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LEVETIRACETAM MILPHARM 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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Package Leaflet: Information for the patient

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.
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 Milpharm 100 mg/ml oral solution 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 partial onset seizures with or
without secondary generalisation
• 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 in adults and adolescents from 12 years
of age with juvenile myoclonic epilepsy.
• primary generalised tonic-clonic seizures in adults and
adolescents from 12 years of age with idiopathic generalised
epilepsy.
2. What you need to know before you take Levetiracetam
Milpharm
Do not take Levetiracetam Milpharm
• If you are allergic (hypersensitive) to levetiracetam or any of the
other ingredients of this medicine (listed in Section 6).
Warnings and Precautions
Talk to your doctor before taking 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.
• If you notice an increase in seizure severity (e.g. increased
number), 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.
Other medicines and Levetiracetam Milpharm
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

P150

P150

Levetiracetam
Milpharm 100 mg/ml
oral solution

Levetiracetam
Milpharm 100 mg/ml
oral solution

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

3. How to take Levetiracetam Milpharm
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor 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.

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
10 kg

0.8 ml twice daily
1 ml twice daily

2.4 ml twice daily
3 ml twice daily

15 kg

1.5 ml twice daily

4.5 ml twice daily

20 kg

2 ml twice daily

6 ml twice daily

25 kg

2.5 ml twice daily

7.5 ml twice daily

From 50 kg

5 ml twice daily

15 ml twice daily

Weight

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
syringeprovided in the cardboard box.
Weight

Starting dose:
0.07 ml/kg twice daily

Maximum dose:
0.21 ml/kg twice daily

4 kg

0.3 ml twice daily

0.85 ml twice daily

5 kg
6 kg
7 kg

0.35 ml twice daily
0.45 ml twice daily
0.5 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.
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).

Levetiracetam Milpharm with food, drink and alcohol
You may take Levetiracetam Milpharm with or without food. As a
safety precaution, do not take Levetiracetam Milpharm with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant or if you think you may be pregnant, please
inform your doctor.
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.
Important information about some of the ingredients of
Levetiracetam Milpharm
Levetiracetam Milpharm oral solution includes methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) 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.

Black



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)

Rare: may affect 1 to 10 users in 10,000
• infection;
• decreased number of all blood cell types;
• severe hypersensitivity reactions (DRESS);
• 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;
• hepatic failure, hepatitis;
• skin rash, which may form blisters and looks like small targets
(central dark spots surrounded by a paler area, with a dark ring
around the edge) (erythema multiforme), a widespread rash
with blisters and peeling skin, particularly around the mouth,
nose, eyes and genitals (Stevens–Johnson syndrome), and a
more severe form causing skin peeling in more than 30% of the
body surface (toxic epidermal necrolysis).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to
Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Levetiracetam Milpharm

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, as with other antiepileptic medicines,
Levetiracetam Milpharm should be discontinued gradually to avoid
an increase of seizures.
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.
Some of the side effects like sleepiness, tiredness and dizziness
may be more common at the beginning of the treatment or at dose
increase. These effects should however decrease over time.
Very common: may affect more than 1 user in 10
• nasopharyngitis;
• somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100
• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia,
nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder), dizziness
(sensation of unsteadiness), lethargy, 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 1000
• 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;
• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

This medicinal product does not require any special storage
conditions.
Do not use after 7 months of first opening the bottle.
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.
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 called 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.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 05/2014.
P150

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. Should your doctor decide to stop
your Levetiracetam Milpharm treatment, he/she will instruct you
about the gradual withdrawal of Levetiracetam Milpharm.

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

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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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