LEVETIRACETAM 100 mg /Ml Infusion Solution

Зміст інструкції

1. Levetiracetam Tillomed 100 mg/ml concentrate for solution for infusion
   1. What is Levetiracetam Tillomed and what it is used for
   2. What you need to know before taking Levetiracetam Tillomed
   3. How to take Levetiracetam Tillomed
   4. Possible side effects
   5. How to store Levetiracetam Tillomed
   6. Package Contents and Other Information
2. Levetiracetam Tillomed concentrate for solution for infusion to reach a daily dose

Levetiracetam Tillomed 100 mg/ml concentrate for solution for infusion

Levetiracetam

Generic medicine

Read this leaflet carefully before you or your child takes this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

• alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which patients have repeated attacks (seizures). Levetiracetam is used for the epileptic form in which the initial attack affects only one part of the brain, but may subsequently extend to larger areas of both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
• as an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without generalization, in adults, adolescents and children starting from 4 years of age
• myoclonic seizures (brief, shock-like spasms of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause). Levetiracetam Tillomed concentrate for solution for infusion constitutes an alternative for patients when the administration of levetiracetam by oral route is temporarily not possible.

2. What you need to know before taking Levetiracetam Tillomed

Do not take Levetiracetam Tillomed
Page 1of 7

• If you are allergicto 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 Levetiracetam Tillomed.

• If you have kidney problems, follow your doctor's instructions. The latter may decide whether the dose needs to be adjusted.
• If you notice a slowing of growth or unexpected development of puberty in the child, contact your doctor.
• A reduced number of patients treated with antiepileptic drugs such as Levetiracetam Tillomed have experienced self-harmful thoughts and suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

• Levetiracetam Tillomed alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Tillomed
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines, including over-the-counter medicines.
Do not take macrogol (a medicine used as a laxative) one hour before and one hour after
taking levetiracetam as it may cause a loss of the latter's effect.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
Levetiracetam can be used during pregnancy, only if, after careful evaluation, this is
considered necessary by the doctor.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects for the fetus cannot be completely excluded.
Breastfeeding is not recommended during treatment.

Driving and using machines
Levetiracetam Tillomed may impair your ability to drive vehicles or use
tools or machinery as it may cause drowsiness. This is more likely at the beginning
of treatment or after a dose increase. You should not drive or use machinery until
you have verified that your ability to perform these activities is not affected.

Levetiracetam Tillomed contains sodium
This medicine contains 19.1 mg of sodium (the main component of table salt) per vial (5 ml), equivalent to 0.796% of the maximum recommended daily intake with the diet of an adult.
Page 2of 7

3. How to take Levetiracetam Tillomed

A doctor or nurse will administer Levetiracetam Tillomed to you as an intravenous
infusion.
Levetiracetam Tillomed must be administered twice a day, once in the morning and
once in the evening, at approximately the same time each day.
The intravenous formulation is an alternative to the oral formulation. It is possible to switch from
an oral formulation to the intravenous formulation, or vice versa, directly without
dose adjustment. The total daily dose and the frequency of administration
remain identical.

Monotherapy
Dose for adults and adolescents (starting from 16 years of age)
Typical dose: between 1,000 mg and 3,000 mg per day.
When you start taking Levetiracetam Tillomed for the first time, your doctor will
prescribe a lower dosefor 2 weeks before giving you the lowest typical dose.

Add-on therapy
Dose for adults and adolescents (12 to 17 years) weighing 50 kg or more
Typical dose: between 1,000 mg and 3,000 mg per day.

Dose for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than
50 kg
Typical dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

Method and route of administration
Levetiracetam Tillomed is for intravenous use.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and
infused over 15 minutes. For doctors and nurses, more detailed information for
correct use of Levetiracetam Tillomed is provided in paragraph 6.

Duration of treatment
There is no experience regarding the administration of levetiracetam by intravenous route for
a period longer than 4 days.

If you stop taking Levetiracetam Tillomed
In case of discontinuation of treatment, as with any other antiepileptic medicine,
Levetiracetam Tillomed must be discontinued gradually to avoid an increase in
seizures. If your doctor decides to stop the treatment with Levetiracetam Tillomed,
he will give you instructions regarding the gradual discontinuation of Levetiracetam Tillomed.
If you have any doubts about 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 everyone will experience them.

