The name of your medicine is TEGRETOL.
TEGRETOL contains the active ingredient carbamazepine and comes in the form of: Syrup: 5 ml (1 measuring spoon) contains 100 mg of carbamazepine. TEGRETOL contains the following inactive ingredients:
Syrup: Avicel RC 581 (cellulose + sodium CMC), caramel aroma 52 929 A, methylparaben, Natrosol 250 G (hydroxyethylcellulose), distilled propylene glycol, polyethylene glycol 400 stearate, propylparaben, crystalline sodium-saccharin, sorbic acid, sorbitol solution, deionized water.
TEGRETOL belongs to a group of medicines known as anti (drugs against seizures), but due to its mechanism of action can be applied to other diseases (see section "WHAT IT IS USED FOR AND HOW DOES TEGRETOL").
Syrup: bottle 250 ml (100 mg / 5 ml) x 1
WHAT IT IS USED FOR AND HOW DOES TEGRETOL?
TEGRETOL is used to treat certain types of seizures (epilepsy). It is also applied in the treatment of certain neurological diseases (e.g. pain face called as "trigeminal neuralgia"), as well as certain psychiatric disorders (disorder known as manic depression, and certain types). TEGRETOL should not be used to the treatment of pain in general.
Epilepsy is a disorder characterized by two or more seizures (convulsions). Seizures occur when impulses from the brain to the muscles are not properly passed along nerve pathways. TEGRETOL helps to control the transmission of these impulses. It regulates and nerve functions for the other diseases mentioned above.
TEGRETOL can be used for other conditions as determined by your doctor.
Do not apply in relation to other health problems without consulting your doctor.
BEFORE YOU USE TEGRETOL
You can take TEGRETOL only after a thorough medical examination. TEGRETOL is suitable for most, but not all patients.
You should not use TEGRETOL, if:
• you have had unusual sensitivity (rash or other possible signs of allergy) to carbamazepine or similar drugs (eg. "Tricyclic antidepressants");
• you have had an unusual hypersensitivity to any of the inactive ingredients described in the section "WHAT TEGRETOL" of this leaflet;
• have serious heart disease;
• you have severe heart disease;
• disturbance in the production of porphyrin, a pigment important for liver function and blood formation ("acute intermittent porphyria");
• taking medications (antidepressants), known as monoamine oxidase inhibitors (MAOIs).
Can you take TEGRETOL, if you have other health problems? Tell your doctor if:
• have a history of heart, liver or kidney disease;
• suffer from blood disorder (including those caused by other drugs);
• have increased intraocular pressure (glaucoma);
• you have a specific mental illness, accompanied by confusion or agitation.
Can you use TEGRETOL, if you are taking other medicines?
Tell your doctor or pharmacist about all the medicines you are planning to take, except TEGRETOL. They can interact with TEGRETOL and this will require a change in dosage or even stop one of the medicines. This applies to both prescription medicines and those without a prescription.
In women taking oral contraceptives (birth control pill) and TEGRETOL, can be observed in the menstrual cycle. It is possible to reduce the effectiveness of the tablets and to warrant the use of other methods of contraception.
Do I need to avoid certain foods and drinks? Do not consume alcohol while taking TEGRETOL.
Use in children and the elderly
TEGRETOL can be used safely in children and the elderly, following the doctor's instructions. In need of more careful dosing and follow-up will be provided specific information (see also "How to properly apply TEGRETOL" and "WHAT ARE THE POSSIBLE SIDE EFFECTS OF TEGRETOL®").
If pregnant or breast-feeding
Tell your doctor if you are pregnant, breastfeeding or planning to become pregnant.
There is a risk to the fetus if the mother is taking anti-drugs (drugs against seizures) during pregnancy. Simultaneously it is important to control epileptic seizures during pregnancy. Your doctor will explain the risks and benefits and decide whether to continue taking TEGRETOL, or not.
The active ingredient of TEGRETOL passes into breast milk. You can breast-feed, with the consent of your doctor and under close supervision of the child for side effects. If side effects, eg. if your child becomes very sleepy, stop breastfeeding and tell your doctor.
When driving or operating machinery
TEGRETOL can make you drowsy, cause dizziness or cause blurred vision, especially at the beginning of treatment or when increasing the dosage. Be careful when driving or operating machinery, and during activities requiring increased alertness.
How to properly apply TEGRETOL?
TEGRETOL Take exactly as it was prescribed by your doctor. This will help you achieve the best results and reduce the likelihood of side effects. Do not take TEGRETOL a higher dose more often or longer than your doctor tells you.
If you take TEGRETOL, not suddenly stop treatment without consulting your doctor. He or she will determine whether and when to stop taking TEGRETOL.
The dosage and duration of treatment prescribed by the doctor.
Treatment of epilepsy in adults usually begins with 100-200 mg tablets or syrup, once or twice daily. The dosage is gradually increased to 800-1200 mg (in some patients to 1600 or even to 2000 mg per day), divided into 2 or 3 doses per day.
Treatment in children usually begins with 100-200 mg a day (10-20 mg / kg body weight) and maintained with 400-800 mg daily. In adolescence can be used between 600 and 1000 mg daily.
For trigeminal neuralgia the starting dosage is 200-400 mg a day is slowly raised until the pain (usually 200 mg 3-4 times daily). In elderly patients is recommended lower starting dose - 100 mg 2 times daily.
In acute mania and maintenance treatment of bipolar disorder usual dose is 400-600 mg daily (dose range between 400-1600 mg daily).
The daily dose TEGRETOL always taking several doses (except for the first day), i. E. From 2-4 times per day according to the condition.
The dosage prescribed by your doctor may differ from those listed above. In these cases, follow your doctor's instructions.
Take TEGRETOL during meals or after meals. Swallow the tablets with liquid; if necessary, they can be broken in half.
What to do if you miss a dose
If you miss a dose TEGRETOL, take it as soon as you remember. If it is almost time for your next dose, skip the missed again and continue your regular dosing schedule. Do not take double the dose.
In case of accidental intake of a much larger number of tablets than you or very large amount of syrup, immediately visit the emergency room of the nearest hospital or contact your doctor.
If you experience difficulty in breathing, rapid or irregular heartbeat, loss of consciousness, seizures, fever, nausea and / or vomiting, probably your dose is very high. Do not take more medicine and tell your doctor immediately.
WHAT ELSE YOU NEED TO KNOW WHEN TAKE TEGRETOL?
Especially important for your doctor regularly to monitor your improvement. He or she can take regular blood tests, especially at the beginning of treatment TEGRETOL. This is normal and should not worry you.
Before you have surgery, including dental or emergency treatment, tell your doctor that you are taking TEGRETOL.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF TEGRETOL?
TEGRETOL, like all drugs, can cause some side effects. They are often mild and occur early in treatment and usually disappear within a few days.
The following side effects usually do not require medical supervision. If they last more than a few days or cause real distress, check with your doctor.
More often: dizziness, drowsiness, nausea, weakness. More rarely, headache, dry mouth.
Rare: constipation, diarrhea, pain in joints and muscles, increased sweating, loss of appetite, hair loss, sexual dysfunction.
Check with your doctor as soon as possible if any of the following side effects. They may require medical attention:
• increased loss of muscle coordination;
• rarely: behavioral changes, confusion, malaise, more frequent seizures, blurred vision, tremors, uncontrollable body movements, uncontrollable eye movements
• rare: vomiting, pruritus, agitation or hostility (especially in the elderly), nausea, difficulty in speaking or slurred speech, depression, anxiety, nervousness or other mood or mental changes, hallucinations, tinnitus or other unexplained sounds in the ears, difficulty breathing, chest pain, fast or unusually slow heartbeat, numbness, tingling in hands and feet, frequent urination, sudden decrease in amount of urine, change in taste.
Immediately consult your doctor or ask one of your relatives to consult with him if any of the following (in rare or rare) side effects. These may be early signs of serious damage to your blood, liver, kidneys or other organs and may need urgent treatment!
• signs such as fever, sore throat, rash, mouth ulcers, swollen glands;
• unexplained bruising, redness or bruising, resulting in bleeding or unexplained skin spots;
• dark urine;
• signs that suggest severe skin reactions such as skin peeling;
• yellowing of the cornea of the eyes or skin;
• swelling of ankles, feet or lower legs;
• disturbances in consciousness.
If you experience other side effects that worry you, talk to your doctor or pharmacist.
Syrup: 5 years from date of manufacture.
Do not use after the expiry date stated on the packaging. Do not forget to return to your doctor or pharmacist any unused medicine.
• Syrup: Keep away from heat and light and stored at a temperature below 30 ° C.
• Keep out of reach of children.