TEGRETOL 20 mg /Ml Suspension

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Tegretol, 20 mg/mL, oral suspension
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Tegretol and what is it used for
4. Important information before taking Tegretol
   1. When not to take Tegretol:
   2. Warnings and precautions:
   3. Children and adolescents (under 18 years) and elderly patients (65 years or older)
   4. Tegretol and other medicines
   5. Taking Tegretol with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnancy
   8. Breastfeeding
   9. Fertility
   10. Women of childbearing age
   11. Driving and using machines
   12. Tegretol contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, and sorbitol
5. How to take Tegretol
   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 dose of Tegretol than recommended
   8. Missing a dose of Tegretol
6. Possible side effects
   1. The patient should immediately contact their doctor or make sure someone else does, 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
   2. Other side effects
   3. Reporting side effects
7. How to store Tegretol
8. Contents of the packaging and other information
   1. What Tegretol contains
   2. What Tegretol looks like and what the pack contains
   3. Marketing authorization holder
   4. Importer/Manufacturer:
   5. Date of last revision of the leaflet: 10/2024

Leaflet accompanying the packaging: patient information

Tegretol, 20 mg/mL, oral suspension

Carbamazepine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tegretol and what is it used for
• 2. Important information before taking Tegretol
• 3. How to take Tegretol
• 4. Possible side effects
• 5. How to store Tegretol
• 6. Contents of the packaging and other information

1. What is Tegretol and what is it used for

Tegretol 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 patient experiencing seizures.
Seizures result from temporary disturbances in the bioelectrical function of the brain, resulting in excessive and very violent discharge of a group of nerve cells.
Tegretol regulates nerve conduction in nerve cells.
Indications for use:

• Epilepsy:
• complex or simple partial seizures.
• tonic-clonic generalized seizures. Mixed forms of seizures.

Tegretol can be used both as a single medicine and in combination with other medicines.
Tegretol 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

Tegretol 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 testing a blood sample from these patients. The doctor will inform if a blood test is necessary before starting treatment with Tegretol.

When not to take Tegretol:

• 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 in the past porphyria of the liver, i.e. disorders in the production of porphyrin, a dye important for liver function and blood formation (acute intermittent porphyria, mixed porphyria, late cutaneous porphyria);
• if the patient is taking monoamine oxidase inhibitor (MAO) antidepressants 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, the patient should discuss it with their doctor or pharmacist.
Tegretol 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 had an allergy to oxcarbazepine or other medicines(rash or other allergic symptoms). In patients allergic to carbamazepine, there may also be an allergy to oxcarbazepine (in about 1 in 4 (25%) patients).
• 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 agitation.
• If the patient is of childbearing age, she should use effective contraception during therapy and for 2 weeks after taking the last dose of Tegretol.
• If the patient is taking hormonal contraceptives:Tegretol may make them ineffective. Therefore, the patient should use other or additional non-hormonal methods of contraception while taking Tegretol. The patient should inform their doctor if they experience 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 with the patient the risk of taking Tegretol during pregnancy, as it may cause harm or abnormalities in the development of the fetus (see "Pregnancy, breastfeeding, and fertility").
• During pregnancy, while taking Tegretol, there is a risk of harmful effects on the unborn child. If the patient is of childbearing age, she should use effective contraception during Tegretol therapy 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 while being treated with Tegretol:

• Ifthe patient experiences allergic reactionssuch as lip swelling, eyelid swelling, facial swelling, throat swelling, mouth swelling, or sudden breathing problems, 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 taking Tegretol, as this may lead to falls.

Do not stop taking Tegretol without consulting a 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 can be used in children and elderly patients, provided that the doctor's instructions are followed. The doctor will inform 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" and "4. Possible side effects").

