TEGRETOL 200 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tegretol CR 200, 200 mg, Modified-Release Tablets
3. Tegretol CR 400, 400 mg, Modified-Release Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
4. What is Tegretol CR and What is it Used For
5. Important Information Before Taking Tegretol CR
   1. When Not to Take Tegretol CR:
   2. Warnings and Precautions:
   3. Children and Adolescents (Under 18 Years) and Elderly Patients (65 Years or Older)
   4. Tegretol CR and Other Medications
   5. Taking Tegretol CR with Food, Drink, and Alcohol
   6. Pregnancy, Breastfeeding, and Fertility
   7. Pregnancy
   8. Breastfeeding
   9. Fertility
   10. Women of Childbearing Age
   11. Driving and Operating Machinery
   12. Tegretol CR Contains Sodium
6. How to Take Tegretol CR
   1. Epilepsy
   2. Adults
   3. Use in Children and Adolescents
   4. Manic Syndrome and Prevention of Relapse of Bipolar Affective Disorder (Manic-Depressive Psychosis)
   5. Alcoholic Withdrawal Syndrome
   6. Trigeminal Neuralgia and Glossopharyngeal Neuralgia
   7. Taking a Higher Than Recommended Dose of Tegretol CR
   8. Missing a Dose of Tegretol CR
7. Possible Side Effects
   1. The Patient Should Immediately Consult a Doctor or Ensure That Someone Else Does So on Their Behalf if They Experience Any of the Following Side Effects (Which May be Early Symptoms of Serious Damage to the Blood, Liver, Kidneys, or Other Organs, Which Require Immediate Medical Attention):
   2. Other Side Effects
   3. Reporting Side Effects
8. How to Store Tegretol CR
9. Contents of the Pack and Other Information
   1. What Tegretol CR Contains
   2. What Tegretol CR Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Importer/Manufacturer:

Package Leaflet: Information for the Patient

Tegretol CR 200, 200 mg, Modified-Release Tablets

Tegretol CR 400, 400 mg, Modified-Release Tablets

Carbamazepine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Tegretol CR and what is it used for
• 2. Important Information Before Taking Tegretol CR
• 3. How to Take Tegretol CR
• 4. Possible Side Effects
• 5. How to Store Tegretol CR
• 6. Contents of the Pack and Other Information

1. What is Tegretol CR and What is it Used For

Tegretol CR belongs to a group of antiepileptic medications (medications used to treat seizures), but its mechanism of action also allows it to be used in other diseases.
Epilepsy is characterized by the occurrence of seizures in the patient.
Seizures result from temporary disturbances in the bioelectrical activity of the brain, resulting in excessive and violent discharge of a group of nerve cells.
Tegretol CR regulates nerve conduction in nerve cells.
Indications for use:

• Epilepsy:
• complex or simple partial seizures.
• generalized tonic-clonic seizures. Mixed forms of seizures. Tegretol CR can be used as the only medication or in combination with other medications. Tegretol CR is usually ineffective in absence seizures (petit mal) and myoclonic seizures.
• Manic syndrome and prevention of relapse of bipolar affective disorder (manic-depressive psychosis).
• Alcoholic withdrawal syndrome.
• Idiopathic trigeminal neuralgia and trigeminal neuralgia in the course of multiple sclerosis. Idiopathic glossopharyngeal neuralgia.

2. Important Information Before Taking Tegretol CR

Tegretol CR can only be used after a thorough medical examination.
The risk of severe skin reactions in patients of Chinese or Thai origin associated with carbamazepine can be predicted by examining a blood sample from these patients. The doctor will inform if a blood test is necessary before starting treatment with Tegretol CR.

When Not to Take Tegretol CR:

• if the patient is allergic to carbamazepine or any of the other ingredients of this medication (listed in section 6);
• if the patient has severe heart disease;
• if the patient has had severe blood diseases in the past;
• if the patient has or has had porphyria in the past (a disorder of porphyrin production, a pigment important for liver function and blood formation);
• if the patient is taking monoamine oxidase inhibitors (MAOIs) at the same time.

If any of the above points apply to the patient, they should tell their doctor.

Warnings and Precautions:

Before starting to take Tegretol CR, the patient should discuss it with their doctor or pharmacist.
Tegretol CR should be taken under close medical supervision:

• If the patient has blood diseases(including those caused by other medications).
• If the patient has ever had an allergic reaction to oxcarbazepine or other medications(rash or other allergy symptoms). In patients allergic to carbamazepine, there may also be an allergic reaction to oxcarbazepine (in about 1 in 4 patients, 25%).
• If the patient has or has had heart, thyroid, liver, or kidney disease.
• If the patient has increased intraocular pressure(glaucoma) or if the patient has difficulty urinating or feels pain while urinating.
• If the patient has been diagnosed with psychotic disorders, which may cause disorientation or agitation.
• If the patient is of childbearing age, she should use effective contraception during therapy and for 2 weeks after taking the last dose.
• If the patient is taking hormonal contraceptives:Tegretol CR may make them ineffective. Therefore, the patient should use other or additional non-hormonal methods of contraception while taking Tegretol CR. The patient should inform the doctor about any breakthrough bleeding or spotting. In case of any doubts, the patient should contact their doctor.
• The patient should inform the doctor if she is pregnant or plans to become pregnant. The doctor will discuss the risks of taking Tegretol CR during pregnancy, as it may cause harm or abnormalities in the development of the fetus (see "Pregnancy, Breastfeeding, and Fertility").
• During treatment with Tegretol CR during pregnancy, there is a risk of harmful effects on the unborn child. If the patient is of childbearing age, she should use effective contraception during treatment with Tegretol CR and for 2 weeks after taking the last dose (see "Pregnancy and Breastfeeding and Fertility").

The patient should immediately consult a doctor or pharmacistif any of the following symptoms occur during treatment with Tegretol CR:

• Ifsuch allergic reactionsoccur as swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen lymph nodes, rash, or blisters on the skin, the patient should immediately inform the doctor or go to the nearest hospital (see "4. Possible Side Effects").
• Ifthe patient experiences severe skin reactions, such as rash, redness of the skin, blisters on the mouth, eyes, and shedding of the skin with accompanying fever, they should immediately contact a doctor or go to the hospital (see "4. Possible Side Effects"). Such reactions may be more common in patients from certain Asian countries (e.g., Taiwan, Malaysia, and the Philippines) and in patients of Chinese origin.
• If the patient experiences an increase in the number of seizures.
• If the patient notices symptoms of hepatitis, such as yellowing of the skin and whites of the eyes, indicating jaundice.
• If the patient has ever thought about harming themselves or taking their own life. A small number of people taking antiepileptic medications have had such thoughts or behaviors.
• If the patient has kidney problemsrelated to low sodium levels in the blood, or if the patient has kidney problems and is taking other medications that lower sodium levels in the blood (diuretics, such as hydrochlorothiazide, furosemide).
• If the patient experiences dizziness, drowsiness, low blood pressure, confusionrelated to taking Tegretol CR, as it may lead to falls.

Do not stop taking Tegretol CR without consulting a doctor first. Sudden withdrawal of the medication may cause a sudden increase in seizures.

Children and Adolescents (Under 18 Years) and Elderly Patients (65 Years or Older)

Tegretol CR can be used in children and elderly patients, provided that the doctor's instructions are followed. The doctor will inform about specific instructions, such as careful adherence to the dosing schedule and the need for close monitoring of the patient (see also "3. How to Take Tegretol CR" and "4. Possible Side Effects").

Tegretol CR and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. This is especially important for Tegretol CR, as many different medications can affect its action.
Sometimes, a change in dosage or discontinuation of some medications may be necessary.
Hormonal contraceptives, e.g., birth control pills, patches, injections, or implants
Tegretol CR may affect the action of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. The patient should discuss with their doctor the most suitable type of contraception during treatment with Tegretol CR. In women taking hormonal contraceptives with Tegretol CR, irregular menstrual bleeding may occur.

