Package Insert: Information for the Patient

Carbamazepine Normon 200 mg Tablets EFG

Carbamazepine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active ingredient is carbamazepine.

Carbamazepine belongs to a group of medicines 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 Carbamazepine Normon.

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 of these patients. Your doctor must tell you if you need to have these tests before taking Carbamazepine Normon.

Do not take Carbamazepine Normon:

• If you are allergic to carbamazepine or to any of the other components of this medication (including those listed in section 6), as well as to any drug with a similar structure to carbamazepine (some antidepressants).Some antiepileptics.
• If you have a serious heart disease.
• If you suffer or have suffered in the past from a serious blood disease.
• If you have problems with porphyrin formation, an important pigment for liver function and blood formation (also called hepatic porphyria).
• 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 this medication. If you think you may be allergic, consult your doctor.

Warnings and precautions

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

• If you have had in the past or suffer from 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.Difficulty urinating.
• If you have a mental disorder 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 important 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 fertile woman, you should use an effective contraceptive method during your entire treatment and for two weeks after you have taken your last dose. If you take oral contraceptives, carbamazepine may make them less effective. Therefore, you should use non-hormonal contraceptives or additional methods while taking this medication. This will help prevent unwanted pregnancies. Consult your doctor if you experience irregular bleeding or spotting while taking Carbamazepine Normon. If you have any doubts, consult your doctor.
• If you are pregnant or intend to become pregnant, inform your doctor immediately. Your doctor will inform you about the potential risk of taking Carbamazepine Normon during pregnancy since it may cause damage or abnormalities in the fetus. There is a risk of damage to the fetus if carbamazepine is used during pregnancy. Fertile women should use an effective contraceptive method during treatment with Carbamazepine Normon 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 appearance 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 with regular visits and makes blood and urine tests at the beginning of treatment and regularly throughout the treatment to rule out the appearance of blood and liver or kidney function alterations, and also in some cases to control the carbamazepine dose that is most suitable.

• Severe skin reactions that can be life-threatening to the patient (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of this medication, initially appearing as red circular spots, often with a central blister. Other additional signs that may appear are mouth ulcers, throat, nose, genitals and conjunctivitis (swollen and red eyes). These skin reactions that can be life-threatening to the patient, often accompany flu-like symptoms. The skin rash may progress to the formation of generalized blisters 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 rash, redness, blisters on lips, eyes or mouth or peeling accompanied by fever, stop taking carbamazepine and inform your doctor immediately. These reactions may be more frequent in patients from Asian countries (e.g. Taiwan, Malaysia and Philippines). Rarely, severe skin reactions may occur while taking Carbamazepine Normon. People of Chinese and Thai origin may have their risk estimated by means of a blood test. If you are of this origin, discuss it with your doctor before taking Carbamazepine Normon. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of this medication, you should not use carbamazepine 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 signs 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 self-harm or suicide. A reduced number of patients treated with antiepileptics have 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 treatment with Carbamazepine Normon, as it may cause you to fall.

Do not stop taking this medication without consulting your doctor. 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 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 measures to be taken will be given (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 measures to be taken will be given (see also section 3 “How to take Carbamazepine Normon” and section 4 “Possible side effects”).

Carbamazepine Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. Carbamazepine Normon may present multiple interactions with a large number of medications that may both increase and 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 medications for epilepsy (such as brivaracetam).

Avoid using medications that contain alcohol during treatment with Carbamazepine Normon.

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

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

Carbamazepine Normon with food and drinks

You can take this medication with or without food.

Avoid consuming grapefruit juice or eating grapefruit, as it may increase the effect of carbamazepine. Other juices, such as orange or apple, do not have this effect.

Pregnancy, breastfeeding and fertility

Pregnancy and fertile women

If you are pregnant or breastfeeding, or if you think you may be 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, malformations in the skull and face, cardiovascular and urinary system malformations, as well as the possible withdrawal syndrome that may occur in the newborn.

Carbamazepine Normon may cause significant congenital malformations. If you take Carbamazepine Normon during pregnancy, your baby will have a risk up to 3 times greater of having a congenital malformation compared to women who do not take an antiepileptic medication. Significant congenital malformations have been reported, such as neural tube defects (opening in the spine), facial malformations, such as cleft lip or palate, skull malformations, heart defects, penile malformations related to the opening of the urinary tract (hypospadias) and finger malformations. If you have taken Carbamazepine Normon during pregnancy, the fetus should be closely monitored.

Neurological developmental 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. It cannot be ruled out that there may be an effect on neurological development.

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

If you are a fertile woman and are planning to become pregnant, discuss it with your doctor before stopping using contraceptives and becoming pregnant to change to other suitable treatments in order 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 talking to your doctor. If you stop 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 Carbamazepine Normon during pregnancy, the baby also has a risk of experiencing bleeding problems just after birth. Your doctor may administer a medication to you and the baby to prevent this.

Therefore, we advise you:

1. If you want to become pregnant, plan your pregnancies by consulting with your specialists.
2. If 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 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 K1 in the last weeks of pregnancy (in this last case also to the newborn). Additionally, pregnancy will be closely monitored.

Lactation

Inform your doctor if you are breastfeeding.

The active substance contained in Carbamazepine Normon passes into breast milk. While your doctor agrees and the baby is being monitored for the appearance of 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 machines

Carbamazepine may cause drowsiness, dizziness, blurred vision, double vision or lack of muscle coordination, especially when starting treatment or increasing the dose and decreasing blood pressure, confusion, sedation and ataxia, which may cause you to fall. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or practice other activities that require special attention, until your doctor evaluates your response to this medication.

Carbamazepine Normon 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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.Do not exceed the recommended dose.

Carbamazepine Normon 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 Carbamazepine Normon, do not take it more frequently than indicated, and do not take it for longer than prescribed.

Do not abruptly stop treatment before consulting your doctor,as this could worsen your condition. Your doctor will indicate what you should do (see section “Warnings and precautions”).

Amount of Carbamazepine Normon 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.

The 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 neuralgia and glossopharyngeal 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 Carbamazepine Normon you should take.

How and when to take Carbamazepine Normon

Except for the first day, Carbamazepine Normon tablets should be divided into 2-4 daily doses, depending on your clinical condition. Take Carbamazepine Normon always during or after meals with a little liquid. If necessary, the tablets can 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 Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

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 carbamazepine. Inform your doctor immediately.

If you forget to take Carbamazepine Normon

Do not take a double dose to compensate for the missed doses. If you forget a dose, take it as soon as possible, 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 Carbamazepine 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 abruptly stopped, 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 elderly patients, 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 you experience any of the following side effects, 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 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 headaches, shortness of breath, dizziness, 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 experience a skin rash with red spots usually on the face that may be accompanied by fatigue, nausea, loss of appetite (sign of systemic lupus erythematosus).
• If you experience yellowing of the white of the eyes or skin (sign of hepatitis).
• If you experience darkening of urine (signs of porphyria or hepatitis).
• If you experience decreased urine output or blood in the urine (signs of kidney damage).
• If you experience severe pain in the upper abdomen, vomiting, loss of appetite (signs of pancreatitis).
• If you experience 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, shortness of breath, 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 twitches, 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 stiffness, 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 colonic inflammation). 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 you experience any of the following side effects, as they may require medical attention:

Very common side effects (may affect more than 1 in 10 patients):muscle coordination loss, skin inflammation with 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.

Uncommon 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, buzzing 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 burgundy-colored papules that may cause itching, elevated ammonia levels in the blood (hyperammonemia). Hyperammonemia symptoms 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 prospectus. You can also report them directly through the Spanish System for the 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.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carbamazepina Normon

The active ingredient is carbamazepine. Each tablet contains 200 mg of carbamazepine.

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

Appearance of the product and contents of the packaging

Carbamazepina Normon 200 mg are white or slightly cream-colored, round, biconvex, scored, marked on one face and blank on the other tablets presented in PVC/AL blister packs of 50, 100, and 500 (clinical packaging) tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:April 2025

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/