Tegretol Cr 400

Leaflet accompanying the packaging: patient information

Tegretol CR 200, 200 mg, tablets with modified release

Tegretol CR 400, 400 mg, tablets with modified release

Carbamazepine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

1. What is Tegretol CR and what is it used for

Tegretol CR belongs to a group of antiepileptic medicines (medicines used to treat epileptic 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 very 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 medicine or simultaneously with other medicines. Tegretol CR is usually ineffective in absence seizures (petit mal) and myoclonic seizures.
• Manic syndrome and prevention of relapses 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 you 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 medicine (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, i.e. disorders in the production of porphyrin, a pigment important for liver function and blood formation (acute intermittent porphyria, mixed porphyria, porphyria cutanea tarda);
• if the patient is taking monoamine oxidase inhibitors (MAO) at the same time.

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

Warnings and precautions:

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

• If the patient has blood diseases(including those caused by other medicines).
• If the patient has ever been hypersensitive to oxcarbazepine or other medicines(rash or other allergic symptoms). In patients allergic to carbamazepine, there may also be hypersensitivity to oxcarbazepine (in about 1 in 4 (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 mental disorders called psychoses, during which they may experience disorientation or excitement.
• If the patient is of childbearing age, they should use effective contraception during therapy and for 2 weeks after taking the last dose of Tegretol CR.
• 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 their doctor about any bleeding or spotting between periods. In case of any doubts, the patient should contact their doctor.
• The patient should inform their doctor if they are pregnant or plan to become pregnant. The doctor will discuss the risks of taking Tegretol CR during pregnancy with the patient, as it may cause harm or abnormalities in the development of the fetus (see "Pregnancy, breastfeeding, and fertility").
• During the use of Tegretol CR during pregnancy, there is a risk of a harmful effect on the unborn child. If the patient is of childbearing age, they should use effective contraception while taking Tegretol CR and for 2 weeks after taking the last dose (see "Pregnancy and breastfeeding and fertility").

The patient should seek medical advice immediatelyif they experience any of the following symptoms during treatment with Tegretol CR:

• Ifthe patient experiences hypersensitivity reactionssuch as lip swelling, eyelid swelling, facial swelling, throat swelling, mouth swelling, or sudden breathing difficulties, fever with lymph node swelling, rash, or blisters on the skin, they should inform their doctor or go to the nearest hospital (see "4. Possible side effects").
• Ifthe patient experiences severe skin reactions, such as: rash, skin redness, blisters on the mouth, eyes, and skin peeling with fever, they should contact their doctor or go to the hospital immediately ( see "4. Possible side effects"). Such reactions may be more common in patients from some 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 medicines 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 also taking other medicines that lower sodium levels in the blood (diuretics, such as hydrochlorothiazide, furosemide).
• If the patient experiences dizziness, drowsiness, low blood pressure, confusionrelated to the use of Tegretol CR, as this may lead to falls.

Do not stop taking Tegretol CR without consulting your doctor first. Sudden withdrawal of the medicine 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 should inform the patient about specific instructions, e.g. the need to carefully follow the dosage instructions 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 medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important for Tegretol CR, as many different medicines can affect its action.
Sometimes it may be necessary to change the dosage or stop taking some of the medicines.
Hormonal contraceptives, e.g. 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 this with their doctor, who will discuss the most suitable type of contraception during treatment with Tegretol CR. In women taking hormonal contraceptives at the same time as Tegretol CR, irregular periods may occur.
Medicines that may interact with Tegretol CR (and vice versa):

