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LEVETIRACETAM AMNEAL 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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Levetiracetam Amneal 100 mg/ml

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Levetiracetam - Leaflet - UK

doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Levetiracetam Amneal
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 Amneal 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.

Package Leaflet: Information for the patient
Levetiracetam Amneal 100 mg/ml oral solution

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 Amneal, your
doctor will prescribe you a lower dose during 2 weeks before giving you the
lowest general dose.

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.

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.

What is in this leaflet:
1. What Levetiracetam Amneal is and what it is used for
2. What you need to know before you take Levetiracetam Amneal
3. How to take Levetiracetam Amneal
4. Possible side effects
5. How to store Levetiracetam Amneal
6. Contents of the pack and other information
What Levetiracetam Amneal is and what it is used for

Weight

Levetiracetam Amneal 100 mg/ml oral solution is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).

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

Levetiracetam Amneal 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.

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

What you need to know before you take Levetiracetam Amneal

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

4 kg
5 kg
6 kg
7 kg

Do not take Levetiracetam Amneal
• If you are allergic to levetiracetam or any of the other ingredients of this
medicine (listed in section 6).

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

Warnings and Precautions
Talk to your doctor or pharmacist before taking Levetiracetam Amneal
• 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 have had thoughts of harming or killing themselves. If you
have any symptoms of depression and/or suicidal ideation, please contact
your doctor.

Method of administration:
Levetiracetam Amneal oral solution may be diluted in a glass of water or baby’s
bottle.

Other medicines and Levetiracetam Amneal
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.



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.

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1.

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 Amneal 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.

Levetiracetam Amneal with food, drink and alcohol
You may take Levetiracetam Amneal with or without food. As a safety precaution,
do not take Levetiracetam Amneal with alcohol.






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

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






Levetiracetam contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol
Levetiracetam oral solution includes methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).

Size: 210 x 420 mm

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or if you think you may be pregnant, please inform your
doctor.
Levetiracetam Amneal should not be used during pregnancy unless clearly
necessary. A risk of birth defects for your unborn child cannot be completely
excluded. Levetiracetam Amneal 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.



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 millilitres (ml) prescribed by your doctor
(figure 5 C).

Levetiracetam oral solution also contains maltitol. If you have been told by your
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Levetiracetam - Leaflet - UK

Review -2

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Rare: may affect up to 1 in 1,000 people
• 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).

• 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).

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 at: www.
mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.






diplopia (double vision), vision blurred;
liver function test abnormal;
hair loss, eczema, pruritus;
muscle weakness, myalgia (muscle pain);
injury.

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)

5.

How to store Levetiracetam Amneal

Keep this medicine out of the sight and reach of children.
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 stated on the carton after EXP. The
expiry date refers to the last day of that month.


Duration of treatment:
• Levetiracetam Amneal is used as a chronic treatment. You should continue
Levetiracetam Amneal 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 Amneal treatment, he/she will instruct you about the
gradual withdrawal of Levetiracetam Amneal.

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.

What Levetiracetam Amneal contains
The active substance is called levetiracetam. Each ml contains 100 mg of
levetiracetam.

If you take more Levetiracetam Amneal than you should:
The possible side effects of an overdose of Levetiracetam Amneal are
sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing
and coma.
Contact your doctor if you took more Levetiracetam Amneal than you should.
Your doctor will establish the best possible treatment of overdose.

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.

If you forget to take Levetiracetam Amneal:
Contact your doctor if you have missed one or more doses. Do not take a double
dose to make up for a forgotten dose.

What Levetiracetam Amneal looks like and contents of the pack
Levetiracetam Amneal 100 mg/ml oral solution is a clear, colourless, grape
flavoured liquid.

If you stop taking Levetiracetam Amneal:
If stopping treatment, as with other antiepileptic medicines, Levetiracetam
Amneal should be discontinued gradually to avoid an increase of seizures.

300 ml amber glass bottle (type III) with a white child resistant closure in a
cardboard box also containing a 10 ml oral syringe (graduated every 0.25 ml)
and an adaptor for the syringe.

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

150 ml amber glass bottle (type III) with a white child resistant closure in a
cardboard box also containing a 3 ml oral syringe (graduated every 0.1 ml) and
an adaptor for the syringe.

Possible side effects

150 ml amber glass bottle (type III) with a white child resistant closure in a
cardboard box also containing a 1 ml oral syringe (graduated every 0.05 ml) and
an adaptor for the syringe.

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.

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4.

Contents of the pack and other information

Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

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

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

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, tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Size: 210 x 420 mm

This leaflet was last revised in 07/2014

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);
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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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