Karbamazepina Tillomed

Patient Information Leaflet: Patient Information

Karbamazepina Tillomed, 200 mg, prolonged-release tablets

Karbamazepina Tillomed, 400 mg, prolonged-release tablets

Carbamazepine

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, please 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the pack

• 1. What Karbamazepina Tillomed is and what it is used for
• 2. Important information before taking Karbamazepina Tillomed
• 3. How to take Karbamazepina Tillomed
• 4. Possible side effects
• 5. How to store Karbamazepina Tillomed
• 6. Contents of the pack and other information

1. What Karbamazepina Tillomed is and what it is used for

Karbamazepina Tillomed contains the active substance carbamazepine. The medicine is specially designed to release the active substance slowly. Carbamazepine is an antiepileptic (anti-seizure) medicine that can also affect the body in other ways, changing certain types of pain and controlling mood disorders. Karbamazepina Tillomed is used

• To treat certain types of epilepsy
• To treat a painful facial condition called trigeminal neuralgia
• To control severe mood disorders when other medicines do not work.

2. Important information before taking Karbamazepina Tillomed

When not to take Karbamazepina Tillomed

• If you are allergic to carbamazepine, medicines with a similar structure (e.g., tricyclic antidepressants), or any of the other ingredients of this medicine (listed in section 6);
• If you have ever had bone marrow depression or a blood disorder;
• If you have heart conduction problems (atrioventricular block);
• If you have certain inherited metabolic disorders (acute intermittent porphyria, mixed porphyria, or porphyria cutanea tarda);
• If you have taken monoamine oxidase inhibitors (MAOIs) for depression in the last 14 days.

Warnings and precautions

• If you have a history of seizures with loss of consciousness, you should not take carbamazepine, as it may cause this type of seizure or worsen existing ones.
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with carbamazepine, which can be life-threatening. They usually start on the trunk as red, target-like, or circular patches (often with blisters in the center). The rash can cause widespread blisters or peeling of the skin. Additional symptoms to watch for include open, painful sores (ulcers) in the mouth, throat, nose, and genitals, as well as redness and swelling of the eyes (conjunctivitis). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms (headache, fever, and body aches).

The greatest risk of these severe skin reactions occurs within the first few weeks of treatment. If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis while taking carbamazepine, you must not take it again. If you experience a skin rash or any of the other symptoms mentioned above, seek medical help immediately. You should inform your doctor that you are taking carbamazepine. These severe skin reactions may occur more frequently in people from certain Asian countries. If you are of Han Chinese or Thai origin, your doctor may perform a blood test to determine if you are at increased risk of these severe skin reactions. Your doctor will inform you whether a blood test is necessary before starting carbamazepine.

Before taking Karbamazepina Tillomed, consult your doctor or pharmacist

If you have any of the following conditions:

• Blood disorders (hematologic disorders);
• Symptoms of unusual hypersensitivity (skin rash or other allergic symptoms) to oxcarbazepine or any other medicine. About 25% of patients allergic to carbamazepine may also be allergic to oxcarbazepine;
• Sodium metabolism disorder;
• Heart, liver, or kidney problems, even if they occurred in the past (see "What are the possible side effects?" and "How to take Karbamazepina Tillomed");
• Increased eye pressure (glaucoma) or difficulty or pain when urinating; in such cases, you should be closely monitored;
• Muscular dystrophy (a degenerative muscle disease; heart conduction problems are common in these patients).

If you have previously stopped taking carbamazepine. If your doctor has diagnosed you with a mental illness called psychosis, which may be accompanied by disorientation and excessive excitement. If you are taking carbamazepine during pregnancy, there is a risk of harm to the unborn child. During treatment with carbamazepine and for 2 weeks after the last dose, women of childbearing age should use effective contraception (see "Pregnancy and breastfeeding"). If you are taking a hormonal contraceptive (the "pill"), you should be aware that carbamazepine may make it less effective. You should use another or additional, non-hormonal method of contraception. This will reduce the risk of an unwanted pregnancy. You should inform your doctor immediately if you experience irregular bleeding or spotting. You should inform your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the possible risks associated with taking carbamazepine during pregnancy, as it may cause harm or birth defects in the unborn child (see "Pregnancy"). A small number of people taking antiepileptic medicines, such as Karbamazepina Tillomed, have had thoughts of self-harm or suicide. If you ever have these thoughts, you should contact your doctor immediately. If any of the above situations apply to you, you must discuss them with your doctor. In such cases, you can only take carbamazepine if you take the necessary precautions. Due to the possibility of increased skin sensitivity to light (phototoxicity), you should protect yourself from strong sunlight while taking carbamazepine.

If any of the following situations apply to you, you should inform your doctor immediately:

• If you experience symptoms such as fever, sore throat, skin allergic reactions, such as rash with lymph node enlargement and/or flu-like symptoms, oral ulcers, bruising, or bleeding under the skin, you should consult your doctor immediately.
• In case of symptoms of an allergic reaction, which may include fever, skin rash, vasculitis, lymph node enlargement, or joint pain, you should contact your doctor or go to the emergency room of the nearest hospital (see "Other possible side effects").
• If you notice that your seizures are occurring more frequently.
• If you experience symptoms of liver inflammation, such as fatigue, loss of appetite, nausea, yellowing of the skin and/or eyes, or liver enlargement.
• If you have kidney problems related to 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 or furosemide).
• If you experience symptoms such as dizziness, feeling faint, low blood pressure, or confusion caused by taking carbamazepine, which can lead to falls.

Karbamazepina Tillomed and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those obtained without a prescription, including herbal medicines. Treatment with MAOIs (medicines used to treat depression) should be stopped at least 2 weeks before starting carbamazepine. You should remember that the following information may also apply to medicines you have taken recently. The effect of carbamazepine on the levels of other medicines in the blood Carbamazepine may increase the activity of certain liver enzymes, thereby reducing the levels of other medicines in the blood. The effect of some other medicines taken at the same time, which are broken down in the same way as carbamazepine, may be reduced or even reversed. If carbamazepine is given at the same time, it may be necessary to adjust the dose of the following active substances with different areas of application, depending on clinical needs

• Pain and anti-inflammatory medicines: buprenorphine, fentanyl, methadone, paracetamol (long-term use of carbamazepine and paracetamol may cause hepatotoxicity), phenazone, tramadol
• Antiparasitic medicines: praziquantel, albendazole
• Anticoagulant medicines: warfarin, phenprocoumon, dicumarol, acenocoumarol, rivaroxaban, dabigatran, apixaban, edoxaban
• Medicines used to treat depression: bupropion, citalopram, mianserin, nefazodone, sertraline, trazodone (but it seems to enhance the antidepressant effect)
• Other medicines used to treat depression (tricyclic antidepressants): imipramine, amitriptyline, nortriptyline, clomipramine
• Medicines used to prevent nausea and vomiting: aprepitant
• Antiepileptic medicines, other medicines used to treat seizures: clonazepam, ethosuximide, felbamate, eslicarbazepine, oxcarbazepine, primidone, lamotrigine, tiagabine, topiramate, valproic acid, zonisamide, phenytoin (phenytoin levels in the blood may be increased or decreased)
• Medicines used to treat systemic fungal infections: caspofungin, azole antifungals, such as itraconazole, voriconazole. In patients treated with voriconazole or itraconazole, alternative antiepileptic medicines are recommended.
• Medicines used to treat viral infections/HIV: indinavir, ritonavir, saquinavir
• Anxiolytic medicines: alprazolam, midazolam, clobazam
• Medicines used to treat respiratory diseases: theophylline
• Medicines used to treat heart diseases: digoxin, simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine
• Immunosuppressive medicines: cyclosporine, tacrolimus, sirolimus, everolimus
• Calcium channel blockers (medicines used to treat dizziness, migraine, high blood pressure): felodipine, flunarizine
• Contraceptives: hormonal contraceptives
• Corticosteroids: prednisolone, dexamethasone
• Medicines used to treat mental disorders: haloperidol, bromperidol, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, zotepine (accelerated metabolism), aripiprazole, paliperidone
• Thyroid hormones: levothyroxine
• Antibiotics: rifabutin, tetracyclines, such as doxycycline
• Medicines used to treat cancer: imatinib, cyclophosphamide, lapatinib, temsirolimus
• Others: quinidine (used to treat heart rhythm disorders), estrogens (hormones), methylphenidate (psychostimulant and used to treat attention deficit hyperactivity disorder), progestogen derivatives (hormones), propranolol (beta-blocker, antihypertensive medicine)
• Medicines used to treat erectile dysfunction: tadalafil

Hormonal contraceptives, such as the pill, patches, injections, or implants.Carbamazepine may affect the effectiveness of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. While taking carbamazepine, you should discuss the most suitable type of contraception with your doctor. Carbamazepine may decrease the levels of bupropion in the blood (a medicine that helps quit smoking) and increase the levels of its metabolite, hydroxybupropion, thereby reducing the clinical effectiveness and safety of bupropion. Decreased carbamazepine levels in the blood may be caused by:

• Antiepileptic medicines, other medicines used to treat seizures: felbamate, methsuximide, oxcarbazepine, phenobarbital, phensuximide, phenytoin, fosphenytoin, primidone, and probably (here the data are partially contradictory) clonazepam, valproic acid, valpromide
• Antituberculosis medicine: rifampicin
• Medicines used to treat respiratory diseases, anti-asthmatic medicines: theophylline, aminophylline
• Medicines used to treat skin diseases: isotretinoin
• Medicines used to treat cancer: cisplatin, doxorubicin
• Others: St. John's Wort (Hypericum perforatum, a herbal product used to treat depressive mood)

On the other hand, valproic acid and primidone may increase the levels of the pharmacologically active metabolite of carbamazepine (10,11-epoxide of carbamazepine) in the blood. Concurrent administration of felbamate may decrease carbamazepine levels in the blood and increase 10,11-epoxide of carbamazepine levels, while decreasing felbamate levels. Due to interactions, especially when taking several antiepileptic medicines at the same time, it is recommended to monitor carbamazepine levels in the blood and adjust the dose if necessary. Increased carbamazepine levels in the blood may be caused by:

• Pain and anti-inflammatory medicines: dextropropoxyphene/propoxyphene, ibuprofen
• Gonadotropin-inhibiting medicines: danazol
• Antibiotics, medicines used to treat bacterial infections: macrolide antibiotics (e.g., erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin)
• Medicines used to treat depression: fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine, probably also desipramine
• Antiepileptic medicines, other medicines used to treat seizures: stiripentol, vigabatrin
• Medicines used to treat systemic fungal infections, azole antifungals, such as itraconazole, ketoconazole, fluconazole, voriconazole. In patients treated with voriconazole or itraconazole, alternative antiepileptic medicines are recommended.
• Medicines used to treat allergic reactions: loratadine, terfenadine
• Medicines used to treat tuberculosis: isoniazid
• Medicines used to treat viral infections/HIV, such as ritonavir
• Medicines used to treat glaucoma: acetazolamide
• Calcium channel blockers (medicines used to treat cardiovascular diseases): diltiazem, verapamil
• Medicines used to relax muscles (muscle relaxants): oxybutynin, dantrolene
• Medicines used to treat mental disorders: loxapine, olanzapine, quetiapine
• Anticoagulant medicines: ticlopidine
• Medicines used to treat stomach and intestinal ulcers: omeprazole, probably cimetidine
• Others: grapefruit juice, nicotinamide (a vitamin, in high doses)

Increased carbamazepine levels in the blood may lead to the occurrence of side effects listed in section 4 "Possible side effects" (e.g., dizziness, fatigue, unsteady gait, double vision). If you experience such symptoms, you should talk to your doctor; then, your doctor will check carbamazepine levels in the blood and adjust the dose if necessary. Other interactions Concurrent use of carbamazepine and loxapine, quetiapine (medicines used to treat mental disorders), primidone, progabide, valproic acid, valnoctamide, valpromide, and brivaracetam (antiepileptic medicines, other medicines used to treat seizures) may lead to increased levels of the active metabolite 10,11-epoxide of carbamazepine in the blood, resulting in the same side effects as an overdose of carbamazepine. Concurrent use of carbamazepine and levetiracetam may increase the toxicity of carbamazepine. Carbamazepine may increase liver damage caused by isoniazid (a medicine used to treat tuberculosis). Concurrent use of carbamazepine and lithium (a medicine used to treat mental disorders), metoclopramide (a medicine used to treat gastrointestinal disorders), or neuroleptics (haloperidol, thiordazine: medicines used to treat mental disorders) may lead to neurological side effects. On the other hand, in patients treated with antipsychotic medicines, carbamazepine may decrease the levels of these medicines in the blood, resulting in worsening of the clinical picture. In this case, your doctor may also consider increasing the dose of the neuroleptic medicine. You should note that concurrent use of lithium (a medicine used to treat certain mental and emotional disorders) and carbamazepine may increase the harmful effects of both active substances on the nervous system. Therefore, it is necessary to closely monitor the levels of both medicines in the blood. Previous treatment with neuroleptics should have taken place at least 8 weeks earlier, not at the same time. You should be careful with the following symptoms: unsteady gait (ataxia), eye twitching or shaking (nystagmus), increased muscle reflexes, muscle shaking (tremor). Concurrent administration of carbamazepine and certain diuretics (hydrochlorothiazide, furosemide) may lead to decreased sodium levels in the blood. Carbamazepine may decrease the effectiveness of certain muscle relaxants used during anesthesia (non-depolarizing muscle relaxants, such as pancuronium). This may lead to faster reversal of neuromuscular blockade. Patients treated with muscle relaxants should be monitored for this and their dose increased if necessary. Concurrent administration of carbamazepine and direct-acting oral anticoagulants (rivaroxaban, dabigatran, apixaban, and edoxaban) may lead to decreased levels of direct-acting oral anticoagulants in the blood. Further information can be found in the following table:

