Tegretol CR (Carbamazepine) 20 Tablets

• Excipients: Aerosil 200, Avisel PH 102, Magnesium stearate, Modified ZSB-10 (sodium carboxymethylcellulose).

Please read this INSTRUCTIONS carefully before using this medicine, 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.

• Tell your doctor if you use this medicine when you go to the doctor or hospital during the use of this medicine.

• 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 TEGRETOL and what is it used for? 2. Things to consider before using TEGRETOL

3. How to use TEGRETOL? 4. What are the possible side effects?

5. TEGRETOL Storing

Headings are included.

1. What is TEGRETOL and what is it used for? The name of your drug is TEGRETOL

®

Tablet. TEGRETOL is presented in blister pack containing 24 and 160 tablets.

TEGRETOL Tablets are notched tablets with white, round, flat, curved edges, diğer CG ”on one side and bir G / K“ on the other.

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Each tablet contains 200 mg of active substanceprovides carbamazepine. TEGRETOL is included in a group of drugs called antiepileptics (drugs used in the treatment of epilepsy). Due to its mechanism of action, it can also be used for other diseases. TEGRETOL is used to treat certain types of seizures (epilepsy, epilepsy).

Mental Health disorders, a type of mental depression (depression) type, ik bipolar mood disorders inde with periods of depression and manic episodes (manic episode), as a result of influences of one of the nerves of the brain and usually caused by severe pain in the face of severe pain It is used in the treatment of the disease called ğ Trigeminal Neuralgia sey. It should not be used for other pains or pain in the body.

Epilepsy is a disease characterized by two or more seizures. Seizures occur when messages from the brain to the muscles are not transmitted properly by the nerve pathways in the body. TEGRETOL helps control the transmission of these messages. TEGRETOL also regulates nerve functions in other diseases mentioned above.

2. Things to consider before using TEGRETOL You may only receive TEGRETOL after a full physical examination.

DO NOT use TEGRETOL if:

• Carbamazepine or TEGRETOL have allergy (hypersensitivity) to any of the excipients listed at the beginning of these instructions for use.

• If you have severe heart disease.

• If you had a serious blood disease before.

• If you have a disorder in the production of porphyrin, which is an important pigment (color donor) for liver function and blood production (called p liver porphyria bu), this disease is a complex group of diseases caused by increased secretion of precursors in the synthesis of porphyrin or porphyrin.

• If you use medicines that belong to a special group of antidepressants (anti-depressive / psycho-depressive drugs) called monoamine-oxidase inhibitors (MAOIs).

CAREFULLY USE TEGRETOL if:

• You have a blood disease (including those caused by other drugs).

• If you have previously shown abnormal sensitivity to oxcarbazepine or any other drug (signs of rash or other allergies). It is important to note that you are allergic to carbamazepine, and your probability of developing an allergic reaction to oxcarbazepine (Trileptal) is about 1 in 4 (25%).

• If you have heart, liver or kidney disease or if you had previously.

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• If you have increased eye pressure (glaucoma).

• Your doctor has told you that you have a mental illness called psychosis (a form of mental disorder) that can be accompanied by confusion and unrest.

• If you are using birth control pills containing hormones. TEGRETOL can neutralize this contraceptive. Therefore, when using TEGRETOL, you should use a different or additional non-hormonal contraceptive method. This will help prevent unwanted pregnancies.

• In the event of irregular menstrual bleeding or bleeding from the reservoir (vagina), report to your doctor immediately. If you have any questions about this, consult your doctor or health care professional.

• If there is an allergic reaction such as fever, rash or blistering of the skin with the swelling of the lymph nodes, report it immediately to your doctor or contact the nearest hospital emergency department (see Possible side effects).

• If you experience severe skin reactions such as fever, rash, redness of the skin, lips, blisters in the eyes or mouth, skin peeling, consult your doctor or consult the nearest hospital's emergency department. These reactions can be observed more frequently in patients of some Asian origin (eg Taiwan, Malaysia and the Philippines), and in patients whose strains are based on China (see Possible side effects).

• If you experience an increase in the number of seizures, report this to your doctor immediately (see Possible side effects).

• If you notice symptoms that suggest hepatitis, such as jaundice (yellowing of the skin and eyes), tell your doctor immediately. (see Possible side effects).

• At any time, if you have thoughts of harming yourself or killing yourself. Such thoughts or behaviors were observed in a small proportion of patients treated with antiepileptics. In such cases, consult your doctor immediately or go to the emergency room at the nearest hospital. Do not stop using TEGRETOL without consulting your doctor. To prevent any sudden worsening of your seizures, do not suddenly discontinue your medication. Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of TEGRETOL with food and drink: You should not use alcohol during TEGRETOL treatment.

