TEGRETOL 400 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

TEGRETOL 400 mg tablets

Carbamazepine

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

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tegretol and what is it used for
2. What you need to know before you take Tegretol
3. How to take Tegretol
4. Possible side effects
5. Storage of Tegretol
6. Contents of the pack and further information

1. What is Tegretol and what is it used for

The active substance is carbamazepine.

Carbamazepine belongs to a group of medicines called antiepileptics. It is used to treat certain types of epilepsy. It is also used to treat mania and to prevent manic-depressive (bipolar) disorders; in alcohol withdrawal syndrome, in essential trigeminal neuralgia, and in glossopharyngeal neuralgia.

2. What you need to know before you take Tegretol

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

Do not take Tegretol:

• If you are allergic to carbamazepine or any of the other ingredients of this medicine (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 disorder in the past;
• If you have problems with porphyrin formation, an important pigment for liver function and blood formation (also called hepatic porphyria);
• If you are taking medicines 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 disease;

• if you have or have had any blood disorder (including those caused by other medicines);
• if you have high intraocular pressure (glaucoma), decreased urination, or difficulty urinating;
• if you have a mental illness called psychosis, and also if you are elderly and have confusion or agitation;
• if signs suggesting a serious skin disease appear;
• if you have observed sensitivity changes (skin rash or other signs of allergy) to oxcarbazepine or other medicines, such as phenytoin (another antiepileptic). It is important to note that if you are allergic to carbamazepine, the possibilities are 1 in 4 (25%) that you may have an allergic reaction to oxcarbazepine (Trileptal);
• if you are a woman of childbearing age, you should 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 contraceptive methods 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;

• Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will inform you about the potential risk of taking Tegretol during pregnancy, as it may cause harm or abnormalities in the fetus. There is a risk of harm to the fetus if Tegretol is used during pregnancy. Women of childbearing age must use an effective contraceptive method during treatment with Tegretol and for two weeks after the last dose (see section on pregnancy, breastfeeding, and fertility).

If you experience 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 monitors your treatment with regular visits and performs blood and urine tests at the beginning of treatment and regularly throughout to rule out the appearance of blood and liver and kidney function alterations, and also to monitor the most suitable Tegretol dose.

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

• If an allergic reaction occurs, such as swelling of the lips, eyelids, face, throat, mouth, or respiratory problems, 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 epileptic seizures, consult your doctor immediately.
• If you notice symptoms suggestive of hepatitis, such as jaundice (yellow skin and 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 suffer from 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 medicines that lower sodium levels in the blood (diuretics such as hydrochlorothiazide, furosemide).
• If you experience dizziness, drowsiness, decreased blood pressure, confusion, sedation, and ataxia due to treatment with Tegretol, as it may cause you to fall.

Do not stop treatment with Tegretol without first consulting your doctor. To prevent worsening of epileptic 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 precautions will be provided (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 precautions will be provided (see also Section 3 "How to take Tegretol" and Section 4 "Possible side effects").

Other medicines and Tegretol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tegretol may interact with many medicines, which can increase or decrease its effect and the effect of these medicines. This warning is valid for medicines purchased with and without a prescription, especially in the case of vitamins (Vitamin B3), oral contraceptives, painkillers such as paracetamol, preparations containing St. John's Wort, and other medicines for epilepsy (such as brivaracetam).

Avoid using medicines that contain alcohol during treatment with Tegretol.

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

Tegretol may affect the functioning of hormonal contraceptives, making them less effective in preventing pregnancy. Consult your doctor, who will explain the most suitable contraceptive method to use while taking Tegretol.

Using Tegretol with food and drinks

You can take Tegretol with or without food.

You should avoid consuming alcohol during treatment with Tegretol. 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 juice, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. While epilepsy already carries a risk of developmental disorders in your offspring, including congenital malformations, higher than in the general population, the different available treatments may increase this risk in general. Specifically, for carbamazepine, there is a possibility that it may increase the risk of spina bifida, malformations in the skull and face, cardiovascular and urinary system, in addition to 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 3 times higher of having a congenital defect compared to women who do not take an antiepileptic drug. Significant congenital defects have been reported, such as neural tube defects (opening in the spine), congenital facial defects, such as cleft lip or palate, congenital head defects, heart defects, congenital defects of the penis related to the opening of the urinary tract (hypospadias), and defects in the fingers. If you have taken Tegretol during pregnancy, the fetus should be closely monitored.

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

If you are a woman of childbearing age and do not plan to become pregnant, you should use an effective contraceptive method during treatment with this medicine. Tegretol may affect the functioning of hormonal contraceptives, such as the birth control pill, and make them less effective in preventing pregnancy. Consult your doctor, who will indicate the most suitable contraceptive method to use while taking Tegretol. If you interrupt treatment with Tegretol, you should continue to use an effective contraceptive method for two weeks after treatment interruption.

If you are a woman of childbearing age and plan to become pregnant, talk to your doctor before stopping the use of contraceptive methods and becoming pregnant to switch 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 medicine without first talking to your doctor. If you stop treatment without consulting your doctor, you may experience epileptic 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 is also at risk of having bleeding problems immediately after birth. Your doctor may give you and the baby a medicine to prevent this.

Therefore, we advise:

1. If you wish to become pregnant, plan your pregnancies by consulting with your specialists.
2. In case you are already pregnant, CONSULT YOUR NEUROLOGIST.
3. In neither case, STOP TREATMENT on your own. Untreated epilepsy harms both the fetus and the mother due to the possible worsening of the disease.

In these situations, it is possible that the doctor will prescribe supplementary treatment with folic acid before and during pregnancy and vitamin K1 in the last weeks of pregnancy (in the latter case, also to the newborn). Additionally, the 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 child is monitored for the appearance of side effects, you can breastfeed. However, if side effects appear in the infant, e.g., drowsiness or skin rashes, stop breastfeeding and consult your doctor.

Driving and using machines

Tegretol may cause drowsiness, dizziness, or blurred vision, double vision, or lack of muscle coordination, especially when starting treatment or increasing the dose, and may decrease reaction capacity. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Tegretol contains sodium

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

3. How to TAKE TEGRETOL

Follow the administration instructions of this medication carefully as indicated by your doctor. 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 serious 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 stop treatment abruptly before consulting your doctor,as this may worsen your illness. The doctor will indicate what to 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 of epilepsyis 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 progressively increased to 400-600 mg. Adolescents may receive between 600 and 1000 mg per day.

For the treatment of trigeminal neuralgiaand glossopharyngeal neuralgia,the initial dose is 200-400 mg daily, slowly 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 is recommended (100 mg twice a day).

For the treatment of mania and for the prevention of bipolar affective disorders,the usual dose is 400-600 mg per day (the dose range is approximately 400 to 1600 mg per day). The doctor will indicate the exact dose of Tegretol to take.

How and when to take Tegretol

Except perhaps on the first day, Tegretol tablets should be divided into 2-4 daily doses, depending on your clinical condition. Always take Tegretol during or after meals with a little liquid. If necessary, the tablets can be halved.

If you take more Tegretol than you should

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

If you have taken more Tegretol than you should, consult your doctor, pharmacist, or call the Toxicology 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 you can, except if it is almost time for the next dose; in this case, wait and return to the usual administration schedule. Do not take a double dose to make up for forgotten doses. If you forget several doses, consult your doctor.

If you interrupt treatment with Tegretol

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

They are more frequent, especially at the start 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 a dose adjustment.

Consult your doctor immediately or make sure someone can do so for you if any of the following side effects appear, as they may be the first signs of serious injury to the blood, skin, liver, heart, kidneys, or other organs and may require urgent medical treatment:

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):loss of muscle coordination, skin inflammation with rash and itching and redness, itchy rash, vomiting, nausea, dizziness, drowsiness, 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 epileptic seizures (due to insufficient sodium in the body), headache, dry mouth.

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

Rare side effects (may affect up to 1 in 1,000 patients):itching, swelling of the glands, agitation or hostility (especially in the elderly), difficulty speaking or slurred speech, depression with restlessness, nervousness, or other mood or mental changes, hallucinations, blurred vision, double vision, itching with redness and swelling in the eyes (conjunctivitis), feeling of pressure/pain in the eyes (sign of increased eye pressure), involuntary eye movements, ringing or other unexplained noises, decreased hearing, rapid or unusually slow heartbeat, numbness or tingling in hands and feet, weakness, increased urination frequency, sudden decrease in urine output, taste disorders, unusual milk secretion, breast enlargement in men, swelling and redness along a very sensitive vein to the touch and often painful (thrombophlebitis), increased skin sensitivity to the sun, bone weakening causing an increased risk of fractures (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 disorders, male infertility, redness and irritation of the tongue, 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 (can be severe with a depressed immune system), complete loss of nails, bone fractures, decreased bone density, sedation, memory loss, purple or reddish-purple papules that may itch, elevated ammonia levels in the blood (hyperammonemia). The symptoms of hyperammonemia may include irritability, confusion, vomiting, loss of appetite, and drowsiness.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tegretol

Keep this medication out of sight and reach of children.

Store below 25°C.

Keep in the original packaging to protect it from moisture.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the packaging is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Tegretol 400 mg tablets

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

Appearance of the product and package contents

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

Only some package sizes may be marketed.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona - Spain

Manufacturer

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

Date of the last revision of this leaflet: April 2024