Patient Information Leaflet: Tegretol 400 mg Tablets

Carbamazepine

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Tegretol is and what it is used for

2. What you need to know before you start taking Tegretol

3. How to take Tegretol

4. Possible side effects

5. Storage of Tegretol

6. Contents of the pack and additional information

The active ingredient is carbamazepine.

Carbamazepine belongs to a group of medications called antiepileptics. It is used for the treatment of certain types of epilepsy. It is also used in the treatment of mania and in the prevention of bipolar disorders; in alcohol withdrawal syndrome, in trigeminal neuralgia and in glossopharyngeal neuralgia.

Follow the instructions given by your doctor. These may be different from the information contained in this leaflet.

Read the following instructions before taking Tegretol.

The risk of severe skin reactions in patients of Chinese Han or Thai origin related to carbamazepine or chemically related compounds can be predicted by means of a blood test in these patients. Your doctor must tell you if you need to have these tests before taking Tegretol.

Do not take Tegretol:

• If you are allergic to carbamazepine or to any of the other components of the formulation of this medication (including those listed in section 6), as well as to any drug with a similar structure to carbamazepine (some antidepressants);
• If you have a serious heart disease;
• If you have had a serious blood disease in the past;
• If you have problems with porphyrin formation, an important pigment for liver function and blood formation (also called porphyria hepatica);
• If you are taking medications belonging to a special group of antidepressants called monoamine oxidase inhibitors (MAOIs).

If you are in any of these situations, consult your doctor before taking Tegretol. If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tegretol.

• If you have had or have heart, liver, or kidney diseases;

• If you have or have had any blood disease (including those caused by other medications);
• If you have high intraocular pressure (glaucoma), decreased urine output, or difficulty urinating;
• If you have a mental illness called psychosis, and also if you are older and have confusion or agitation;
• If you notice signs suggesting a serious skin disease;
• If you have observed sensitivity changes (skin rash or other signs of allergy) to oxcarbazepine or to other medications, such as phenytoin (another antiepileptic). It is essential to note that if you are allergic to carbamazepine, the chances are 1 in 4 (25%) that you may have an allergic reaction to oxcarbazepine (Trileptal);
• If you are a woman of childbearing age, you must use an effective contraceptive method during your entire treatment and for two weeks after your last dose. If you take oral contraceptives, Tegretol may make them less effective. Therefore, you should use non-hormonal contraceptives or additional methods while taking Tegretol. This will help prevent unwanted pregnancies. Consult your doctor if you experience irregular bleeding or spotting while taking Tegretol. If you have any doubts, consult your doctor;

• Inform your doctor if you are pregnant or intend to become pregnant. Your doctor will inform you about the potential risk of taking Tegretol during pregnancy since it may cause damage or abnormalities in the fetus. There is a risk of damage to the fetus if Tegretol is used during pregnancy. Women of childbearing age must use an effective contraceptive method during Tegretol treatment and for two weeks after the last dose (see Pregnancy, Breastfeeding, and Fertility section).

If you are in any of the following situations, consult your doctor immediately:

• In case of fever, sore throat, skin rash, mouth ulcers, easy bruising without apparent reason, or purple spots on the skin (see Section 4 “Possible side effects”).

It is very important that your doctor controls your treatment with regular visits and performs blood and urine tests at the beginning of treatment and regularly throughout it to rule out the appearance of blood and liver and kidney function abnormalities, and also in some cases to control the most suitable Tegretol dose.

• Severe skin reactions that can be life-threatening in patients have been described with the use of Tegretol, initially appearing as red spots or patches, often with a central blister. Other additional signs that may appear are mouth, throat, nose, genital, and conjunctivitis (swollen and red eyes). These life-threatening skin reactions often occur with flu-like symptoms. The skin reaction may progress to generalized blistering or skin peeling. The highest risk period for severe skin reactions is during the first months of Tegretol treatment.If a skin reaction such as rash, redness, blisters on lips, eyes, or mouth, or peeling accompanied by fever, stop taking Tegretol and inform your doctor immediately. These reactions may be more frequent in patients from Asian countries (e.g., Taiwan, Malaysia, and the Philippines). Rarely, severe skin reactions may occur while taking Tegretol. Patients of Chinese and Thai origin may have their risk estimated by a blood test. If you are of this origin, discuss it with your doctor before taking Tegretol.If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Tegretol, you must not use Tegretol again at any time.

