CARBAMAZEPINE NORMON 400 mg TABLETS

Introduction

Patient Information Leaflet

Carbamazepine Normon 400 mg Tablets EFG

Carbamazepine

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Carbamazepine Normon and what is it used for
2. What you need to know before taking Carbamazepine Normon
3. How to take Carbamazepine Normon
4. Possible side effects
5. Storage of Carbamazepine Normon
6. Package contents and additional information

1. What is Carbamazepine Normon and what is it used for

The active ingredient 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 disorders (bipolar); in alcohol withdrawal syndrome, in essential trigeminal neuralgia, and in essential glossopharyngeal neuralgia.

2. What you need to know before taking Carbamazepine Normon

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

Read the following instructions before taking Carbamazepine Normon.

The risk of serious skin reactions in patients of Chinese Han or Thai origin related to carbamazepine or chemically related compounds can be predicted by a blood test. Your doctor should indicate whether you need to undergo these tests before taking Carbamazepine Normon.

Do not take Carbamazepine Normon:

• 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 severe heart disease.
• If you suffer or have suffered from a severe 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 this medicine. If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• If you have suffered from heart, liver, or kidney disease in the past or if you suffer from them.
• If you have or have had a 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 of a severe 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 essential to mention 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 should use an effective contraceptive method during the entire treatment and for two weeks after the last dose. If you take oral contraceptives, carbamazepine may make them less effective. Therefore, non-hormonal contraceptive methods should be used, or additional methods should be used while taking this medicine. This will help prevent unwanted pregnancies. Consult your doctor if you experience irregular or spotting bleeding while taking Carbamazepine Normon. 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 Carbamazepine Normon during pregnancy, as it may cause harm or abnormalities in the fetus. There is a risk of harm to the fetus if carbamazepine is used during pregnancy. Women of childbearing age should use an effective contraceptive method during treatment with Carbamazepine Normon and for two weeks after the last dose (see section on pregnancy, breastfeeding, and fertility).

If you find yourself 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 the treatment in periodic visits and performs blood and urine tests at the beginning of the treatment and regularly throughout it to rule out the appearance of blood alterations and liver or kidney function, and also to control the most suitable carbamazepine 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 this medicine. Initially, they appear as red spots or circular patches, 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 severe skin reactions is during the first months of treatment with Carbamazepine Normon. If a skin reaction appears, such as a rash, redness, blisters on the lips, eyes, or mouth, or peeling accompanied by fever, stop taking carbamazepine and inform your doctor immediately. These reactions can be more frequent in patients from Asian countries (e.g., Taiwan, Malaysia, and the Philippines). Rare but serious skin side effects can occur while taking Carbamazepine Normon. 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 Carbamazepine Normon. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of this medicine, do not use carbamazepine again at any time.
• If an allergic reaction appears, such as lip, eyelid, face, throat, mouth, or breathing 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 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 Carbamazepine Normon, as it may cause you to fall.

Do not interrupt treatment with this medicine without consulting your doctor first. 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 Carbamazepine Normon.

Use in the elderly

Carbamazepine Normon 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 Carbamazepine Normon" and section 4 "Possible side effects").

Use in children

Carbamazepine 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 Carbamazepine Normon" and section 4 "Possible side effects").

Taking Carbamazepine Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine. Carbamazepine Normon may interact with many medicines, which can either increase or decrease its effect and that 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).

During treatment with Carbamazepine Normon, avoid using medicines that contain alcohol. Hormonal contraceptives, such as pills, patches, injections, or implants. Carbamazepine Normon 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 Carbamazepine Normon.

Taking Carbamazepine Normon with food and drinks

You can take this medicine with or without food.

You should avoid consuming alcohol during treatment with carbamazepine. Alcohol may increase the risk of side effects.

Do not drink grapefruit juice or eat grapefruit, as it may increase the effect of carbamazepine. 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 offspring, including congenital malformations, higher than in the general population, the different available treatments may generally increase this risk. In particular, 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 from treatment that may occur in the newborn.

Carbamazepine Normon may cause significant congenital defects. If you take Carbamazepine Normon 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 Carbamazepine Normon during pregnancy, the fetus should be closely monitored.

Neurological development problems (brain) have been reported in babies born to mothers who used carbamazepine during pregnancy. Some studies have shown that carbamazepine negatively affects the neurological development of children exposed to carbamazepine in the womb, 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. Carbamazepine Normon 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 Carbamazepine Normon. If you interrupt treatment with Carbamazepine Normon, you should continue to use an effective contraceptive method for two weeks after the interruption of treatment.

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 interrupt 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 Carbamazepine Normon during pregnancy, the baby is also at risk of suffering from bleeding problems shortly after birth. Your doctor may administer a medicine 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. In case you are already pregnant, CONSULT YOUR NEUROLOGIST.
3. In neither case, INTERRUPT 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 Carbamazepine Normon 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 breastfed baby, e.g., drowsiness or skin rash, interrupt breastfeeding and consult your doctor.

Driving and using machines

Carbamazepine 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.

Carbamazepine Normon contains sodium

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

3. How to take Carbamazepina Normon

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

Carbamazepina Normon 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 Carbamazepina Normon, 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 this could worsen your illness. The doctor will indicate what to do (see section "Warnings and precautions").

Amount of Carbamazepina Normon to take

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

In general, 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 neuralgia and glossopharyngeal neuralgia,the initial dose is 200-400 mg per day, 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 400-1600 mg per day). The doctor will indicate the exact dose of Carbamazepina Normon to take.

How and when to take Carbamazepina Normon

Except perhaps on the first day, the tablets of Carbamazepina Normon should be divided into 2-4 daily doses, depending on the clinical condition. Always take Carbamazepina Normon during or after meals with a little liquid.

If necessary, the tablets can be broken in half.

If you take more Carbamazepina Normon than you should

In case of overdose or accidental ingestion, inform your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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 carbamazepine. Inform your doctor immediately.

If you forget to take Carbamazepina Normon

Do not take a double dose to make up for forgotten doses. 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. If you forget several doses, consult your doctor.

If you interrupt treatment with Carbamazepina Normon

If you have any other doubts about the use of this medication, ask your doctor or pharmacist. Do not change or interrupt your treatment without consulting your doctor first. If treatment is interrupted abruptly, epileptic seizures may appear.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people 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 a dose adjustment.

Consult your doctor immediately or ensure that someone can do so for you if any of the following adverse 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:

• If you have a fever, sore throat, rash, mouth ulcers, or swollen glands, or if you are prone to infections (signs of a lack of white blood cells).
• If you feel tired, have a headache, are short of breath when exercising, are dizzy, pale, have frequent infections with fever, chills, sore throat, or mouth ulcers, if you bleed or have more bruises than usual, or if your nose bleeds (signs of a lack of blood cells).
• If you have a skin rash with reddish spots, usually on the face, which may be accompanied by fatigue, nausea, loss of appetite (sign of systemic lupus erythematosus).
• If you have yellowing of the whites of the eyes or skin (sign of hepatitis).
• If you have dark urine (signs of porphyria or hepatitis).
• If you have decreased urine output or blood in the urine (signs of kidney problems).
• If you experience severe pain in the upper abdomen, 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 pain (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, rash, fever, abdominal cramps, discomfort, or tightness in the chest, difficulty breathing, loss of consciousness (signs of angioedema and severe allergic reactions).
• If you experience lethargy, confusion, muscle twitching, or significant worsening of seizures (signs that may be associated with low sodium levels in the blood).
• If you have a fever, nausea, vomiting, headache, stiff neck, or extreme sensitivity to bright light (signs of meningitis).
• If you experience muscle stiffness, high fever, altered consciousness, increased blood pressure, excessive salivation (signs of malignant neuroleptic syndrome).
• If you have an irregular heartbeat, chest pain.
• If you experience altered consciousness, fainting.
• If you have diarrhea, abdominal pain, and fever (signs of colon inflammation). The frequency of this adverse effect is unknown.
• If you experience a fall caused by dizziness, drowsiness, decreased blood pressure, confusion.

Other adverse effects

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

Very common adverse effects (may affect more than 1 in 10 patients):loss of muscle coordination, skin inflammation with itchy rash and redness, itchy rash, vomiting, nausea, dizziness, drowsiness, instability, weight gain.

Common adverse 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 adverse effects (may affect up to 1 in 100 patients):Tremors, abnormal involuntary movements, muscle spasms.

Rare adverse 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, itchy and reddened 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 sensitive and often painful vein (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, tongue irritation, mouth ulcers, skin pigmentation changes, acne, and severe skin reactions.

Adverse 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 can cause itching, elevated ammonia levels in the blood (hyperammonemia). The symptoms of hyperammonemia may include irritability, confusion, vomiting, loss of appetite, and drowsiness.

Reporting adverse effects

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

5. Storage of Carbamazepina Normon

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Carbamazepina Normon

The active ingredient is carbamazepine. Each tablet contains 400 mg of carbamazepine.

The other components (excipients) are microcrystalline cellulose, sodium carboxymethyl starch type A (potato), colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and package contents

Carbamazepina Normon 400 mg are white or slightly creamy, round, biconvex, scored tablets, marked on one face and anonymous on the other, presented in PVC/AL blister packs of 30, 100, and 500 (clinical packaging) tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this prospectus:April 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/