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What is in your medicine?
The active substance in Trileptal tablets called oxcarbazepine. Oxcarbazepine is an anticonvulsant drug designed to help control seizures or in patients who have epilepsy.
Your tablets are available in three different types in terms of their potency, containing 150 mg, 300 mg or 600 mg oxcarbazepine. This 150 mg is slightly gray-green, oval, with marked off both sides and marked "T / D" on one side and "CG" on the other. The 300 mg tablet is yellow, oval, with marked off both sides and marked "TE / TE" on one side and "CG / CG" on the other side. 600 mg tablet is slightly pink, oval, with marked off both sides and marked "TF / TF" on one side and "CG / CG" on the other.
Your tablets contain the following inactive ingredients: colloidal anhydrous silica gel, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, talc, titanium dioxide (E 171), yellow iron oxide (E172) for those of 150 mg and 300 mg, black iron oxide ( E172) for these 150 mg and 600 mg, red iron oxide (E172) for these 150 mg and 600 mg, macrogol 4000 for those of 150 mg and 600 mg macrogol 8000 and only those of 300 mg.
Trileptal can be used alone or together with other anti-epileptic lekarstva.Ako necessary, the tablets can be broken in half to swallow.
Tablets are available in blister packages of 50 tablets.
Who produces your medicine
Novartis Pharma S.p.A., Via Provinciale Schito, 131, I-80058 Torre Annunziata, Italy.
Marketing Authorisation Holder
Novartis Pharma Services Inc., Lichtstrasse 35, CH-4056, Basel, Switzerland
Before taking Trileptal tablets
Tell your doctor before you start taking Trileptal tablets if you answer "yes" to any of the questions below:
• Have you ever had an unusual sensitivity (rash or any other sign of allergy) to oxcarbazepine or any of the other ingredients in your tablets listed in the "What's in your medicine?"
• Have you ever had an unusual sensitivity (rash or any other sign of allergy) to carbamazepine or any other drugs?
• Are you pregnant, breast-feeding you plan to become pregnant (see also section "Other special precautions")?
Do you now or have you ever had:
• Severe kidney disease?
• Severe liver disease?
• Low levels of sodium in the blood?
• Heart disease?
Are you taking any other medicines?
Before taking any other medicine while taking Trileptal, talk to your doctor or pharmacist. This applies to medicines dispensed by prescription, and those without a prescription, especially:
• Oral contraceptives (birth control pills) (see "Other special precautions")
• Other antiepileptic drugs (particularly phenobarbitone, phenytoin or carbamazepine)
• Drugs that may decrease levels of sodium in your blood, for example. diuretics (drugs that increase the excretion of urine), desmopressin and non-steroidal anti-inflammatory drugs (NSAIDs, eg. indomethacin)
• immunosuppressive drugs, e. cyclosporine
Other special warnings
• Do not stop taking Trileptal without consulting your doctor first. To prevent sudden worsening of your seizures, never stop suddenly taking your medicine.
• In rare cases, Trileptal may cause a drop in the level of sodium in your blood, which may, but may not be accompanied by symptoms. If you experience symptoms of sodium deficiency (see "After taking your medicine") tell your doctor.
• In the event of an allergic reaction such as severe skin reactions (such as rash or blistering, consult your doctor immediately or go to the emergency room of the nearest hospital. If you are allergic to carbamazepine, the chance of an allergic reaction to oxcarbazepine is one in four (25%).
• Trileptal tablets may make you feel dizzy or sleepy, and if so, can be dangerous to drive or operate machinery.
• If you drink alcohol while taking Trileptal tablets, the combination can make you too sleepy. Then you will need extra care.
• If you are a woman taking oral contraceptives (the pill), Trileptal may make the pill less effective. You should talk to your doctor about using a different or additional non-hormonal method of contraception while taking Trileptal. Tell your doctor immediately if you get irregular vaginal bleeding or spotting.
• You should talk to your doctor if you are pregnant, breastfeeding or planning to become pregnant. It is important to control epileptic seizures during pregnancy.