Tegretol 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, 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 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 Tegretol therapy. In women taking hormonal contraceptives at the same time as Tegretol, irregular menstrual bleeding may occur.
Medicines that may interact with Tegretol (and vice versa):

• Medicines used in depression and anxiety: desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine, bupropion, citalopram, mianserin, nefazodone, 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 whole-body 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 or 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 in stomach ulcers: cimetidine, omeprazole
• Medicines used in dermatology: isotretinoin
• -Antiemetic medicines: aprepitant
• Medicines used in glaucoma: acetazolamide
• Medicines used in 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 in thyroid diseases: levothyroxine
• Medicines used in erectile dysfunction: tadalafil
• Medicines used to treat worms: 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, niacinamide (only in large quantities).

The patient should be particularly careful when taking Tegretol with levetiracetam, isoniazid, lithium salts, or metoclopramide.

Taking Tegretol with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Tegretol may cause serious birth defects. If the patient takes Tegretol 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. If the patient takes Tegretol during pregnancy, the unborn child should be closely monitored.
In infants born to mothers who took Tegretol during pregnancy, developmental problems (brain development) have been reported. Some studies have shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in the womb, while others have not found such an effect. 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 Tegretol therapy. Tegretol 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 Tegretol therapy. If the patient stops taking Tegretol, they should continue to use effective contraception for another 2 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 Tegretol until they have discussed it with their doctor. Stopping Tegretol 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 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 baby to prevent this .
It is very important to control seizures during pregnancy. However, if the patient takes antiepileptic medicines during pregnancy, there is a risk to the child.
The doctor will discuss with the patient the risk of taking Tegretol during pregnancy.
The patient should not stop taking Tegretol without consulting their doctor first.

Breastfeeding

The patient should inform their doctor about breastfeeding. The active substance of Tegretol passes into breast milk. If the doctor agrees, the patient can continue breastfeeding. However, in this special case, the baby should be carefully monitored to avoid side effects.
If side effects occur, such as the baby 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.
In women taking hormonal contraceptives (birth control) at the same time as Tegretol, irregular menstrual bleeding may occur. The effectiveness of hormonal contraceptives may be reduced while taking Tegretol, so the patient should use other or additional non-hormonal methods of contraception.

Driving and using machines

Tegretol 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 machines or perform other activities that require increased attention.

Tegretol contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, and sorbitol

Tegretol oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
Tegretol also contains sorbitol (250 mg/mL). Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should contact their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e. the medicine is considered "sodium-free".
Tegretol contains 25 mg of propylene glycol in each milliliter. Before administering the medicine to a child under 4 weeks of age, the patient should contact their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Before administering the medicine to a child under 5 years of age, the patient should contact their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Patients with liver or kidney function disorders should not take this medicine without their doctor's recommendation. The doctor may decide to perform additional tests on such patients.

3. How to take Tegretol

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 suddenly without consulting their doctor first.
Tegretol oral suspension can be taken during or after a meal or between meals. The suspension should be shaken before use.
The prescribed dose of Tegretol in the form of oral suspension causes higher maximum concentrations in the blood than the same dose in the form of tablets, and therefore the doctor will recommend starting treatment with small doses, which will then be gradually increased.
Switching from tablets to suspension: The doctor will recommend the same amount of medicine (in mg per day), but in smaller single doses, increasing the frequency of administration, e.g. recommending 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.
1 measuring cup of the medicine (5 mL), attached to the packaging, is 100 mg of carbamazepine.
Recommended dose

Epilepsy

Treatment starts with a small 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 concentration of the medicine in the blood, as this may be helpful in determining the optimal dosage.
If Tegretol 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 the 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

In children under 4 years of age, the recommended initial dose is 20 mg to 60 mg per day, and may be increased by 20 mg to 60 mg every other day.
In children over 4 years of age, treatment with carbamazepine can be started at a dose of 100 mg per day, with the dose increased by 100 mg at weekly intervals.
Maintenance dose: 10 mg to 20 mg/kg body weight per day, in divided doses, e.g.:
up to 1 year of age - 100 mg to 200 mg per day, i.e. 1 to 2 measuring cups of oral suspension;
1 to 5 years - 200 mg to 400 mg per day, i.e. 1 to 2 measuring cups of oral suspension 2 times a day;
6 to 10 years - 400 mg to 600 mg per day, i.e. 2 measuring cups of oral suspension 2 to 3 times a day;
11 to 15 years - 600 mg to 1000 mg per day, i.e. 2 to 3 measuring cups of oral suspension 3 times a day (plus an additional 5 mL measuring cup in case of a 1000 mg dose).
>15 years - 800 mg to 1200 mg per day, i.e. 2 to 3 measuring cups of oral suspension 4 times a 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 states, 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 medicine.

