Levetiracetam 100mg/ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). ITALEPT is used:
- on its own in patients 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 patients from one month of age
– Myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy
– Primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy.
ITALEPT is used as a chronic treatment. You should continue ITALEPT treatment for as long as your doctor has told you.
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure. ITALEPT must be taken twice a day, half
of the daily dose in the morning and half of the daily dose in the evening, at about
the same time each day. Take the oral solution following your doctor’s instructions.
- When given orally: Drowsiness or giddiness arising 1-3 hours after ingestion of the medicine. At times there is breast tenderness and abdominal bloating. In case of drowsiness after 1 to 3 hours of oral administration, the dosage may be reduced or the patient may be put on once daily evening dose. Alternatively, the vaginal route for administration of the drug could be resorted to.
- When given vaginally / rectally: irritation, soreness or dryness may occur when administered by these routes. Some leakage of the capsule base might occur at times.
- Menses: menstrual cycle may be shortened or there might be intermenstrual bleeding. Menstruation may occur earlier than expected or at times might be delayed.
In case of shortening of menstrual cycle or intermittent bleeding, Shift the initiation of the treatment to the late date, e.g., 19th day of the cycle instead of 17th day.
Effects on ability to drive and use machine: Progesterone soft gelatin capsules may cause drowsiness and / or dizziness in a minority of patients; therefore, caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.
- 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 first start taking ITALEPT, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
- 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 ITALEPT according to the age, weight and dose.
An oral solution is a presentation more appropriate to infants and children below 6 years of age.
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||Starting dose : 0.1 ml/kg twice daily||Maximum dose : 0.3 ml/kg twice daily|
|6 Kg||0.6 ml twice daily||1.8 ml twice daily|
|8 Kg||0.8 ml twice daily||2.4 ml twice daily|
|10 Kg||1 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|
|Da 50 kg||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 (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||Starting dose : 0.07 ml/kg twice daily||Maximum dose : 0.21ml/kg twice daily|
|4 Kg||0.3 ml 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|
- somnolence (sleepiness), headache.
- 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);
- abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
- asthenia/fatigue (tiredness).
ITALEPT 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).
- Plug the adaptor into the neck of the bottle (Figure 2). Make sure it is secure.
- Take the syringe and insert it into the adaptor (Figure 2).
- Turn the bottle upside down (Figure 3).
- Fill the syringe with a small amount of solution by pulling the piston down (Figure 4), then push the piston upward in order to remove any possible bubble (Figure 5). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 6).
- Turn the bottle the right way up.
- Remove the syringe from the adaptor (Figure 6).
- 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).
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking ITALEPT with food and drink.
You may take ITALEPT with or without food. As a safety precaution, do not take ITALEPT with alcohol.
Talk to your doctor before taking ITALEPT.
- 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 slowdown 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 ITALEPT have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
- Ask your doctor or pharmacist for advice before taking any medicine.
- 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.
- ITALEPT should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown.
- ITALEPT 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.
- 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 box and blister after EXP: The expiry date refers to the last day of the month.
- Do not use after 7 months of first opening the bottle.
- Do to sensitivity to light, store in the original container.
- Store in a vertical position.
ITALEPT 100 mg / ml oral solution is a clear liquid. 300 ml of solution in an amber glass bottle with a child-resistant closure, in a cardboard box also containing a 10 ml syringe for oral use (with notch graduated every 0.25 ml) and an adaptor for the syringe.
So.Se.PHARM S.r.l, Italy
Farnoush Darou Teb Co.