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DESITREND 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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MOCKUP

Format: 154 x 420 mm  –  Laetus-Code: ohne

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
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 genera­
li­sation 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 development of your child,
please contact your doctor.
• A small number of people being treated with antiepileptics such as Desitrend 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 is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Desitrend
Tell your doctor or pharmacist if you are taking or
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 reduction 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 this medicine.
Desitrend should not be used during pregnancy
unless clearly necessary. A risk of birth defects for
your unborn child cannot be completely excluded. Desitrend has shown unwanted reproductive
effects in animal studies at dose levels higher than
you would need to control your seizures. Breastfeeding is not ­recommended during treatment.
Driving and using machines
Desitrend may impair your ability to drive or ­operate
any tools or machinery, as it 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.
Desitrend contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and
maltitol
Desitrend oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenDesitrend_50_150_300_ml-GB MOCKUP.indd 1

zoate (E216) which may cause allergic reactions
(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
before taking this medicinal product.
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 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):
General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per 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 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per day.
Dose in infants (6 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 Desitrend according to the
age, weight and dose.
General dose: between 0.2 ml (20 mg) and 0.6 ml
(60 mg) per kg bodyweight each day, divided in 2
intakes per day. The exact quantity of oral solution
formulation should be delivered using the syringe
provided in the cardboard box.
Weight

6 kg
8 kg
10 kg
15 kg
20 kg
25 kg
From
50 kg

Starting dose:
0.1 ml/kg twice daily
0.6 ml twice daily
0.8 ml twice daily
1 ml twice daily
1.5 ml twice daily
2 ml twice daily
2.5 ml twice daily

Maximum dose:
0.3 ml/kg twice daily
1.8 ml twice daily
2.4 ml twice daily
3 ml twice daily
4.5 ml twice daily
6 ml twice daily
7.5 ml twice daily

5 ml twice daily

15 ml twice daily

Dose in infants (1 month to less than
6 months):
General dose: between 0.14 ml (14 mg) and 0.42 ml
(42 mg) per kg bodyweight each day, divided in 2
intakes per day. The exact quantity of oral solution
formulation should be delivered using the syringe
provided in the cardboard box.
Weight

4 kg
5 kg
6 kg
7 kg

Starting dose:
0.07 ml/kg twice daily
0.3 ml twice daily
0.35 ml twice daily
0.45 ml twice daily
0.5 ml twice daily

Maximum dose:
0.21 ml/kg twice daily
0.85 ml twice daily
1.05 ml twice daily
1.25 ml twice daily
1.5 ml twice daily

Method of administration:
Desitrend oral solution may be diluted in a glass of
water or baby’s bottle. You may take Desitrend oral
solution with or without food.
1
Instructions for use:
• Open the bottle: press the cap
and turn it anticlockwise
(figure 1).
2

3

4

• Insert the syringe adaptor into
the bottle neck (figure 2). Ensure
it is well fixed.
• Take the syringe and put it in the
adaptor opening (figure 2).
• T
 urn the bottle upside down
(figure 3).

5

6

03.06.16 10:54

MOCKUP

Format: 154 x 420 mm  –  Laetus-Code: ohne

• F
 ill 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).
• D
 rink 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 for­
gotten 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 medicines, this medicine can cause side
effects, although not everybody gets them.
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 disorder), 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).
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;

• s evere 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;
• 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).
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.
50 ml solution (sample pack) 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) and an adaptor for the
syringe.
150 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) and an adaptor for the syringe.
150 ml solution in an amber glass bottle with a
white child resistant closure is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
300 ml solution in an amber glass bottle with a
white child resistant closure is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
Not all pack sizes may be marketed.
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 03/2016.

05/16   Desitrend_50_150_300_ml-GB

Desitrend_50_150_300_ml-GB MOCKUP.indd 2

03.06.16 10:54

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

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 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.

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 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).

Monotherapy

2. What you need to know before you take
Desitrend

Weight Starting dose: Suitable Maximum dose: Suitable

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

twice daily 1ml 10 ml twice daily
1ml 10 ml
6 kg 0.6 ml
1.8 ml

twice daily yes no twice daily
yes no
8 kg 0.8 ml
2.4 ml

twice daily yes no twice daily
yes no
10 kg 1 ml
3 ml

twice daily yes no twice daily
no yes
15 kg 1.5 ml
4.5 ml

twice daily yes no twice daily
no yes
20 kg 2 ml
6 ml

twice daily yes no twice daily
no yes
25 kg 2.5 ml
7.5 ml

twice daily no yes twice daily
no yes
From
50 kg 5 ml
15 ml

twice daily no yes twice daily
no yes

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 antiepileptics such as Desitrend 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 is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Desitrend
Tell your doctor or pharmacist if you are taking or
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 reduction of
its effect.

Dose in adults and adolescents
(from 16 years of age):
General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per 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 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per day.
Dose in infants (6 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 Desitrend according to the
age, weight and dose.
General dose: between 0.2 ml (20 mg) and 0.6 ml
(60 mg) per kg bodyweight each day, divided in 2
intakes per day. The exact quantity of oral solution
formulation should be delivered using one of the
syringes provided in the cardboard box. The 1 ml
syringe should be used for dosages of up to 2.5 ml
(250 mg) and the 10 ml syringe should be used for
dosages of more than 2.5 ml (250 mg).

Dose in infants
(1 month to less than 6 months):
General dose: between 0.14 ml (14 mg) and
0.42 ml (42 mg) per kg bodyweight each day,
divided in 2 intakes per day. The exact quantity of
oral solution formulation should be delivered using
the 1 ml syringe provided in the cardboard box.
Weight

4 kg
5 kg
6 kg
7 kg

Starting dose:
0.07 ml/kg twice daily
0.3 ml twice daily
0.35 ml twice daily
0.45 ml twice daily
0.5 ml twice daily

Maximum dose:
0.21 ml/kg twice daily
0.85 ml twice daily
1.05 ml twice daily
1.25 ml twice daily
1.5 ml twice daily

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 this medicine.
Desitrend should not be used during pregnancy
unless clearly necessary. A risk of birth defects for
your unborn child cannot be completely excluded. Desitrend has shown unwanted reproductive
effects in animal studies at dose levels higher than
you would need to control your seizures. Breastfeeding is not ­recommended during treatment.

Method of administration:
Desitrend oral solution may be diluted in a glass of
water or baby’s bottle. You may take Desitrend oral
solution with or without food.

Driving and using machines
Desitrend may impair your ability to drive or ­operate
any tools or machinery, as it 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.

2

Desitrend contains methyl parahydroxyben­
zoate, propyl parahydroxybenzoate and
maltitol
Desitrend oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions
(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
before taking this medicinal product.
Desitrend 10400511-GB MOCKUP.indd 1

1

Instructions for use:
• Open the bottle: press the cap
and turn it anticlockwise
(figure 1).
• Choose the syringe and adaptor
suitable for your dosage (see
dosage information).
• Insert the syringe adaptor into
the bottle neck (figure 2). Ensure
it is well fixed.
• Take the syringe and put it in the
adaptor opening (figure 2).

3

• Turn the bottle upside down
(figure 3).

4

5

6

03.06.16 10:44

Format: 154 x 420 mm  –  Laetus-Code: ohne

• 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 for­
gotten 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 medicines, this medicine can cause side
effects, although not everybody gets them.
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).
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.

MOCKUP

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;
• 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).
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 03/2016.

05/16 DesiSaft300 ml-GB

Desitrend 10400511-GB MOCKUP.indd 2

03.06.16 10:44

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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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