• If you experience an allergic reaction such as swelling of lips, eyelids, face, throat, mouth, or sudden respiratory problems, fever with swollen lymph nodes, skin rash, or blisters, consult your doctor immediately or go to the nearest hospital (see Section 4 “Possible side effects”).
• If you experience an increase in the number of seizures, consult your doctor immediately.
• If you notice symptoms suggestive of hepatitis, such as jaundice (yellow skin and white of the eyes), consult your doctor immediately.
• If at any time you have thoughts of harming yourself or committing suicide. A small number of patients treated with antiepileptics experience such thoughts or behaviors.
• If you have kidney problems associated with low sodium levels in the blood or if you have kidney problems and are taking medications that lower sodium levels in the blood (diuretics such as hydrochlorothiazide, furosemide).
• If you experience dizziness, somnolence, decreased blood pressure, confusion, sedation, and ataxia due to Tegretol treatment, as it may cause you to fall.

Do not stop taking Tegretol without consulting your doctor first. To prevent a worsening of seizures, do not discontinue treatment abruptly.

Before any surgical intervention, even dental or emergency treatment, inform the doctor attending you that you are taking Tegretol.

Use in the elderly

Tegretol can be used safely in elderly patients following the doctor's instructions. If necessary, special information on dosage and measures to be taken will be given (see also Section 3 “How to take Tegretol” and Section 4 “Possible side effects”).

Use in children

Tegretol can be used safely in children following the doctor's instructions. If necessary, special information on dosage and measures to be taken will be given (see also Section 3 “How to take Tegretol” and Section 4 “Possible side effects”).

Other medications and Tegretol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Tegretol may present multiple interactions with a large number of medications that may either increase or decrease its effect and that of these medications. This warning is valid for medications acquired with and without a prescription and especially in the case of vitamins (Vitamin B3), oral contraceptives, analgesics such as paracetamol, preparations containing St. John's Wort, and other antiepileptic medications (such as brivaracetam).

Avoid using medications containing alcohol during Tegretol treatment.

Oral contraceptives, for example, pills, patches, injections, or implants

Tegretol may affect the functioning of oral contraceptives, making them less effective in preventing pregnancy. Consult your doctor, who will explain the type of contraceptive most suitable for you while taking Tegretol.

Use of Tegretol with food and drinks

You can take Tegretol with or without food.

Avoid consuming alcohol during Tegretol treatment. Alcohol may increase the risk of side effects.

Do 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

Pregnancy and women of childbearing age

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.While epilepsy already carries a risk of developmental disorders in your offspring, including congenital malformations, greater than in the general population, the different treatments available may increase this risk in general. Specifically, for carbamazepine, there is a possibility that it may increase the risk of spina bifida, facial, cranial, cardiovascular, and urinary system malformations, as well as the possible withdrawal syndrome that may occur in the newborn.

Tegretol may cause significant congenital defects. If you take Tegretol during pregnancy, your baby will have a risk up to three times greater of having a congenital defect compared to women who do not take an antiepileptic medication. Significant congenital defects, such as neural tube defects (opening in the spine), facial defects, such as cleft lip or palate, cranial defects, heart defects, penile defects related to the opening of the urinary tract (hypospadias), and finger defects, have been reported. If you have taken Tegretol during pregnancy, the fetus should be closely monitored.

Neurological developmental problems (brain) in babies born to mothers who used Tegretol during pregnancy have been reported. Some studies have shown that carbamazepine negatively affects neurological development in children exposed to carbamazepine in the womb, while other studies have not found such an effect. It cannot be ruled out that there may be an effect on neurological development.

If you are a woman of childbearing age and do not intend to become pregnant, you must use an effective contraceptive method during treatment with this medication. Tegretol may affect the functioning of oral contraceptives, making them less effective in preventing pregnancy. Consult your doctor, who will explain the type of contraceptive most suitable for you while taking Tegretol. If treatment with Tegretol is interrupted, you should continue using an effective contraceptive method for two weeks after treatment interruption.

If you are a woman of childbearing age and plan to become pregnant, discuss it with your doctor before stopping the contraceptive methods and becoming pregnant to change to other suitable treatments to avoid exposing the fetus to carbamazepine.

If you are pregnant or think you may be pregnant, inform your doctor immediately. Do not stop taking the medication without first consulting your doctor. If you interrupt treatment without consulting your doctor, you may experience seizures that could be dangerous for you and the fetus. Your doctor may decide to change your treatment.

If you take Tegretol during pregnancy, the baby also has a risk of experiencing bleeding problems shortly after birth. Your doctor may administer a medication to you and the baby to prevent this.

