Karbalex Retard (Carbamazepine) 50 Tablets

INSTRUCTIONS FOR USE

Excipients: Ammonia Methacrylate Copolymer (Eudragit RS-PO), Methacrylic acid-Ethilacrylate Copolymer (1: 1) dispersion 30% (Eudragit L 30 D), Colloidal anhydrous silica, Magnesium stearate, Pure talc, Sodium starch glycolate (Type A Microcrystalline cellulose.

Before using this medicine, please read this INSTRUCTIONS carefully, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is KARBALEX and what is it used for? 2. Things to consider before using KARBALEX 3. How to use KARBALEX? 4. What are the possible side effects? 5. Storage of the KARBALEX

Headers are included.

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

Carbamazepine has a preventive effect on various seizure types and has a mood-regulating effect. KARBALEX used in the treatment of the following diseases:

Various, including seizures that psychic changes in the forefront of epilepsy (epilepsy) types

Mani

Manic-preventing depressive disorder

emerging suddenly in the face, jabbing nature of pain episodes (trigeminal neuralgia)

Diabetes due to nerve damage

Alcohol withdrawal syndrome

Sugar-free diabetes

2. Things to consider before usinghave

KARBALEX DO NOT use CARBALEX in the following caseshypersensitivity to

•

If youcarbamazepine or related substances (tricyclic antidepressants = one type of drugs used against depression) or excipients,

• your

current heart conduction disorders If not,

• Do

not use if you have severe liver failure or bone marrow abnormalities.

KARBALEX •

tablets should not be given to children under 1 year old.

USE KARBALEX ATTENTIONInform your doctor

•

if you have cardiovascular disease, liver and / or renal dysfunction, liver damage, or intraocular tension (glaucoma). Your doctor will take this into consideration before prescribing the drug.

•

Inform your doctor or pharmacist if you have other illnesses or allergies.

•

If you plan to become pregnant, pregnant or breastfeeding your baby, inform your doctor or pharmacist.

•

Blood and liver function tests should be performed as described by your doctor.

•

If side effects occur (especially skin reactions, fever, sore throat or deep sores or jaundice in the throat, mouth or other places), consult your doctor immediately.

• The

effectiveness of hormonal contraceptives may decrease with carbamazepine. Therefore, alternative birth control methods should be used.

•

If, in some rare cases, heart rhythm (decreased cardiac activity), blood formation (paleness, fatigue, infection resistance, increased frequency of bleeding) or renal dysfunction, consult your doctor immediately.

•

Serious skin side effects rarely occur.

•

A small number of people treated with medications used to treat epilepsy, such as carbamazepine, may think to harm or kill themselves. If you have these thoughts at any moment, consult your doctor immediately.

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

Handling of KARBALEX with food and drink Avoid drinking alcohol and grapefruit juice during treatment.

Pregnancy

Consult your doctor or pharmacist before using the medicine. KARBALEX should not be used during pregnancy unless necessary, but your doctor will decide whether or not to use KARBALEX.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medication. Carbamazepine passes into breast milk. Your doctor will decide whether you are going to stop taking drugs or breastfeeding.

Use ofmachine The use of

thisthis medicine may affect reactivity and the ability to drive. KARBALEX reduces reactivity. Care must therefore be taken when driving or operating any machine!

Important information about some of the excipients in the content of KARBALEX If you do not have an extreme sensitivity to the substances in the content of KARBALEX, there is no adverse effect on these substances.

with other drugs

CombinationCARBALEX can reduce the effects of anticoagulants (anticoagulants), certain antibiotics (such as doxycillin), certain drugs used in irregular heartbeats (quinidine) and oral hormonal contraceptives. Some other drugs, as well as grapefruit juice, can increase the concentration of carbamazepine in the blood and, as a result, change its effect:

-

Some antibiotics (eg erythromycin, troleandomycin, isoniazid), against cardiovascular disease (eg verapamil, diltiazem), pain (dextropropoxifen), against depression (viloxazine), various drugs used against gastric acid (cimetidine) and some epilepsy drugs (phenytoin, pyrimidone, valproic acid). Combination with some drugs (lithium) used in the treatment of psychiatric disorders may cause unrest and confusion. Some medications used against mental disorders (MAO inhibitors) should be discontinued and at least 2 weeks should be put in place when starting KARBALEX treatment. Valeria may increase the central nervous system suppression. Avoid using with herbal products such as John's wort (Hypericum perforatum), kava kava and gotu kola. Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use KARBALEX

Instructions for appropriate use and dose / frequency of administration: Always take KARBALEX as recommended by your doctor. If you are not sure, check with your doctor or pharmacist. In addition to the KARBALEX 300 mg tablet, KARBALEX 600 mg tablet is also available. The dosage and duration of treatment will be individually adjusted to your treating physician. Seizure disorders: In general, treatment starts twice a day with a dose of 150 mg (half retard tablet). Your doctor will then increase your dose until the appropriate dose is achieved. This is usually the daily dose of 800-1200 mg administered in two divided doses. In some cases, it can reach 1600 mg or even 2000 mg. Mania and Manic-depressive (bipolar) disorder: The dose is usually about 300-1500 mg per day, taken in two divided doses. It is usually given daily by dividing 600 mg (2 retard tablets) in half.

Sudden painful bouts of pain in the face (trigeminal neuralgia): The dose is usually 300 mg per day at the beginning of treatment (1 tablet). Your doctor will then increase your dose until the appropriate dose is achieved. Mostly, a daily dose of 600 mg (2 retard tablets) is suitable. Diabetic nerve damage, diabetes-free diabetes (central diabetes insipidus): Generally, once a day (2 tablets) or 2 times divided (300 mg in the morning and evening) 600 mg. Short-term, immediate symptoms of alcohol withdrawal: Usually 600 mg / day (2 tablets). In severe cases, 1200 mg (4 retard tablets) can be administered daily during the first few days of treatment.

Method and method of administration: After ingestion or after meals, it should be swallowed with sufficient amount of liquid. The tablets may be cleaved without losing their extended effect.

If desired, it can be dissolved in water, milk, tea or orange juice (but not in grapefruit juice!). The solution should be drunk immediately after preparation.

Different age groups: Use in children: 150 mg (half tablet) twice a day (morning and evening) in children aged 1 to 5 years. For children aged 6 to 10 years: 150-300 mg (half-one tablet) is used twice a day (morning and evening). KARBALEX tablets should not be given to children under 1 year of age.

Use in the elderly: There is no specific dose adjustment in the elderly.

Specific conditions of use: Liver failure: Inform your doctor if there is any damage to your liver function. Do not use if you have severe liver failure. Severe renal failure: If you have a kidney dysfunction, your doctor will give you a lower dose. If you have an impression that the effect of KARBALEX is too strong or too weak, talk to your doctor or pharmacist.

If you have used more KARBALEX than you should:

talk to a doctor or pharmacist if you have used more than you should use from KARBALEX. Symptoms of short-term overdose include vomiting, tremors, extreme restlessness, contraction, blood pressure change, superficial respiration or sometimes respiratory arrest, impaired consciousness, or loss of consciousness. Emergency medical attention is required.

If you forget to use KARBALEX:

Do not take double doses to compensate for forgotten doses. Continue your treatment as normal.

Effects that may occur when treatment is terminated with KARBALEX Treatment of CARBALEX should not be initiated or discontinued without medical advice.

4. What are the possible side effects?

As with all medicines, there may be side effects in individuals who are susceptible to substances contained in the content of KARBALEX.

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

• Inflammation of the lymph nodes very rarely, blood clot formation and allergic pneumonitis (inflammation of the lungs)

. All these are serious side effects. Emergency medical intervention may be required.

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

• Kidney dysfunction (blood or protein excretion in the urine),

• High doses of tremor,

• Changes in blood pressure,

• Blood formation disorders (pallor, fatigue, infectionsIncreased incidence, increased frequency of bleeding,

•• Very rarely headache, dizziness, drowsiness, coordination disorders, sensation of touch, limb numbness and speech disorders, confusion in elderly patients, extreme restlessness and - very rarely - visual delusions occur. It may occur. These side effects usually disappear within 8-14 days without taking any precautions or temporarily reducing the dose according to your doctor's recommendations.

• Rare heart rhythm disturbances (decreased cardiac activity),

• Acute intermittent porphyria (a metabolic disease that can damage the liver),

• Coordination disorder, blurred vision, speech disorder, numbness, involuntary movements, tinnitus, sensitivity to sound. All these are serious side effects. Emergency medical intervention may be required.

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

• Rarely fever,

• Very rarely fatigue, tearing, visual disturbances, redness of the skin to affect the nose and cheeks,

• Decrease in T3 and T4 (thyroid hormones), decrease in vitamin D production,

• Increased cholesterol and triglycerides in the blood;

• Skin diseases (hypersensitivity reactions such as flushing, itching and allergy); and rarely severe skin reactions;

• Hair loss;Loss of

•appetite at the beginning of treatment; dry mouth and throat; nausea; vomiting; diarrhea or constipation.

• Frequent urination. These are mild side effects of KARBALEX.

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

5. Storage of

KARBALEX Keep KARBALEX out of reach of children and in its packaging. Store at room temperatures below 25 ° C. Store in original packaging to protect from light.

Use in accordance with expiration dates. Do not use KARBALEX after the expiration date in the packaging.