• Medicines used to treat 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 to treat 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 medicines: azoles, e.g. itraconazole, ketoconazole, fluconazole, voriconazole
• Pain and anti-inflammatory medicines: paracetamol, dextropropoxyphene, tramadol, methadone, buprenorphine, ibuprofen, phenazone
• Other antiepileptic medicines: 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
• Medicines used to treat stomach ulcers: cimetidine, omeprazole
• Medicines used in dermatology: isotretinoin
• -Antiemetic medicines: aprepitant
• Medicines used to treat glaucoma: acetazolamide
• Medicines used to treat endometriosis: danazol
• Medicines that dilate the airways or are used to treat asthma: theophylline
• -Immunosuppressive medicines used after transplants: cyclosporine, everolimus, tacrolimus, sirolimus
• Antipsychotic medicines used to treat schizophrenia: clozapine, haloperidol, and bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone
• Anticancer medicines: imatinib, cyclophosphamide, lapatinib, temsirolimus, cisplatin, doxorubicin
• Antiviral medicines: HIV protease inhibitors, e.g. indinavir, ritonavir, saquinavir
• Medicines used to treat thyroid disorders: levothyroxine
• Medicines used to treat erectile dysfunction: tadalafil
• Medicines used to treat worm infestations: praziquantel, albendazole
• Diuretics: hydrochlorothiazide, furosemide
• Medicines used to treat tuberculosis: isoniazid, rifampicin
• Muscle relaxants: oxybutynin, dantrolene, pancuronium
• Medicines containing estrogens and/or progesterone: hormone replacement therapy (HRT)
• Cardiovascular medicines: 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, nicotinamide (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 this 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 child, they should consult their doctor or pharmacist before taking this medicine.

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 medicines. 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 related to the opening of the urethra (hypospadias) and finger 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 neurological development 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 the contraceptive pill, and reduce their effectiveness in preventing pregnancy. The patient should discuss this with their doctor, who will discuss 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 another two weeks after stopping the medicine.
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 medicine until they have discussed it with their doctor.
Stopping the medicine 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 shortly after delivery. The doctor may prescribe a medicine to the patient and the child to prevent this.
It is very important to control seizures during pregnancy. However, if the patient takes antiepileptic medicines (seizure medicines) during pregnancy, there is a risk to the child.
The risk of developmental disorders in children of women with epilepsy treated with carbamazepine alone or in combination with other antiepileptic medicines during pregnancy cannot be ruled out.
The doctor will discuss the risks of taking Tegretol CR during pregnancy with the patient.
The patient should not stop taking Tegretol CR without consulting their doctor first.

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 particular 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) at the same time as Tegretol CR, irregular periods may occur. The effectiveness of hormonal contraceptives may be lower when taking Tegretol CR, so the patient is advised to use other or additional non-hormonal methods of contraception.

Driving and operating machinery

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

Tegretol CR contains sodium

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

3. How to take Tegretol CR

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The patient should not exceed the recommended dose prescribed by the doctor.
The patient should not stop taking Tegretol CR suddenly without consulting their doctor first. The doctor will inform the patient whether and when they can stop taking the medicine (see "Warnings and precautions").
The tablets should be taken with food, after food, or between meals. The tablets should be swallowed with a small amount of liquid. The tablets can be divided.
The tablets (depending on the doctor's instructions, the whole tablet 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 tablets with modified release allows them to be taken twice a day.
Switching from tablets to suspension: The doctor will prescribe the same amount of medicine (in mg per day), but in smaller single doses, increasing the frequency of administration, e.g. the doctor will prescribe the suspension to be taken three times a day instead of tablets twice a day.
The doctor will exercise special caution when adjusting the dose for elderly patients.
Recommended dose

Epilepsy

Treatment starts with a low daily dose, and the doctor will gradually increase the dose until the optimal effect is achieved.
The doctor may order a blood test to determine the level of the medicine in the blood, as this may be helpful in determining the optimal dosage.
If Tegretol CR is to be added to the existing antiepileptic treatment regimen, the doctor will introduce the medicine gradually, maintaining or, if necessary, modifying the dosage of other antiepileptic medicines.

Adults

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

Use in children and adolescents

For children under 6 years of age, 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 relapses 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 to the medicine.

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 the symptoms of the withdrawal syndrome are worsening, the doctor may administer Tegretol CR in combination with sedative medicines (e.g. chlormethiazole, chlordiazepoxide). After the acute phase has passed, treatment will be continued with Tegretol CR only.

Trigeminal neuralgia and glossopharyngeal neuralgia

The initial dose is 200 mg to 400 mg per day and will be gradually increased by the doctor until the pain disappears (usually 200 mg 3 to 4 times a day). The maximum dose is 1200 mg per day.
Then the doctor will gradually decrease 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 dose of Tegretol CR than recommended

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

Missing a dose of Tegretol CR

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they 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 medicines, 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 people

The patient should seek medical advice immediately if they experience any of the following side effects (which may be early symptoms of serious damage to the blood system, 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 the patient has significantly reduced urine output or blood in their urine.
• If the patient has severe abdominal pain, vomiting, loss of appetite (symptoms of pancreatitis).
• If the patient has a rash on the skin, skin redness, blisters on the lips, eyelids, or mouth, or skin peeling with fever (symptoms of severe skin reactions).
• If the patient has a swollen face, eyes, or tongue, difficulty swallowing, wheezing, and a generalized itching, rash, abdominal cramps, a feeling of pressure 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 photophobia (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 people
loss of coordination, skin inflammation with itching rash and redness, itching rash, vomiting, nausea, dizziness, drowsiness, fatigue, leukopenia.
Common: may affect less than 1 in 10 people
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 people
abnormal involuntary movements, such as tremors, asterixis (flapping of the hands), 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 people
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, speech difficulties or slurred speech, abnormal muscle movements (choreoathetosis occurring alternately with slow twisting movements of the body), sensory disturbances, numbness, tingling in the hands and feet, sensation of electric shock, weakness, conduction disorders, hypertension or hypotension, abdominal pain, jaundice, liver failure, skin peeling, hypersensitivity to light, erythema multiforme, lupus-like syndrome, skin pigmentation disorders, purpura, acne, excessive sweating, 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 level in the blood/azotemia), frequent urination, sudden decrease in urine output, sexual disorders/erectile dysfunction, spermatogenesis disorders (decreased sperm count or motility), increased thyroid-stimulating hormone (TSH) levels in the blood.
Very rare: may affect less than 1 in 10,000 people
abnormal blood test results, anemia, gamma globulin deficiency, unexpected milk secretion from 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, lens clouding, conjunctivitis, hearing disorders (tinnitus, hyperacusis, hearing loss, change in perception of high tones), chest pain, extremely slow heartbeats, worsening of coronary artery disease, circulatory collapse, blood clots, swelling and redness along the vein, which becomes very sensitive to touch, often felt as painful (thrombophlebitis), shortness of breath, fever, and pneumonia (pulmonary hypersensitivity), tongue inflammation, oral mucosa inflammation, liver failure, blisters on the oral mucosa and genital organs (Stevens-Johnson syndrome), toxic epidermal necrolysis, hypersensitivity to light, erythema multiforme, lupus-like syndrome, skin pigmentation disorders, purpura, acne, excessive sweating, 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 level in the blood/azotemia), frequent urination, sudden decrease in urine output, sexual disorders/erectile dysfunction, spermatogenesis disorders (decreased 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug 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, it is possible to gather more information on the safety of the medicine.

5. How to store Tegretol CR

• The medicine 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 medicine if the packaging is damaged or shows signs of opening.
• Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tegretol CR contains

• The active substance of the medicine is carbamazepine. One tablet with modified release contains 200 mg (Tegretol CR 200) or 400 mg (Tegretol CR 400) of the active substance.
• The other ingredients are: colloidal anhydrous silica, ethylcellulose aqueous dispersion (ethylcellulose, sodium lauryl sulfate, cetyl alcohol), microcrystalline cellulose, methacrylic acid and 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 are tablets of a 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 side, and a dividing line on both sides.
Tegretol CR 400 are tablets of a 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 side, and a dividing line on both sides.
Tegretol CR 200, tablets with modified release, 200 mg, are available in a cardboard box containing 50 tablets in blisters (PVC/PE/PVDC)/Aluminum.
Tegretol CR 400, tablets with modified release, 400 mg, are 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 leaflet:10/2024