PDF ⇩
Transcript
Format: 154 x 420 mm –

Laetus-Code: ohne

MOCKUP

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Desitrend®

100 mg/ml oral solution

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

Desitrend must be taken twice a day, once in the
morning and once in the evening, at about the
same time each day.
Take the oral solution following your doctor’s
instructions.

Monotherapy
Dose in adults and adolescents
(from 16 years of age):
1. What Desitrend is and what it is used for
Levetiracetam is an antiepileptic medicine (a medi- Measure the appropriate dosage using the 10 ml
syringe.
cine used to treat seizures in epilepsy).
General dose: Desitrend is taken twice daily, in
Desitrend is used:
two equally divided doses, each individual dose
• on its own in adults and adolescents from­ being measured between 5 ml (500 mg) and 15 ml
16 years of age with newly diagnosed epilepsy, (1,500 mg).
to treat a certain form of epilepsy. Epilepsy is a When you will first start taking Desitrend, your doccondition where the patients have repeated fits tor will prescribe you a lower dose (500 mg each
(seizures). Levetiracetam is used for the epilepsy day) during 2 weeks before giving you the lowest
form in which the fits initially affect only one side general dose of 1,000 mg.
of the brain, but could thereafter extend to larger
areas on both sides of the brain (partial onset Add-on therapy
seizure with or without secondary generalisation). Levetiracetam has been given to you by Dose in adults and adolescents
(12 to 17 years) weighing 50 kg or more:
your doctor to reduce the number of fits.
• as an add-on to other antiepileptic medicines to Measure the appropriate dosage using the 10 ml
syringe.
treat:
– partial onset seizures with or without generali­ General dose: Desitrend is taken twice daily, in
sation in adults, adolescents, children and two equally divided doses, each individual dose
being measured between 5 ml (500 mg) and
infants from one month of age
– myoclonic seizures (short, shock-like jerks of 15 ml (1,500 mg).
a muscle or group of muscles) in adults and Dose in children 6 months and older:
adolescents from 12 years of age with juvenile For dosages of up to 2.5 ml (250 mg), use the
myoclonic epilepsy
1 ml syringe.
– primary generalised tonic-clonic seizures For dosages of more than 2.5 ml (250 mg), use
(major fits, including loss of consciousness) in the 10 ml syringe.
adults and adolescents from 12 years of age Both syringes, 1 ml and 10 ml, are included in the
with idiopathic generalised epilepsy (the type package.
of epilepsy that is thought to have a genetic
General dose: Desitrend is taken twice daily, in two
cause).
equally divided doses, each individual dose being
measured between 0.1 ml (10 mg) and 0.3 ml (30
2. What you need to know before you take
mg), per kg bodyweight of the child (see table
Desitrend
below for dose examples).
Do not take Desitrend
• if you are allergic to levetiracetam, pyrrolidone Dose in children 6 months and older:
derivatives or any of the other ingredients of this
Weight Starting dose: Suitable Maximum dose: Suitable
medicine (listed in section 6).

0.1 ml/kg
syringe size 0.3 ml/kg
syringe size

twice daily
1ml 10 ml twice daily
1ml 10 ml
Warnings and precautions
6 kg 0.6 ml
1.8 ml
Talk to your doctor before taking Desitrend
twice daily
yes no twice daily
yes no
• If you suffer from kidney problems, follow your
8 kg 0.8 ml
2.4 ml
doctor’s instructions. He/she may decide if your

twice daily
yes no twice daily
yes no
dose should be adjusted.
10 kg 1 ml
3 ml
• If you notice any slow down in the growth or
twice daily
yes no twice daily
no yes
unexpected puberty development of your child,
15 kg 1.5 ml
4.5 ml
please contact your doctor.
twice daily
yes no twice daily
no yes
• A small number of people being treated with anti-
20 kg 2 ml
6 ml
epileptics such as Desitrend have had thoughts
twice daily
yes no twice daily
no yes
of harming or killing themselves. If you have any
25 kg 2.5 ml
7.5 ml
symptoms of depression and/or suicidal idea
twice daily
no yes twice daily
no yes
tion, please contact your doctor.
From
Children and adolescents
50 kg 5 ml
15 ml
Desitrend is not indicated in children and adoles-
twice daily
no yes twice daily
no yes
cents below 16 years on its own (monotherapy).
Dose in infants
(1 month to less than 6 months):
Other medicines and Desitrend
Tell your doctor or pharmacist if you are taking, For infants 1 month to less than 6 months,
have recently taken or might take any other medi- measure the appropriate dosage using the 1 ml syringe.
cines.
General dose: Desitrend is taken twice daily, in two
Do not take macrogol (a drug used as laxative) equally divided doses, each individual dose being
for one hour before and one hour after taking measured between 0.07 ml (7 mg) and 0.21 ml
levetiracetam as this may result in a reduction of (21 mg), per kg bodyweight of the infant (see table
its effect.
below for dose examples).
Dose in infants (1 month to less than 6
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may months):
be pregnant or are planning to have a baby, ask
Weight Starting dose:
Maximum dose:
your doctor for advice before taking this medicine.
0.07 ml/kg twice daily 0.21 ml/kg twice daily
Desitrend should not be used during pregnancy
4 kg
0.3 ml twice daily
0.85 ml twice daily
unless clearly necessary. A risk of birth defects for
5 kg
0.35 ml twice daily
1.05 ml twice daily
your unborn child cannot be completely exclud6 kg
0.45 ml twice daily
1.25 ml twice daily
ed. Desitrend has shown unwanted reproductive
7 kg
0.5 ml twice daily
1.5 ml twice daily
effects in animal studies at dose levels higher than
you would need to control your seizures.
Method of administration:
Breast-feeding is not ­recommended during treat- After measuring the correct dose with an appropriment.
ate syringe, Desitrend oral solution may be diluted
in a glass of water or baby’s bottle. You may take
Driving and using machines
Desitrend may impair your ability to drive or ­operate Desitrend oral solution with or without food.
any tools or machinery, as it may make you feel Instructions for use:
sleepy. This is more likely at the beginning of treat• Open the bottle: press the cap
ment or after an increase in the dose. You should 1
and turn it anticlockwise
not drive or use machines until it is established
(figure 1).
that your ability to perform such activities is not
• Choose the syringe and adaptor
affected.
suitable for your dosage (see
Desitrend contains methyl parahydroxyben­
dosage information).
zoate, propyl parahydroxybenzoate and
2
• Insert the syringe adaptor into
maltitol
the bottle neck (figure 2). Ensure
Desitrend oral solution includes methyl parahyit is well fixed.
droxybenzoate (E218) and propyl parahydroxyben• Take the syringe and put it in the
zoate (E216) which may cause allergic reactions
adaptor opening (figure 2).
(possibly delayed).
Desitrend oral solution also contains maltitol. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor 3
• Turn the bottle upside down
before taking this medicinal product.
(figure 3).
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.

