Tegretol: detailed information

Package leaflet: Information for the patient

Tegretol, 20 mg/mL, oral suspension
Carbamazepine
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Tegretol is and what it is used for
Important information before taking Tegretol
How to take Tegretol
Possible side effects
How to store Tegretol
Contents of the pack and other information

1. What Tegretol is and what it is used for

Tegretol belongs to a group of antiepileptic medicines (medicines used in the treatment of epileptic seizures), but its mechanism of action means it can also be used in other conditions.
Epilepsy is characterized by seizures.
Epileptic seizures result from transient disturbances in the brain's bioelectrical activity, leading to excessive and sudden discharges in a group of nerve cells. Tegretol regulates nerve conduction in nerve cells.

Indications:

Epilepsy:
- Complex or simple partial seizures.
- Generalized tonic-clonic seizures. Mixed seizure forms.

Tegretol may be used either as monotherapy or in combination with other antiepileptic drugs. Tegretol is generally ineffective in absence seizures (petit mal) and myoclonic seizures.

Manic episodes and prevention of relapses in bipolar affective disorder (manic-depressive psychosis).
Alcohol withdrawal syndrome.
Idiopathic trigeminal neuralgia and trigeminal neuralgia associated with multiple sclerosis. Idiopathic glossopharyngeal neuralgia.

2. Important information before using Tegretol

Tegretol should only be used after a full medical examination.
The risk of severe skin reactions associated with carbamazepine in patients of Chinese or Thai descent can be predicted by a blood test. Your doctor will inform you if such a blood test is required before starting treatment with Tegretol.
When not to use Tegretol:

if the patient is allergic to carbamazepine or to medicines with a similar chemical structure (e.g. tricyclic antidepressants), or to any of the other ingredients of this medicine (listed in section 6);
if the patient has severe heart disease;
if the patient has previously had serious blood disorders;
if the patient has or has previously had hepatic porphyria, i.e. disorders in the production of porphyrin, a pigment important for liver function and blood formation (acute intermittent porphyria, mixed porphyria, late cutaneous porphyria);
if the patient is currently taking antidepressants known as monoamine oxidase inhibitors (MAO inhibitors);
in newborns under 4 weeks of age, unless no other treatment options are available (see Warnings and precautions).

If any of the above points apply to the patient, you must inform your doctor.
Warnings and precautions:
Before starting treatment with Tegretol, discuss this with your doctor or pharmacist.
Tegretol should only be used under strict medical supervision:

If the patient has blood disorders (including those caused by other medicines).
If the patient has ever experienced hypersensitivity to oxcarbazepine or other medicines (rash or other allergic symptoms). Patients allergic to carbamazepine may (in approximately 1 in 4 (25%)) also experience hypersensitivity to oxcarbazepine.
If the patient has or has previously had heart, thyroid, liver, or kidney disease.
If the patient has increased intraocular pressure (glaucoma) or if the patient has difficulty or pain when urinating.
If the patient has been diagnosed with psychiatric disorders called psychoses, during which the patient may experience disorientation or agitation.
If the patient is of childbearing age, effective contraception should be used during therapy and for 2 weeks after taking the last dose.
If the patient is using hormonal contraceptives: Tegretol may reduce the effectiveness of these contraceptives. Therefore, the patient should use other or additional non-hormonal methods of contraception while taking Tegretol. Inform your doctor if you experience bleeding or spotting between periods. If in doubt, consult your doctor. Inform your doctor if you are pregnant or planning to become pregnant. Your doctor will discuss the risks of using Tegretol during pregnancy, as it may cause damage or developmental abnormalities in the unborn child (see "Pregnancy, breastfeeding and fertility").
During treatment with Tegretol in pregnancy, there is a risk of harmful effects on the unborn child. If the patient is of childbearing age, she should use an effective method of contraception during treatment with Tegretol and for two weeks after taking the last dose (see "Pregnancy, breastfeeding and fertility").

You should immediately consult your doctor or pharmacist if any of the following symptoms occur during treatment with Tegretol:

If hypersensitivity reactions occur, such as swelling of the lips, eyelids, face, throat, or mouth, sudden breathing difficulties, fever with swollen lymph nodes, rash, or blisters on the skin, you must immediately inform your doctor or go to the nearest hospital (see "4. Possible side effects").
If the patient develops severe skin reactions, such as rash, redness of the skin, blistering of the lips or eyes, or peeling of the outer layer of skin accompanied by fever, contact your doctor immediately or go to the nearest 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 descent.
If the number of epileptic seizures increases.
If the patient shows signs of liver inflammation, such as yellowing of the skin or whites of the eyes, indicating jaundice.
If the patient has ever had thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines have had such thoughts or behaviors.
If the patient has kidney problems related to low sodium levels in the blood, or if the patient has kidney problems and is also taking other medicines that lower blood sodium levels (diuretics such as hydrochlorothiazide, furosemide).
If the patient experiences dizziness, drowsiness, low blood pressure, or confusion related to taking Tegretol, as this may lead to falls.