Immediately inform your doctor or go to the nearest emergency room if you experience:

• weakness, a feeling of lightheadedness or dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)

Page 3of 7

• swelling of the face, lips, tongue and throat (angioedema)
• flu-like symptoms and a rash on the face, followed by a widespread rash with high fever, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cells in the blood (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may be a sign of sudden decrease in kidney function
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) ( erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome)
• a more severe form of rash that causes peeling of the skin in more than 30% of the body surface area ( toxic epidermal necrolysis)
• signs of severe mental alterations or if someone around you notices signs of confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, somnolence, headache, fatigue and dizziness. At the beginning of treatment or when the dose is increased, side effects such as somnolence, fatigue and dizziness may be more common. These effects should, in any case, decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis
• somnolence, 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, dizziness (feeling unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (sensation of spinning)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (tiredness)

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells in the blood
• weight loss, weight gain
• attempted suicide and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation
• amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), impaired attention (loss of concentration)
• diplopia (double vision), blurred vision
• elevated/abnormal values in liver function tests

Page 4of 7

• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• trauma

Rare: may affect up to 1 in 1,000 people

• infection
• decreased number of all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], angioedema [swelling of face, lips, tongue and throat])
• decreased concentration of sodium in the blood
• suicide, personality disorders (behavioral problems), altered thinking (slowed thinking, inability to concentrate)
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• pancreatitis
• liver failure, hepatitis
• sudden decrease in kidney function
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) ( erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin in more than 30% of the body surface area ( toxic epidermal necrolysis)
• rhabdomyolysis (muscle tissue breakdown) and increased blood creatine phosphokinase associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• limping gait or difficulty walking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Tillomed

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 label and
on the packaging after “EXP.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Levetiracetam Tillomed contains

• The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam. Each vial of 5 ml contains 500 mg of levetiracetam. Page 5of 7
• The other ingredients are: sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injections.

Description of the appearance of Levetiracetam Tillomed and package contents
Levetiracetam Tillomed concentrate for solution for infusion is a clear, colorless liquid.
Levetiracetam Tillomed concentrate for solution for infusion is packaged in a cardboard
box containing 1 or 10 vials of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Tillomed Italia S.r.l.
viale Richard 1, Torre A
20143, Milano
Italy

Manufacturer
Emcure Pharma UK Limited
Basepoint Business Centre
110 Butterfield
Great Marlings
Luton
LU2 8DL United Kingdom
Tillomed Pharma GmbH
Manhagener Allee 36,
22926, Ahrensburg,
Germany

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations:
CountryProduct Name
Germany Levetiracetam Tillomed 100 mg/ml Concentrate for the preparation of an
infusion solution
France LEVETIRACETAM TILLOMED 100 mg/ml, solution for dilution for
infusion
Italy Levetiracetam Tillomed
Spain Levetiracetam Tillomed 100 mg/ml concentrate for solution for
infusion EFG
Page 6of 7
The following information is intended exclusively for healthcare professionals:
Instructions for the correct use of Levetiracetam Tillomed are provided in paragraph 3.
See Table 1 for the recommended preparation and administration of

Levetiracetam Tillomed concentrate for solution for infusion to reach a daily dose

total of 500 mg, 1000 mg, 2000 mg or 3000 mg in two separate doses.
Table 1. Preparation and administration of Levetiracetam Tillomed concentrate for
solution for infusion

This medicinal product is intended for single use only, any residual product
must be discarded.
Validity during use:
Chemical and physical stability during use has been demonstrated for 24 hours at 25 °C and ± 2 °C
(room temperature) in polypropylene vials and flexible PVC bags.
From a microbiological point of view, the product must be used immediately after
dilution. If not used immediately, storage times during use and
storage conditions prior to use are the responsibility of the user and
normally should not exceed 24 hours at 2-8 °C, unless it has been diluted in
controlled and validated aseptic conditions.
Levetiracetam Tillomed concentrate for solution for infusion has been found to be compatible from
a physical point of view and chemically stable when mixed with the following diluents:

• Sodium chloride 9 mg/ml (0.9%) injectable solution
• Ringer lactate injectable solution
• Glucose 50 mg/ml (5%) injectable solution

Page 7of 7