Desitrend_300 ml-GB MOCKUP.indd 1

18.01.17 10:12

Format: 154 x 420 mm –

4

Laetus-Code: ohne

5

6

• Fill the syringe with a small amount of solution by
pulling the piston down (figure 4), then push the
piston upward in order to remove any possible
bubble (figure 5). Pull the piston down to the
graduation mark corresponding to the quantity in
milliliters (ml) prescribed by your doctor (figure 6).
• Turn the bottle the right way up.
• Remove the syringe from the adaptor.
7
• Empty the contents of the
syringe in a glass of water or
baby’s bottle by pushing the
­piston to the bottom (figure 7).
• Drink the whole contents of the glass / baby’s
bottle.
8
• Close the bottle with the plastic
screw cap.
• Wash the syringe with water
only (figure 8).
Duration of treatment:
Desitrend is used as a 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 Desitrend
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, Desitrend should be discontinued gradually to avoid an increase of seizures.
Should your doctor decide to stop your Desitrend
treatment, he/she will instruct you about the gradual withdrawal of Desitrend.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all me dicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately, or go to your
nearest emergency department, if you experience:
• weakness, feel light-headed or dizzy or have
difficulty breathing, as these may be signs of a
serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue and throat
(Quincke’s oedema)
• flu-like symptoms and a rash on the face followed
by an extended rash with a high temperature,
increased levels of liver enzymes seen in blood
tests and an increase in a type of white blood
cell (eosinophilia) and enlarged lymph nodes
(Drug Reaction with Eosinophilia and Systemic
Symptoms [DRESS])
• symptoms such as low urine volume, tiredness,
nausea, vomiting, confusion and swelling in the
legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
• a skin rash which may form blisters and look 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)
• a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic
epidermal necrolysis)
• signs of serious mental changes or if someone
around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory),
memory impairment (forgetfulness), abnormal
behaviour or other neurological signs including
involuntary or uncontrolled movements. These
could be symptoms of an encephalopathy.
The most frequently reported adverse reactions
were 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.
Very common: may affect more than 1 user in
10 people
• nasopharyngitis;
• somnolence (sleepiness), headache.
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 dis­
order), dizziness (sensation of unsteadiness),
lethargy (lack of energy and enthusiasm), tremor
(involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

MOCKUP

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.
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, hyperkinesia (hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• 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 (StevensJohnson syndrome), and a more severe form
causing skin peeling in more than 30 % of the
body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue)
and associated blood creatine phosphokinase
increase. Prevalence is significantly higher in
Japanese patients when compared to non-Japanese patients.
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 cardboard box and bottle after EXP:.
The expiry date refers to the last day of the month.
Do not use after 7 months of first opening the
bottle.
Store in the original bottle, in order to protect from
light.
Store in an upright position.
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 ml
contains 100 mg of levetiracetam.
The other ingredients are: sodium citrate, citric
acid monohydrate, methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid
(E965), acesulfame potassium (E950), grapefruit
flavour, purified water.
What Desitrend looks like and contents of
the pack
Desitrend 100 mg/ml oral solution is a clear liquid.
300 ml solution in an amber glass bottle with a
white child resistant closure is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) with adaptor and a 10 ml oral
syringe (graduated every 0.25 ml) with adaptor.
Marketing Authorisation Holder
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany
medinfo@desitin.co.uk
Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho de Bispo
3045-016 Coimbra
Portugal
This medicinal product is authorised in the
Member States of the EEA under the following names:
United Kingdom: Desitrend 100 mg/ml
oral solution
This leaflet was last revised in 01/2017.

Desitrend_300 ml-GB

Desitrend_300 ml-GB MOCKUP.indd 2

18.01.17 10:12

Expand view ⇕

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.

Hide