Therefore, we advise:

1. If you wish to become pregnant, plan your pregnancies by consulting with your specialists.

2. If you are already pregnant, CONSULT YOUR NEUROLOGIST.

3. In neither caseSTOP TREATMENT on your own. Untreated epilepsy harms both the fetus and the mother by the possible worsening of the disease.

In these situations, your doctor may prescribe additional treatment with folic acid before and during pregnancy and vitamin K1in the last weeks of pregnancy (in this case, also for the newborn). Additionally, pregnancy will be closely monitored.

Breastfeeding

Inform your doctor if you are breastfeeding.

The active substance in Tegretol passes into breast milk. While your doctor agrees and the baby is monitored for side effects, you can breastfeed. However, if side effects appear in the baby, such as drowsiness or skin rash, stop breastfeeding and consult your doctor.

Driving and operating machinery

Tegretol may cause drowsiness, dizziness, blurred vision,double vision or lack of muscular coordinationespecially when starting treatment or increasing the doseand may decrease your reaction time. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor evaluates your response to this medication.

Tegretol contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor carefully. In case of doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Tegretol should be taken regularly and exactly as your doctor indicates; this will help you achieve better results and reduce the risk of severe side effects.Do not take additional doses of Tegretol, do not take it more frequently than indicated, and do not take it for longer than prescribed.

Do not interrupt treatment abruptly before consulting your doctor,as it could worsen your condition. Your doctor will indicate what you should do (see Section “Be especially careful with Tegretol”).

Amount of Tegretol to take

The doses prescribed by your doctor may be different from those indicated. Always follow your doctor's instructions.

Generally, the initial dose in adults for the treatment ofepilepsyis 100-200 mg once or twice a day; this dose is gradually increased to 800-1200 mg per day (in some patients, a dose of 1600 mg per day may be necessary), divided into 2 or 3 fractional doses.

Treatment in children usually starts with a dose of 100-200 mg per day (10-20 mg/kg/day) and is gradually increased to 400-600 mg. Adolescents may receive between 600 and 1000 mg per day.

For the treatment oftrigeminal neuralgiaandglossopharyngeal neuralgia,the initial dose is 200-400 mg per day, gradually increasing until the pain disappears, usually 200 mg 3-4 times a day. The maximum dose is 1200 mg per day. In elderly patients, a lower initial dose (100 mg twice a day) is recommended.

For thetreatment of mania and for the prevention of bipolar affective disorders,the usual dose is 400-600 mg per day (the dose range varies between approximately 400 and 1600 mg per day). Your doctor will indicate the exact dose of Tegretol you should take.

How and when to take Tegretol

Except for possibly the first day, Tegretol tablets should be divided into 2-4 daily doses, depending on your clinical condition. Take Tegretol always during or after meals with a little liquid. If necessary, the tablets can be split in half.

If you take more Tegretol than you should

In case of Tegretol overdose, inform your doctor immediately. You may need medical attention. If you experience difficulty breathing, rapid and irregular heart rate, loss of consciousness, tremors, dizziness, nausea, and/or vomiting, you may be taking too much Tegretol. Inform your doctor immediately.

If you have taken more Tegretol than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Tegretol

If you forget a dose, take it as soon as possible, except if it is almost time for the next one; in this case, wait and return to the usual administration schedule.Do not take a double dose to compensate for the missed doses.If you forget several doses, consult your doctor.

If you interrupt treatment with Tegretol

Do not change or interrupt your treatment without consulting your doctor first. If treatment is interrupted abruptly, seizures may occur.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

They are more frequent, especially at the beginning of treatment, if the dose is too high or in some people, such as the elderly, and usually disappear after a few days of treatment or after adjusting the dose.

Consult your doctor immediately or make sure someone can do it for you if any of the following side effects appear, as they may be the first signs of severe blood, skin, liver, heart, kidney, or other organ damage and may require urgent medical treatment:

• if you have a fever, sore throat, rash, mouth sores, swollen lymph nodes, or are prone to infections (signs of low white blood cell count)
• if you feel tired, have a headache, get short of breath when exercising, feel dizzy, pale, have frequent infections with fever, chills, sore throat, or mouth ulcers, if you bleed or have more bruises than normal, if your nose bleeds (signs of low blood cell count)
• if you have a skin rash with red spots usually on the face that may be accompanied by fatigue, nausea, loss of appetite (signs of systemic lupus erythematosus)
• if you have yellowing of the white of the eyes or skin (signs of hepatitis)
• if you have darkening of the urine (signs of porphyria or hepatitis)
• if you have decreased urine output or blood in the urine (signs of kidney damage)
• if you experience severe abdominal pain, vomiting, loss of appetite (signs of pancreatitis)
• if you have a skin rash, redness of the skin, blisters on the lips, mouth, or eyes, skin peeling, accompanied by fever, chills, headache, cough, or body aches (signs of severe skin reactions). See section 2

