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LEVETIRACETAM MILPHARM 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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Levetiracetam Milpharm 100 mg/ml oral solution
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 Levetiracetam Milpharm is and what it is used for
2. What you need to know before you take Levetiracetam Milpharm
3. How to take Levetiracetam Milpharm
4. Possible side effects
5. How to store Levetiracetam Milpharm
6. Contents of the pack and other information

P15XXXXX

Levetiracetam Milpharm

Levetiracetam Milpharm

P15XXXXX

Package leaflet: Information for the user

day, divided in 2 intakes per day. When you will first start taking
Levetiracetam Milpharm, your doctor will prescribe you a lower dose
during 2 weeks before giving you the lowest general dose.
Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50 kg
or more:
General dose: between 10 ml (1000 mg) and 30 ml (3000 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 Levetiracetam Milpharm 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.

6 kg

Starting dose:
0.1 ml/kg twice daily
0.6 ml twice daily

Maximum dose:
0.3 ml/kg twice daily
1.8 ml twice daily

8 kg

0.8 ml twice daily

2.4 ml twice daily

Weight

10 kg

1 ml twice daily

3 ml twice daily

1. What Levetiracetam Milpharm is and what it is used for

15 kg

1.5 ml twice daily

4.5 ml twice daily

Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).

20 kg

2 ml twice daily

6 ml twice daily

25 kg

2.5 ml twice daily

7.5 ml twice daily

Levetiracetam Milpharm 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 generalisation 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).

From 50 kg

5 ml twice daily

15 ml twice daily

2. What you need to know before you take Levetiracetam
Milpharm

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.

4 kg

Starting dose:
0.07 ml/kg twice daily
0.3 ml twice daily

Maximum dose:
0.21 ml/kg twice daily
0.85 ml twice daily

5 kg

0.35 ml twice daily

1.05 ml twice daily

6 kg

0.45 ml twice daily

1.25 ml twice daily

7 kg

0.5 ml twice daily

1.5 ml twice daily

Weight

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

Do not take Levetiracetam Milpharm
• 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 or pharmacist before taking Levetiracetam
Milpharm
• 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 Milpharm have had thoughts of harming or
killing themselves. If you have any symptoms of depression and/
or suicidal ideation, please contact your doctor.



Separate the adaptor from the syringe (figure 2). Insert the
adaptor into the bottle neck (figure 3). Ensure it is well fixed.



Take the syringe and put it in the adaptor opening (figure 4). Turn
the bottle upside down (figure 5).



Fill the syringe with a small amount of solution by pulling the
piston down (figure 5 A), then push the piston upward in order
to remove any possible bubble (figure 5 B). Pull the piston down
to the graduation mark corresponding to the quantity in milliliters
(ml) prescribed by your doctor (figure 5 C).



Turn the bottle the right way up (figure 6A). Remove the syringe
from the adaptor (figure 6B).



Empty the contents of the syringe in a glass of water or baby’s
bottle by pushing the piston to the bottom of the syringe (figure 7).





Drink the whole contents of the glass/baby’s bottle.
Close the bottle with the plastic screw cap.
Wash the syringe with water only (figure 8)

Children and adolescents
• Levetiracetam Milpharm is not indicated in children and
adolescents below 16 years on its own (monotherapy)
Other medicines and Levetiracetam Milpharm
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Levetiracetam Milpharm 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
Levetiracetam Milpharm may impair your ability to drive or operate
any tools or machinery, as Levetiracetam Milpharm 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.
Levetiracetam Milpharm contains methyl parahydroxybenzoate
(E 218) and propyl parahydroxybenzoate (E 216)
Levetiracetam Milpharm oral solution contains methyl
parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E
216) which may cause allergic reactions (possibly delayed).
Levetiracetam Milpharm oral solution 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 Levetiracetam Milpharm
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Levetiracetam Milpharm 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 (1000 mg) and 30 ml (3000 mg) each

Black

Duration of treatment:
• Levetiracetam Milpharm is used as a chronic treatment. You
should continue Levetiracetam Milpharm 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 Levetiracetam Milpharm than you should:
The possible side effects of an overdose of Levetiracetam Milpharm
are sleepiness, agitation, aggression, decrease of alertness,
inhibition of breathing and coma.

Contact your doctor if you took more Levetiracetam Milpharm than
you should. Your doctor will establish the best possible treatment of
overdose.
If you forget to take Levetiracetam Milpharm:
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 Levetiracetam Milpharm:
If stopping treatment, Levetiracetam Milpharm should be
discontinued gradually to avoid an increase of seizures. Should your
doctor decide to stop your Levetiracetam Milpharm treatment, he/
she will instruct you about the gradual withdrawal of Levetiracetam
Milpharm.

includes any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme at
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 Levetiracetam Milpharm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use after 7 months of first opening the bottle.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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.

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, 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.

What Levetiracetam Milpharm contains
• The active substance is levetiracetam. Each ml contains 100 mg
of levetiracetam.
The other ingredients are: maltitol liquid (E965), glycerol (E422),
propylene glycol, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), citric acid monohydrate, sodium
citrate (dihydrate), acesulfame potassium (E950), mafco
magnasweet (glycerine monoammonium glycyrrhizinate), grape
flavour (flavourings, propylene glycol, ascorbic acid), purified
water.

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 in 10 people
• nasopharyngitis;
• somnolence (sleepiness), headache.
Common: may affect up to 1 in 10 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 up to 1 in 100 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 up to 1 in 1,000 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 (Stevens–Johnson 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 nonJapanese patients.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This

What Levetiracetam Milpharm looks like and contents of the
pack
Levetiracetam Milpharm 100 mg/ml oral solution is a clear,
colourless, grape flavoured liquid.
300 ml amber glass bottle (type III) with a white child resistant
closure in a cardboard box also containing a 10 ml graduated oral
syringe and an adaptor for the syringe.
150 ml amber glass bottle (type III) with a white child resistant
closure in a cardboard box also containing a 3 ml graduated oral
syringe and an adaptor for the syringe.
150 ml amber glass bottle (type III) with a white child resistant
closure in a cardboard box also containing a 1 ml graduated oral
syringe and an adaptor for the syringe.
Marketing Authorisation Holder
Milpharm Limited
Ares block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of
the EEA under the following names:
France:
Germany:

Lévétiracétam Arrow 100 mg/ml, solution buvable
Levetiracetam Aurobindo 100 mg/ml Lösung zum
Einnehmen
The Netherlands Levetiracetam Aurobindo 100 mg/ml drank
Spain:
Levetiracetam Aurobindo 100 mg/ml solución oral
EFG
United Kingdom: Levetiracetam Milpharm 100 mg/ml oral solution
This leaflet was last revised in 12/2016.

Package leaflet: Information for the user
Levetiracetam Milpharm 100 mg/ml oral solution
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 Levetiracetam Milpharm is and what it is used for
2. What you need to know before you take Levetiracetam Milpharm
3. How to take Levetiracetam Milpharm
4. Possible side effects
5. How to store Levetiracetam Milpharm
6. Contents of the pack and other information

1.

What Levetiracetam Milpharm is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Milpharm 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 generalisation 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 Levetiracetam Milpharm

Do not take Levetiracetam Milpharm
 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 or pharmacist before taking Levetiracetam Milpharm
 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 Milpharm 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
 Levetiracetam Milpharm is not indicated in children and adolescents below 16 years on its own
(monotherapy)
Other medicines and Levetiracetam Milpharm
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Levetiracetam Milpharm 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
Levetiracetam Milpharm may impair your ability to drive or operate any tools or machinery, as
Levetiracetam Milpharm 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.
Levetiracetam Milpharm contains methyl parahydroxybenzoate (E 218) and propyl
parahydroxybenzoate (E 216)
Levetiracetam Milpharm oral solution contains methyl parahydroxybenzoate (E 218) and propyl
parahydroxybenzoate (E 216) which may cause allergic reactions (possibly delayed).
Levetiracetam Milpharm oral solution 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 Levetiracetam Milpharm

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Levetiracetam Milpharm 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 (1000 mg) and 30 ml (3000 mg) each day, divided in 2 intakes per day.
When you will first start taking Levetiracetam Milpharm, your doctor will prescribe you a lower dose
during 2 weeks before giving you the lowest general dose.
Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 10 ml (1000 mg) and 30 ml (3000 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 Levetiracetam Milpharm
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
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
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:
Levetiracetam Milpharm oral solution may be diluted in a glass of water or baby’s bottle. You may take
Levetiracetam Milpharm with or without food.
Instructions for use:

Open the bottle: press the cap and turn it anticlockwise (figure 1)



Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3).
Ensure it is well fixed.



Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure
5).



Fill the syringe with a small amount of solution by pulling the piston down (figure 5 A), then push the
piston upward in order to remove any possible bubble (figure 5 B). Pull the piston down to the
graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5 C).



Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).



Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the
bottom of the syringe (figure 7).





Drink the whole contents of the glass/baby’s bottle.
Close the bottle with the plastic screw cap.
Wash the syringe with water only (figure 8)

Duration of treatment:
 Levetiracetam Milpharm is used as a chronic treatment. You should continue Levetiracetam Milpharm
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 Levetiracetam Milpharm than you should:
The possible side effects of an overdose of Levetiracetam Milpharm are sleepiness, agitation, aggression,
decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Levetiracetam Milpharm than you should. Your doctor will establish
the best possible treatment of overdose.
If you forget to take Levetiracetam Milpharm:
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 Levetiracetam Milpharm:
If stopping treatment, Levetiracetam Milpharm should be discontinued gradually to avoid an increase of
seizures. Should your doctor decide to stop your Levetiracetam Milpharm treatment, he/she will instruct
you about the gradual withdrawal of Levetiracetam Milpharm.
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.
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 in 10 people
 nasopharyngitis;
 somnolence (sleepiness), headache.
Common: may affect up to 1 in 10 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 up to 1 in 100 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 up to 1 in 1,000 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 (Stevens–Johnson 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 Yellow Card Scheme at
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 Levetiracetam Milpharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use after 7 months of first opening the bottle.
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 Levetiracetam Milpharm contains
 The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
The other ingredients are: maltitol liquid (E965), glycerol (E422), propylene glycol, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, sodium
citrate (dihydrate), acesulfame potassium (E950), mafco magnasweet (glycerine monoammonium
glycyrrhizinate), grape flavour (flavourings, propylene glycol, ascorbic acid), purified water.
What Levetiracetam Milpharm looks like and contents of the pack
Levetiracetam Milpharm 100 mg/ml oral solution is a clear, colourless, grape flavoured liquid.
300 ml amber glass bottle (type III) with a white child resistant closure in a cardboard box also containing
a 10 ml graduated oral syringe and an adaptor for the syringe.
150 ml amber glass bottle (type III) with a white child resistant closure in a cardboard box also containing
a 3 ml graduated oral syringe and an adaptor for the syringe.
150 ml amber glass bottle (type III) with a white child resistant closure in a cardboard box also containing
a 1 ml graduated oral syringe and an adaptor for the syringe.
Marketing Authorisation Holder
Milpharm Limited
Ares block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
France:
Germany:
The Netherlands
Spain:
United Kingdom:

Lévétiracétam Arrow 100 mg/ml, solution buvable
Levetiracetam Aurobindo 100 mg/ml Lösung zum Einnehmen
Levetiracetam Aurobindo 100 mg/ml drank
Levetiracetam Aurobindo 100 mg/ml solución oral EFG
Levetiracetam Milpharm 100 mg/ml oral solution

This leaflet was last revised in 12/2016.

Package leaflet: Information for the user
Levetiracetam Milpharm 100 mg/ml oral solution
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 Levetiracetam Milpharm is and what it is used for
2. What you need to know before you take Levetiracetam Milpharm
3. How to take Levetiracetam Milpharm
4. Possible side effects
5. How to store Levetiracetam Milpharm
6. Contents of the pack and other information

1.

What Levetiracetam Milpharm is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Milpharm 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 generalisation 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 Levetiracetam Milpharm

Do not take Levetiracetam Milpharm
 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 or pharmacist before taking Levetiracetam Milpharm
 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 Milpharm 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
 Levetiracetam Milpharm is not indicated in children and adolescents below 16 years on its own
(monotherapy)
Other medicines and Levetiracetam Milpharm
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Levetiracetam Milpharm 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
Levetiracetam Milpharm may impair your ability to drive or operate any tools or machinery, as
Levetiracetam Milpharm 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.
Levetiracetam Milpharm contains methyl parahydroxybenzoate (E 218) and propyl
parahydroxybenzoate (E 216)
Levetiracetam Milpharm oral solution contains methyl parahydroxybenzoate (E 218) and propyl
parahydroxybenzoate (E 216) which may cause allergic reactions (possibly delayed).
Levetiracetam Milpharm oral solution 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 Levetiracetam Milpharm

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Levetiracetam Milpharm 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 (1000 mg) and 30 ml (3000 mg) each day, divided in 2 intakes per day.
When you will first start taking Levetiracetam Milpharm, your doctor will prescribe you a lower dose
during 2 weeks before giving you the lowest general dose.
Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 10 ml (1000 mg) and 30 ml (3000 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 Levetiracetam Milpharm
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
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
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:
Levetiracetam Milpharm oral solution may be diluted in a glass of water or baby’s bottle. You may take
Levetiracetam Milpharm with or without food.
Instructions for use:

Open the bottle: press the cap and turn it anticlockwise (figure 1)



Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3).
Ensure it is well fixed.



Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure
5).



Fill the syringe with a small amount of solution by pulling the piston down (figure 5 A), then push the
piston upward in order to remove any possible bubble (figure 5 B). Pull the piston down to the
graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5 C).



Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).



Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the
bottom of the syringe (figure 7).





Drink the whole contents of the glass/baby’s bottle.
Close the bottle with the plastic screw cap.
Wash the syringe with water only (figure 8)

Duration of treatment:
 Levetiracetam Milpharm is used as a chronic treatment. You should continue Levetiracetam Milpharm
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 Levetiracetam Milpharm than you should:
The possible side effects of an overdose of Levetiracetam Milpharm are sleepiness, agitation, aggression,
decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Levetiracetam Milpharm than you should. Your doctor will establish
the best possible treatment of overdose.
If you forget to take Levetiracetam Milpharm:
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 Levetiracetam Milpharm:
If stopping treatment, Levetiracetam Milpharm should be discontinued gradually to avoid an increase of
seizures. Should your doctor decide to stop your Levetiracetam Milpharm treatment, he/she will instruct
you about the gradual withdrawal of Levetiracetam Milpharm.
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.
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 in 10 people
 nasopharyngitis;
 somnolence (sleepiness), headache.
Common: may affect up to 1 in 10 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 up to 1 in 100 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 up to 1 in 1,000 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 (Stevens–Johnson 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 Yellow Card Scheme at
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 Levetiracetam Milpharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use after 7 months of first opening the bottle.
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 Levetiracetam Milpharm contains
 The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
The other ingredients are: maltitol liquid (E965), glycerol (E422), propylene glycol, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, sodium
citrate (dihydrate), acesulfame potassium (E950), mafco magnasweet (glycerine monoammonium
glycyrrhizinate), grape flavour (flavourings, propylene glycol, ascorbic acid), purified water.
What Levetiracetam Milpharm looks like and contents of the pack
Levetiracetam Milpharm 100 mg/ml oral solution is a clear, colourless, grape flavoured liquid.
300 ml amber glass bottle (type III) with a white child resistant closure in a cardboard box also containing
a 10 ml graduated oral syringe and an adaptor for the syringe.
150 ml amber glass bottle (type III) with a white child resistant closure in a cardboard box also containing
a 3 ml graduated oral syringe and an adaptor for the syringe.
150 ml amber glass bottle (type III) with a white child resistant closure in a cardboard box also containing
a 1 ml graduated oral syringe and an adaptor for the syringe.
Marketing Authorisation Holder
Milpharm Limited
Ares block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
France:
Germany:
The Netherlands
Spain:
United Kingdom:

Lévétiracétam Arrow 100 mg/ml, solution buvable
Levetiracetam Aurobindo 100 mg/ml Lösung zum Einnehmen
Levetiracetam Aurobindo 100 mg/ml drank
Levetiracetam Aurobindo 100 mg/ml solución oral EFG
Levetiracetam Milpharm 100 mg/ml oral solution

This leaflet was last revised in 0412/2016.

Expand Transcript

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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