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Patient Info Service - information for patients

1. What Tegretal 200 mg retard is and what it is used for

Tegretal 200 mg retard contains the active ingredient carbamazepine. It is a medicine used to treat epileptic seizure disorders and other seizure disorders, as well as certain pain conditions, and to prevent certain mental disorders.

Tegretal 200 mg retard is used to treat:

  • Epilepsies:
    Seizures that start in a specific area of ​​the brain (focal seizures). The seizures can occur without disturbances of consciousness (simple partial seizures) or accompanied by disturbances of consciousness (complex partial seizures, psychomotor seizures);
    seizures affecting both hemispheres of the brain (generalized seizures), especially if they originate in a specific area of ​​the brain (sleep grand mal, diffuse grand mal);
    mixed forms of epilepsy;

  • seizure-like facial pain (trigeminal neuralgia);

  • attack-like pain of unknown cause in the pharynx (genuine glossopharyngeal neuralgia);

  • Painful conditions with nerve damage caused by diabetes (diabetic neuropathy);

  • non-epileptic seizures in multiple sclerosis, such as B. Trigeminal neuralgia, tonic seizures (seizures with uniform muscle tension), seizure-like speech and movement disorders, abnormal sensations (paroxysmal dysarthria and ataxia, paroxysmal paresthesia) and attacks of pain;

  • to prevent seizures in alcohol withdrawal syndrome;

  • for the prevention of manic-depressive phases (certain psychological disorders with mood swings), if the therapy with lithium has failed or if patients under lithium experienced rapid phase changes and if treatment with lithium is not allowed.

2. What you need to know before you take Tegretal 200 mg retard?

Do not take Tegretal 200 mg retard if you

  • are allergic to carbamazepine, structurally related drugs (e.g. tricyclic antidepressants, i.e. certain anti-depression drugs), or any of the other ingredients listed in section 6;

  • have a history of bone marrow damage or blood formation disorders in the bone marrow;

  • Have cardiac conduction disorders (atrioventricular block);

  • suffer from certain hereditary metabolic defects (acute intermittent porphyria, porphyria variegata, porphyria cutanea tarda);

  • are being treated concomitantly with a monoamine oxidase inhibitor (antidepressant);

  • are treated at the same time with voriconazole (a medicine against fungal diseases), as this can lead to treatment failure of this medicine.

Warnings and Precautions

If you suffer from absenteeism (clouding of consciousness), Tegretal 200 mg retard should not be used because this medication can cause such seizures or make them worse.

Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), which are possibly life-threatening, have been reported with the use of Tegretal 200 mg retard. These initially appear as reddish, target-like or circular spots (often with a blister in the middle) on the trunk of the body. The rash can cause widespread blistering or peeling of the skin. Additional symptoms to watch out for include open, painful areas (ulcers) in the mouth, throat, nose and genital area, and red and swollen eyes (conjunctivitis). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms (headache, fever and body aches).

The highest risk of these severe skin reactions occurring is in the first few weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis in connection with the use of Tegretal 200 mg retard, you must never be treated with Tegretal 200 mg retard again.

If you develop a rash or any of the other symptoms on your skin, see a doctor straight away. Tell him that you are taking Tegretal 200 mg retard.

The severe skin reactions described above may occur more frequently in people from certain Asian countries. If you are Han Chinese or Thai, your doctor may do a blood test to determine if you are at increased risk of these severe skin reactions. Your doctor can tell you if you need to have a blood test before taking carbamazepine.

Talk to your doctor or pharmacist before taking Tegretal 200 mg retard,

  • if you have any of the following diseases:

    • Diseases of the blood-forming organs (haematological diseases);

    • Signs of unusual sensitivity (rash or other signs of allergy) to oxcarbazepine or any other medicine. If you are allergic to carbamazepine, the chance is about 25% that you will also be allergic to oxcarbazepine;

    • disturbed sodium metabolism;

    • Heart, liver and kidney problems, even if you have suffered from them in the past (see “Possible side effects?” And “How to take Tegretal 200 mg retard?”);

    • increased pressure in the eye (glaucoma) or discomfort or pain when urinating; in this case you should be carefully monitored;

    • myotonic dystrophy (degenerative muscle disease, in these patients conduction disorders often occur in the heart).

  • if you have previously stopped taking carbamazepine.

  • if your doctor has diagnosed you with a mental illness called psychosis, which may be accompanied by states of confusion and overexcitation.

If you are a woman of childbearing potential, you should use effective contraception during treatment and for two weeks after the last dose. If you are taking a hormonal contraceptive (the “pill”) you should know that Tegretal 200 mg retard can make it ineffective. You should use a different or an additional non-hormonal method of contraception. In this way you can reduce the risk of an unwanted pregnancy.

Please inform your doctor immediately if irregular vaginal bleeding or spotting occurs.

Please tell your doctor if you are pregnant or planning to become pregnant. Your doctor will discuss the possible risks of taking Tegretal 200 mg retard during pregnancy, as it can cause damage or malformations in the unborn child (see section “Pregnancy”).

A small number of people being treated with anti-epileptic drugs such as Tegretal 200 mg retard have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

If any of the above apply to you, be sure to talk to your doctor about them. You may then only take Tegretal 200 mg retard under appropriate precautionary measures.

Due to the possibility of increased sensitivity of the skin to light (photosensitization), you should protect yourself from strong sunlight during treatment with Tegretal 200 mg retard.

Please tell your doctor immediately if any of the following applies to you:

  • If you experience symptoms such as fever, sore throat, allergic skin reactions such as skin rash with swollen lymph nodes and / or flu-like symptoms, mouth ulcers, tendency to develop "bruises", punctiform or extensive skin bleeding, contact your doctor immediately.

  • If you notice any signs of an allergic reaction that may include symptoms such as fever, skin rash, vascular inflammation, swelling of the lymph nodes or joint pain, talk to your doctor immediately or go to the emergency room of the nearest hospital (see "Possible side effects?" ).

  • If you find yourself having seizures more often.

  • If you get signs of inflammation of the liver such as fatigue, loss of appetite, nausea, yellowing of the skin and / or eyes, enlarged liver.

  • If you have kidney problems associated with low blood sodium levels or if you have kidney problems and you are taking medicines that lower the level of sodium in the blood (diuretics such as hydrochlorothiazide, furosemide).

  • If, as a result of taking Tegretal, you have symptoms such as dizziness, light-headedness, drop in blood pressure, confusion, which could lead to falls.

children

Tegretal 200 mg retard is unsuitable for children under 6 years of age due to its high active ingredient content and lack of experience with prolonged-release tablets.

Elderly people

A lower dose is indicated in elderly patients.

Other medicines and Tegretal 200 mg retard

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or intend to take / use any other medicines.

Treatment with MAO inhibitors (medicines used to treat depression) must be completed at least 2 weeks before starting treatment with Tegretal 200 mg retard.

Please note that the following information can also apply to recently used medicines.

Effects of Tegretal 200 mg retard on the plasma concentration of other medicinal products

Tegretal 200 mg retard can increase the activity of certain liver enzymes and thereby lower the plasma levels of other medicines.

The effects of some other medicines taken at the same time, which are broken down in the same way as carbamazepine, may therefore be weakened or even canceled.

If Tegretal 200 mg retard is administered at the same time, the dosage of the following active ingredients from different areas of application may have to be adjusted to the clinical requirements:

  • Painkillers, anti-inflammatory substances: buprenorphine, fentanyl, methadone, paracetamol (long-term use of carbamazepine and paracetamol (acetaminophen) can lead to hepatotoxicity), phenazone, tramadol

  • Medicines against parasites: praziquantel, albendazole

  • Anticoagulants: warfarin, phenprocoumon, dicumarol, acenocumarol, rivaroxaban, dabigatran, apixaban, edoxaban

  • Drugs used to treat depression: bupropion, citalopram, mianserin, nefazodone, sertraline, trazodone (but apparently enhances the depressive effects)

  • Other agents used to treat depression (so-called tricyclic antidepressants): imipramine, amitriptyline, nortryptiline, clomipramine

  • Anti-nausea and vomiting agent: aprepitant

  • Anti-epileptics, other agents used to treat seizure disorders: clonazepam, ethosuximide, felbamate, eslicarbazepine, oxcarbazepine, primidone, lamotrigine, tiagabine, topiramate, valproic acid, zonisamide, phenytoin (the plasma levels of phenytoin may increase or decrease)

  • Agents for the treatment of (systemic) fungal infections: caspofungin, antimycotics of the azole type: e.g. B. Itraconazole, Voriconazole. Alternative anticonvulsants are recommended for patients treated with voriconazole or itraconazole.

  • Agents against viral diseases / HIV: z. B. indinavir, ritonavir, saquinavir

  • Anti-anxiety drugs: alprazolam, midazolam, clobazam

  • Medicines used to treat respiratory diseases: theophylline

  • Means for the treatment of heart diseases: digoxin, simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine

  • Agent to inhibit defense mechanisms after organ transplants, immunosuppressant: ciclosporin, tacrolimus, sirolimus, everolimus

  • Calcium antagonists (medicines used to treat dizziness, migraines, high blood pressure): felodipine, flunarizine

  • Medicines used to prevent pregnancy: hormonal contraceptives

  • Corticosteroids: e.g. B. prednisolone, dexamethasone

  • Medicines for the treatment of mental and emotional disorders: haloperidol, bromperidol, clozapine, olanzapine, risperidone, quetiapine, ziprasonide, zotepine (accelerates the breakdown), aripiprazole, paliperidone

  • Thyroid hormones: levothyroxine

  • Antibiotics: rifabutin, tetracyclines, e.g. B. Doxycycline

  • Medicines used to treat cancer: imatinib, cyclophosphamide, lapatinib, temsirolimus

  • Others: Quinidine (used to treat cardiac arrhythmias), oestrogens (hormones), methylphenidate (psychostimulant, used to treat attention disorders), progesterone derivatives (hormones), propranolol (beta blocker, antihypertensive agent)

  • Means to treat erectile dysfunction: Tadalafil

Unexpected breakthrough bleeding or spotting may occur when taking a hormonal contraceptive (the “pill”). In addition, the effect of the hormonal contraceptive may be weakened during treatment with Tegretal 200 mg retard, i.e. In other words, it can lead to an unwanted pregnancy. Therefore, in consultation with your doctor, other effective, non-hormonal contraceptive methods should be considered (see "Warnings and precautionary measures" above).

Tegretal 200 mg retard can lower the plasma level of bupropion (medicine to support smoking cessation) and increase the level of the breakdown product hydroxybupropion and thus reduce the clinical efficacy and safety of bupropion.

Decreased plasma concentration of Tegretal 200 mg retard due to other medicinal products

The plasma levels of Tegretal 200 mg retard can be reduced by:

  • Antiepileptics, other agents used to treat seizure disorders: felbamate, methosuximide, oxcarbazepine, phenobarbital, phensuximide, phenytoin, fosphenytoin, primidone, progabide and possibly (here the data are partly contradicting) clonazepam, valproic acid, valpromide

  • Anti-tuberculosis drug: rifampicin

  • Medicines for the treatment of respiratory diseases, antiasthmatics: theophylline, aminophylline

  • Skin disease agent: isotretinoin

  • Medicines used to treat cancer: cisplatin, doxorubicin

  • Other: St. John's wort (Hypericum perforatum, herbal remedy for depressive moods)

On the other hand, the plasma levels of the pharmacologically active degradation product of carbamazepine (carbamazepine-10,11-epoxide) can be increased by valproic acid and primidone.

Simultaneous administration of felbamate can reduce the plasma level of carbamazepine and increase that of carbamazepine-10,11-epoxide; at the same time, the felbamate level can be lowered.

Due to the mutual influence, especially when several anti-epileptic drugs are administered at the same time, it is advisable to monitor the plasma level and adjust the dosage of Tegretal 200 mg retard if necessary.

Increased plasma concentration of Tegretal 200 mg retard due to other medicinal products

The following active substances can increase the plasma concentrations of Tegretal 200 mg retard:

  • Painkillers, anti-inflammatory substances: dextropropoxyphene / propoxyphene, ibuprofen

  • Medicines to inhibit the sex hormone gonadotropin: danazol

  • Antibiotics, agents used to treat bacterial infections: macrolide antibiotics (e.g. erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin)

  • Agents used to treat depression: fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine, possibly desipramine

  • Anti-epileptics, other agents used to treat seizure disorders: stiripentol, vigabatrin

  • Agents for the treatment of (systemic) fungal infections, antimycotics of the azole type such. B. itraconazole, ketoconazole, fluconazole, voriconazole. Alternative anticonvulsants are recommended for patients treated with voriconazole or itraconazole.

  • Means for treating allergic reactions: loratadine, terfenadine

  • Medicines to treat tuberculosis: isoniazid

  • Agents against viral diseases / HIV, e.g. B. ritonavir

  • Medicines used to treat glaucoma: acetazolamide

  • Calcium antagonists (agents used to treat cardiovascular diseases): diltiazem, verapamil

  • Medicines to relax muscles (muscle relaxants): oxybutynin, dantrolene

  • Medicines for the treatment of mental and emotional disorders: loxapine, olanzapine, quetiapine

  • Anticoagulants: ticlopidine

  • Medicines used to treat gastrointestinal ulcers: omeprazole, possibly cimetidine

  • Others: grapefruit juice, nicotinamide (vitamin of the B group, in high dosage)

Increased plasma levels of Tegretal 200 mg retard can lead to the effects listed under "What side effects are possible?" symptoms (e.g. dizziness, tiredness, unsteady gait, double vision). If you experience such symptoms, talk to your doctor; he will then check the plasma levels and change the dose if necessary.

Other interactions

Simultaneous use of Tegretal 200 mg retard and loxapine, quetiapine (medicinal product for the treatment of mental and emotional disorders), primidone, progabide, valproic acid, valnoctamide and valpromide (anti-epileptic drugs, other agents for the treatment of seizure disorders) can increase the plasma level of the active breakdown product Carbamazepine-10,11-epoxide and thus lead to the same side effects as too high a dosage of Tegretal 200 mg retard.

Concomitant use of carbamazepine and levetiracetam may increase the toxicity of carbamazepine.

Isoniazid (a drug used to treat tuberculosis) can be more harmful to the liver with Tegretal 200 mg retard.

The simultaneous use of Tegretal 200 mg retard and lithium (medicine for the treatment of psychiatric diseases), metoclopramide (medicine for the treatment of gastrointestinal disorders) or neuroleptics (haloperidol, thioridazine: medicines for the treatment of mental and emotional diseases) can lead to the occurrence of neurological side effects favor.

On the other hand, in patients being treated with neuroleptics, Tegretal 200 mg retard can lower the plasma levels of these drugs and thereby cause the clinical picture to worsen. The doctor may therefore consider it necessary to increase the dose of the respective neuroleptic.

It should be noted that the simultaneous use of lithium (medicine for the treatment and prevention of certain mental and emotional disorders) and Tegretal 200 mg retard can increase the nervous system damage of both active ingredients. Therefore, careful monitoring of the blood levels of both is necessary. Previous treatment with neuroleptics should be more than 8 weeks ago and should not take place simultaneously. Pay attention to the following signs: Unsteady gait (ataxia), twitching or trembling of the eyes (horizontal nystagmus), increased muscle reflexes, muscle twitching (muscle fasciculations).

The combined administration of Tegretal 200 mg retard and some diuretics (hydrochlorothiazide, furosemide) can lead to a reduced sodium content in the blood serum.

The effectiveness of certain medicines for muscle relaxation that are used during anesthesia (non-depolarizing muscle relaxants such as pancuronium) can be impaired by Tegretal 200 mg retard. This enables the neuromuscular blockade to be lifted more quickly. Patients treated with muscle relaxants should be monitored for this and their dosage increased if necessary.

Simultaneous administration of Tegretal 200 mg retard and direct-acting oral anticoagulants (rivaroxaban, dabigatran, apixaban and edoxaban) can lead to reduced plasma levels of the direct-acting oral anticoagulants. Please refer to the following table for further details:

Direct-acting oral anticoagulants (NOAC)

Recommendations for the simultaneous use of NOAC and Tegretal 200 mg retard

Apixaban

  • In the prophylaxis of venous thromboembolism (VTE) after elective hip or knee replacement surgery, in the prophylaxis of strokes and systemic embolisms in patients with non-valvular atrial fibrillation (NVAF) and in the prophylaxis of recurrent deep vein thrombosis (LE) and pulmonary embolism (DVT) concomitant use with caution.

  • When treating DVT and PE, concomitant use should be avoided.

Rivaroxaban

Concomitant use should be avoided unless the patient is closely monitored for signs and symptoms of thrombosis.

Dabigatran

Simultaneous use should be avoided.

Edoxaban

Simultaneous administration should only be done with caution.

In the literature there are indications that the additional intake of carbamazepine with pre-existing neuroleptic therapy increases the risk of developing a so-called neuroleptic malignant syndrome (possibly life-threatening condition with an increase in body temperature and stiffness of the muscles) or Stevens-Johnson syndrome (severe skin reaction) increased.

If isotretinoin (active ingredient for acne treatment) and Tegretal 200 mg retard are administered at the same time, the carbamazepine plasma level should be monitored.

The simultaneous administration of Tegretal 200 mg retard with paracetamol (pain reliever and antipyretic drug) can reduce the bioavailability and thus the effectiveness of paracetamol.

Tegretal 200 mg retard appears to increase the excretion (elimination) of thyroid hormones and to increase the need for them in patients with hypothyroidism. Therefore, thyroid parameters should be determined at the beginning and at the end of therapy with Tegretal 200 mg retard in these patients receiving substitution therapy. If necessary, the dose of thyroid hormone preparations should be adjusted.

Simultaneous administration of antidepressants of the serotonin reuptake inhibitor type (drugs that relieve depression such as fluoxetine) can lead to toxic serotonin syndrome.

It is recommended not to use Tegretal 200 mg retard in combination with nefazodone (depressant agent), since Tegretal 200 mg retard can lead to a significant reduction in the nefazodone plasma level or even loss of effectiveness. In addition, if nefazodone and Tegretal 200 mg retard are taken at the same time, the carbamazepine plasma level is increased and that of its active breakdown product carbamazepine-10,11-epoxide is reduced.

Simultaneous use of carbamazepine and other drugs that can cause cardiac conduction disorder (stimulation spread disorders in the heart), such as antiarrhythmics (drugs against cardiac arrhythmias), cyclic antidepressants (drugs that relieve depression) or erythromycin (antibiotic disorders), increases the risk of cardiac conduction disorders.

Tegretal 200 mg retard with food, drink and alcohol

Grapefruit juice / grapefruit can potentially increase the plasma levels of carbamazepine and possibly cause side effects.

Carbamazepine, like other substances that have an effect on the central nervous system, can mean that you can only tolerate little alcohol or no alcohol at all. You should therefore avoid alcohol consumption during treatment with Tegretal 200 mg retard.

Pregnancy, breastfeeding and fertility

If you are taking a hormonal contraceptive (the “pill”) you should know that Tegretal 200 mg retard can make it ineffective. You should use another or an additional non-hormonal method of contraception while you are taking Tegretal 200 mg retard and for two weeks after the last dose. In this way you can reduce the risk of an unwanted pregnancy.

pregnancy

Carbamazepine may only be prescribed during pregnancy after the attending physician has carefully weighed the benefits and risks. If women want to have children, they should definitely seek advice from a doctor and ensure regular medical monitoring of the pregnancy.

As with some other anti-epileptic drugs, various types of malformations have been described with carbamazepine. Various studies have shown a 1% increase in the risk of cleft formation in the spine (spina bifida). It has not yet been clarified to what extent treatment with carbamazepine is responsible for the malformations, as a connection with the underlying disease or hereditary factors cannot be ruled out. Diagnostic measures such as ultrasound and alpha-fetoprotein determination are recommended for the early detection of possible damage to the fruit.

If possible, carbamazepine should be used as monotherapy in women of childbearing potential, especially during pregnancy, since the risk of malformations increases with combination therapy with other anti-epileptic drugs.

If pregnancy occurs or is planned with carbamazepine treatment, or if treatment with carbamazepine is to be started during pregnancy, your doctor must carefully weigh the need for seizure control against the possible risk to the unborn child. The lowest effective dose should be used during the first three months of pregnancy, which are particularly prone to malformations, and especially between the 20th and 40th day after fertilization, as malformations are likely to be caused by high plasma concentrations of the active ingredient. Monitoring of plasma levels is recommended.

Under no circumstances should you stop taking it without medical advice, as epileptic seizures can cause harm to the child.

Folic acid deficiency can occur during pregnancy. Anti-epileptic drugs can make this worse. The folic acid deficiency can be an additional factor in the development of malformations. Therefore, folic acid administration before and during pregnancy can be useful. To avoid blood clotting disorders, the preventive administration of vitamin K is also recommended1 Recommended to the mother in the last weeks of pregnancy or to the newborn after birth.

Breastfeeding

The active substance carbamazepine passes into breast milk. Nevertheless, breastfeeding is usually possible during treatment. However, the breastfed infant should be monitored for possible adverse effects and if the infant is found to be poorly weight gain or excessive need for sleep (sedation) or allergic skin reactions, breastfeeding should be discontinued.

Fertility

There have been isolated cases of sexual dysfunction, such as B. Impotence or decreased libido. Reduced male fertility and / or abnormal sperm production have been reported very rarely.

Driving and using machines

Known central nervous side effects of Tegretal 200 mg retard, such as B. dizziness, drowsiness, tiredness, blurred vision, double vision, impaired movement coordination, at the beginning of treatment, when increasing the dose or taking higher doses and / or at the same time taking other drugs that also affect the central nervous system lead to impairment of the ability to drive, even if used as intended and the ability to use machines.

Therefore, you are not allowed to drive motor vehicles, operate machines or carry out other dangerous activities. This applies even more in combination with alcohol.

Important information about some of the ingredients of Tegretal 200 mg retard

Macrogol glycerol hydroxystearate can cause stomach upset and diarrhea.

3. How should Tegretal 200 mg retard be taken?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage is to be determined and controlled individually by the (specialist) doctor, whereby freedom from seizures should be sought with the lowest possible dosage, especially during pregnancy.

In order not to jeopardize the success of the treatment, you must not make any changes to the treatment or dose without first consulting your doctor.

A gradual (creeping) build-up of the dosage up to the optimally effective dose is recommended.

The daily dose is usually given in 1 to 2 single doses.

The general daily dose range is between 400 and 1,200 mg carbamazepine.

As a rule, a total daily dose of 1,600 mg carbamazepine should not be exceeded, as higher doses cause more side effects.

The therapeutic dose should be determined, especially in the case of combination therapy, by determining the plasma level and depending on the effectiveness. Experience has shown that the therapeutic carbamazepine level is between 4 and 12 micrograms / ml.

In individual cases, the required dose can differ considerably from the stated initial and maintenance dose (e.g. due to accelerated degradation through enzyme induction or due to drug interactions when other drugs are taken at the same time).

Tegretal 200 mg retard should preferably be used alone (monotherapy) for the treatment of epilepsy. Treatment should be supervised by a specialist experienced in treating epilepsy.

When switching to treatment with Tegretal 200 mg retard, the dose of the medicinal product to be discontinued for seizure disorders should be gradually reduced.

The following general dosage regimen is recommended for the treatment of epileptic seizure disorders:

Starting dose

daily in mg

(or number of prolonged-release tablets)

Maintenance dose

daily in mg

(or number of prolonged-release tablets)

Adults

200 mg in the evening

(1 prolonged release tablet)

200 to 600 mg in the morning

(1 to 3 prolonged-release tablets)

400 to 600 mg in the evening

(2 to 3 prolonged-release tablets)

Children*

6-10 years

200 mg in the evening

(1 prolonged release tablet)

200 mg (1 prolonged-release tablet) in the morning

200 to 400 mg in the evening

(1 to 2 prolonged-release tablets)

11-15 years

200 mg in the evening

(1 prolonged-release tablet)

200 to 400 mg in the morning

(1 to 2 prolonged-release tablets)

400 to 600 mg in the evening

(2 to 3 prolonged-release tablets)

> 15 years

according to the adult dose

* Note:

For children under 6 years Non-retarded dosage forms are available for initial and maintenance dosing (suspension or tablets). The administration of prolonged-release tablets cannot be recommended due to insufficient knowledge.
Recommended maximum dose:
6-15 years: 1,000 mg / day
> 15 years: 1,200 mg / day

Seizure disorders (epilepsy):

In general, the starting dose for adults should be 1 to 2 prolonged-release tablets Tegretal 200 mg retard (corresponding to 200 to 400 mg carbamazepine / day) slowly up to the maintenance dose of 4 to 6 prolonged-release tablets Tegretal 200 mg retard (corresponding to 800 to 1200 mg carbamazepine / day) can be increased.

In general, the maintenance dose for children averages 10 to 20 mg carbamazepine / kg body weight / day.

For the recommended dosage scheme, see above.

Attack-like facial pain (trigeminal neuralgia), attack-like pain of unknown cause in the pharynx area (genuine glossopharyngeal neuralgia):

The daily dose is from an initial dose of 1 to 2 prolonged-release tablets Tegretal 200 mg retard (corresponding to 200 to 400 mg carbamazepine) until pain relief occurs on average to 2 to 4 prolonged-release tablets Tegretal 200 mg retard (corresponding to 400 to 800 mg carbamazepine) - distributed over 1 to 2 gifts - to increase. The maximum dose is 1200 mg per day. Subsequently, in some of the cases, it is possible to continue the treatment with a lower maintenance dose of 1 prolonged-release tablet Tegretal 200 mg retard twice a day (equivalent to 400 mg carbamazepine).

For elderly and sensitive patients, an initial dose of 1 prolonged-release tablet Tegretal 200 mg retard (equivalent to 200 mg carbamazepine) in the morning or in the evening is sufficient once a day.

Pain conditions caused by damage to the peripheral nerves due to diabetes (diabetic neuropathy):

The average daily dose is 1 prolonged-release tablet in the morning, 2 Tegretal 200 mg retard retard tablets in the evening (equivalent to 600 mg carbamazepine), in exceptional cases up to 2 times a day 3 Tegretal 200 mg retard prolonged-release tablets (equivalent to 1,200 mg carbamazepine).

Non-epileptic seizures in multiple sclerosis:

The average daily dose is 1 to 2 prolonged-release tablets Tegretal 200 mg retard twice (equivalent to 400 to 800 mg carbamazepine).

Seizure prevention during inpatient alcohol withdrawal syndrome treatment:

The average daily dose is 1 extended-release tablet in the morning and 2 extended-release tablets Tegretal 200 mg retard in the evening (equivalent to 600 mg carbamazepine).

In severe cases, it can be increased to 3 prolonged-release tablets Tegretal 200 mg retard (equivalent to 1,200 mg carbamazepine) twice a day for the first few days.

The combination of Tegretal 200 mg retard with sedative-hypnotic agents (tranquilizers, sleeping pills) is not recommended. However, depending on the clinical requirements, Tegretal 200 mg retard can be combined with other substances used in alcohol withdrawal treatment if required.

Carbamazepine levels should be checked regularly. Because of the central nervous and vegetative side effects (see section “Side Effects” for withdrawal symptoms), careful clinical observation is recommended.

Prophylaxis of manic-depressive phases:

The starting dose, which is usually sufficient as a maintenance dose, is 1 to 2 tablets of Tegretal 200 mg retard per day (equivalent to 200 to 400 mg carbamazepine). If necessary, the dose can be increased up to 2 times 2 prolonged-release tablets Tegretal 200 mg retard (equivalent to 800 mg carbamazepine) daily.

Note:

A lower dose is indicated in patients with severe cardiovascular disease, liver and kidney problems and in the elderly.

type of application

The prolonged-release tablets are divisible. Please take the prolonged-release tablets during or after meals with sufficient liquid (e.g. 1 glass of drinking water (200 ml)).

In some cases, dividing the daily dose into 4 to 5 individual doses has proven to be particularly effective.In these cases, non-delayed-release dosage forms of carbamazepine are preferable to delayed-release dosage forms.

Duration of application

The duration of use depends on the respective indication and the individual reaction of the patient and is determined by the attending physician.

The anti-epileptic therapy is basically a long-term therapy.

A specialist experienced in epilepsy treatment should decide on the setting, duration of treatment and discontinuation of Tegretal 200 mg retard on a case-by-case basis.

In general, a dose reduction and discontinuation of the medication should not be considered until after two to three years of seizure freedom at the earliest.

Discontinuation must take place in a gradual dose reduction over one to two years; Children can outgrow the dose per kg body weight instead of adjusting the dose according to their age, whereby the EEG result should not worsen.

In the Neuralgia treatment It has proven useful to carry out the therapy over a few weeks with a maintenance dose that is just sufficient to ensure freedom from pain. Careful dose reduction should determine whether spontaneous remission has occurred in the meantime.

If pain attacks recur, the original maintenance dose should be used.

For the duration of the treatment Pain conditions associated with diabetic neuropathy and the non-epileptic seizures in multiple sclerosis the same is true.

To Seizure prevention in alcohol withdrawal syndrome treatment Therapy with Tegretal 200 mg retard should be discontinued after 7 to 10 days with gradually increasing dosage.

The Prophylaxis of manic-depressive phases is a long-term treatment.

Please talk to your doctor or pharmacist if you have the impression that the effect of Tegretal 200 mg retard is too strong or too weak.

If you take more Tegretal 200 mg retard than you should

Immediate medical treatment is required in the event of an overdose.

In the event of an overdose of Tegretal 200 mg retard, the undesirable symptoms mentioned under “What side effects are possible?” May appear more pronounced.

Central nervesystem

Depression of the nervous system, impaired consciousness (drowsiness, sleepiness (somnolence), rigidity (stupor), coma), dizziness, disorientation, restlessness, agitation, confusion, sudden feeling of heat (flushing), hallucinations, blurred vision, inarticulate or slurred speech (nystagmus ), unsteady gait (ataxia), disorders or malfunctions of movement sequences (dyskinesia), reflex anomalies (initially increased, then weakened reflexes), seizures of the brain (tonic-clonic convulsions), psychomotor disorders, muscle twitching (myoclonus), opisthotonus, involuntary movements, Shaking (tremor), body temperature that is too low (hypothermia), dilated pupils (mydriasis), EEG disorders

Respiratory system

Breathing disorders (respiratory depression), water in the lungs (pulmonary edema), blue discoloration of the face (cyanosis), respiratory failure

Cardiovascular system

Increased heartbeat (tachycardia), mostly low (hypotonic) blood pressure, possibly also high blood pressure (hypertension), disturbances in the spread of excitation in the heart (EKG changes, arrhythmias, AV block), syncope, cardiac arrest, severe reddening of the skin with a sensation of heat (flushing)

Gastrointestinal tract

Nausea, vomiting, delayed gastric emptying, decreased bowel motility

Urinary tract, genital organs

Urinary behavior, decreased or absent urine production, water retention in the body

Laboratory findings

Decreased sodium content in the blood serum (hyponatremia), possible acidification of the blood, possibly increased blood sugar (hyperglycaemia), increased muscle creatine phosphokinase, increased or decreased number of white blood cells (leukocytosis, leukopenia, neutropenia), excretion of sugar in the urine (glycosuria), increase a certain metabolic product in the urine (acetonuria)

A doctor must be informed immediately of any application error. If high doses have been taken, emergency measures must be initiated (admission to a hospital).

A specific antidote for acute poisoning with Tegretal 200 mg retard does not yet exist.

The treatment of an overdose with Tegretal 200 mg retard depends on the symptoms and usually has to be done in hospital.

If you forget to take Tegretal 200 mg retard

Please continue to take your medication as intended in its application. Under no circumstances should you make up for a forgotten dose by taking a double dose.

If you stop taking Tegretal 200 mg retard

Under no circumstances should you interrupt treatment with Tegretal 200 mg retard yourself or end it prematurely. You can jeopardize the success of the treatment and trigger epileptic seizures again. Please talk to your doctor beforehand if you have any intolerance or a change in your clinical picture.

If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, this medicine can have side effects, although not everybody gets them.

The frequency of side effects is based on the following categories:

Very often:

may affect more than 1 in 10 people

Often:

may affect up to 1 in 10 people

Occasionally:

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

The following side effects can have serious consequences:

Look for right away Contact your doctor if you experience any of the following side effects. These can be early signs of severe damage to the blood, liver, kidneys, or other organs and may need urgent medical attention.

  • If you get flu-like symptoms, fever, sore throat, skin rash, mouth ulcers, swelling of the lymph glands or you are more susceptible to infections (signs of certain changes in your blood count, especially a decrease in white blood cells)

  • If tiredness, headache, shortness of breath during exercise, dizziness, pale appearance, frequent infections that lead to fever, chills, sore throat, mouth ulcers, if bruising is easier than normal, nosebleeds (signs of certain changes in the blood count, especially pancytopenia )

  • If a red, blotchy rash occurs mainly on the face with simultaneous exhaustion, fever, nausea, loss of appetite (signs of systemic lupus erythematosus)

  • If the skin or the whites of the eyes become yellow (signs of hepatitis)

  • If the urine turns dark (signs of porphyria or hepatitis)

  • If there is a decrease in urine output due to impaired kidney function and if there is blood in the urine

  • If there is severe pain in the upper abdomen, vomiting, loss of appetite (signs of pancreatitis)

  • If you have a rash, reddening of the skin, blisters on the lips, eyes or in the mouth, peeling of the skin and simultaneous fever, chills, headache, cough, pain all over the body (signs of severe skin reactions)

  • If you have swelling of the face, eyes or tongue, difficulty swallowing, wheezing, hives or itching all over your body, rash, fever, abdominal cramps, chest discomfort or tightness around the chest, difficulty breathing, loss of consciousness (signs of angioedema or severe allergic reactions)

  • If you feel weak, confused, twitching muscles or if your seizures become significantly worse (symptoms that may be related to low blood sodium levels)

  • For fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to light (signs of meningitis)

  • For muscle stiffness, high fever, changes in consciousness, high blood pressure, excessive salivation (signs of neuroleptic malignant syndrome)

  • If you have an irregular heartbeat and chest pain

  • For impaired consciousness and fainting

  • For diarrhea, abdominal pain and fever (signs of inflammation of the bowel). The frequency of this side effect is unknown *

  • When falling due to dizziness, drowsiness, drop in blood pressure, confusion.

Possible other side effects:

The observed side effects occur less frequently when Tegretal 200 mg retard is administered alone (monotherapy) than when other anti-epileptic drugs are administered at the same time (combination therapy).

Some of the side effects occur in a dose-dependent manner, especially at the beginning of treatment, when the initial dose is too high or very frequently or frequently in elderly patients, such as central nervous disorders (dizziness, headache, gait disorders, drowsiness, sedation, exhaustion, double vision, accommodation disorders such as blurred vision ), Gastrointestinal disorders (nausea, vomiting) and allergic skin reactions.

Dose-dependent side effects usually subside within a few days or after a temporary dose reduction. Therefore, Tegretal 200 mg retard should be dosed gradually as possible. Central nervous disorders can be a sign of relative overdose or large fluctuations in plasma levels; therefore it is advisable in these cases to determine the plasma level.

Infections and parasitic diseases

The frequency of reactivation of a herpes virus infection is not known (this can be serious if the immune system is impaired). *

Blood and lymphatic systems

Changes in the blood count such as a reduced number of white blood cells (leukopenia) are very common. According to the literature, the most common of these is benign leukopenia, temporary in about 10% of cases and persistent in 2%. Benign leukopenia occurs mainly within the first four months of therapy.

Often an increased number of a certain type of white blood cell (eosinophilia) or a decreased number of blood platelets (thrombocytopenia) occurs.

An increased number of other white blood cells (leukocytosis) or swelling of the lymph nodes and a deficiency in folic acid occur rarely.

Certain, sometimes life-threatening blood cell damage such as agranulocytosis, aplastic anemia, pancytopenia, aplasia of the red blood cells, as well as other forms of anemia (megaloblastic, possibly hemolytic), reticulocytosis and various forms of porphyria (acute intermittent porphyria, porphyria cutyriaiegata) occur very rarely on. Splenic enlargement has been reported very rarely.

Hypersensitivity reactions

Occasionally, delayed hypersensitivity reactions affecting several organ systems occur with fever, skin rash, vascular inflammation, lymph node swelling, pseudolymphoma, joint pain, changes in the number of white blood cells (leukopenia, eosinophilia), enlargement of the liver and spleen, changes in liver function values ​​and liver diseases of the intra-biliary ducts with destruction and swelling. These symptoms can occur in various combinations and also affect other organs such as the lungs, kidneys, pancreas or the heart muscle and colon.

An acute allergic general reaction and aseptic (not caused by bacteria and viruses) meningitis (meningitis) with muscle twitching (myoclonus) and an increase in certain white blood cells (eosinophilia), anaphylactic (shock) reactions and swelling of the skin and mucous membranes (angioedema) have been very rare ) observed.

The frequency of rash with blood count changes and systemic symptoms (Drug Rash with Eosinophilia and Systemic Symptoms) is not known. *

Metabolism (water and mineral balance), hormone status

Tissue water retention (edema), decreased fluid excretion, weight gain, hyponatremia (decreased sodium content in the blood serum) and decreased plasma osmolality occur frequently, which can rarely lead to water intoxication with lethargy, vomiting, headache, confusion and other neurological disorders.

Increases in prolactin levels with or without clinical symptoms such as swelling of the male mammary glands (gynecomastia) or milk flow (galakthorrö) have been reported very rarely.

The thyroid function parameters T3, T4, TSH and FT4 can be influenced, especially when used at the same time as other medicines for seizure disorders. Usually there are no clinical symptoms.

Tegretal 200 mg retard can lower the serum calcium level by accelerating the breakdown of 25-OH-cholecalciferol. Very rarely this can lead to osteomalacia (softening of the bones).

Elevated cholesterol levels, including HDL cholesterol and triglycerides, can occur very rarely, as can an increase in free serum cortisol.

Carbamazepine can lower the folic acid level in the serum, and there is also evidence of decreased vitamin B12Levels and increased serum homocysteine ​​levels with carbamazepine.

psyche

Very often drowsiness, dizziness, tiredness, sleepiness, gait and movement disorders, occasionally headache, confusion and agitation (agitation) in the elderly may occur.

Illusions of the senses (visual and acoustic hallucinations), mood changes such as depression, depressive or manic (with a raised mood, aggression), loss of appetite, restlessness, aggressive behavior, confusion and restlessness (agitation) were observed.

Phobic disorders (anxiety disorders), thinking difficulties and lack of drive occurred very rarely. During treatment with Tegretal 200 mg retard, latent psychoses (subliminal mental illnesses) can be activated.

Nervous system

Drowsiness, dizziness, tiredness, sleepiness, gait and movement disorders and exhaustion can occur very frequently.

Often headaches, double vision and accommodation disorders (e.g. blurred vision), occasionally eye movement disorders accompanied by eye tremors (nystagmus), involuntary movements (e.g. tremors, flutter tremors, tics, dystonia) occur.

In addition, movement disorders such as B. involuntary movements in the mouth and face area such as grimacing (orofacial dyskinesia), screwed movements (choreoathetosis) occur as well as speech disorders (dysarthria, slurred speech), paresthesia, muscle weakness, nerve diseases (polyneuropathy), nerve inflammation (peripheral neuritis, peripheral neuropathy) Paresis).

Taste disorders or neuroleptic malignant syndrome have been reported very rarely.

The frequency of memory loss is unknown. *

There is some evidence that carbamazepine may make the symptoms of multiple sclerosis worse.

As with other anti-seizure medications, carbamazepine can lead to an accumulation of seizures; In particular, absenteeism (a special type of seizure originating from both hemispheres) can be increased or new.

eyes

Conjunctivitis, clouding of the lens and increased intraocular pressure occur very rarely.

Retinotoxicity (damage to the retina) has been reported in two patients in association with long-term carbamazepine therapy and decreased after discontinuation of carbamazepine.

Ear and organ of equilibrium

Hearing disorders such as ringing in the ears (tinnitus), increased or decreased hearing sensitivity (hyper- or hypoacusis) and changes in pitch perception occur very rarely.

Cardiovascular system

Occasionally there are conduction disorders in the heart (AV block), in individual cases with loss of consciousness, as well as high or low blood pressure.

Occasionally to rarely, a slowing down of the heartbeat (bradycardia) and cardiac arrhythmias, circulatory collapse, heart failure and worsening of a pre-existing coronary artery disease can occur. In addition, inflammation of the veins (thrombophlebitis) and blood clots (thromboembolism) have been observed.

Respiratory system

Hypersensitivity reactions of the lungs with fever, shortness of breath, pneumonia (pneumonitis, pneumonia, alveolitis) and individual cases of pulmonary fibrosis have been described in the scientific literature very rarely.

Gastrointestinal tract

The most common symptoms are nausea and vomiting, frequent loss of appetite, dry mouth, occasionally diarrhea or constipation. Abdominal pain, very rarely inflammation of the mucous membranes in the oropharynx (stomatitis, gingivitis, glossitis) or pancreatitis have been reported.

Liver and bile

Changes (increases) in liver function values ​​are found very frequently with gamma-GT, frequently with alkaline phosphatase, occasionally with transaminases, jaundice or liver inflammation rarely occur (hepatitis in different forms: cholestatic, hepatocellular, granulomatous, mixed) and liver diseases with destruction and disappearance of the intrahepatic bile ducts. Life-threatening acute hepatitis or liver failure can rarely occur, especially within the first few months of therapy.

Skin, mucous membranes, vascular system

Very often allergic, even severe, skin reactions with and without fever and hives (urticaria) are reported, occasionally skin inflammations in which the skin or mucous membranes peel off (exfoliative dermatitis), inflammatory reddening and scaling affecting the whole body Skin (erythroderma), rarely through severe and possibly life-threatening skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section 2), itching (pruritus) or lupus erythematosus disseminatus (autoimmune disease with vascular inflammation). Photosensitivity, skin reddening with disc or nodular changes and bleeding (erythema exudativum multiforme et nodosum), small patches of skin bleeding (purpura), hair loss, increased sweating, changes in skin pigmentation, acne, hirsutism (increased hair of the male type) occur very rarely Women), inflammation of the blood vessels (vasculitis). The frequency of an acute generalized rash (acute generalized exanthemic pustulosis), the occurrence of purple to reddish-purple patchy skin changes that may be itchy, and the frequency of nail loss are not known.

Musculoskeletal system

Muscle weakness has been reported rarely, and joint pain (arthralgia), muscle pain (myalgia) and muscle cramps have been reported very rarely. After discontinuing Tegretal 200 mg retard these symptoms disappeared.

Cases of decreased bone density (osteoporosis to fractures) have been reported. Please consult your doctor or pharmacist if you have been using anti-epileptic drugs for a long time, if you have been diagnosed with osteoporosis, or if you are taking cortisone or other steroid hormones at the same time.

Urinary tract, genital organs

Occasionally, kidney disorders such as B. Excretion of protein in the urine (albuminuria), blood in the urine (hematuria), decreased urine production (oliguria) or increased urea nitrogen in the blood (azotemia), very rarely interstitial nephritis (inflammation of the kidney tissue) or kidney failure or other symptoms when urinating (frequent urination, pain when urinating) Urination, urge to urinate frequently without increased urination (pollakiuria), urinary retention).

Furthermore, sexual disorders such as B. impotence, decreased libido, decreased male fertility and / or changed formation of sperm cells (decreased sperm count and / or mobility).

Laboratory tests

A decrease in gamma globulins in the blood (hypogammaglobulinaemia) has been found very rarely.

* Spontaneous reports and literature cases of side effects (frequency cannot be estimated from the available data).

In the course of experience after the market launch of Tegretal, side effects were known based on spontaneous reports and literature. Since the reports were made voluntarily and from an unknown population size, the frequency cannot be estimated from the available data.

If you notice one or more of the above-mentioned side effects, notify your doctor immediately so that he can decide on the severity and what action to take if necessary.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How should Tegretal 200 mg retard be stored?

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

You may use this medicinal product according to the “Use by” or “Exp. Do not use until “stated expiry date. The expiry date refers to the last day of the month.

Never throw away any medicines via wastewater (e.g. not using the toilet or sink). Ask your pharmacy how to throw away medicines you no longer use. You help to protect our environment. You can find more information at www.bfarm.de/arzneimittelentsorgung.

Storage conditions

Do not store above 30 ° C.
Store in the original container in order to protect from moisture.

6. Contents of the pack and other information

What Tegretal 200 mg retard contains

The active ingredient is: carbamazepine.

One prolonged-release tablet contains 200 mg carbamazepine.

The other ingredients are:

Cetyl alcohol (Ph.Eur.), Croscarmellose sodium, ethyl cellulose, highly dispersed silicon dioxide (Ph.Eur.), Hypromellose, macrogol glycerol hydroxystearate (Ph.Eur.), Magnesium stearate (Ph.Eur.), Microcrystalline cellulose (Ph.Eur.), Sodium dodecyl sulfate (Ph.Eur.), Poly (ethyl acrylatecomethyl methacrylate) (2: 1), talc (Ph.Eur.), titanium dioxide (E 171), iron (III) oxide (E 172), iron (III) hydroxide oxide (E 172).

What Tegretal 200 mg retard looks like and contents of the pack

Tegretal 200 mg retard are beige-orange, oval, slightly convex tablets with a partial notch on each side, with “H / C” debossed on one side and “C / G” on the other. The tablets can be divided into equal halves.

Tegretal 200 mg retard is packed in blisters made of PVC / PE / PVDC and aluminum and is available in packs with 50 prolonged-release tablets, 100 prolonged-release tablets and 200 (4 x 50) prolonged-release tablets.

Not all pack sizes may be marketed.

Pharmaceutic entrepreneur

Novartis Pharma GmbH

90327 Nuremberg

Telephone: (09 11) 273-0

Fax: (09 11) 273-12 653

Internet / email: www.novartis.de

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito 131

80058 Torre Annunziata (NA)

Italy

This leaflet was last revised in February 2020.