• if you experience swelling in the face, eyes, or tongue, difficulty swallowing, wheezing, hives, and generalized itching, skin rash, fever, abdominal cramps, chest discomfort, difficulty breathing, or loss of consciousness (signs of angioedema and severe allergic reactions)
• if you experience lethargy, confusion, muscle tics, or significant worsening of seizures (signs that may be associated with low sodium levels in the blood)
• if you experience fever, nausea, vomiting, headache, neck stiffness, or extreme sensitivity to bright light (signs of meningitis)
• if you experience muscle rigidity, high fever, altered consciousness, increased blood pressure, excessive salivation (signs of neuroleptic malignant syndrome)
• if you experience irregular heartbeat, chest pain
• if you experience altered consciousness, fainting
• if you experience diarrhea, abdominal pain, and fever (signs of colitis. The frequency of this side effect is unknown)
• if you experience a fall caused by dizziness, somnolence, low blood pressure, confusion

Other side effects

Consult your doctor as soon as possible if any of the following side effects appear, as they may require medical attention:

Very common side effects (may affect more than 1 in 10 patients):muscle coordination loss,skin inflammation with a rash and itching, skin rash with itching, vomiting, nausea, dizziness, somnolence, instability, weight gain.

Common side effects (may affect up to 1 in 10 patients):swelling of ankles, feet, and legs (edema), changes in behavior, confusion, weakness, increased seizure frequency (seizure exacerbation, due to insufficient sodium levels in the body), headache, dry mouth.

Rare side effects (may affect up to 1 in 100 patients):tremors, abnormal involuntary movements, muscle spasms.

Rare side effects (may affect up to 1 in 1,000 patients):itching, swelling of glands, agitation or hostility (especially in the elderly), difficulty speaking or mumbling, depression with anxiety, nervousness, or other mood or mental changes, hallucinations,blurred vision, double vision, itching with redness and swelling in the eyes (conjunctivitis), feeling of pressure or pain in the eyes (sign of increased eye pressure), involuntary eye movements,ringing in the ears or other unexplained sounds, hearing loss, rapid or irregular heartbeat, numbness or tingling in the hands and feet, weakness, increased urination frequency, sudden decrease in urine output, unusual taste, excessive milk secretion, breast enlargement in men, swelling and redness along a vein that is very sensitive to the touch and often painful (thrombophlebitis), increased skin sensitivity to the sun, bone weakening causing an increased risk of fracture (vitamin D deficiency, osteoporosis), constipation, diarrhea, abdominal pain, joint or muscle pain, increased sweating, loss of appetite, hair loss, excessive body and facial hair, sexual dysfunction, male infertility, tongue redness and irritation, mouth sores, skin pigmentation changes, acne, and severe skin reactions.

Side effects of unknown frequency (cannot be estimated from available data):reactivation of herpes virus infection (may be severe with immunosuppressed patients), complete nail loss, bone fracture, bone density decrease, sedation, memory loss, purple or maroon papules that may cause itching,high levels of ammonia in the blood (hyperammonemia). The symptoms of hyperammonemia may include irritability, confusion, vomiting, loss of appetite, and somnolence.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Store below 25°C.

Store in the original packaging to protect it from moisture.

Do not usethis medicationafter the expiration date that appears on thecontainerafter CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observethat the container is damaged or shows signs of handling.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tegretol 400 mg tablets

• The active ingredient is carbamazepine. Each tablet contains 400 mg of carbamazepine.
• The other components are: anhydrous colloidal silica, magnesium stearate, microcrystalline cellulose, sodium carboxymethylcellulose.

Appearance of the product and content of the container

Tegretol 400 mg tablets are presented in blister packs containing 100 and 500 white, elongated tablets with a groove on both sides and marked “CG” on one face and “LR” on the other and on both sides of the groove.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona - Spain

Responsible for manufacturing

Novartis Farma S.p.A

Via provinciale Schito 131

I-80058 Torre Annunziata

Italy

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

Last review date of this leaflet: April 2024