Properties
- Form
- tableti
- Dosage mg
- 100
- Pack
- 30
What is it?
What is LAMICTAL and what is it used for LAMICTAL is a member of the group of medicines called antiepileptics. Blackcurrant scented, white to off-white, multi-faceted and embossed oval tablets, with slight mottling, imprinted with "GSCL7" on one side and "100" on the other. Each box contains 30 tablets in child-resistant blister packs. LAMICTAL is used in the following situations: To treat epilepsy in children aged 2-12 years, for partial seizures and tonic-clonic seizures. It is used in combination with other medicines for generalized seizures, including seizures associated with Lennox-Gastaut syndrome (during convulsive shaking of seizures) and Lennox-Gastaut syndrome (a special epilepsy picture in which various types of seizures are observed). Once the patient's seizures are controlled, use may continue alone. In the treatment of a type of epilepsy called typical absence seizures (symmetric seizures with sudden onset and termination) in children aged 2-12 years. Used alone. In the treatment of epilepsy in children over 12 years of age and adults, for partial seizures and tonic-clonic seizures and is used alone or in combination with other medicines for generalized seizures, including seizures associated with Lennox-Gastaut syndrome. Used to treat bipolar disorder (bipolar mood disorder) in adults over 18 years of age. 2. Before using LAMICTAL Do not use LAMICTAL in the following conditions If you are allergic to lamotrigine and any of the other ingredients of LAMICTAL (see list of excipients at the beginning of the instructions for use) Use LAMICTAL with caution in the following situations Skin rash has been observed, usually within the first 8 weeks of starting LAMICTAL therapy. Most of these rashes are mild and limited, but serious rashes requiring hospitalization and discontinuation of LAMICTAL therapy may also occur. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reactions with eosinophilia and systemic symptoms (DRESS). The risk of serious skin rash is higher in children than in adults. The overall risk of rash increases in the following situations: - High starting doses of LAMICTAL - Exceeding the recommended dose increase during LAMICTAL therapy - Concomitant use of valproate with LAMICTAL Important information about potentially life-threatening reactions A small number of people taking lamotrigine develop an allergic reaction or potentially life-threatening skin reactions that can develop into more serious problems if left untreated. These can be Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to be aware of the symptoms to watch out for when taking LAMICTAL. The initial appearance of a rash in children may be mistaken for an infection. If you have had a rash before after using lamotrigine or other medicines for bipolar disorder or epilepsy. If you have started or stopped using hormonal contraceptives during treatment with LAMICTAL, the effectiveness of the contraceptive may be reduced in female patients using hormonal contraceptives when using LAMICTAL. Menstrual irregularities, such as unexpected bleeding, may occur for this reason. Lamotrigine dosage adjustment may be necessary in such cases. If you have kidney failure. If you have liver disorder. If you are using other preparations containing lamotrigine. If you have had meningitis (inflammation of the meninges) when using lamotrigine. If you have a condition called Brugada syndrome. Brugada syndrome is a genetic disorder resulting from abnormal electrical activity of the heart. ECG abnormalities that can lead to arrhythmias (abnormal heart rhythm) can be caused by lamotrigine. Hemophagocytic lymphohistiocytosis Rarely, but very serious immune system interference has been observed in patients taking lamotrigine. Seek immediate medical attention or consult your doctor or pharmacist if you experience the following symptoms while using LAMICTAL: fever, rash, neurological symptoms (e.g., tremor or shaking, confused state, impaired brain function). In addition, suicidal thoughts and behavior have been reported in patients treated with this medication. Therefore, patients should be closely monitored for suicidal thoughts and behavior. When suicidal thoughts or behavior occur, the patient or relative should be advised to seek medical help: when you first start treatment. If you have ever had thoughts of harming yourself or suicide. If you are under 25 years of age. If you have disturbing thoughts or experiences, or if you feel worse, or develop new symptoms while taking LAMICTAL: consult your doctor as soon as possible or go to the nearest hospital for help. It may help to tell a family member, caregiver, or close friend that you may be depressed or experiencing significant changes in your mood, and ask them to read this leaflet. You can ask them to tell you if they are aware of your depression or other changes in your behavior. Patients with bipolar disorder may be at increased risk of worsening symptoms, suicidal thoughts and behavior, and self-harm. Patients with a history of suicidal thoughts, young people, and patients who have significant suicidal thoughts before starting treatment may be at higher risk. Therefore, patients taking LAMICTAL should be closely monitored, especially at the start of treatment. Due to the risk of rash, the dose should not be exceeded at the start and during subsequent dose increases. In some types of epilepsy, taking lamictal may lead to worsening or more frequent occurrence of seizures. Some patients may experience severe seizures, leading to serious health problems. If your seizures are more frequent or if you have had severe seizures, consult your doctor as soon as possible. LAMICTAL should not be used to treat bipolar disorder in adolescents and children under 18 years of age. Medications used to treat depression (mood disorder) and other mental health problems increase the risk of suicidal thoughts and behavior in children and adolescents under 18 years of age. Please consult your doctor if these warnings apply to you, even in the past at any time. Use of LAMICTAL with food and drink Can be taken on an empty stomach or with food. Pregnancy Before using the medicine, consult your doctor or pharmacist. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide if you can use LAMICTAL during pregnancy. You should not stop treatment without talking to your doctor. This is especially important if you have epilepsy. Pregnancy can alter the effectiveness of LAMICTAL, so blood tests and adjustment of your LAMICTAL dose may be necessary. There may be a small increased risk of birth defects, including cleft lip or palate, if LAMICTAL is taken during the first 3 months of pregnancy. If you are planning to become pregnant and are pregnant, your doctor may recommend taking extra folic acid. If you become pregnant during treatment, consult your doctor or pharmacist immediately. Breastfeeding Before using this medication, consult your doctor or pharmacist. If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. The active substance of LAMICTAL passes into breast milk and may affect your baby. Your doctor will assess the risks and benefits of breastfeeding while using LAMICTAL and will check your baby periodically for lethargy, rash, or slight weight gain if you decide to breastfeed. If you notice any of these symptoms in your baby, inform your doctor immediately. Use of machinery and vehicles LAMICTAL treatment may cause side effects such as dizziness and double vision, so do not drive unless you are sure that the drug does not affect you. If you have epilepsy, consult your doctor about driving. Important information about some of the excipients in LAMICTAL There are no excipients that require a warning. Concomitant use with other medicines Talk to your doctor if you are taking, have recently taken, or might take any other medicines. This also applies to herbal remedies or over-the-counter medicines. Some medicines interact with LAMICTAL or increase the likelihood of people developing side effects. These medicines are: Valproate (treatment of epilepsy and mental health problems). Carbamazepine (treatment of epilepsy and mental health problems) Phenytoin (treatment of epilepsy) Primidone (treatment of epilepsy) Phenobarbital (treatment of epilepsy) Rifampicin (treatment of infection) Risperidone (treatment of mental disorders) Lopinavir/ritonavir or atazanavir and ritonavir (treatment of human immunodeficiency virus (HIV) infection) Ethinylestradiol/levonorgestrel combination (hormonal contraceptives) If you are taking other medicines to treat epilepsy or mental health problems, your doctor should be aware of this to ensure you are taking the correct dose of LAMICTAL. These medicines are: Lithium (treatment of mental disorders) Bupropion (treatment of mental disorders or smoking cessation) Olanzapine (treatment of mental disorders) Oxcarbazepine (treatment of epilepsy) Felbamate (treatment of epilepsy) Gabapentin (treatment of epilepsy) Levetiracetam (treatment of epilepsy) Pregabalin (treatment of epilepsy) Topiramate (treatment of epilepsy) Masna Ristila Zonisamide (treatment of epilepsy) Aripiprazole (treatment of mental disorders) Hormonal contraceptives (such as the pill) can affect how LAMICTAL works. Your doctor may recommend that you use a certain type of hormonal contraceptive or another method of contraception, such as a condom, cap, or coil. If you are using a contraceptive such as the pill, your doctor may take a blood sample to check your LAMICTAL levels. If you are using or planning to use hormonal contraceptives, talk to your doctor who will discuss appropriate contraception with you. LAMICTAL can also affect how hormonal contraceptives work, but it is less likely to make them less effective. If you are using a hormonal contraceptive and notice any changes in your menstrual cycle, such as unexpected bleeding or spotting between periods, consult your doctor. This may be a sign that LAMICTAL is affecting the way your contraceptives work. If you are currently using or have recently used a prescription or over-the-counter medicine, please inform your doctor or pharmacist about them. How to use LAMICTAL? Proper use instructions and dose/frequency of use Always use your medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. Use for the treatment of epilepsy/epilepsy: Adolescents and adults over 12 years of age: The dose used for seizure control is 100 mg to 700 mg, taken once daily or in two divided doses. When you first start taking LAMICTAL, your doctor will give you a much lower dose and then gradually increase the dose over several weeks. Children aged 2-12 years: The dose is calculated based on body weight. Treatment starts with a minimum dose of 0.15-0.6 mg/kg/day once daily or in two divided doses, depending on the medicine taken with LAMICTAL, and the dose is gradually increased to 1-15 mg/kg/day in 1 or 2 divided doses. The dose used alone to treat typical absence seizure type epilepsy in children is 1 mg/kg to 10 mg/kg per day in one or two divided doses. Use for the treatment of bipolar disorder: Adults over 18 years of age: The dose used for bipolar disorder is 100 mg to 400 mg, taken once daily or in two divided doses. When you first start taking LAMICTAL, your doctor will give you a much lower dose and then gradually increase the dose over several weeks. Take LAMICTAL exactly as your doctor tells you. The dose your doctor gives you will depend on whether you are taking other medications. This is especially true for any preparations containing valproate. It is important if you do this. Your doctor or pharmacist will tell you how many tablets to take and when. If a skin rash develops during treatment with LAMICTAL, consult your doctor immediately. It should not be used in children and adolescents under 18 years of age for the treatment of bipolar disorder. Route and method of administration: LAMICTAL can be chewed, dissolved in a small amount of water, or swallowed whole with a small amount of water. Instructions for use of child-resistant blister tablets: Child-resistant blister back: Figure 3 The paper under the blister perforation is removed from the corner by removing the colored triangle indicated by the second arrow. Aluminum foil becomes visible under the paper. Figure 4 The tablet is removed by pressing on the blister. Different age groups Use in children: Use for the treatment of epilepsy/epilepsy: There is no information on use in children under 2 years of age. Do not use in this age group without consulting your doctor. Use for the treatment of bipolar disorder: It should not be used to treat bipolar disorder in adolescents and children under 18 years of age. Use in the elderly: No further dose adjustment is required in this age group. Special cases of use: Use in kidney failure: If you have kidney failure, your doctor will determine the dose of your medication based on the severity of your condition. Use in liver failure: If you have liver failure, your doctor will determine the dose of your medication based on the severity of your condition. Other: Use in patients using hormonal contraceptives: Your doctor will determine the dose of your medication based on the contraceptives you use. If you have the impression that the effect of LAMICTAL is too strong or too weak, consult your doctor or pharmacist. If you use more LAMICTAL than you should: If you take more LAMICTAL than you should, you may experience more serious side effects, which can be fatal. If you take more LAMICTAL than you should, possible side effects include: rapid, involuntary eye movements (nystagmus) clumsiness and lack of coordination affecting your balance (ataxia) decreased or loss of consciousness, seizures (convulsions) or coma changes in heart rhythm (usually detected on ECG) If you take more LAMICTAL than you should, call your doctor immediately or go to the nearest hospital emergency department. If possible, show your medicine box to the hospital. If you have used more LAMICTAL than you should, talk to your doctor or pharmacist. If you forget to use LAMICTAL Do not take extra tablets to make up for a missed dose. Just take the next dose at the usual time. If you forget to take more than one dose of LAMICTAL, consult your doctor for advice on how to restart taking LAMICTAL. It is important that you do this. Ask your doctor what to do if you forget to take a dose. Do not take a double dose to make up for a missed dose. Effects that may occur when treatment with lamictal is stopped. You should take LAMICTAL for as long as your doctor recommends. Do not stop taking LAMICTAL unless your doctor tells you to. In patients treated for epilepsy: Sudden discontinuation of LAMICTAL may cause a recurrence of epileptic seizures. If it is not necessary to stop your medication suddenly for safety reasons (e.g., rash), your doctor will gradually reduce the dose of your medication over 2 weeks. In patients with bipolar disorder: Discontinuation of the dose may be possible without gradual reduction. It may take some time for LAMICTAL to work, so you will not feel better quickly. If you stop taking LAMICTAL, gradual reduction of your dose is not necessary. However, if you wish to stop taking LAMICTAL, you should consult your doctor first. 4. What are the possible side effects? Like all medicines, side effects can occur in people who are sensitive to the substances contained in LAMICTAL. If any of the following occur, stop using LAMICTAL and inform your doctor immediately or go to the nearest hospital emergency department: A small number of people using LAMICTAL may experience an allergic reaction or a potentially life-threatening skin reaction; this can lead to more serious problems if left untreated. These symptoms are more likely to occur in the first few months of LAMICTAL treatment, especially if the starting dose is too high or the dose is increased too quickly, or when LAMICTAL is used with valproate. Some symptoms are more common in children. Therefore, parents should monitor these symptoms with particular care. Symptoms of these reactions include: skin rash or redness; generalized rash and peeling of the skin (Stevens-Johnson syndrome), especially with fluid-filled blisters in the mouth, nose, eyes, and genitals, excessive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis) or liver, blood, or other body organs can become life-threatening skin reactions, including generalized rash (drug reactions with eosinophilia and systemic symptoms, also known as DRESS hypersensitivity syndrome). Sores in the mouth, throat, nose, or genitals. Mouth sores or red or swollen eyes (conjunctivitis). Swelling around the face or swollen neck glands. Fever, flu-like symptoms, or dizziness. Swollen lymph nodes in the neck, armpits, and groin, facial swelling (lymphadenopathy). Sudden bleeding or bruising, or blueness of the fingers (disseminated intravascular coagulation). Sore throat or more infections than usual (e.g., colds). Increased levels of liver enzymes in blood tests. Increase in a type of white blood cell (eosinophils) in the blood. Enlarged lymph nodes. Involvement of body organs, including the liver and kidneys. In many cases, these symptoms will be signs of less serious side effects. However, you should remember that these side effects are potentially life-threatening and can lead to more serious problems. If you notice any of these symptoms, inform your doctor immediately. Your doctor may decide to perform liver, kidney, or blood tests and tell you to stop using LAMICTAL. If you have had Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will no longer prescribe LAMICTAL. Hemophagocytic lymphohistiocytosis (HLH) (see Section 2: Before using LAMICTAL) These are very serious side effects. You may need emergency medical attention or hospitalization. All these very serious side effects are very rare. Side effects are listed in the following categories: Very common: May affect more than 1 in 10 people. Common: Affects less than 1 in 10 people but more than 1 in 100 people. Uncommon: Affects less than 1 in 100 people but more than 1 in 1000 people. Rare: Affects less than 1 in 1000 people but more than 1 in 10000 people. Very rare: May affect less than 1 in 10000 people. Unknown: Cannot be estimated from the available data. Widespread: Headache. Skin rash. Common: Irritation or redness. Drowsiness or dizziness. Feeling dizzy. Tremor or shaking. Difficulty sleeping (insomnia). Feeling anxious. Diarrhea. Dry mouth. Nausea or vomiting. Feeling tired. Pain in the back or joints or other areas. Uncommon: Clumsiness and lack of coordination (ataxia). Double or blurred vision. Unusual hair loss and thinning (alopecia). Rare: Rapid, involuntary eye movements (nystagmus). Aseptic meningitis (a group of symptoms including fever, nausea, vomiting, headache, stiff neck, and hypersensitivity to bright light) includes. This is caused by inflammation of the membrane covering the brain and spinal cord. These symptoms usually disappear after stopping treatment. But if symptoms persist or worsen, consult your doctor. Life-threatening skin reactions (Stevens-Johnson syndrome): (see Section 4 beginning for information). Itchy eyes, discharge, and on the eyelids (conjunctivitis). Very rare: Life-threatening skin reaction (toxic epidermal necrolysis), characterized by excessive peeling of the skin: (see Section 4 for information). See beginning) Multiple organ failure or sudden bleeding, severe blood clotting disorder (disseminated intravascular coagulation), which can lead to bruising. Intravascular coagulation): (see Section 4 beginning for information). Facial swelling (edema) or swelling of glands in the neck, armpits, or groin (lymphadenopathy): (see Section 4 beginning for information). High fever: (see Section 4 beginning for information). In patients with epilepsy, increased epileptic seizures. Involuntary body movements (tics), involuntary muscle spasms (choreoathetosis) or tremors affecting the eyes, head, and trunk. Unusual body movements such as tremor or stiffness. Feeling of imbalance. Confusion (disorientation). Seeing or hearing things that are not there (hallucinations). Worsening of Parkinson's disease symptoms. Lupus-like reaction (symptoms: back and joint pain accompanied by fever and poor general health). Reduced number of white blood cells (neutropenia, leukopenia, agranulocytosis). Changes in liver function tests or liver failure: (see Section 4 beginning for information). Reduced number of red blood cells (anemia). Reduced number of platelets in the blood (thrombocytopenia). Reduced number of all blood cells (pancytopenia). Bone marrow disorder (aplastic anemia). Drug reaction with increased number of eosinophils (a type of allergic cell) in the blood (eosinophilia) and systemic symptoms (DRESS): (see Section 4 beginning for information). Hemophagocytic lymphohistiocytosis (HLH) (developed as a result of overstimulation of the immune system and with findings in various systems). A severe hereditary disease that manifests itself) (see Section 2: Before using LAMICTAL). Unknown: Seeing nightmares. Reports of osteopenia and osteoporosis (bone thinning) and bone disorders, including fractures, have been received. For a long time, consult your doctor or pharmacist if you are taking antiepileptic drugs, have a history of osteoporosis, or are taking steroids. Low levels of antibodies called immunoglobulins in the blood, which help protect against infections due to impaired immunity. Storage of LAMICTAL Store LAMICTAL out of reach of children and in its packaging. Store below 30°C in a dry, light-protected place. Use according to expiry dates. Do not use LAMICTAL after the expiry date indicated on the packaging. Do not dispose of expired or unused medicines! Hand them over to the collection system determined by the Ministry of Environment and Urbanization.