Do not stop treatment with Tegretol without first consulting your doctor. Abruptly stopping the medicine may cause a sudden worsening of epileptic seizures.
Children (aged 4 weeks or older) and adolescents (under 18 years) and elderly patients (65 years or older)
Tegretol may be used in children aged 4 weeks or older and in elderly patients, provided the doctor's instructions are followed. The doctor should provide detailed advice, such as careful adherence to dosing instructions and close monitoring of the patient (see also "3. How to take Tegretol" and "4. Possible side effects").
Tegretol with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This is particularly important with Tegretol, as many different medicines may affect its action.
Sometimes, dosage adjustments or discontinuation of certain medicines may be necessary.
Hormonal contraceptives, e.g. pills, patches, injections, or implants
Tegretol may affect the action of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. Discuss with your doctor the most appropriate type of contraception during treatment with Tegretol. Women who use hormonal contraceptives simultaneously with Tegretol may experience irregular menstrual periods.
Medicines that may interact with Tegretol (and vice versa):

Medicines used for depression and anxiety: desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, vilazodone, bupropion, citalopram, mianserin, nefazodone, sertraline, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortriptyline, clomipramine), alprazolam, midazolam
Corticosteroids used for inflammatory conditions, including asthma, inflammatory bowel disease, muscle and joint pain: prednisolone, dexamethasone
Anticoagulants: e.g. warfarin, phenprocoumon, dicoumarol, 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
Painkillers 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, methsuximide, phenobarbital, fensuximide, phenytoin and fosphenytoin, primidone, levetiracetam, brivaracetam
Antihistamines used for allergies, including hay fever and itching: terfenadine
Medicines for peptic ulcer disease: cimetidine, omeprazole
Medicines used in dermatology: isotretinoin
Antiemetic medicines: aprepitant
Medicines used in glaucoma: acetazolamide
Medicines used in endometriosis: danazol
Bronchodilators or anti-asthmatic medicines: theophylline
Immunosuppressants used after organ transplants: cyclosporine, everolimus, tacrolimus, sirolimus
Antipsychotic medicines used in 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 for thyroid disorders: levothyroxine
Medicines for erectile dysfunction: tadalafil
Antiparasitic medicines: praziquantel, albendazole
Diuretics: hydrochlorothiazide, furosemide
Antituberculosis medicines: isoniazid, rifampicin
Muscle relaxants: oxybutynin, dantrolene, pancuronium
Medicines containing estrogen 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 high doses)

Particular caution is required when using Tegretol concomitantly with levetiracetam, isoniazid, lithium salts, or metoclopramide.
Taking Tegretol with food, drink, and alcohol
Do not consume alcohol during treatment with Tegretol.
Do not drink grapefruit juice or eat grapefruit, as it may enhance the effect of Tegretol. Other juices, such as orange or apple juice, do not have this effect.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Tegretol may cause serious congenital malformations. If the patient takes Tegretol during pregnancy, the risk of congenital malformation in the child is up to three times higher than in women who do not take antiepileptic medicines. Serious congenital malformations have been reported, including neural tube defects (spina bifida), facial malformations such as cleft lip and palate, skull malformations, microcephaly (small head), heart defects, penile malformations associated with an open urethral opening (hypospadias), and finger malformations.
If the patient takes Tegretol during pregnancy, her child may be smaller and weigh less than expected at birth (small for gestational age [SGA]). In one study among women with epilepsy, approximately 13 out of every 100 children born to mothers taking carbamazepine during pregnancy were smaller and weighed less than expected at birth, compared to 11 out of every 100 children of women who did not take antiepileptic medicines during pregnancy. If the patient takes Tegretol during pregnancy, the unborn child should be closely monitored.
Neurological development problems (brain development) have been reported in infants born to mothers who used Tegretol during pregnancy. Some studies have shown that carbamazepine has a negative impact on the neurological development of children exposed to carbamazepine in utero, while other studies have not found such an effect. An effect on neurological development cannot be ruled out.
If the patient is of childbearing age and does not plan to become pregnant, she should use effective contraception during treatment with Tegretol. 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 her doctor the most appropriate type of contraception during treatment with Tegretol. If treatment with Tegretol is discontinued, effective contraception should be continued for an additional two weeks after stopping the medicine.
If the patient is of childbearing age and plans to become pregnant, she should consult her doctor before stopping contraception and before becoming pregnant, to change the treatment method to another one appropriate for protecting the unborn child from exposure to carbamazepine.
If the patient is or suspects she may be pregnant, she should immediately inform her doctor. Do not stop taking the medicine until you have discussed it with your doctor. Stopping the medicine without consulting a doctor may cause epileptic seizures, which may be dangerous for both the patient and her 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 immediately after delivery. The doctor may prescribe a medicine for both the patient and the child to prevent this.
It is very important to control epileptic seizures during pregnancy. However, if the patient takes antiepileptic medicines (anti-seizure medicines) during pregnancy, there is a risk to the child. The risk of neurodevelopmental disorders in children of women with epilepsy treated with carbamazepine alone or in combination with other antiepileptic medicines during pregnancy cannot be excluded.
The doctor will discuss with the patient the risks of using Tegretol during pregnancy.
Do not stop treatment with Tegretol without first consulting your doctor.
Breastfeeding
Inform your doctor if you are breastfeeding. The active substance of Tegretol passes into breast milk. If the doctor gives approval, breastfeeding may continue. However, in this particular case, the child should be carefully monitored to avoid adverse effects.
If adverse effects occur, for example, if the child becomes very drowsy, breastfeeding should be stopped and the doctor contacted.
Fertility
There are very rare reports of fertility disorders in men and/or disturbances in spermatogenesis.
Women of childbearing age
Effective contraceptive methods should be used during therapy and for 2 weeks after taking the last dose of Tegretol.
In women who use hormonal contraceptives (birth control) simultaneously with Tegretol, irregular menstrual periods may occur. The effectiveness of hormonal contraceptives may be reduced during treatment with Tegretol; therefore, the use of other or additional non-hormonal contraceptive methods is recommended.
Driving and operating machinery
Tegretol may cause drowsiness, dizziness, visual disturbances, double vision, or lack of motor coordination, especially at the beginning of treatment or after dose increases. If such symptoms occur, do not drive a car or operate machinery or perform other activities requiring increased attention.
Tegretol contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, propylene glycol, and sorbitol
Tegretol oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, meaning the medicine is considered "sodium-free".
The medicine contains 125 mg of propylene glycol in each 5 mL of oral suspension, equivalent to 25 mg per millilitre. Children under 4 weeks of age should not receive this medicine without careful assessment by the treating doctor and only if no other treatment options are available. At this age, the child may be unable to metabolize propylene glycol, which may lead to severe adverse effects, including kidney and liver problems. The risk increases if the child receives other medicines containing propylene glycol or other alcohols. If treatment with this medicine is necessary, the child will be monitored for these adverse effects. Parents of premature infants should consult their doctor. Before administering the medicine to a child under 4 weeks of age, contact a 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, contact a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Patients with impaired liver or kidney function, pregnant or breastfeeding women, should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests in such patients.
The medicine also contains 875 mg of sorbitol in each 5 mL of oral suspension, equivalent to 175 mg per millilitre. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact the doctor before taking the medicine or giving it to a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

3. How to take Tegretol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Do not exceed the prescribed dose. Do not stop taking Tegretol suddenly without first discussing it with your doctor. Your doctor will inform you whether and when it is possible to discontinue treatment (see "Warnings and precautions").

The oral suspension can be taken during or after a meal or between meals. Shake the suspension well before use.

A given dose of Tegretol administered as oral suspension results in higher maximum serum concentrations than the same dose given as tablets. Therefore, to avoid adverse effects, your doctor will recommend starting treatment with low doses and gradually increasing them.

Switching from tablets to suspension: Your doctor will prescribe the same total daily dose (in mg per day), but in smaller individual doses with increased frequency of administration, e.g., taking the suspension three times daily instead of tablets twice daily.

Your doctor will exercise particular caution when adjusting the dosage for elderly patients.

1 measuring spoon (5 mL) of the medicine, supplied with the package, contains 100 mg of carbamazepine.

Recommended dose

Epilepsy

Treatment starts with a low daily dose. Your doctor will recommend gradually increasing the dose until optimal effect is achieved.

Your doctor may recommend monitoring plasma levels of the drug, as this may help determine the optimal dosage.

If Tegretol is to be added to an existing antiepileptic treatment regimen, your doctor will introduce the drug gradually, maintaining or, if necessary, adjusting the dosage of other antiepileptic drugs.