There are reports in the literature that previous treatment with neuroleptics, followed by additional carbamazepine, increases the risk of developing a potentially life-threatening condition called neuroleptic malignant syndrome or Stevens-Johnson syndrome. When isoniazid (a medicine used to treat tuberculosis) and carbamazepine are used concurrently, you should monitor carbamazepine levels in the blood. Concurrent use of carbamazepine and paracetamol (a pain and fever medicine) may decrease the bioavailability and effectiveness of paracetamol. It appears that carbamazepine increases the excretion (elimination) of thyroid hormones and increases the need for these hormones in patients with hypothyroidism. Therefore, in patients receiving replacement therapy, thyroid function parameters should be measured at the beginning and end of carbamazepine treatment. If necessary, the dose of thyroid hormones should be adjusted. Concurrent use of antidepressant medicines from the class of selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine) may lead to a toxic serotonin syndrome. It is not recommended to use carbamazepine in combination with nefazodone (an antidepressant medicine), as carbamazepine may significantly decrease nefazodone levels in the blood, leading to loss of its effectiveness. Additionally, when nefazodone and carbamazepine are used concurrently, carbamazepine levels in the blood increase, and the levels of its active metabolite, 10,11-epoxide of carbamazepine, decrease. Concurrent use of carbamazepine and other medicines that may cause heart conduction problems (arrhythmias), such as antiarrhythmic medicines (medicines used to treat heart rhythm disorders), tricyclic antidepressants, or erythromycin (an antibiotic), increases the risk of heart conduction problems.

Taking Karbamazepina Tillomed with food, drink, and alcohol

• Drinking alcohol may have a stronger effect on you than usual. You should discuss with your doctor whether you should stop drinking alcohol.
• Eating grapefruits or drinking grapefruit juice may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Pregnancy Karbamazepina Tillomed may cause serious birth defects. The risk of birth defects in the child is up to 3 times higher in women taking carbamazepine than in women not taking antiepileptic medicines. The main reported birth defects are neural tube defects (a hole in the spine), facial defects, such as cleft lip and palate, head defects, heart defects, genital defects, including hypospadias, and finger defects. If you take Karbamazepina Tillomed during pregnancy, your unborn child should be closely monitored. Children born to mothers taking Karbamazepina Tillomed during pregnancy have reported developmental problems (brain development). Some studies have shown that carbamazepine has a negative effect on the development of children exposed to carbamazepine in the womb, while other studies have not shown this effect. The effect of the medicine on brain development cannot be ruled out. Women of childbearing age who do not plan to become pregnant should use effective contraception while taking carbamazepine. Karbamazepina Tillomed may affect the effectiveness of hormonal contraceptives, such as the pill, and reduce their effectiveness in preventing pregnancy. Irregular bleeding or spotting may occur. While taking Karbamazepina Tillomed, you should discuss the most suitable type of contraception with your doctor. If you plan to become pregnant, you should discuss changing your treatment with your doctor before stopping contraception and becoming pregnant. If you are pregnant or think you may be pregnant, you should inform your doctor immediately. You should not stop taking the medicine before discussing it with your doctor. Stopping the medicine without consulting your doctor may lead to a seizure, which can be dangerous for you and your unborn child. Your doctor may decide to change your treatment. If you take Karbamazepina Tillomed during pregnancy, your child is also at risk of bleeding problems shortly after birth. Your doctor may give you and your child a medicine to prevent this. Breastfeeding Carbamazepine passes into breast milk. The benefits of breastfeeding should be weighed against the small risk of side effects in the breastfed child. Children breastfed by mothers taking carbamazepine should be closely monitored for side effects, such as poor weight gain, excessive sleepiness, or skin allergic reactions. Fertility There have been single reports of sexual disorders, such as impotence or decreased libido. Very rarely, decreased fertility has been reported in men and/or abnormal sperm production.

