Epixx (Levetiracetam) 50 Tablets

these Instructions for Use:

1. What is EPIXX XR and what is it used for? 2. Considerations before using the EPIXX XR 3. How to use the EPIXX XR? 4. What are the possible side effects? 5. EPİXX XR storage

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1. What is EPIXX and what is it used for?

EPIXX XR is a film-coated tablet that is supplied in packages of 30, 50 and 100 tablets containing 500 mg of levetiracetam. EPIXX XR 500 mg Film Tablet; white, oval, biconvex, film tablet. EPİXX XR is an antiepileptic drug used to treat epilepsy (epileptic seizures).

EPİXX XR is used alone for partial onset seizures with or without secondary spreading in patients 16 years of age or older,

USAGE INSTRUCTIONS The

3. How to use EPIXX XR?

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

Your doctor will tell you how many tablets you will use EPIXX XR, always take your medicine exactly as it is indicated by your doctor. If in doubt, consult your doctor or pharmacist.

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

The initial treatment dose of EPIXX XR is 1000 mg once daily. Your doctor may increase the dose when he considers it necessary. You should take the EPIXX XR'1, once a day, at approximately the same time every day. You can take it with or without food. Contact your doctor if you have any signs of return, but do not interrupt the EPIXX XR reception unless your doctor tells you to do so.

• Method and method of:

administration EPIXX XR tablets are for oral use. Ingestion of EPIXX XR tablets with a sufficient amount of liquid (eg a glass of water).

• Different age groups:

Use in children: EPIXX XR Film Tablet is not recommended for children and adolescents under 16 years of age because of lack of safety and efficacy.

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

• Special Use Cases:

Kidney / Liver Failure:

If you have kidney failure, your dose of EPIXX XR 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.

If you have an impression that the effect of EPIXX XR is too strong or weak, talk to your doctor or pharmacist.

If you have used more EPIXX XR than you should use: The possible side effects of overdosing EPIX XR intake are drowsiness, extreme restlessness, hostile behavior / aggression, blurred consciousness, respiratory arrest and coma. Your doctor will apply the best possible treatment for overdose.

Talk to a doctor or pharmacist if you have used more than you should use from the EPIXX XR.

If you forget to use the EPIXX XR: If you have missed one or more doses, consult your doctor. Do not take double doses to compensate for forgotten doses.

The following effects may occur when treatment with EPIXX XR:

• EPİXX XR is used as a chronic (long-term) treatment. You should continue with EPIXX XR treatment as long as your doctor tells you.

• 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 EPİXX XR treatment. Your doctor will inform you about the termination of EPIXX XR with a gradual dose reduction.

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

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4. What are the possible side effects?

Like all medicines, side effects may occur in people who are sensitive to the substances contained in the content of the EPIXX XR.

Side effects are listed as shown in the following categories:

Very common Common Uncommon Uncommon

: At least 1 of 10 patients can be seen. Less than 1 in 10 patients, but more than 1 in 100 patients. Less than 1 in 100 patients, but more than 1 in 1000 patients: less than 1 in 1000 patients, but more than 1 in 10,000 patients

. : Less than 1 in 10,000 patients. : Can not be predicted based on available data

Very rare Unknown

Very common:

• Nasopharyngitis (nose and pharynx)

Drowsiness (Somnolence) Headache

Common: Loss of appetite (Anorexia) Depression Hostile behavior / aggression

Anxiety

• Insomnia (Insomnia)

Irritability or warning Overreaction (Irritability)

• Involuntary muscle contractions (Convulsion)

• Stability disturbance

•

Drowsiness Unconscious tremor (Tremor)

Immobility accompanied by consciousness numbness (lethargy)cough

• Rotation sensation (Vertigo)

• Increased

• Abdominal pain

• Diarrhea,

• Indigestion (Dyspepsia)

• Fungal

• Vomiting

• Rash. Fatigue (asthenia)

Uncommon:

• Reduction in the number of cells that provide clotting

blood• Reduction in the number of white blood cells. Weight

loss • Weight loss

• Suicide attempt and suicidal ideation

• Mental disorder

Abnormal behaviors. See or hear things that aren't real (hallucination, hallucination)

• Anger

Mind confusion (Confusion) Panic attack

Emotional variability / mood fluctuations

• Extreme restlessness (agitation)

Memory loss (Amnesia), distraction (Concentration loss) Forgetfulness (memory failure)

Coordination Disorder / maladaptive movement disorder (Ataxia)

• Feeling of pincushion (Paresthesia)

• Double vision

Blurred vision Abnormalities in liver function tests Hair loss Skin inflammation (Extraction) Itching Muscle weakness Muscle pain (Myalgia)

Injuries

Sparse

• Infection

• Reduction of neutrophil count in

blood Decrease in the number of types

• Suicide

• Personality disorders (behavioral disorder)

Abnormal thought (Slow thinking, inability to concentrate)

• Uncontrolled muscle contractions (Coreoatetosis)

• Difficulty in controlling motions (Dyskinesia))

• Hyperactivity, hyperactivity (Hyperactivity Kinesi)

Pancreatic inflammation (Pancreatitis)

• Liver failure

• Hepatic inflammation (Hepatitis)

• Various types of skin and mucosa (Papule, vesicle, bulla, etc.) at the same time with blisters

(Multiforme erythema) Formation of bubbles in the skin, mouth, eyes and genital area (Stevens Johnson syndrome) Skin peeling (toxic epidermal necrolysis, a serious condition affecting more than 30% of the body surface)

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.

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Inform your doctor or pharmacist if you experience any side effects not these instructions.

5. Storage of EPİXX XR

Keep out of the reach of children and in the container.

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Store at room temperature under 25 ° C and in a dry place.

Use in accordance with expiration dates. Do not use the EPİXX XR after the expiry date indicated on the package. Do not use the EPIXX XR if you notice any defects in the product and / or its packaging.