NOEPIX 250 mg. 30 tablets

WHAT NOEPIX AND WHAT IT IS USED
Noepix 250 mg, 500 mg, 750 mg or 1000 mg tablets are antiepileptic drugs (medicines used to treat seizures in epilepsy).

Noepix be used:
Alone in patients over 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalization (a secondary generalization is when the attack cover the brain);
In addition to other antiepileptic medicines to treat:
partial onset seizures with or without generalization in patients from 1 month of age;
myoclonic seizures in patients 12 years of age with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures in patients 12 years of age with idiopathic generalized epilepsy (epilepsy type, which is believed to have a genetic cause).

2. BEFORE YOU TAKE NOEPIX
Do not take Noepix
If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Noepix.

Take special care with Noepix
If you have kidney problems, follow your doctor's instructions. Your doctor may decide that your dose should be adjusted;
If you notice any slowdown or unexpected puberty development of your child, please tell your doctor;
If you notice an increase in seizure severity (eg increased number), please tell your doctor;
A small number of people being treated with antiepileptics such as Noepiks have had thoughts of harming or killing themselves. If you have symptoms of depression and / or suicidal thoughts, please contact your doctor.

Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Noepiks with food and drink
You can take Noepiks with or without food. As a precaution, do not take Noepiks alcohol.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. If you are pregnant or think you are pregnant, please tell your doctor. Noepiks should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Studies with levetiracetam in animals have shown adverse reproductive effects at doses that are significantly higher than those that you need to control your seizures.
Breastfeeding is not recommended during treatment.

Driving and using machines
Noepiks may affect the ability to drive and use machines as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Do not use any tools or machines until it is established that your ability to perform such activities is not affected.

Only about 750 mg film-coated tablets
Important information about some of the ingredients of Noepiks
Noepiks contains the coloring agent Sunset Yellow (E110) which may cause allergic reactions.

3. HOW TO TAKE NOEPIX
Always take Noepix just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Noepiks should be taken twice daily, once in the morning and once in the evening, at the same time each day.
Take the number of tablets exactly as your doctor has told you.
250 mg tablets
monotherapy
Adults and adolescents (16 years of age):
Usual dose: between 1000 mg (4 tablets) and 3000 mg (12 tablets) every day.
When you initially start taking Noepiks, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.
For example: if your daily dose is 1000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

Add-on therapy
Adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg (4 tablets) and 3000 mg (12 tablets) every day.
For example: if your daily dose is 1000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose. Oral solution is more suitable form for infants and children under 6 years of age.
Usual dose: between 20 mg per kg body weight and 60 mg per kg of body weight each day. For example, at a total dose of 20 mg per kilogram of body weight every day, you need to give your child with a weight of 25 kg 1 tablet in the morning and 1 tablet in the evening.

Dosage in infants (1 month to less than 6 months):
The oral solution is more suitable form for use in infants.

500 mg film-coated tablets
monotherapy
Adults and adolescents (16 years of age):
Usual dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) each day. When you initially start taking Noepiks, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.
For example: if your daily dose is 2000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

Add-on therapy
Adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) each day.
For example: if your daily dose is 1000 mg, you must take one tablet in the morning and 1 tablet in the evening.

Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose. Oral solution is more suitable form for infants and children under 6 years of age.
Usual dose: between 20 mg per kg body weight and 60 mg per kg of body weight each day.

Dosage in infants (1 month to less than 6 months):
The oral solution is more suitable form for use in infants.

750 mg film-coated tablets
monotherapy
Adults and adolescents (16 years of age):
Usual dose: between 1000 mg and 3000 mg each day.
When you initially start taking Noepiks, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.
For example: if your daily dose is 3000 mg, you must take 2 tablets in the morning and 2 tablets in the evening.

Add-on therapy
Adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg and 3000 mg each day.
For example: if your daily dose is 1500 mg, you must take one tablet in the morning and 1 tablet in the evening.

Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose. Oral solution is more suitable form for infants and children under 6 years of age.
Usual dose: between 20 mg per kg body weight and 60 mg per kg of body weight each day.

Dosage in infants (1 month to less than 6 months):
The oral solution is more suitable form for use in infants.

1000 mg film-coated tablets
monotherapy
Adults and adolescents (16 years of age):
Usual dose: between 1000 mg and 3000 mg each day.
When you initially start taking Noepiks, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.
For example: if your daily dose is 2000 mg, you must take one tablet in the morning and 1 tablet in the evening.

Add-on therapy
Adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg and 3000 mg each day.
For example: if your daily dose is 2000 mg, you must take one tablet in the morning and 1 tablet in the evening.

Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose. Oral solution is more suitable form for infants and children under 6 years of age.
Usual dose: between 20 mg per kg body weight and 60 mg per kg of body weight each day.

Dosage in infants (1 month to less than 6 months):
The oral solution is more suitable form for use in infants.

Method of administration
Swallow the tablets Noepiks with sufficient liquid (eg a glass of water).

Duration of treatment
Noepiks be used as a chronic treatment. You should take Noepiks as long as you advise your doctor.
Do not stop treatment without your doctor's advice as this could increase your seizures.
If your doctor decides to stop your treatment with Noepix, he will explain how to gradually reduce intake of NOEPIX

If you take more than the amount NOEPIX
Possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, attention deficit, respiratory depression and coma. Tell your doctor if you take more tablets. Your doctor will take the best possible treatment of overdose.

If you forget to take NOEPIX
Tell your doctor if you have missed one or more doses. Do not take a double dose to make up for a missed tablet.

If you stop taking NOEPIX
If stopping treatment, as with other antiepileptic drugs intake Noepiks should be withdrawn gradually to avoid an increase of seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Noepiks can cause side effects, although not everybody gets them.
Tell your doctor if you develop any of the following and they worry you.
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 effects are expected to decrease over time.

The frequency of possible side effects listed below is defined using the following convention:
Very common (affecting more than 1 in 10 patients);
Common (affects 1 to 10 of 100 patients);
Uncommon (affects 1 to 10 of 1000 patients);
Rare (affects 1 to 10 in 10,000 patients);
Very rare (affects less than 1 in 10,000 patients);
Not known (from the available data can not be estimated).

Very common:
somnolence (sleepiness);
asthenia / fatigue (tiredness).

common:
infection, nasopharyngitis;
reducing the number of blood platelets;
anorexia (loss of appetite), weight increase;
anxiety, depression, emotional lability / mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), mental status changes (slow thinking, unable to concentrate);
dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (lack of coordination of movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (tripping), violation of attention (loss of concentration), memory impairment (forgetfulness);
diplopia (double vision), blurred vision;
vertigo (feelings of dizziness);
cough (increase of pre-existing cough);
abdominal pain, nausea, dyspepsia (digestive disorder), diarrhea, vomiting;
rash, eczema, pruritus;
myalgia (muscle pain);
accidental injury.

Not known:
reduce the number of red and / or white blood cells;
weight loss;
abnormal behavior, anger, anxiety, confusion, hallucinations, mental disorder, suicide, suicide attempt and suicidal thoughts;
paraesthesia (tingling); difficulties in controlling movements, uncontrollable muscle spasms affecting the head, torso and limbs;
pancreatitis, hepatic failure, hepatitis test abnormal liver function;
hair loss, blistering of the skin, mouth, eyes and genital area, skin rash.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE NOEPIX
Keep out of reach of children.
Do not use after the expiry date stated on the carton and blister after "EXP" The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Noepix
The active substance is levetiracetam. Each tablet contains 250 mg, 500 mg, 750 mg or 1000 mg levetiracetam.
Other ingredients are:
film-coated tablets 250 mg: crospovidone; povidone; silica colloidal anhydrous; magnesium stearate; polyvinyl alcohol - partially hydrolyzed; macrogol; talc; titanium dioxide (E171); indigo carmine (E132);