• Medications used in depression and anxiety: desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine, bupropion, citalopram, mianserin, sertraline, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline, clomipramine), alprazolam, midazolam
• Corticosteroids used in inflammatory conditions, including asthma, inflammatory bowel disease, muscle and joint pain: prednisolone, dexamethasone
• Anticoagulants: e.g., warfarin, phenprocoumon, dicumarol, acenocoumarol, rivaroxaban, dabigatran, apixaban, edoxaban
• Antibiotics used to treat skin and systemic infections: e.g., ciprofloxacin, erythromycin, troleandomycin, josamycin, clarithromycin, doxycycline, rifabutin
• Antifungal medications: azoles, e.g., itraconazole, ketoconazole, fluconazole, voriconazole
• Pain and anti-inflammatory medications: paracetamol, dextropropoxyphene, tramadol, methadone, buprenorphine, ibuprofen, phenazone
• Other antiepileptic medications: clobazam, clonazepam, ethosuximide, felbamate, lamotrigine, eslicarbazepine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide, metsuximide, phenobarbital, phensuximide, phenytoin, and fosphenytoin, primidone, levetiracetam, brivaracetam
• Antihistamines used to treat allergies, including hay fever, itching: terfenadine
• Medications used in stomach ulcers: cimetidine, omeprazole
• Medications used in dermatology: isotretinoin
• -Antiemetic medications: aprepitant
• Medications used in glaucoma: acetazolamide
• Medications used in endometriosis: danazol
• Bronchodilators or anti-asthmatic medications: theophylline
• -Immunosuppressive medications used after transplants: cyclosporine, everolimus, tacrolimus, sirolimus
• Antipsychotic medications used to treat schizophrenia: clozapine, haloperidol, and bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone
• Anticancer medications: imatinib, cyclophosphamide, lapatinib, temsirolimus, cisplatin, doxorubicin
• Antiviral medications: HIV protease inhibitors, e.g., indinavir, ritonavir, saquinavir
• Medications used in thyroid disorders: levothyroxine
• Medications used in erectile dysfunction: tadalafil
• Medications used in worm infestations: praziquantel, albendazole
• Diuretics: hydrochlorothiazide, furosemide
• Medications used in tuberculosis: isoniazid, rifampicin
• Muscle relaxants: oxybutynin, dantrolene, pancuronium
• Medications containing estrogens and/or progesterone: hormone replacement therapy (HRT)
• Cardiovascular medications: e.g., felodipine, digoxin, simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine, diltiazem, verapamil
• Platelet aggregation inhibitors: ticlopidine
• Herbal preparations containing St. John's Wort (Hypericum perforatum)
• Other interactions: grapefruit juice, niacinamide (only in large quantities).

Special attention should be paid when taking Tegretol CR with levetiracetam, isoniazid, lithium salts, or metoclopramide.

Taking Tegretol CR with Food, Drink, and Alcohol

During treatment with Tegretol CR, the patient should not consume alcohol.
The patient should not drink grapefruit juice or eat grapefruit, as it may increase the action of Tegretol CR. Other juices, such as orange or apple, do not have this effect.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should ask their doctor or pharmacist for advice before taking this medication.

Pregnancy

Tegretol CR may cause serious birth defects. If the patient takes Tegretol CR during pregnancy, the risk of birth defects in the child is even three times higher than in women who do not take antiepileptic medications. Serious birth defects have been reported, including neural tube defects (spina bifida), facial defects, such as cleft lip and palate, head defects, heart defects, and genital defects. If the patient takes Tegretol CR during pregnancy, the unborn child should be closely monitored.
In infants born to mothers who took Tegretol CR during pregnancy, developmental problems (brain development) have been reported. In some studies, it has been shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in the womb, while in other studies, no such effect has been found. The effect on neurodevelopment cannot be ruled out.
If the patient is of childbearing age and does not plan to become pregnant, they should use effective contraception during treatment with Tegretol CR. Tegretol CR may affect the action of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. The patient should discuss with their doctor the most suitable type of contraception during treatment with Tegretol CR. If the patient stops taking Tegretol CR, they should continue to use effective contraception for 2 weeks after stopping the medication.
If the patient is of childbearing age and plans to become pregnant, they should consult their doctor before stopping contraception and before becoming pregnant, so that the doctor can change the treatment to another one that is safe for the unborn child.
If the patient is or thinks they may be pregnant, they should tell their doctor immediately. The patient should not stop taking the medication until they have discussed it with their doctor.
Stopping the medication without consulting a doctor may cause seizures, which can be dangerous for the patient and their unborn child. The doctor may decide to change the treatment.
If the patient takes Tegretol CR during pregnancy, there is also a risk of bleeding problems in the patient and the newborn. The doctor may prescribe medication to the patient and the child to prevent this.

Breastfeeding

The patient should inform their doctor about breastfeeding. The active substance of Tegretol CR passes into breast milk. If the doctor agrees, the patient can continue breastfeeding. However, in this special case, the child should be carefully monitored to avoid side effects. If side effects occur, such as the child becoming very sleepy, the patient should stop breastfeeding and contact their doctor.

Fertility

There are very rare reports of fertility disorders in men and/or spermatogenesis disorders.

Women of Childbearing Age

The patient should use effective contraception during therapy and for 2 weeks after taking the last dose of Tegretol CR.
In women taking hormonal contraceptives (birth control) with Tegretol CR, irregular menstrual bleeding may occur. The effectiveness of hormonal contraceptives may be reduced during treatment with Tegretol CR, so the patient should use other or additional non-hormonal methods of contraception.

Driving and Operating Machinery

Tegretol CR may cause drowsiness, dizziness, or vision disturbances, double vision, lack of coordination, especially at the beginning of treatment or when increasing the dose. If such symptoms occur, the patient should not drive a car or operate machinery or perform other activities that require increased attention.

Tegretol CR Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Tegretol CR

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not exceed the recommended dose prescribed by the doctor.
The patient should not suddenly stop taking Tegretol CR without consulting their doctor first. The doctor will inform the patient if and when they can stop taking the medication (see "Warnings and Precautions").
Tablets should be taken during a meal, after a meal, or between meals. Tablets should be swallowed with a small amount of liquid. Tablets can be divided.
Tablets (depending on the doctor's instructions, whole or half a tablet) should be swallowed by the patient without chewing, with a small amount of liquid. A oral suspension containing carbamazepine is also available, which is particularly suitable for patients who have difficulty swallowing tablets or require careful dose adjustment during the initial treatment period.
The slow, controlled release of the active substance from the modified-release tablets allows for twice-daily administration.
Switching from tablets to oral suspension: The doctor will prescribe the same amount of medication (in mg per day), but in smaller single doses, increasing the frequency of administration, e.g., taking the suspension three times a day instead of tablets twice a day.
The doctor will exercise particular caution when adjusting the dosage for elderly patients.
Recommended dose

Epilepsy

Treatment starts with a low daily dose, and the doctor will gradually increase the dose until optimal efficacy is achieved.
The doctor may order blood tests to determine the optimal dosage.
If Tegretol CR is added to the existing antiepileptic treatment regimen, the doctor will introduce the medication gradually, maintaining or modifying the dosage of other antiepileptic medications as necessary.

Adults

The initial dose is 100 mg to 200 mg once or twice a day; the doctor will gradually increase the dose until optimal therapeutic efficacy is achieved - usually up to 400 mg 2 to 3 times a day. In some patients, a dose of 1600 mg, and even 2000 mg per day, may be necessary.

Use in Children and Adolescents

For children under 6 years of age, the medicinal product Tegretol is available in the form of an oral suspension.
In children over 6 years of age, treatment with carbamazepine can be started at a dose of 100 mg per day, increasing the dose by 100 mg at weekly intervals.
Maintenance dose: 10 to 20 mg/kg body weight per day, in divided doses, e.g.:
6 to 10 years
400 mg to 600 mg per day
11 to 15 years
600 mg to 1000 mg per day
>15 years
800 mg to 1200 mg per day (the same dose as for adults)
Maximum recommended doses:
up to 6 years: 35 mg/kg body weight per day
6 to 15 years: 1000 mg per day
>15 years: 1200 mg per day

Manic Syndrome and Prevention of Relapse of Bipolar Affective Disorder (Manic-Depressive Psychosis)

Dose range: approximately 400 mg to 1600 mg per day, usually 400 mg to 600 mg per day, in 2 to 3 divided doses. In the treatment of acute manic episodes, the doctor will increase the dose fairly quickly, while in the prevention of bipolar disorders, the dose increase will be slower to ensure optimal tolerance of the medication.

Alcoholic Withdrawal Syndrome

Average dosage: 200 mg 3 times a day. In severe cases, the doctor may increase the dose during the first few days (e.g., up to 400 mg 3 times a day). During the initial treatment period, when symptoms of withdrawal syndrome are worsening, the doctor may administer Tegretol CR in combination with sedative medications (e.g., chlormethiazole, chlordiazepoxide). After the acute phase has passed, treatment will continue with Tegretol CR only.

Trigeminal Neuralgia and Glossopharyngeal Neuralgia

Initial dose 200 mg to 400 mg per day will be gradually increased by the doctor until the pain subsides (usually 200 mg 3 to 4 times a day). The maximum dose is 1200 mg per day.
Then the doctor will gradually reduce the dose to the smallest possible maintenance dose. In elderly patients, treatment starts with a dose of 100 mg 2 times a day.
If the patient feels that the action of Tegretol CR is too strong or too weak, they should consult their doctor.

Taking a Higher Than Recommended Dose of Tegretol CR

In case of taking a higher dose of Tegretol CR than recommended, the patient should immediately consult a doctoror go to the emergency room of the nearest hospital. The patient may need to be monitored.
If the patient experiences breathing problems, rapid and irregular heartbeat, loss of consciousness, fainting, tremors, malaise, and/or vomiting, they should immediately stop taking Tegretol CR and inform their doctor.

Missing a Dose of Tegretol CR

In case of missing a dose, the patient should take the medication as soon as possible. However, if it is almost time for the next dose, the patient should not take the missed dose, but take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

4. Possible Side Effects

Like all medications, Tegretol CR can cause side effects, although not everybody gets them.
Most of these side effects are mild to moderate and usually disappear after a few days of treatment.
Some side effects can be seriousand may affect less than 1 in 1000 patients

The Patient Should Immediately Consult a Doctor or Ensure That Someone Else Does So on Their Behalf if They Experience Any of the Following Side Effects (Which May be Early Symptoms of Serious Damage to the Blood, Liver, Kidneys, or Other Organs, Which Require Immediate Medical Attention):

Immediately:

• If the patient has developed a fever, sore throat, rash, mouth ulcers, swollen lymph nodes, or more frequent infections (a sign of a low white blood cell count).
• If the patient feels tired, has headaches, dizziness, shortness of breath during exertion, is pale, bruises more easily than usual, and has nosebleeds (a sign of a low count of all types of blood cells).
• If the patient has a red, spotty rash, mainly on the face, which may be accompanied by fatigue, fever, nausea, loss of appetite (symptoms of systemic lupus erythematosus).
• If the patient has yellowing of the whites of the eyes or skin (symptoms of hepatitis).
• If the patient's urine is dark in color (symptoms of porphyria or hepatitis).
• If there is a significant decrease in the amount of urine excreted or if the patient finds blood in their urine.
• If the patient has severe abdominal pain, vomiting, loss of appetite (symptoms of pancreatitis).
• If the patient has a severe rash on the skin, redness of the skin, blisters on the lips, eyes, or mouth, or shedding of the skin with accompanying fever (symptoms of severe skin reactions).
• If the patient has swollen face, eyes, or tongue, difficulty swallowing, wheezing, and a generalized itching, rash, abdominal cramps, a feeling of compression or discomfort in the chest, difficulty breathing, loss of consciousness (symptoms of angioedema and severe allergic reactions).
• If the patient is lethargic, disoriented, has tremors or a significant increase in seizures (symptoms that may be related to low sodium levels in the blood);
• If the patient has a fever, nausea, vomiting, headache, stiff neck, and severe sensitivity to light (symptoms of meningitis).
• If the patient has muscle stiffness, high fever, altered consciousness, high blood pressure, excessive salivation (symptoms of neuroleptic malignant syndrome).
• If the patient has an irregular heartbeat, chest pain.
• If the patient experiences disturbances of consciousness, fainting.
• If the patient has diarrhea, abdominal pain, and fever (symptoms of colitis). The frequency of this side effect is unknown.
• If the patient experiences falls caused by dizziness, drowsiness, low blood pressure, confusion.

Other Side Effects

Very common: may affect more than 1 in 10 patients
loss of coordination, skin inflammation with accompanying itching rash and redness, itching rash, vomiting, nausea, dizziness, drowsiness, fatigue, leukopenia.
Common: may affect less than 1 in 10 patients
swelling around the ankles, feet, or legs, fluid retention, weight gain, headache, dry mouth, double vision, blurred vision, thrombocytopenia, eosinophilia.
Uncommon: may affect less than 1 in 100 patients
involuntary movements, such as tremors, athetosis (twisting and writhing movements), dystonia (twisting and bending of different parts of the body), tics, oculogyric crisis, diarrhea, constipation, exfoliative dermatitis.
Rare: may affect less than 1 in 1000 patients
itching, swollen lymph nodes, leukocytosis, multi-organ hypersensitivity, folic acid deficiency, decreased appetite, hallucinations, depression, aggression, anxiety, agitation, confusion, uncoordinated and involuntary movements of the limbs and body, uncontrolled eye movements, difficulty speaking or slurred speech, abnormal muscle movements (chorea occurring alternately with slow, twisting movements of the body), sensory disturbances, numbness, tingling in the hands and feet, a feeling of electric shock, weakness, conduction disorders, hypertension or hypotension, abdominal pain, jaundice, muscle weakness.
Very rare: may affect less than 1 in 10,000 patients
abnormal blood test results, anemia, immunoglobulin deficiency (gamma globulin), unexpected milk production by the breasts, breast enlargement in men, disorders of porphyrin production, a pigment important for liver function and blood formation, anxiety, changes in mental state, taste disturbances, cataract, conjunctivitis, hearing disturbances (tinnitus, hypersensitivity to sound, hearing loss, changes in perception of high tones), chest pain, extremely slow heartbeats, worsening of coronary artery disease, circulatory collapse, blood clots, swelling and redness along a vein, which becomes very sensitive to touch, often felt as painful (thrombophlebitis), shortness of breath, fever, and pneumonia (hypersensitivity pneumonitis), tongue inflammation, oral mucositis, liver failure, blisters on the mucous membranes of the mouth and genitals (Stevens-Johnson syndrome), toxic epidermal necrolysis, hypersensitivity to light, erythema multiforme, lupus-like syndrome, skin pigmentation disorders, purpura, excessive sweating, hair loss, hirsutism, bone metabolism disorders leading to demineralization of bones/osteoporosis, joint pain, muscle pain, interstitial nephritis, kidney failure, kidney function disorders (e.g., proteinuria, hematuria, oliguria, and increased urea nitrogen levels in the blood/azotemia), frequent urination, sudden decrease in urine output, sexual disorders/erectile dysfunction, spermatogenesis disorders (reduced sperm count or motility), increased thyroid-stimulating hormone (TSH) levels in the blood.
Frequency not known: frequency cannot be estimated from the available data
sedation, memory loss, purple or reddish-purple spots, which may be itchy, drug rash with eosinophilia and systemic symptoms, lichenoid keratosis, reactivation of herpesvirus 6 infection (may be severe due to immune system disorders), complete loss of nails, fractures, decreased bone density, bone marrow failure, i.e., the bone marrow produces an insufficient number of red and white blood cells, as well as platelets, colitis, high ammonia levels in the blood (hyperammonemia). Symptoms of hyperammonemia may include irritability, disorientation, vomiting, loss of appetite, and drowsiness.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Tegretol CR

• The medication should be stored out of sight and reach of children.
• Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
• Do not use this medication if the packaging is damaged or shows signs of opening.
• Do not use this medication after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
• Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Tegretol CR Contains

• The active substance of Tegretol CR is carbamazepine. One modified-release tablet contains 200 mg (Tegretol CR 200) or 400 mg (Tegretol CR 400) of the active substance.
• Other ingredients are: colloidal anhydrous silica, ethylcellulose aqueous dispersion (ethylcellulose, sodium lauryl sulfate, cetyl alcohol), microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), magnesium stearate, sodium carmellose, talc. The coating contains: hypromellose, hydroxypropyl methylcellulose, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), and talc.

What Tegretol CR Looks Like and Contents of the Pack

Tegretol CR 200 is a tablet of uniform color (from beige to orange), oval, slightly convex on both sides, with the inscription "H/C" on one side and "C/G" on the other, and a dividing line on both sides.
Tegretol CR 400 is a tablet of uniform color (from brown to orange), oval, slightly convex on both sides, with the inscription "ENE/ENE" on one side and "CG/CG" on the other, and a dividing line on both sides.
Tegretol CR 200, modified-release tablets, 200 mg, is available in a cardboard box containing 50 tablets in blisters (PVC/PE/PVDC)/Aluminum.
Tegretol CR 400, modified-release tablets, 400 mg, is available in a cardboard box containing 30 tablets in blisters (PVC/PE/PVDC)/Aluminum.

Marketing Authorization Holder

Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Phone: +48 22 375 48 88

Importer/Manufacturer:

Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy
Date of last revision of the package leaflet:10/2024