Adults

Initial dose: 100 mg to 200 mg once or twice daily. Your doctor will gradually increase the dose until optimal therapeutic effect is achieved—usually up to 400 mg two to three times daily. In some patients, doses of up to 1600 mg, and even 2000 mg per day, may be required.

Use in children and adolescents

In children aged 4 years or younger, the recommended initial dose is 20 mg to 60 mg per day, which may be increased by 20 mg to 60 mg every other day.

In children older than 4 years, treatment with carbamazepine may start at 100 mg per day, increasing the dose 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 spoons of oral suspension;
1 to 5 years: 200 mg to 400 mg per day, i.e., 1 to 2 measuring spoons of oral suspension twice daily;
6 to 10 years: 400 mg to 600 mg per day, i.e., 2 measuring spoons of oral suspension two to three times daily;
11 to 15 years: 600 mg to 1000 mg per day, i.e., 2 to 3 measuring spoons of oral suspension three times daily (plus an additional 5 mL spoonful when administering a 1000 mg dose);
15 years: 800 mg to 1200 mg per day, i.e., 2 to 3 measuring spoons of oral suspension four times daily (same dose as for adults).

Maximum recommended doses:

Up to 6 years: 35 mg/kg body weight/day
6 to 15 years: 1000 mg/day
15 years: 1200 mg/day

Tegretol is contraindicated in neonates under 4 weeks of age unless no other treatment option is available.

Manic syndrome and prevention of relapse in bipolar affective disorder (manic-depressive psychosis)

Dosage range: approximately 400 mg to 1600 mg per day. The usual dose is 400 mg to 600 mg per day, given in 2 to 3 divided doses. In the treatment of acute manic episodes, your doctor will increase the dose relatively quickly, whereas in the prophylaxis of bipolar disorders, the dose will be increased more slowly to ensure optimal drug tolerance.

Alcohol withdrawal syndrome

Average dosage: 200 mg three times daily. In severe cases, your doctor may increase the dose during the first few days (e.g., up to 400 mg three times daily). During the initial phase of treatment, when withdrawal symptoms are most intense, your doctor may prescribe Tegretol in combination with sedative-hypnotic drugs (e.g., clomethiazole, chlordiazepoxide). After the acute phase subsides, treatment will continue with Tegretol alone.

Trigeminal neuralgia and glossopharyngeal neuralgia

Initial dose: 200 mg to 400 mg per day, gradually increased by your doctor until pain relief is achieved (usually 200 mg three to four times daily). Maximum daily dose: 1200 mg. Subsequently, your doctor will gradually reduce the dose to the lowest possible maintenance dose. In elderly patients, treatment should start at 100 mg twice daily.

If you feel that the effect of Tegretol is too strong or too weak, consult your doctor.

Taking more Tegretol than prescribed

If you take more Tegretol than prescribed, seek immediate medical advice or go to the nearest hospital emergency department. The patient may require observation.

If the patient experiences breathing difficulties, rapid or irregular heartbeat, loss of consciousness, fainting, tremor, malaise, and/or vomiting, stop taking Tegretol immediately and contact your doctor.

Missed dose of Tegretol

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Instead, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most of these adverse reactions are mild to moderate and usually resolve within a few
days of starting treatment.
Some reactions may be serious and may affect fewer than 1 in 1000 patients.
You should contact your doctor immediately or ensure that someone else does so on your behalf
if any of the following adverse reactions occur (these may be early signs of severe
blood-forming system, liver, kidney or other organ damage, requiring
immediate medical intervention):

If the patient develops fever, sore throat, rash, mouth ulcers, swollen lymph nodes, or experiences more frequent infections (signs of low white blood cell count).
If the patient feels fatigued, has headaches, dizziness, shortness of breath during exertion, appears pale, bruises or bleeds more easily than usual, or has nosebleeds (low counts of all blood cell types).
If the patient develops a red, blotchy rash, mainly on the face, possibly accompanied by fatigue, fever, nausea, and loss of appetite (symptoms of systemic lupus erythematosus).
If the patient's eyes or skin turn yellow (signs of hepatitis).
If the patient's urine becomes dark in color (signs of porphyria or hepatitis).
If the patient's urine output significantly decreases or blood appears in the urine.
If the patient experiences severe upper abdominal pain, vomiting, or loss of appetite (symptoms of pancreatitis).
If the patient develops a skin rash, redness of the skin, blisters on the lips, eyelids, or inside the mouth, or skin peeling, accompanied by fever, chills, headache, cough, or body aches (signs of severe skin reactions).
If the patient has facial, eye, or tongue swelling, difficulty swallowing, wheezing, hives, generalized itching, rash, cramping abdominal pain, chest tightness or discomfort, difficulty breathing, or loss of consciousness (symptoms of angioedema and severe allergic reactions).
If the patient is drowsy, confused, has muscle twitching, or a significant increase in seizure frequency (symptoms possibly related to low blood sodium levels).
If the patient has fever, nausea, vomiting, headache, neck stiffness, and severe light sensitivity (symptoms of meningitis).
If the patient develops muscle rigidity, high fever, altered consciousness, high blood pressure, excessive salivation (symptoms of neuroleptic malignant syndrome).
If the patient feels an irregular heartbeat or chest pain.
If the patient experiences altered consciousness or fainting.
If the patient develops diarrhea, abdominal pain, and fever (symptoms of colitis). The frequency of this adverse reaction is unknown.
If the patient experiences falls due to dizziness, drowsiness, low blood pressure, or confusion.

Other adverse reactions
Very common: may affect more than 1 in 10 patients
loss of motor coordination, skin inflammation with accompanying itchy rash and redness,
itchy rash, vomiting, nausea, dizziness, drowsiness, fatigue, leukopenia.
Common: may affect fewer than 1 in 10 patients
swelling around ankles, feet, or lower legs, fluid retention, weight gain, headache,
dry mouth, double vision, blurred vision, thrombocytopenia, eosinophilia.
Uncommon: may affect fewer than 1 in 100 patients
involuntary abnormal movements such as tremor, asterixis (flapping tremor of the hands), dystonia (twisting and posturing of various body parts), tics, nystagmus, diarrhea, constipation, desquamative skin inflammation.
Rare: may affect fewer than 1 in 1000 patients
itching, swollen lymph nodes, leukocytosis, multi-organ hypersensitivity, folic acid deficiency, decreased appetite, hallucinations, depression, aggression, restlessness, agitation, confusion, uncoordinated and involuntary movements of limbs and whole body, uncontrolled eye movements, difficulty speaking or slurred speech, abnormal muscle movements (chorea alternating with slow writhing movements), sensory disturbances, numbness, tingling in hands and feet, electric shock-like sensations, muscle weakness, cardiac conduction disorders, hypertension or hypotension, abdominal pain, jaundice, muscle weakness.
Very rare: may affect fewer than 1 in 10,000 patients
abnormal blood test results, anemia, immunoglobulin deficiency (gamma globulins), unexpected milk secretion from mammary glands, breast enlargement in males, porphyrin production disorders (a pigment important for liver function and blood formation), anxiety, altered mental state, taste disturbances, lens opacities, conjunctivitis, hearing disorders (tinnitus, hyperacusis, hearing loss, altered perception of high tones), chest pain, extremely slow heart rate, worsening of angina symptoms, circulatory collapse, thrombosis, swelling and redness along a vein that becomes very tender to touch, often painful (thrombophlebitis), shortness of breath, fever and lung inflammation (pulmonary hypersensitivity), glossitis, stomatitis, liver failure, blisters on the mucous membranes of the mouth and genital organs (Stevens-Johnson syndrome), toxic epidermal necrolysis, photosensitivity, erythema multiforme, nodular erythema, skin pigmentation disorders, purpura, acne, excessive sweating, alopecia, hirsutism, bone metabolism disorders leading to bone demineralization/osteoporosis, joint pain, muscle pain, muscle cramps, tubulointerstitial 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 dysfunction/erectile dysfunction, spermatogenesis disorders (reduced sperm count or sperm motility), increased blood levels of thyroid-stimulating hormone (TSH).
Frequency not known: frequency cannot be estimated from available data
drug-induced sedation, memory loss, purple or reddish-purple blisters which may be itchy, drug rash with eosinophilia and systemic symptoms (DRESS), lichenoid keratosis, reactivation of human herpesvirus 6 infection (may be severe due to immune system dysfunction), complete nail loss, fractures, decreased bone density, bone marrow failure (i.e. insufficient production of red blood cells, white blood cells, and platelets by the bone marrow), colitis, high blood ammonia levels (hyperammonemia). Symptoms of hyperammonemia may include irritability, disorientation, vomiting, loss of appetite, and drowsiness.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tegretol

Keep the medicine out of sight and reach of children.
Store below 30°C and protect from light.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Tegretol contains

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

What Tegretol looks like and contents of the pack
Tegretol is available in an amber glass bottle closed with a polypropylene or polyethylene screw cap,
packaged in a cardboard box. A 5 mL measuring spoon is included with the packaging. 1 bottle contains
100 mL or 250 mL of Tegretol oral suspension.
Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Tel. + 48 22 375 48 88
Manufacturer/Importer
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain