Epitam (Levetiracetam) 50 Tablets

In these Instructions for Use:

1. What is EPITA®M and what is it used for? 2 andshould be considered before using epitam®

3I EPİTA

®

How to use?

4. What are the possible side effects? 5 The EPITAM® storage

heads are included.

1. What is EPITAM® and what is it used for?

EPITAM® tablets are yellow, oval film on one side and ik 500 “on the other. Each box contains 50 or 100 tablets.

EPITAM

®

is an antiepileptic drug to prevent epilepsy (epileptic seizures).

Page

1/7 ® EPITAM

is used alone in the treatment of partial seizures in patients 16 years and older.

EPITAM®, which already uses another antiepileptic drug; It is also used in addition to antiepileptic drugs used by patients with other type of epileptic seizures.

2. CautionsEPITAM

®

before usingDO NOT use EPITAM® in the following cases

• If you are allergic to any of the excipients of levetiracetam or EPITAM® (if you are hypersensitive).

USE EPITAM® CAREFULLY

• Observe your doctor's instructions if you have kidney problems. Your doctor may decide whether your dose should be adjusted.

• In children receiving EPITAM®, EPITAM® has no effect on puberty and growth. However, long-term effects in children are unknown.

• If you notice an increase in the severity of the seizure (eg number increase), please consult your doctor.

• FewEPITAM

®

individuals treated with an antiepileptic drug such ashave the idea of ​​self-harm or self-killing. Please consult your doctor if you are experiencing symptoms of depression and / or suicidal ideation.

Please consult your doctor if these warnings are valid for you, even in the past.

Using EPITAM

®

with food and drink You can take EPITAM® with or without meals. As a safety precaution, do notEPITAM

®

takewith alcohol.

Pregnancy

• Consult your doctor or pharmacist before using the medication.

• If you are pregnant or think you are pregnant, please inform your doctor.

• EPITAM

® should

not be used during pregnancy unless absolutely necessary. TheEPİTAM

®

potential risk ofon your unborn child is unknown. InEPITAM

®

animal studies,has shown undesirable effects on reproduction at higher dose levels than required for the control of your seizures.

• If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding

• Consult your doctor or pharmacist before using the medication.

• Breastfeeding is not recommended during treatment.

Page 2 of 7 Using the

machine and the machine

EPITAM

®

may make you feel sleepy, which may disrupt your ability to use any tool or machine. This is most likely possible at the beginning of treatment or after an increase in dose. In theEPITAM

®

treatment of, do not use machinery and vehicles until your doctor evaluates and permits your response to treatment.

EPİTAM

®

Important information about some of the excipients contained inIf you do not have an extreme sensitivity to the excipients contained in EPITAM®, there is no adverse effect on these substances.

Use with other medicines

If you are currently using any prescription or non-prescription medication, or if you have recently

used it, please inform your doctor or pharmacist.

3. How to use EPITAM®?

• Instructions for proper use and dose / frequency of administration:

Adults (≥18 years) and use in adolescents (12-17 years) of 50 kg or more:

Your doctor will tell you how many tablets you will use EPITAM®, take the tablets according to him.

• General dose: 1000 mg (2 tablets) -3000 mg (6 tablets) per day.

• You should take EPITAM® twice a day, in the morning and in the evening, at approximately the same time every day.

For example, if your daily dose is 1000 mg, you should take a tablet in the morning and evening.

For children aged 4-11 years and adolescents under 12 kg (12-17 years):

Give your child the number of tablets that your doctor says for your child.

• General dose: between 20 mg / kg and 60 mg / kg per day.

• Your child should take EPITAM® twice a day, in the morning and in the evening, at approximately the same time every day.

• Method and method of:

EPITAM

®

administrationtablets are for oral use. Swallow the EPITAM® tablets with a sufficient amount of liquid (eg a glass of water).

Page 3 of 7

• Different age groups:

Use in children: EPITAM

® is

used in children and adults over the age of 4 years.

It is not recommended for children under 4 years of age.

Use in the elderly: In elderly patients (above 65 years), if the kidney function is decreased, the dose of EPITAM® will be adjusted by your doctor.

• Special use cases:

Kidney / Liver failure:

If you have kidney failure, your dose of EPITAM® will be adjusted by your doctor according to your kidney function.

If you have severe liver failure, your dose will be reduced by your doctor.

EPITAM

® is

if you feel the effect oftoo strong or too weak

Talk to your doctor or pharmacist.

If you have used more EPITAM® than you should use: If you use more than you should use EPITAM®, talk to a doctor or pharmacist.

EPITAMmissed

®

Ifforget to use:

youIf you haveone or more doses, consult your doctor.

Do not take double doses to compensate for forgotten doses.

The following may occur when treatment with EPITAM® is terminated:

• EPITAM® is used as a chronic (long-term) treatment. As long as your doctor tells you, you should continue with the EPITAM® treatment.

• Do not discontinue treatment without the advice of your doctor as this may increase your seizures. Your doctor should decide on the termination of the EPITAM® treatment. Your doctorEPITAM

®

will inform you about the termination oftreatment with a gradual dose reduction.

Consult your doctor or pharmacist if you have further questions about the use of the drug.

Page 4 of 7

4. What are the possible side effects?

Like all medicines, side effects may occur in people who are sensitive to the substances contained in EPITAM®.

If you notice any of the following, tell your doctor immediately or you should contact the emergency department of the hospital nearest you:

• Sleepiness (Somnolans),

• Fatigue (Asthenia),

• Involuntary muscle contractions (convulsions)

• Compatible movement disorder (Ataxia),

• Dysfunction ,

• Over dysphoria (agitation)

• depression

• Emotional variability / mood swings,

• hostile behavior / aggression,

• nervousness or warning to overreact show (irritability),

• Kanda reduction in platelet count

• abnormal behaviors

• anger

• Anxiety,

• Confusion

• Seeing or hearing things that are not real (hallucinations, hallucinations),

• Mental disorder,

• Suicide, suicide attempt and suicidal ideation,

• Pancreatic inflammation (Pancreatitis),

• Hepatic inflammation (Hepatitis). )

• Red blood cells and / or a reduction in the number of white blood

These are all serious side effects d. Emergency medical intervention may be required. Serious side effects are very rare.

If you notice any of the following, tell your doctor:

• Drowsiness,

• Headache,

• Hyperactivity, hyperactivity (Hyperkinesis),

• Involuntary tremors,

• Memory loss (Amnesia), distractibility (loss of concentration),

• Forgetfulness ( Memory failure),

• Insomnia (Insomnia),

• personality disorders (behavioral problems),

• abnormal thinking (slow thinking, inability to concentrate),

• abdominal pain,

• diarrhea,

• indigestion (dyspepsia),

Page 5/7

• Nausea

• Vomiting,

• Loss of appetite (Anorexia),

• Weight gain,

• Rotation sensation (Vertigo),

• Double vision,

• Blurred vision,

• Muscle pain (Myalgia),

• Accidental injuries,

• Infection,

• Nasopharyngitis (Nasal and pharynx),

• Increased,

• Rash,

• Skin inflammation (eczema),

• Itching,

cough• Feeling of pain (Paresthesia),

• Liver failure,

• Abnormalities in liver function tests,

• Weight loss,

• Hair loss

These areEPITAM

®

mild side effects of.

Some side effects, such as drowsiness, fatigue, dizziness, can be seen more frequently at the start of therapy or in dose increases. However, these effects should decrease over time.

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.