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KEPPRA 100 mg. / ml. 5 ml. 10 vials

Product Code: KEPPRA 100 mg. / ml. 5 ml. 10 vials
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What Keppra is and what it is used for
Keppra 100 mg / ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:
alone in adults and adolescents 16 years of age and older with newly diagnosed epilepsy for the treatment of partial onset seizures with or without secondary generalization;
in addition to other anti-epileptic medicines for the treatment of:
partial seizures with or without generalization in adults, adolescents, children and infants one month and over;
myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures in adults and adolescents of 12 years of age and older with idiopathic generalized epilepsy.
2. What you need to know before you take Keppra
Do not take Keppra:
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 Keppra:
If you have kidney problems, follow the doctor's instructions. Your doctor may decide whether your dosage should be adjusted;
If you notice any growth retardation or unexpected development of your child's puberty, please tell your doctor;
If you notice an increase in the severity of seizures (for example, an increase in their number), please tell your doctor;
Few people treated with antiepileptics such as Keppra have had thoughts of self-harm or suicide. If you have symptoms of depression and / or suicidal thoughts, please contact your doctor.
Other medicines and Keppra
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Keppra with food, beverages and alcohol
You can take Keppra with or without food. As a precautionary measure, do not take Keppra with alcohol.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or think you are pregnant, please tell your doctor.
Keppra should not be used during pregnancy unless clearly necessary. The risk of birth defects for your unborn child can not be totally excluded. Animal studies with Keppra show unintended reproductive toxicity but at doses that are significantly higher than those you need to control your seizures.
Breastfeeding is not recommended during treatment.

Driving and using machines
Keppra may affect the ability to drive and use machines as Keppra may cause drowsiness. This is more likely at the start of treatment or after increasing the dose. Do not use any technique or machinery until it is determined that your ability to perform these activities is not affected.

Keppra contains sodium
The maximum single dose of Keppra concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be considered in patients on a controlled sodium diet.

3. How to take Keppra
Your doctor or nurse will be given Keppra intravenous infusion.
Keppra should be given twice a day, once in the morning and once in the evening, at the same time each day.
Intravenous form is an alternative to oral administration.
You can switch from film-coated tablets or oral solution to intravenous form or vice versa, directly, without changing the dose. The total daily dose and frequency of administration will remain the same.

Monotherapy
Dosage in adults and adolescents (16 years and older):
Usual dose: between 1000 mg and 3000 mg every day.
When you first start taking Keppra, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest usual dose.
Complementary treatment
Dosage in adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1 000 mg and 3 000 mg every day.

Dosage in children (4 to 11 years) and adolescents (12-17 years) weighing less than 50 kg:
Usual dose: between 20 mg per kg of body weight and 60 mg per kg of body weight each day.

Method and route of administration:
Keppra should be diluted in at least 100 ml of compatible solvent and administered intravenously as a 15-minute infusion.
More detailed information for doctors and nurses about the correct use of Kerga is given in point 6.

Duration of treatment:
Keppra is used for chronic treatment. You should take Keppra as long as your doctor has told you;
Do not stop taking Keppra without your doctor's advice, as this may increase your seizures. If your doctor decides to stop your treatment with Keppra, he will tell you how to gradually stop taking Keppra;
There is no experience for the intravenous administration of levetiracetam over a longer period than 4 days.
If you stop taking Keppra
Upon cessation of therapy, as well as with other antiepileptic drugs, Keppra 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 everyone gets them.
Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of treatment or when increasing the dose. These reactions are expected to decrease over time.

Very common: may affect more than 1 in 10 patients:
nasopharyngitis;
somnolence (somnolence), headache.
Common: may affect 1 to 10 patients in 100:
anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
convulsion, disturbed balance (loss of balance), dizziness (feeling of instability), lethargy, tremor (involuntary shaking);
vertigo (a sense of vertigo);
coughing;
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia / fatigue (exhaustion).
Uncommon: may affect 1 to 10 users in 1,000:
decreased number of platelets, decreased leucocyte count;
weight loss, weight gain;
suicidal attempts and suicidal thoughts, mental disorders, unusual behavior, hallucinations, anger, confusion, panic attack, emotional instability / mood swings, anxiety;
amnesia (memory loss), memory impairment (forgetfulness), impaired coordination / ataxia (lack of coordination of movements), paraesthesia (numbness), disturbance of attention (loss of concentration);
diplopia (double vision), blurred vision;
deviation from normal liver test results;
hair loss, eczema, pruritus;
muscle weakness, myalgia (muscle pain);
injury.
Rare: may affect 1 to 10 users in 10,000:
infection;
reduced number of all types of blood cells;
severe hypersensitivity reactions (DRESS);
decrease in sodium concentration in the blood;
suicide, personality disorders (behavioral problems), change in thinking (slow thinking, inability to concentrate);
uncontrolled muscle spasms affecting the head, body and extremities, difficulty in controlling movements, hyperkinesia (increased activity);
pancreatitis;
hepatic failure, hepatitis;
skin rash, which may be in the form of blisters and appear to be small targets (dark spots in the center surrounded by darker areas with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and scaling , especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a heavier form that causes skin scaling to more than 30% of the body surface (toxic epidermal necrolysis).
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store Keppra
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.

6. Package Contents and Additional Information
What Keppra contains
The active substance is levetiracetam. Each ml of the infusion solution contains 100 mg levetiracetam.
The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride and water for injections.

What Keppra looks like and contents of the pack
Keppra concentrate for solution for infusion (Keppra concentrate) is a clear, colorless and sterile liquid.
Keppra concentrate vials of 5 ml are packed in cartons of 10 vials.

The following information is intended for medical professionals only:
Instructions for the correct use of Keppra are listed in section 3.
One vial of Keppra concentrate for solution for infusion contains levetiracetam 500 mg (5 ml concentrate 100 mg / ml). See Table 1 for the recommended preparation and administration of Keppra concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg and 3000 mg divided into two doses.

Table 1 Preparation and administration of Keppra concentrate
Dose Volume withdrawn Volume of infusion Time of infusion Frequency of application Total daily dose
250 mg 2.5 ml (half vial 5 ml) 100 ml 15 minutes Twice a day 500 mg / day
500 mg 5 ml (one vial 5 ml) 100 ml 15 minutes Twice a day 1000 mg / day
1000 mg 10 ml (two vials 5 ml) 100 ml 15 minutes Twice a day 2000 mg / day
1500 mg 15 ml (3 vials 5 ml) 100 ml 15 minutes Two times daily 3000 mg / day
The medicinal product is for single use only. Any unused solution should be destroyed.

Shelf life of the diluted medicinal product:
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, storage times and conditions prior to use are the responsibility of the person using it and usually not longer than 24 hours at 2 to 8 ° C unless dilution is performed under controlled and validated aseptic conditions.

Keppra concentrate has been shown to be physically compatible and chemically stable when mixed with the following solvents for at least 24 hours and stored in PVC bags at a controlled room temperature of 15-25 ° C.
Solvents:
Sodium chloride (0.9%) solution for injection;
Ringer's lactate solution for injection;
Dextrose 5% solution for injection.

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