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, 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.

Table of Contents of the Leaflet

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

Karbamazepina Tillomed contains the active substance carbamazepine.
Karbamazepina Tillomed is designed to release the active substance slowly.
Carbamazepine, the active substance of this medicine, can affect the body in several ways. It is an antiepileptic (preventing the occurrence of seizures), it can also change certain types of pain and control mood disorders.
Karbamazepina Tillomed is used

• In the treatment of certain forms of epilepsy
• In the treatment of a painful facial condition called trigeminal neuralgia
• To control severe mood disorders when other medications do not work.

2. Important information before taking Karbamazepina Tillomed

When not to take Karbamazepina Tillomed

• If you are allergic to carbamazepine, drugs with a similar structure (e.g., tricyclic antidepressants, certain antidepressants) or any of the other ingredients of this medicine (listed in section 6);
• If you have had bone marrow damage or blood cell production disorders in the past;
• If you have heart conduction disorders (atrioventricular block);
• If you have certain inherited metabolic disorders (acute intermittent porphyria, mixed porphyria, late cutaneous porphyria);
• If you have taken monoamine oxidase inhibitor (MAOI) drugs, used to treat depression, within the last 14 days.

Warnings and precautions

• If you experience unconsciousness (clouding of consciousness), you should not take carbamazepine, as this medicine can cause such seizures or worsen existing ones.
• During carbamazepine treatment, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, which can be life-threatening. They appear on the torso, initially as reddish, target-like or round spots (often with blisters in the center). The rash can cause extensive blisters or peeling of the skin. Additional symptoms to watch out for are open, painful spots (ulcers) in the mouth, throat, nose, and genital organs, 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 in connection with carbamazepine treatment, you should not take it again.
If you develop a skin rash or any of the other skin symptoms mentioned above, you should seek medical attention 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 Chinese Han or Thai descent, 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 if a blood test is necessary before starting carbamazepine treatment.

Before taking Karbamazepina Tillomed, consult your doctor or pharmacist

If you have any of the following conditions:

• Blood disorders (hematological 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, and kidney disorders, 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, the patient's condition should be closely monitored;
• Myotonic dystrophy (a degenerative muscle disease, heart conduction disorders are common in these patients).

If carbamazepine treatment was previously discontinued.
If your doctor has diagnosed a mental illness called psychosis, which may be accompanied by disorientation and excessive agitation.
If carbamazepine is taken during pregnancy, there is a risk of harm to the unborn child. During carbamazepine treatment and for two weeks after taking 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 can reduce the risk of unwanted pregnancy.
You should immediately inform your doctor if you experience irregular bleeding or spotting from the vagina.
You should inform your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss with you 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 treated with antiepileptic drugs, such as Karbamazepina Tillomed, have had thoughts of self-harm or suicide. If you ever have such thoughts, you should contact your doctor immediately.
If any of the above situations apply to you, you must discuss this with your doctor. In such cases, you can only take carbamazepine if you take appropriate precautions.
Due to the possibility of increased skin sensitivity to light (phototoxicity), you should protect yourself from strong sunlight during carbamazepine treatment.

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

• If you experience symptoms such as fever, sore throat, allergic skin reactions, such as rash with lymph node enlargement and/or flu-like symptoms, oral ulcers, bruising, petechiae or purpura, you should consult your doctor immediately.
• In case of symptoms of an allergic reaction, which may be accompanied by symptoms such as fever, skin rash, vasculitis, lymph node swelling, or joint pain, you should immediately 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 hepatitis, such as fatigue, loss of appetite, nausea, yellowing of the skin and/or eyes, liver enlargement.
• If you have kidney problems related to low sodium levels in the blood or if you have kidney problems and are also taking sodium-lowering diuretics (e.g., hydrochlorothiazide, furosemide).
• If you experience symptoms such as dizziness, feeling of emptiness in the head, low blood pressure, 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 currently taking or have recently taken, as well as any medicines you plan to take, including those obtained without a prescription, including herbal medicines.
Treatment with MAO inhibitors (drugs used to treat depression) should be discontinued at least 2 weeks before starting carbamazepine treatment.
Please note that the following information may also apply to recently taken medicines.
Effect of carbamazepine on the concentration of other medicines in the blood
Carbamazepine may increase the activity of certain liver enzymes and thus decrease the concentration of other medicines in the blood.
The effect of some other medicines taken at the same time, which are metabolized in the same way as carbamazepine, may therefore be weakened or even reversed.
If carbamazepine is administered 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
and the specific situation:

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

Hormonal contraceptives, e.g., the pill, patches, injections, or implants.
Carbamazepine may affect the effectiveness of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. During carbamazepine treatment, you should discuss with your doctor the most suitable type of contraception.
Carbamazepine may decrease the blood level of bupropion (a drug that helps quit smoking) and increase the blood level of its metabolite hydroxybupropion, thereby reducing the clinical effectiveness and safety of bupropion.
Decreased carbamazepine blood levels caused by other medicines
The following active substances may decrease carbamazepine blood levels:

• Antiepileptic drugs, other drugs used to treat seizures: felbamate, methsuximide, oxcarbazepine, phenobarbital, phensuximide, phenytoin, fosphenytoin, primidone, progabide, and probably (here the data are partially contradictory) clonazepam, valproic acid, valpromide
• Antitubercular drug: rifampicin
• Drugs used to treat respiratory diseases, anti-asthmatic drugs: theophylline, aminophylline
• Drugs used to treat skin diseases: isotretinoin
• Drugs 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 blood level of the pharmacologically active carbamazepine metabolite (10,11-epoxide carbamazepine).
Concomitant administration of felbamate may decrease carbamazepine blood levels and increase 10,11-epoxide carbamazepine blood levels, while decreasing felbamate blood levels.
Due to interactions, especially when several antiepileptic drugs are administered concomitantly, it is recommended to monitor carbamazepine blood levels and adjust the carbamazepine dose if necessary.
Increased carbamazepine blood levels caused by other medicines
The following active substances may increase carbamazepine blood levels:

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

Increased carbamazepine blood levels 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 discuss them with your doctor; then your doctor will check your carbamazepine blood levels and adjust the dose if necessary.
Other interactions
Concomitant use of carbamazepine and loxapine, quetiapine (drugs used to treat mental disorders), primidone, progabide, valproic acid, valnoctamide, valpromide, and brivaracetam (antiepileptic drugs, other drugs used to treat seizures) may lead to an increase in the blood level of the active metabolite 10,11-epoxide carbamazepine, and thus to the same side effects as an overdose of carbamazepine.
Concomitant use of carbamazepine and levetiracetam may increase the toxicity of carbamazepine.
Carbamazepine may increase liver damage caused by isoniazid (a drug used to treat tuberculosis).
Concomitant use of carbamazepine and lithium (a drug used to treat mental disorders), metoclopramide (a drug used to treat gastrointestinal disorders), or neuroleptics (haloperidol, thioridazine: drugs used to treat mental disorders) may promote the occurrence of neurological side effects.
On the other hand, in patients treated with antipsychotic drugs, carbamazepine may decrease the blood levels of these drugs, thereby worsening the clinical picture.
In this regard, your doctor may also consider the need to increase the dose of the neuroleptic drug.
Please note that, in particular, concomitant use of lithium (a drug used to treat and prevent certain mental and emotional disorders) and carbamazepine may enhance the harmful effects of both active substances on the nervous system. Therefore, it is necessary to closely monitor the blood levels of both drugs.
Previous treatment with neuroleptics should have taken place at least 8 weeks earlier, and 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 twitching (fasciculations).
Concomitant administration of carbamazepine and certain diuretics (hydrochlorothiazide, furosemide) may lead to a decrease in sodium levels in the blood serum.
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.
Concomitant administration of carbamazepine and direct-acting oral anticoagulants (rivaroxaban, dabigatran, apixaban, and edoxaban) may lead to a decrease in the blood levels of direct-acting oral anticoagulants.
Further information can be found in the following table:

There are reports in the literature that, in cases of previous neuroleptic treatment, additional carbamazepine treatment increases the risk of developing a so-called malignant neuroleptic syndrome (a life-threatening disease characterized by elevated body temperature and muscle stiffness) or Stevens-Johnson syndrome (a severe skin reaction).
In cases of concomitant administration of isotretinoin (a substance used to treat acne) and carbamazepine, carbamazepine blood levels should be monitored.
Concomitant administration of carbamazepine and paracetamol (a pain reliever and antipyretic) may decrease the bioavailability and thus the 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 determined at the beginning and end of carbamazepine treatment. If necessary, the dose of thyroid hormone-containing drugs should be adjusted.
Concomitant administration of antidepressant drugs from the group of serotonin reuptake inhibitors (e.g., fluoxetine) may lead to the development of a toxic serotonin syndrome.
It is not recommended to use carbamazepine in combination with nefazodone (an antidepressant), as carbamazepine may lead to a significant decrease in nefazodone blood levels, up to a loss of its effectiveness. Additionally, when nefazodone and carbamazepine are taken concomitantly, carbamazepine blood levels increase, and the blood level of its active metabolite, 10-11-epoxide carbamazepine, decreases.
Concomitant administration of carbamazepine and other drugs that may cause heart conduction disorders (arrhythmias), such as antiarrhythmic drugs (drugs used to treat heart rhythm disorders), tricyclic antidepressants, or erythromycin (an antibiotic), increases the risk of heart conduction disorders.

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 likelihood 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. In cases of carbamazepine treatment during pregnancy, the risk of birth defects in the child is up to 3 times higher than in women not taking antiepileptic drugs. The main reported birth defects are neural tube defects (a hole in the spine), facial birth defects, such as cleft lip and palate, head birth defects, heart defects, birth defects of the penis, including urethral opening (hypospadias), and finger defects. In cases of Karbamazepina Tillomed treatment during pregnancy, the 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 such an effect. The effect of the drug on brain development cannot be ruled out.
Women of childbearing age who do not plan to become pregnant should use effective contraceptive measures during carbamazepine treatment. Karbamazepina Tillomed may affect the effectiveness of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. Irregular bleeding or spotting may occur.
During Karbamazepina Tillomed treatment, you should discuss with your doctor the most suitable type of contraception. If you plan to become pregnant, you should discuss with your doctor the possibility of changing your treatment to avoid exposing the unborn child to carbamazepine.
If you are pregnant or think you may be pregnant, you should immediately inform your doctor. You should not stop taking the medicine before discussing this with your doctor. Stopping the medicine without consulting your doctor may lead to the occurrence of seizures, 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 immediately 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. Breastfed children whose mothers are treated with 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 drowsiness, blurred vision, double vision, or lack of muscle coordination, especially at the beginning of treatment or after changing the dose. If you experience such side effects or vision disorders, you should not drive or operate machinery.

Karbamazepina Tillomed contains lactose

If you have been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to take Karbamazepina Tillomed

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dosage will be determined and checked individually by your doctor (specialist), aiming to eliminate seizures using the smallest 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.
As a rule, 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 the case of combination therapy, based on carbamazepine blood levels and depending on the effectiveness of the treatment. Experience has shown that the therapeutic carbamazepine level 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 enzymatic 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 changing treatment to carbamazepine, the dose of the discontinued antiepileptic drug should be gradually decreased.
For the treatment of seizures, the following general dosage regimen is recommended:

* Note:
For children under 6 years old, dosage forms with non-prolonged 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, usually, the initial dose of 1 or 2 carbamazepine prolonged-release tablets (corresponding to 200-400 mg of carbamazepine per day) should be gradually increased to a maintenance dose of 4-6 carbamazepine prolonged-release tablets (corresponding to 800-1200 mg of carbamazepine per day).
Usually, the maintenance dose in children is on average from 10 to 20 mg of carbamazepine/kg body weight/day.
Recommended dosage regimen, see 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 smaller dose.
Manic-depressive phase prophylaxis:
The initial dose, which is usually also sufficient as a maintenance dose, is 1 or 2 tablets of 200 mg of carbamazepine prolonged-release (corresponding to 200-400 mg of carbamazepine) per day.
If necessary, the dose can be increased to 2 tablets of 200 mg of carbamazepine prolonged-release (corresponding to 800 mg of carbamazepine) twice a day.
Note:
In patients with severe cardiovascular, liver, and kidney diseases, as well as in elderly patients, a smaller dose is recommended.

Method of administration

Prolonged-release tablets should be swallowed whole, without chewing or crushing.
Prolonged-release tablets should be taken during or after meals, 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 4-5 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 the individual patient's response, and is determined by the treating doctor.
Basically, antiepileptic therapy is long-term therapy.
The decision to start and stop treatment, as well as the duration of carbamazepine treatment, should be made by a specialist doctor experienced in treating epilepsy.
Reducing the dose and stopping the medicine should generally be considered only after at least two or three years have passed since the last seizure.
Stopping the medicine should be done by gradually reducing the dosage over one year or two 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 useful for a period of several weeks. The dose should be reduced cautiously 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

In case of accidental ingestion of too many tablets, you should immediately contact your doctor or the emergency department of the nearest hospital.
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 (drowsiness, 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
Respiratory disorders (respiratory depression), fluid in the lungs (pulmonary edema), blue discoloration of the face (cyanosis), respiratory arrest.
Cardiovascular system
Increased heart rate (tachycardia), usually decreased (hypotonic) blood pressure, possibly also hypertension, disorders of cardiac 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, genital organs
Urinary retention, decreased or absent urine production, fluid retention in the body.
Laboratory test results
Low sodium levels in the blood serum (hyponatremia), possible acidosis, possible increased blood sugar levels (hyperglycemia), increased creatine phosphokinase activity in the 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).
In case of any error in treatment, you should immediately inform your doctor.
In case of ingestion of large doses, emergency measures should be taken (hospitalization).
There is no specific antidote for acute carbamazepine poisoning. Treatment of carbamazepine overdose depends on the symptoms and usually requires hospital treatment.

Stopping Karbamazepina Tillomed treatment

You should never stop carbamazepine treatment or end it prematurely on your own initiative. This may jeopardize the success of your treatment and lead to the recurrence of seizures. In case of intolerance or changes in the clinical picture, you should discuss this with your doctor.
In case of any further doubts about the use of this medicine, you should consult 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. There are no special precautions for storage of the medicinal product. Medicines should not be disposed of via wastewater or household waste. The patient 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, cornstarch, 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 tablet with prolonged release Netherlands Carbamazepine Tillomed 200 mg and 400 mg tablets with prolonged release 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: