NORMEG 1000 mg. 30 tablets

What is Normeg and what it is used
Normeg is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Normeg be used:
alone in patients 16 years and older with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalization;
in addition to other antiepileptic medicines to treat:
partial seizures with or without generalization in patients of one or more months;
myoclonic seizures in patients 12 years and older with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures in patients 12 years and older with idiopathic generalized epilepsy.
Normeg oral solution is the preferred formulation for use in infants and children under 6 years of age.

2. What you need to know before taking Normeg
Do not take Normeg:
If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Normeg (see section 6).

Warnings and precautions:
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 Normeg have had thoughts of harming or killing themselves. If you have symptoms of depression and / or suicidal thoughts, please ask your doctor.
Other medicines and Normeg
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

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

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to have a baby, talk to your doctor before taking this medicine. Normeg should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Normeg studies in animals have shown adverse reproductive effects at doses which are significantly higher than those that you need to control your seizures.
Breastfeeding is not recommended during treatment.

Driving and using machines
Normeg may affect the ability to drive and use machines as Normeg can 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.

3. How to take Normeg
Always take Normeg just as you have been told by your doctor. If you're not sure, ask your doctor.
Normeg should be taken twice a day, half the daily dose in the morning and the second half of the evening, at the same time every day.
Take the number of tablets exactly as your doctor has told you.

Route of administration
Swallow the tablets Normeg with sufficient liquid (eg a glass of water).

monotherapy
Adults and adolescents (16 years and over):
Usual dose: between 1000 mg and 3000 mg each day.
When you initially start taking Normeg, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.

Add-on therapy
Adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg and 3000 mg each day.
Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing 50 kg or more:
Your doctor will prescribe the most appropriate form of Normeg according to age, weight and dosage.

The dose should be administered as an oral solution for children weighing less than 25 kg.
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):
Normeg oral solution is the preferred formulation for use in infants.

Duration of treatment:
Normeg be used as a chronic treatment. You should take Normeg as long as you advise your doctor;
Do not stop taking Normeg without advice from your doctor as this could increase your seizures. If your doctor decides to stop your treatment with Normeg, he will explain how to gradually reduce intake of Normeg.
The score line is not intended for breaking the tablet.

If you take more than the amount Normeg:
Possible side effects of an overdose of Normeg were somnolence, anxiety, aggression, attention deficit, respiratory depression and coma. Tell your doctor if you take more tablets. Your doctor will take the best possible measures overdose.

If you forget to take Normeg:
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 Normeg:
If stopping treatment, as with other antiepileptic drugs Normeg should be discontinued 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 Normeg 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.

Very common (affecting more than 1 in 10 patients):
nasopharyngitis;
somnolence (sleepiness), headache.
Common (affects 1 to 10 of 100 patients):
anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
convulsions, headache, impaired balance (tripping), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary twitching);
vertigo (feelings of dizziness);
cough;
abdominal pain, diarrhea, dyspepsia (digestive disorder), vomiting, nausea;
rash;
asthenia / fatigue (tiredness).
Uncommon (affects 1 in 10 of 1000 patients):
reduction of platelet count, decrease the number of white blood cells;
weight loss, weight gain;
suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, emotional instability / mood swings, agitation;
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination / ataxia (incoordination of movements), disturbance in attention (loss of memory);
diplopia (double vision), blurred vision;
deviation from normal results from a study of the liver;
hair loss, eczema, pruritus;
muscular weakness, myalgia (muscle pain);
injury.
Rare (affects 1 to 10 in 10,000 patients):
infection;
reduce the number of red and / or white blood cells;
suicide, personality disorders (behavioral problems), mental status changes (slow thinking, unable to concentrate);
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
pancreatitis;
liver failure;
blistering of the skin, mouth, eyes and genital area, skin rash.
If you get any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Normeg
Keep out of reach of children.
This medicine does not require any special storage conditions.
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.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Normeg
The active substance is levetiracetam.
Normeg 1000 mg: Each tablet contains 1,000 mg levetiracetam.

The other ingredients are;
Core:
Povidone 30, croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate.