Carbamazepine Normon 400 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Carbamazepine Normon 400 mg Tablets EFG

Carbamazepine

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Carbamazepine Normon is and what it is used for
2. What you need to know before taking Carbamazepine Normon
3. How to take Carbamazepine Normon
4. Possible adverse effects
5. How to store Carbamazepine Normon
6. Contents of the pack and other information

1. What Carbamazepine Normon is and what it is 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 in the treatment of mania and in the prevention of manic-depressive disorders (bipolar); in alcohol withdrawal syndrome, in essential trigeminal neuralgia, and in essential glossopharyngeal neuralgia.

2. What you need to know before starting Carbamazepine Normon

Follow the instructions given to you by your doctor. These may differ from the information contained in this leaflet.

Read the following instructions before taking Carbamazepine Normon.

The risk of severe 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 advise you whether you need to undergo this test before taking Carbamazepine Normon.

Do not take Carbamazepine Normon:

• If you are allergic to carbamazepine, or to any of the other components of this medicine (listed in section 6), or to any drug with a structure similar to carbamazepine (some antidepressants).
• If you have a serious heart disease.
• If you currently suffer or have previously suffered from a serious blood disorder.
• If you have problems with porphyrin formation, an important pigment for liver function and blood formation (also known as 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

Talk to your doctor or pharmacist before starting this medicine:

• If you currently have or have previously had heart, liver, or kidney disease.
• If you have or have previously had a blood disorder (including those caused by other medicines).
• If you have increased intraocular pressure (glaucoma), reduced urge to urinate, or difficulty urinating.
• If you have a mental illness called psychosis, or if you are elderly and experience confusion or agitation.
• If signs appear suggesting a serious skin disease.
• If you have experienced sensitivity reactions (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, there is a 1 in 4 chance (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 throughout your treatment and for two weeks after your last dose. If you take oral contraceptives, carbamazepine may reduce their effectiveness. Therefore, non-hormonal contraceptive methods, either different or additional, should be used while taking this medicine. This will help prevent unintended pregnancies. Consult your doctor if you experience irregular bleeding or spotting while taking Carbamazepine Normon. If you have any doubts, speak with your doctor.
• Inform your doctor if you are pregnant or planning 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 fetal harm if carbamazepine is used during pregnancy. Women of childbearing age must 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 experience any of the following, contact your doctor immediately:

• Fever, sore throat, skin rash, mouth ulcers, unexplained easy bruising, or purplish spots on the skin (see section 4 “Possible side effects”).

It is very important that your doctor monitors your treatment during regular visits and orders blood and urine tests at the beginning of treatment and periodically throughout treatment to rule out blood disorders and liver or kidney function problems, and occasionally to monitor the most appropriate carbamazepine dose.

• Severe, potentially life-threatening skin rashes (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis) have been reported with this medicine. These initially appear as red or pink circular spots, often with a central blister. Additional symptoms may include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen, red eyes). These life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling. The highest risk period for severe skin reactions is during the first few months of treatment with Carbamazepine Normon. If you develop a skin reaction such as rash, redness, blisters on lips, eyes or mouth, or skin peeling accompanied by fever, stop taking carbamazepine immediately and contact your doctor without delay. These reactions may be more common in patients from Asian countries (e.g., Taiwan, Malaysia, and the Philippines). Serious skin side effects may rarely occur during treatment with Carbamazepine Normon. Patients of Chinese or Thai origin may have their risk assessed with a blood test. If you are of this origin, discuss this with your doctor before taking Carbamazepine Normon. If you have previously experienced Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis with this medicine, you must never take carbamazepine again.
• If you experience an allergic reaction such as swelling of the lips, eyelids, face, throat, or mouth, sudden breathing problems, fever with swollen lymph nodes, skin rash, or blisters, contact 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, contact your doctor immediately.
• If you notice symptoms suggestive of hepatitis, such as jaundice (yellowing of the skin or whites of the eyes), contact your doctor immediately.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor immediately. A small number of patients treated with antiepileptic medicines have experienced 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 your blood sodium levels (diuretics such as hydrochlorothiazide, furosemide). If you experience dizziness, drowsiness, low blood pressure, confusion, sedation, or ataxia due to treatment with Carbamazepine Normon, you may be at increased risk of falling.

Do not stop treatment with this medicine without first consulting your doctor. To prevent worsening of epileptic seizures, do not discontinue treatment abruptly.

Before any surgical procedure, including dental procedures or emergency treatment, inform the attending doctor that you are taking Carbamazepine Normon.

Use in elderly patients

Carbamazepine Normon can be used safely in elderly patients when following the doctor’s instructions. Special information on dosage and precautions may be necessary (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 when following the doctor’s instructions. Special information on dosage and precautions may be necessary (see also section 3 “How to take Carbamazepine Normon” and section 4 “Possible side effects”).

Taking Carbamazepine Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Carbamazepine Normon may interact with many medicines, either increasing or decreasing their effects or its own. This warning applies to both prescription and over-the-counter medicines, and especially to vitamins (Vitamin B3), oral contraceptives, painkillers such as paracetamol, preparations containing St. John’s wort, and other epilepsy medicines (such as brivaracetam).

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

Carbamazepine Normon may affect the effectiveness of hormonal contraceptives, making them less effective in preventing pregnancy. Consult your doctor, who will advise you on the most suitable type of contraceptive to use while taking Carbamazepine Normon.

Taking Carbamazepine Normon with food and drinks

You may take this medicine with or without food.

You should avoid alcohol consumption during treatment with carbamazepine. Alcohol may increase the risk of adverse 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 itself carries a higher risk of developmental disorders in offspring—including congenital malformations—compared to the general population, available treatments may generally increase this risk. Specifically for carbamazepine, there is a possibility of increased risk of spina bifida, craniofacial malformations, cardiovascular and urinary system defects, and possible neonatal withdrawal syndrome.

Carbamazepine Normon may cause major congenital defects. If you take Carbamazepine Normon during pregnancy, your baby has up to three times higher risk of congenital defects compared to women who do not take antiepileptic drugs. Major congenital defects reported include neural tube defects (spinal opening), facial malformations such as cleft lip or cleft palate, head malformations, cardiac defects, penile defects related to urethral opening (hypospadias), and finger defects. If you take Carbamazepine Normon during pregnancy, the fetus should be closely monitored.

Neurological development problems (brain development) have been reported in babies born to mothers who used carbamazepine during pregnancy. Some studies have shown that carbamazepine negatively affects neurological development in children exposed in utero, while others have not found such an effect. A potential effect on neurological development cannot be ruled out.

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 medicine. Carbamazepine Normon may affect the effectiveness of hormonal contraceptives, such as the oral contraceptive pill, making them less effective in preventing pregnancy. Consult your doctor, who will advise you on the most suitable contraceptive method to use during treatment with Carbamazepine Normon. If treatment with Carbamazepine Normon is discontinued, you must continue using an effective contraceptive method for two additional weeks after stopping treatment.

If you are a woman of childbearing age and planning to become pregnant, speak with your doctor before stopping contraception and becoming pregnant, so that your treatment can be changed to a suitable alternative to avoid fetal exposure to carbamazepine.

If you are pregnant or think you may be pregnant, inform your doctor immediately. Do not stop taking the medicine without first discussing it with your doctor. Stopping treatment without medical advice may lead to epileptic seizures, which could be dangerous for both you and the fetus. Your doctor may decide to change your treatment.

If you take Carbamazepine Normon during pregnancy, the baby also has a risk of bleeding problems shortly after birth. Your doctor may give you and your baby a medicine to prevent this.

Therefore, we advise you:

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

In these situations, your doctor may prescribe you additional treatment with folic acid before and during pregnancy, and vitamin K1 during the last weeks of pregnancy (in the latter case, also to the newborn). In addition, your pregnancy will be monitored more closely.

Breastfeeding

Inform your doctor if you are breastfeeding.

The active substance in Carbamazepine Normon passes into breast milk. With your doctor’s approval and if the infant is monitored for side effects, you may breastfeed. However, if adverse effects occur in the infant, such as drowsiness or skin rash, stop breastfeeding and consult your doctor.

Driving and using machines

Carbamazepine may cause drowsiness, dizziness, blurred or double vision, or lack of muscle coordination, especially at the start of treatment or when the dose is increased, and may reduce reaction ability. These effects, as well as the underlying condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

Carbamazepine Normon contains sodium

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

3. How to take Carbamazepine Normon

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Carbamazepine Normon should be taken regularly and exactly as directed by your doctor; this will help you achieve the best results and reduce the risk of serious side effects. Do not take additional doses of Carbamazepine Normon, do not take it more frequently than indicated, and do not take it for longer than prescribed.

Do not stop treatment abruptly without first consulting your doctor, as this could worsen your condition. Your doctor will advise you on what to do (see section “Warnings and precautions”).

Amount of Carbamazepine Normon to take

The doses prescribed by your doctor may differ from those indicated here. Always follow your doctor’s instructions.

In general, the initial dose in adults for the treatment of epilepsy is 100–200 mg once or twice daily; this dose is gradually increased up to 800–1200 mg daily (in some patients, a dose of 1600 mg daily may be required), divided into 2 or 3 divided doses.

Treatment in children usually starts at a dose of 100–200 mg daily (10–20 mg/kg/day), gradually increased up to 400–600 mg. Adolescents may receive between 600 and 1000 mg daily.

For the treatment of trigeminal neuralgia and glossopharyngeal neuralgia, the initial dose is 200–400 mg daily, slowly increased until pain disappears, usually 200 mg 3–4 times daily. The maximum dose is 1200 mg daily. In elderly patients, a lower initial dose is recommended (100 mg twice daily).

For the treatment of mania and prevention of bipolar affective disorders, the usual dose is 400–600 mg daily (the dose range is approximately 400–1600 mg daily). Your doctor will determine the exact dose of Carbamazepine Normon you should take.

How and when to take Carbamazepine Normon

Except possibly on the first day, Carbamazepine Normon tablets should be divided into 2–4 daily doses, depending on your clinical condition. Always take Carbamazepine Normon during or after meals with some liquid.

If necessary, the tablets may be split in half.

If you take more Carbamazepine Normon than you should

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

You may require medical attention. If you experience breathing difficulties, irregular and rapid 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 Carbamazepine Normon

Do not take a double dose to make up for missed doses. If you miss a dose, take it as soon as possible, unless it is almost time for the next dose; in this case, wait and resume your regular dosing schedule. If you miss several doses, consult your doctor.

If you stop taking Carbamazepine Normon

If you have any further questions about the use of this medicine, ask your doctor or pharmacist. Do not change or stop your treatment without first consulting your doctor. Abruptly stopping treatment may trigger epileptic seizures.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

These are more common especially at the beginning of treatment, if the dose is too high, or in certain individuals such as elderly patients, and usually disappear after a few days of treatment or following a dose adjustment.

Contact your doctor immediately or ensure someone else does so on your behalf if any of the following adverse effects occur, as they may be early signs of serious damage to the blood, skin, liver, heart, kidneys, or other organs, and may require urgent medical treatment:

• If you have fever, sore throat, rash, mouth ulcers, swollen glands, or are prone to infections (signs of low white blood cell count).
• If you feel tired, have headaches, become short of breath during exercise, feel dizzy, look pale, have frequent infections with fever, chills, sore throat or mouth ulcers, bleed or bruise more easily than normal, or have nosebleeds (signs of low blood cells).
• If you develop a skin rash with red spots, usually on the face, which may be accompanied by fatigue, nausea, or loss of appetite (signs of systemic lupus erythematosus).
• If you notice yellowing of the whites of the eyes or skin (signs of hepatitis).
• If your urine becomes darker (signs of porphyria or hepatitis).
• If you notice reduced urine output or blood in the urine (signs of kidney problems).
• If you experience severe pain in the upper abdomen, vomiting, or loss of appetite (signs of pancreatitis).
• If you develop 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 serious skin reactions). See section 2.
• If you experience swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives, widespread itching, skin rash, fever, abdominal cramps, discomfort or tightness in the chest, difficulty breathing, or loss of consciousness (signs of angioedema and severe allergic reactions).
• If you experience lethargy, confusion, muscle twitching, or a marked worsening of seizures (signs possibly associated with low sodium levels in the blood).
• If you have 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 have an irregular heartbeat or chest pain.
• If you experience altered consciousness or fainting.
• If you have diarrhoea, abdominal pain, and fever (signs of inflammation of the colon). The frequency of this adverse effect is unknown.
• If you experience a fall due to dizziness, drowsiness, low blood pressure, or confusion.

Other adverse effects

Contact your doctor as soon as possible if any of the following adverse effects occur, as medical attention may be required:

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

Common adverse effects (may affect up to 1 in 10 patients): swelling of ankles, feet, and legs (oedema), changes in behaviour, confusion, weakness, increased frequency of epileptic seizures (episodes, due to insufficient sodium levels 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, swollen 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, eye itching with redness and swelling (conjunctivitis), sensation of pressure/pain in the eyes (sign of increased eye pressure), involuntary eye movements, ringing or other unexplained noises in the ears (tinnitus), decreased hearing, abnormally fast or slow heart rate, numbness or tingling in hands and feet, weakness, increased frequency of urination, sudden decrease in urine output, taste disturbances, unusual milk secretion, breast enlargement in men, redness and swelling along a vein that is very tender to touch and often painful (thrombophlebitis), increased skin sensitivity to sunlight, bone weakening leading to increased risk of fractures (due to vitamin D deficiency, osteoporosis), constipation, diarrhoea, abdominal pain, joint or muscle pain, increased sweating, loss of appetite, hair loss, excessive body and facial hair, sexual disturbances, male infertility, redness and irritation of the tongue, mouth ulcers, changes in skin pigmentation, acne, and serious skin reactions.

Adverse effects with unknown frequency (cannot be estimated from available data): reactivation of herpes virus infection (can be severe if the immune system is suppressed), complete nail loss, bone fractures, decreased bone density, sedation, memory loss, purple or dark red spots that may itch, elevated blood ammonia levels (hyperammonaemia). Symptoms of hyperammonaemia may include irritability, confusion, vomiting, loss of appetite, and drowsiness.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carbamazepine Normon

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carbamazepine Normon

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

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

Appearance of the product and contents of the pack

Carbamazepine Normon 400 mg are white or slightly cream-colored, round, biconvex, scored tablets, marked on one side and unmarked on the other, supplied in PVC/AL blisters containing 30, 100 and 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 2025

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