Use in children
Trileptal is only suitable for children over six years old. How to take your lekarstvoPriemayte your medicine exactly as you have been told by your doctor or pharmacist.
Trileptal should be taken twice a day, every day, unless your doctor tells you otherwise. Taking the tablets at the same time each day will have the best effect on controlling your epilepsy. This will also help you remember when to take the tablet (s).
Your doctor will tell you how long your treatment / your child's treatment with Trileptal. The duration of treatment is based on your type of seizure / seizures of your child. You can have long-term treatment for years to control the seizures. Do not change your dose or stop treatment without first talking to your doctor.
The usual starting dose of Trileptal for adults (including elderly patients) is 600 mg per day. Take one 300 mg tablet twice a day or two 150 mg twice a day. Your doctor may increase your dose gradually if necessary, to achieve the best results. This usually occurs at doses between 600 mg and 2400 mg per day.
The dosage is the same if Trileptal is taken with another antiepileptic drug.
If you have kidney problems, your doctor will usually start your treatment with half the usual starting dose and may slow to rise.
The dosage for children (over six years) depends on their weight. The starting dose is 8-10 mg / kg body weight per day, "divided into two portions. For example, a 30 kg child would start treatment with a single dose of 150 mg twice a day. If necessary, this dose may be increased gradually to achieve the best results. The usual maintenance dose is 30 mg / kg body weight per day. The maximum dose for children is 46 mg / kg body weight den.Ako not sure about the dose of your child, your doctor or pharmacist will They can help.
Your doctor may take a blood sample during your treatment period in order to monitor your levels of sodium.
If you or a child accidentally take too large a dose of this medicine, contact your doctor or the emergency department of the nearest hospital.
If you forget to take only one dose, take it as quickly as soon as you remember. However, if time or very little time for the next dose, do not take the missed dose. Just go back to your regular dosing timetable. Never take a double doza.Ako have forgotten to take several doses, contact your doctor. Once you take your medicine
Like most drugs in addition to beneficial effects, Trileptal can have side effects.
Immediately contact your doctor or visit the emergency department of the nearest hospital (or make sure someone else can do it for you) if you develop any of the following side effects:
• Swelling of the lips, face or neck, accompanied by difficulty in breathing, speaking or swelling (signs of angioedema) or other signs of hypersensitivity reactions such as skin rash, fever and joint pain.
• Severe blistering of the skin and / or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of syndrome of Steven Johnson).
• Fever, sore throat, sores in the mouth, unexplained bruising, reddish or purplish patches, or unexplained blotches on the skin (signs of decreased number of platelets in the blood, or low white blood cells).
• Rash in the form of red spots on the face, which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of systemic lupus erythematosus).
• lethargy, confusion, muscle twitching or significant worsening of convulsions (symptoms of low sodium levels in the blood) (see "Other special precautions").
• Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (signs of hepatitis).
• Severe abdominal pain with or without vomiting (signs of inflammation of the pancreas)
These are signs of a rare but potentially serious side effects that require urgent medical treatment.
If you experience any of the following side effects, contact your doctor as soon as possible since they may require medical vnimanie.Treperene, loss of muscle coordination, involuntary eye movements, feelings of anxiety or nervousness, feeling depression, rash or abnormal (fast or too slow) heart udari.Kazhete your doctor if you have any of the following and then you worry: Fatigue, headache, dizziness, nausea, vomiting, double vision, weakness, drowsiness, memory impairment , impaired concentration, apathy, agitation, confusion, blurred vision, constipation, diarrhea, abdominal pain, acne and hair loss.
These side effects of Trileptal are mostly transient and usually disappear vremeto. Some people may have other side effects that have not been described so far and not mentioned in this leaflet. Tell your doctor if you notice anything else that makes you feel unwell.
Caring for your medicine
• Do not use Trileptal after the expiry date printed on the carton and blister.
• Return any unused tablets to your pharmacy for safe destruction.
• Keep Trileptal out of reach of children.
• Store at temperatures below 30 ° C
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