Product Details

What you need to know before you take Lamotrigine Tablets

DO NOT take Lamotrigine Tablets • if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6). Lamotrigine 100 mg tablets • if you are allergic to lamotrigine, sunset yellow aluminium lake or any of the other ingredients of this medicine (listed in section 6). If this applies to you: → Tell your doctor, and don’t take Lamotrigine Tablets Warnings and precautions Talk to your doctor or pharmacist before taking Lamotrigine • if you have any kidney problems • if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy; or if you experience a rash or sunburn after taking lamotrigine and having been exposed to sun or artificial light (e.g. solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself against the sun (e.g., use of a sunscreen and/or to wear protective clothing). • if you have ever developed meningitis after taking lamotrigine (read the description of these symptoms in Section 4 of this leaflet: Rare side effects) • if you are already taking medicine that contains lamotrigine. If any of these applies to you: → Tell your doctor, who may decide to lower the dose, or that Lamotrigine Tablets is not suitable for you. Brugada syndrome Brugada syndrome is a genetic disease that results in abnormal electrical activity within the heart. ECG abnormalities which may lead to arrhythmias (abnormal heart rhythm) can be triggered by lamotrigine. Talk to your doctor, if you have this condition. Haemophagocytic lymphohistiocytosis (HLH) There have been reports of a rare but very serious immune system reaction, in patients taking lamotrigine. Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. shaking or tremor, confusional state, disturbances of brain function). Important information about potentially serious reactions A small number of people taking Lamotrigine get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking lamotrigine. → Read the description of these symptoms in section 4 of this leaflet under ‘Potentially life-threatening reactions: get a doctor’s help straight away’. Thoughts of harming yourself or suicide Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide. If you have bipolar disorder, you may be more likely to think like this: • when you first start treatment • if you have previously had thoughts about harming yourself or about suicide • if you are under 25 years old. If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you’re taking Lamotrigine: → See a doctor as soon as possible or go to the nearest hospital for help. You may find it helpful to tell a family member, caregiver or close friend that you can become depressed or have significant changes in mood, and ask them to read this leaflet. You might ask them to tell you if they are worried about your depression or other changes in your behaviour. A small number of people being treated with anti-epileptics such as Lamotrigine Tablets have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. If you’re taking Lamotrigine Tablets for epilepsy The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking Lamotrigine Tablets. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often, or if you experience a severe seizure while you’re taking Lamotrigine Tablets: → See a doctor as soon as possible. Lamotrigine Tablets should not be given to people aged under 18 years to treat bipolar disorder. Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years. Other medicines and Lamotrigine Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines – including herbal medicines or other medicines you bought without a prescription. Your doctor need to know if you are taking other medicines to treat epilepsy or mental health problems. This is to make sure you take the correct dose of Lamotrigine. These medicines include: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy • lithium,olanzapine or aripiprazole, used to treat mental health problems • bupropion, used to treat mental health problems or to stop smoking → Tell your doctor if you are taking any of these. Some medicines interact with Lamotrigine Tablets or make it more likely that people will have side effects. These include: • valproate, used to treat epilepsy and mental health problems • carbamazepine, used to treat epilepsy and mental health problems • phenytoin, primidone or phenobarbitone, used to treat epilepsy • risperidone, used to treat mental health problems • rifampicin, which is an antibiotic • medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir) • hormonal contraceptives, such as the Pill (see below). → Tell your doctor if you are taking any of these, or if you start or stop taking any. Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine Tablets works Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil. If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamotrigine Tablets. If you are using a hormonal contraceptive, or if you plan to start using one: → Talk to your doctor, who will discuss suitable methods of contraception with you. Lamotrigine Tablets can also affect the way hormonal contraceptives work, although it’s unlikely to make them less effective. If you are using a hormonal contraceptive, and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods: → Tell your doctor. These may be signs that Lamotrigine Tablets is affecting the way your contraceptive is working. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine • You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy. • Pregnancy may alter the effectiveness of Lamotrigine, so you may need blood tests and your dose of Lamotrigine may be adjusted. • There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if Lamotrigine is taken during the first 3 months of pregnancy. • Your doctor may advise you to take extra folic acid if you’re planning to become pregnant and while you’re pregnant. → If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. The active ingredient of Lamotrigine Tablets passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while you’re taking Lamotrigine Tablets, and will check your baby from time to time, whether drowsiness, rash or poor weight gain occurs if you decide to breast-feed. Inform your doctor if you observe any of these symptoms in your baby. Driving and using machines Lamotrigine Tablets can cause dizziness and double vision. → Don’t drive or operate machines unless you are sure you’re not affected. If you have epilepsy, talk to your doctor about driving and using machines. Lamotrigine Tablets tablets contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Lamotrigine Tablets 100 mg tablets contain sunset yellow aluminium lake, which may cause allergic reactions. Lamotrigine tablets contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free