Do not drink grapefruit juice or eat grapefruit, as they may increase the effect of TEGRETOL. Other fruit juices such as orange or apple juice have no such effect.

Pregnancy Consult your doctor or pharmacist before using the medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

It is important to check for epileptic seizures during pregnancy. However, if you use epilepsy drugs (antiepileptic drugs, epilepsy) during pregnancy, there is a potential risk for your baby. Your doctor will share with you the potential risks of using TEGRETOL during pregnancy.

Do not stop using TEGRETOL without consulting your doctor. 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 medicine. Tell your doctor if you are breastfeeding. The active substance in TEGRETOL passes into breast milk. If your doctor sees fit for you and your baby is closely monitored for side effects, you can continue breastfeeding while using the drug. But if side effects occur, for example, if your baby becomes more sleepy, stop breastfeeding and report the condition to your doctor.

Driving and using machines TEGRETOL may cause you to feel drowsy, dizziness, or blurred, especially when starting treatment or increasing the dose. Therefore, be careful when using the vehicle or machine or performing other activities that require attention.

Use with other drugs TEGRETOL may interact with many other drugs, so do not forget to tell your doctor about the medications you have received or are taking recently.

It may be necessary to change the dose of the drug or sometimes discontinue one of the drugs. Hormonal contraceptive (contraceptive) and women using TEGRETOL may experience irregularities in menstruation (menstruation). As the effect of hormonal contraceptives may be reduced, you should consider using other contraceptive methods.

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 TEGRETOL? Instructions for appropriate use and dose / frequency of application: Observe the doctor's instructions carefully. Do not exceed the recommended dose. Be sure to take this medicine on a regular basis and definitely as instructed by your doctor.

Doing so will help you get the best results and reduce the risk of side effects. Do not take extra doses of non-prescribed TEGRETOL, do not use the drug more frequently or longer than your doctor says. Do not leave TEGRETOL suddenly without consulting your doctor. Your doctor will tell you when and how to discontinue taking this medicine. Treatment of epilepsy in adults is started with doses of 100 mg to 200 mg, usually one or two times a day, with all tablet forms and oral suspensions (syrup). The dosage is then

gradually increased to 800 to 1200 mg per day (divided into2 or 3 doses) (in some patients, 1600 mg or 2000 mg / day may be necessary).

The treatment of günde Trigeminal Neuralgia kadar, a disease usually caused by severe pain in one hundred half, is gradually increased to 200 mg / 400mg / day (usually 3-4 times a day, 3-4 times a day) until there is no pain. For older patients, a lower initial dose, ie 100 mg twice a day, is recommended. In the treatment of mental illness called mg bipolar mood disorders yaklaşık, with periods of depression and overturning, manic episodes and maintenance therapy, the usual dose is 400 to 600 mg per day (dosage range: about 400 to 1600 mg per day).

Your doctor will tell you exactly how many doses you should take.

Method and method of administration: TEGRETOL is always taken at a rate of 2 to 4 times a day depending on your medical condition, ie, by dividing the daily dose (except perhaps the first day).

The dose prescribed by your doctor may differ from the dose listed above. In this case, follow your doctor's instructions.

You can take TEGRETOL with or after dinner. Swallow tablets with a glass of water. If necessary, the tablets may be broken into half by breaking the line.

Different age groups Use in children: TEGRETOL can be used safely in children by following the doctor's instructions. In children, treatment is usually initiated with doses of 100 to 200 mg per day (based on 10 to 20 mg / kg body weight per day) and the daily dose is maintained between 400 and 600 mg. Adolescents may use a dose of 600 to 1000 mg per day.

Elderly use (65 years and older): TEGRETOL can be used safely in the elderly by following the doctor's instructions.

Specific use cases There is no information on dose adjustment in patients with renal / hepatic impairment.

Unless your doctor recommends otherwise follow these instructions. Your doctor will tell you how long your treatment will take with TEGRETOL. Do not discontinue treatment early, because stopping TEGRETOL may cause your illness to deteriorate.

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

If you have used more TEGRETOL than you should use, talk to a doctor or pharmacist if you have used more than you should use from TEGRETOL.

If

breathing difficulties, rapid and irregular heartbeats, loss of consciousness, fainting, dizziness, nausea, and / or vomiting occur, this may indicate a very high dose. Stop taking the medication and consult your doctor immediately.

If you forget to take TEGRETOL, if you forget to take a dose, take this dose as soon as possible. But if it is almost time for the next dose, do not take the dose you missed; return to your normal dose schedule. Do not take double doses to compensate for forgotten doses.

Other things to know when treating TEGRETOL: It is very important for your doctor to check the course of your condition with regular examinations. Your doctor may request a periodic blood test, especially when you start taking TEGRETOL. This is completely normal and doesn't require you to worry.

Before using any type of surgical intervention, including dental or emergency treatment, tell your doctor that you are using TEGRETOL.

Effects when treatment with TEGRETOL is discontinued: Stopping TEGRETOL may cause your illness to deteriorate.

Unless indicated by your doctor, stop treatment.

4. What are the Possible Side Effects? As with all medications, TEGRETOL may have side effects in people who are sensitive to the substances contained in its content.

If it is one of the following, stop using TEGRETOL and IMMEDIATELY tell your doctor or contact the emergency department of your nearest hospital.

• Fever, sore throat, rash, ulcers in the mouth, swelling in the glands or an easier infection (symptoms related to white blood cell deficiency).

• Fatigue, headache, shortness of breath during exercise, dizziness; pale appearance, frequent infections leading to fever, chills, sore throat or ulcers in the mouth; bleeding or easier than normal injury, nosebleed (deficiency in all blood cells).

• Red-stained rashes, which may be accompanied by fatigue, fever, nausea and loss of appetite (possible symptoms of systemic lupus erythematosus).

• Irritation of eyes or skin (signs of hepatitis).

• Urinary color darkening (signs of porphyria or hepatitis).

• Severe decrease in the amount of urine due to kidney disorder, blood in urine.

• Severe upper abdominal pain, vomiting, loss of appetite (signs of pancreatitis).

• Fever, chills, headache, cough and skin rash accompanied by pain in the body, redness of the skin, swelling of the lips, eyes or mouth, skin peeling (signs of severe skin reaction).

• Percentage, swelling in the eyes or tongue, difficulty swallowing, wheezing, urticaria and diffuse itching, rash, fever, abdominal cramps, chest pain or stenosis, difficulty breathing, unconsciousness (angioedema and symptoms of severe allergic reaction ).

• Fatigue, blur of consciousness, muscle twitching or worsening of seizures (symptoms that may be attributed to low levels of sodium in the blood).

• Fever, nausea, vomiting, headache, neck stiffness, and hypersensitivity to bright light (symptoms of meningitis).

• Muscle stiffness, high fever, change in consciousness, high blood pressure, excessive salivation (symptoms of neuroleptic malign syndrome).

• Irregular heartbeat, chest pain.

• Unconsciousness, fainting. These are all very serious side effects. If you have one of these, you have a serious allergy to TEGRETOL. You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare.

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

• Loss of muscle harm

• Allergic skin reactions Less common

• Swelling of the ankle, foot or lower legs (edema)

• Behavior changes

• Blur of consciousness

• Weakness

• Increase in seizures (blows)

• Blurred vision

• Double vision

• Itching in combination with redness and swelling (conjunctivitis)

• Pressure / pain in the eyes (symptoms related to pressure increase in the eyes)

• Chills

• Uncontrolled body movements

• Muscle spasms

• Uncontrolled eye movements. Sparse

• Itching

• Swelling of the glands • Uneasiness

or extreme anger (especially in the elderly)

• Fainting

• Speech difficulty or indefinite speech

• Depression in theanxiety

presence of• Irritability or other mood related or mental changes

• Sensory hallucinations (hallucinations) , hearing, etc.)

• Ringing in the ears or other unexplained sounds

• Hearing loss

• Challenging breathing

• Chest pain

• Fast or abnormally slow heartbeat

• numbness

• Tingling in hands and feet

• Frequent urination

• Sudden reduction in urine

• Flavor abnormalities

• Abnormal milk secretion

• Breast enlargement in males

• Extremely painful swelling and redness (thrombophlebitis), which are over-sensitive when touched on the vein

• Increased skin sensitivity to the sun

• Softening leading to increased fracture risk in the bones

• Thin lme or attenuation (vitamin D deficiency, bone resorption). All these are serious side effects. Emergency medical intervention may be required.

Tell your doctor if you notice any of the following: More common

• Vomiting

• Nausea

• Feeling of

drowsinessSleepiness

•• Uneasiness, restlessness

• Weight gain. Less common

• Headache

• Dry mouth. Sparse

• Constipation

• Diarrhea

• Abdominal painPain in

•joints or muscles

• Increased sweating

• Loss of appetite

• Hair loss

• Extreme hair growth in face and body

• Sexual disorders

• Infertility in men

• Redness and pain in tongue

• Injuries in the mouth

• Changes in skin color

• Acne. These are usually mild to moderate side effects of TEGRETOL. Most of these effects are temporary and usually decrease over time.

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

5. Storage of TEGRETOL Keep TEGRETOL out of the reach of children and in its container.

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Store at room temperature belowC and protect from moisture.

Use in accordance with expiration dates.

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