Alcoholic withdrawal syndrome

Average dosage: 200 mg 3 times a day. In severe cases, the doctor may increase the dose in the first few days (e.g. up to 400 mg 3 times a day). In the initial period of treatment, when the symptoms of withdrawal syndrome are most severe, the doctor may administer Tegretol in combination with sedative medicines (e.g. chlormethiazole, chlordiazepoxide). After the acute phase has passed, treatment will continue with Tegretol 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 effect of Tegretol is too strong or too weak, they should consult their doctor.

Taking a higher dose of Tegretol than recommended

If the patient has taken a higher dose of Tegretol than recommended, they should immediately consult their 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 and inform their doctor.

Missing a dose of Tegretol

If the patient misses a dose, they should take it 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 medicines, Tegretol 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 therapy.
Some side effects can be seriousand may affect less than 1 in 1000 patients

The patient should immediately contact their doctor or make sure someone else does, 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):

• If the patient has a fever, sore throat, rash, mouth ulcers, swollen lymph nodes, or 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, redness of the skin, blisters on the lips, eyelids, or mouth, or skin peeling with fever (symptoms of severe skin reactions).
• If the patient has swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, and a generalized itching, rash, abdominal cramps, a feeling of tightness or discomfort in the chest, difficulty breathing, loss of consciousness (symptoms of angioedema and severe allergic reactions).
• If the patient is drowsy, 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 patients
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 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
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 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, speech difficulties 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, 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, acne, 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 blood urea nitrogen/azotemia), frequent urination, sudden decrease in urine output, sexual disorders/erectile dysfunction, spermatogenesis disorders (reduced sperm count or motility), increased thyroid-stimulating hormone (TSH) in the blood.
Very rare: may affect less than 1 in 10,000 patients
abnormal blood test results, anemia, immunoglobulin deficiency, unexpected milk secretion from the breasts, breast enlargement in men, disorders of porphyrin production, a dye important for liver function and blood formation, anxiety, changes in mental state, taste disturbances, cataract, conjunctivitis, hearing disturbances (tinnitus, hyperacusis, hearing loss, change in perception of high tones), chest pain, extremely slow heartbeats, worsening of coronary artery disease, circulatory collapse, thrombophlebitis, swelling and redness along the 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, acne, 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 blood urea nitrogen/azotemia), frequent urination, sudden decrease in urine output, sexual disorders/erectile dysfunction, spermatogenesis disorders (reduced sperm count or motility), increased thyroid-stimulating hormone (TSH) 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 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,
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tegretol

• The medicine should be stored out of sight and reach of children.
• Store in a temperature not exceeding 30°C, protected from light.
• 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 contains

• The active substance of Tegretol is carbamazepine. 1 mL of oral suspension contains 20 mg of carbamazepine.
• The other ingredients are: macrogol 400 stearate, sodium saccharin, hydroxyethylcellulose, microcrystalline cellulose, sodium carmellose, liquid sorbitol, non-crystallizing, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbic acid, caramel flavor 52929 A, purified water.

What Tegretol looks like and what the pack contains

Tegretol is available in an orange glass bottle, closed with a polypropylene or polyethylene cap, in a cardboard box. A 5 mL measuring cup is attached to the packaging. 1 bottle contains 100 mL or 250 mL of Tegretol oral suspension.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska Street 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

Date of last revision of the leaflet: 10/2024