Driving and using machines

Karbamazepina Tillomed may cause dizziness or sleepiness, blurred vision, double vision, or lack of muscle coordination, especially at the beginning of treatment or when changing the dose. If you experience any of these side effects or vision problems, you should not drive or operate machinery.

Karbamazepina Tillomed contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Karbamazepina Tillomed

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist. The dose will be determined and checked individually by your doctor (specialist), aiming to eliminate seizures using the lowest possible dose, especially during pregnancy. You should not make any changes to your treatment or dosage without consulting your doctor first, as this may jeopardize the success of your treatment. It is recommended to gradually (slowly) increase the dose to the optimal, effective dose. The daily dose is usually given in 1 or 2 single doses. The general daily dose range of carbamazepine is from 400 to 1200 mg. In principle, the total daily dose of carbamazepine should not exceed 1600 mg, as higher doses are associated with more side effects. The therapeutic dose should be determined, especially in combination therapy, based on carbamazepine levels in the blood and depending on the effectiveness of the treatment. Experience has shown that the therapeutic level of carbamazepine is between 4 and 12 micrograms/ml. In individual cases, the required dose may significantly differ from the initial and maintenance dose (e.g., due to accelerated degradation due to enzyme induction or due to drug interactions when taking other medicines). In the treatment of epilepsy, carbamazepine is best used alone (monotherapy). Treatment should be supervised by a specialist doctor with experience in treating epilepsy. When switching to carbamazepine, the dose of the other antiepileptic medicine should be gradually reduced. The recommended dosage scheme is as follows:

* Note: For children under 6 years old, other dosage forms with immediate release (suspension or tablets) are available for initial and maintenance dosing. The recommendation for prolonged-release tablets is not possible due to insufficient knowledge. Maximum recommended dose: From 6 to 15 years old: 1000 mg/day Over 15 years old: 1200 mg/day Seizures (epilepsy):In adults, the initial dose is usually 1 or 2 prolonged-release tablets of carbamazepine (corresponding to 200-400 mg of carbamazepine per day), which is gradually increased to a maintenance dose of 4-6 prolonged-release tablets of carbamazepine (corresponding to 800-1200 mg of carbamazepine per day). In children, the maintenance dose is usually between 10 and 20 mg of carbamazepine per kilogram of body weight per day. The recommended dosage scheme is as above. Facial pain (trigeminal neuralgia):The usual dose is 600-800 mg per day. The maximum dose is 1200 mg per day. Elderly patients may need a lower dose. Manic-depressive phase prophylaxis:The initial dose, which is usually also the maintenance dose, is 1 or 2 tablets of 200 mg of carbamazepine per day (corresponding to 200-400 mg of carbamazepine). If necessary, the dose can be increased to 2 tablets of 200 mg of carbamazepine per day (corresponding to 800 mg of carbamazepine) twice a day. Note: In patients with severe cardiovascular, liver, or kidney diseases, as well as in elderly patients, it is recommended to use a lower dose.

Method of administration

Prolonged-release tablets should be swallowed whole, without chewing or crushing. Prolonged-release tablets should be taken during or after a meal, with a sufficient amount of liquid (e.g., 1 glass of water, 200 ml). In some cases, it has been found that dividing the daily dose into 4 to 5 single doses is particularly effective. In these cases, carbamazepine products with immediate release are more suitable than prolonged-release products.

Duration of treatment

The duration of treatment depends on the specific indication and individual patient response and is determined by your doctor. In principle, antiepileptic therapy is long-term. The decision to start and stop treatment with carbamazepine and the duration of treatment should be made by a specialist doctor with experience in treating epilepsy. Reduction of the dose and withdrawal of the medicine should usually be considered only after at least 2 or 3 years without seizures. Withdrawal of the medicine should be done by gradually reducing the dosage over 1 or 2 years; in children, instead of adjusting the dose to age, it can be maintained at the same level, reducing the dose per kilogram of body weight as the child gains weight, and EEG results should not deteriorate. In the treatment of trigeminal neuralgia, it has been found that treatment with a maintenance dose that is sufficient to relieve pain is effective for several weeks. The dose should be reduced carefully to determine whether spontaneous remission has occurred during treatment. If pain attacks recur, the original maintenance dose should be continued. Manic-depressive phase prophylaxis is long-term treatment. If you feel that the effect of carbamazepine is too strong or too weak, you should consult your doctor or pharmacist.

Missing a dose of Karbamazepina Tillomed

You should not take a double dose to make up for a missed dose. You should continue taking the medicine as prescribed.

Taking more Karbamazepina Tillomed than prescribed

If you have taken too many tablets, you should contact your doctor or the emergency department of the nearest hospital immediately. In case of carbamazepine overdose, the side effects listed in section 4 "Possible side effects" may be intensified. Central nervous system Depression of the nervous system, impaired consciousness (sleepiness, lethargy), stiffness (stupor), coma, dizziness, disorientation, restlessness, agitation, confusion, feeling of heat (heat stroke), hallucinations, blurred vision, inarticulate or unclear speech, eye twitching (nystagmus), unsteady gait (ataxia), movement disorders or abnormal movement sequences (dyskinesias), reflex disorders (initially increased, then decreased reflexes), convulsions (tonic-clonic seizures), psychomotor disorders, muscle twitching (myoclonus), opisthotonus, involuntary movements, tremors, low body temperature (hypothermia), dilated pupils, EEG abnormalities. Respiratory system Breathing disorders (respiratory depression), fluid in the lungs (pulmonary edema), blue discoloration of the face (cyanosis), respiratory arrest. Cardiovascular system Rapid heart rate (tachycardia), usually decreased (hypotonic) blood pressure, possibly also high blood pressure, disorders of heart conduction (changes in the ECG, arrhythmias, atrioventricular block), loss of consciousness, cardiac arrest, intense flushing with a feeling of heat (heat stroke). Gastrointestinal tract Nausea, vomiting, delayed gastric emptying, decreased intestinal motility. Urinary tract and genitals Urinary retention, decreased or absent urine production, fluid retention in the body. Laboratory test results Low sodium levels in the blood (hyponatremia), possible acidosis, possible increased blood sugar levels (hyperglycemia), increased creatine phosphokinase activity in muscles, increased or decreased white blood cell count (leukocytosis, leukopenia, neutropenia), glucose in the urine (glycosuria), increased levels of a certain metabolite in the urine (acetonuria). If you have made a mistake while taking your medicine, you should immediately inform your doctor. In case of overdose, you should seek emergency medical attention (go to the hospital). There is no specific antidote for acute carbamazepine poisoning. Treatment of carbamazepine overdose depends on the symptoms and usually requires hospitalization.

Stopping Karbamazepina Tillomed

You should never stop taking carbamazepine or finish your treatment prematurely without consulting your doctor first. This may jeopardize the success of your treatment and lead to the recurrence of seizures. If you experience intolerance or changes in your clinical condition, you should discuss them with your doctor. If you have any further questions about your medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is based on the following categories: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people Not known: frequency cannot be estimated from the available data

5. How to store the medicinal product Karbamazepina Tillomed

The medicinal product should be stored out of sight and reach of children.

Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

No special precautions for storage of the medicinal product are necessary.

Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Karbamazepina Tillomed contains

Each prolonged-release tablet contains 200 mg of carbamazepine.

Each prolonged-release tablet contains 400 mg of carbamazepine.

Other ingredients are:ammonio methacrylate copolymer type B, triethyl citrate, talc, microcrystalline cellulose, lactose monohydrate, corn starch, sodium carboxymethylcellulose type A, magnesium stearate.

What Karbamazepina Tillomed looks like and contents of the pack

Karbamazepina Tillomed 200 mg, prolonged-release tablets: White or almost white, round, biconvex tablets, with the inscription "297" on one side and "HP" on the other side.

Karbamazepina Tillomed 400 mg, prolonged-release tablets: White or almost white, round, biconvex tablets, with the inscription "298" on one side and "HP" on the other side.

Tablets are available in blisters containing 30, 50, 56, 100, and 200 tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tillomed Pharma GmbH

Mittelstrasse 5/5a

12529 Schönefeld

Germany

Importer

MIAS Pharma Limited

Suite 2, Stafford House

Strand Road

Portmarnock, Co. Dublin

Ireland

Tillomed Malta Ltd.

Malta Life Sciences Park

LS2.01.06 Industrial Estate

San Gwann, SGN 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Croatia

Karbamazepin Tillomed 200 mg and 400 mg prolonged-release tablets

Netherlands

Carbamazepine Tillomed 200 mg and 400 mg prolonged-release tablets

Germany

Carbamazepin Tillomed 200 mg and 400 mg retard tablets

Poland

Karbamazepina Tillomed

Sweden

Carbamazepine Tillomed

Italy

Carbamazepina Zentiva

Date of last revision of the leaflet: