Patient Medication Information: uses, side effects, how to take - Lamotrigine-25
Serious Warnings and Precautions
Serious Skin Rashes:
While taking LAMOTRIGINE, some people have developed serious skin reactions and have had to go to the hospital. There is a higher risk of developing a serious skin rash if you:
- take more tablets than your doctor has told you to.
- are taking valproic acid.
- have a history of allergy or rash to other medications used to treat epilepsy.
Symptoms of a serious skin reaction may include:
- blistering or peeling of the skin that may start around the eyes, lips, mouth or genitals
- swelling of the face and/or tongue
- swollen lymph nodes
- hives
- fever
In children, a serious skin reaction can be mistaken for an infection. If you or your child develops a rash and fever while taking LAMOTRIGINE, contact your doctor immediately.
What is LAMOTRIGINE used for?
LAMOTRIGINE is used in adults and children (who weigh at least 9 kg) to control epilepsy. Please follow your doctor's recommendations carefully.
How does LAMOTRIGINE work?
LAMOTRIGINE works by stopping your brain from releasing chemicals that are thought to be a cause of seizures. This helps to control epileptic seizures.
What are the ingredients in LAMOTRIGINE?
Medicinal ingredient: Lamotrigine
Non-medicinal ingredients: Colloidal silicon dioxide, ferric oxide yellow (150 mg tablets only), magnesium stearate, microcrystalline cellulose, sodium starch glycolate and yellow aluminum lake (100 mg tablets only)
LAMOTRIGINE comes in the following dosage forms:
Tablets: 25 mg, 100 mg and 150 mg of lamotrigine.
Do not use LAMOTRIGINE if:
- you are allergic to lamotrigine or to any of the other ingredients of LAMOTRIGINE (see What are the ingredients in LAMOTRIGINE?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you/your child take LAMOTRIGINE. Talk about any health conditions or problems you may have, including if you or your child:
- Are taking any other antiepileptic drugs.
- Are already taking lamotrigine or have previously taken lamotrigine, but had to stop taking it.
- Have ever had a rash during previous treatment with lamotrigine or with any other antiepileptic drug.
- Have ever had meningitis.
- Are pregnant or are planning to become pregnant. LAMOTRIGINE can cause birth defects if taken during pregnancy.
- Are breast-feeding. Lamotrigine passes into breast milk and may cause side-effects in a breast-fed baby.
- Are taking oral birth control pills or other female hormonal products.
- Have liver, kidney or heart disease.
- Have a family history of sudden cardiac death or suffer from a condition called Brugada syndrome (a genetic disease that affects the heart), or other heart problems (including problems with your heart rhythm).
- Consume alcohol on a regular basis.
- Have/has repeated infections.
- Have had genetic testing and been told that you or your child are positive for the HLA-B*1502 allele, usually in people from Asian origin (mainly Han Chinese and Thai). The risk of serious skin reactions with lamotrigine may be associated with this genetic variant.
Other warnings you should know about:
Stopping your treatment: Do NOT suddenly stop taking LAMOTRIGINE without talking to your healthcare professional first. If you do this, it may cause you to have more seizures. Stopping your treatment must be a gradual process that you discuss with your healthcare professional.
Pregnancy: LAMOTRIGINE may harm your unborn baby. Only take LAMOTRIGINE during pregnancy if you and your doctor have discussed the risks and have decided that you should. If you become pregnant while taking LAMOTRIGINE, talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/.
Suicidal thoughts and behaviour: If you have thoughts of harming or killing yourself at any time, contact a healthcare professional or go to a hospital right away. You may find it helpful to tell a relative or close friend how you are feeling and ask them to tell you if they notice any changes in your behaviour.
Driving and using machines: Patients with uncontrolled epilepsy should not drive or operate machinery. LAMOTRIGINE may cause you to feel dizzy, drowsy, have poor coordination and/or blurred vision. Avoid doing tasks which require special attention until you know how LAMOTRIGINE affects you.
Tell your healthcare professional about all the medicines you/your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LAMOTRIGINE:
- Other medications used to treat epilepsy such as, valproic acid (valproate), carbamazepine, phenytoin, phenobarbital, primidone.
- Risperidone, used to treat psychotic disorders (e.g., schizophrenia, bipolar disorder).
- Rifampin, an antibiotic used to treat bacterial infections.
- Procainamide, used to treat heart rhythm problems.
- Metformin, used to treat diabetes.
- Combination of lopinavir and ritonavir, or atazanavir and ritonavir, used in the treatment of HIV/AIDS.
- Birth control pills or other female hormonal products.
- Acetaminophen (rarely, cases of seizure have been reported).
- Any medications that affect your heart rhythm.
- Zonisamide (not available in Canada), used to treat epilepsy and Parkinson’s disease.
Do not start or stop using birth control pills or other female hormonal products, without consulting with your doctor.
Tell your doctor as soon as possible if you experience changes in your menstrual pattern (e.g., break-through bleeding) while taking LAMOTRIGINE and birth control pills or other female hormonal products.
LAMOTRIGINE may interfere with some laboratory tests to detect other drugs. If you require a laboratory test, tell the healthcare professional that you are taking LAMOTRIGINE.
How to take LAMOTRIGINE:
- Take LAMOTRIGINE exactly as your healthcare professional has told you to.
- Do not stop taking LAMOTRIGINE suddenly as this can increase the number of seizures you have and their severity.
- It is important to keep your appointments for medical checkups.
LAMOTRIGINE can be taken with or without food.
Tablets: swallow tablets whole, do NOT chew or crush them.
Usual dose:
Your healthcare professional will decide the best dose of LAMOTRIGINE for you. They may increase or decrease the dose depending on your response to the medication. Carefully follow the instructions you were given. Do not change your dose unless your healthcare professional tells you to.
Overdose:
If you think you, or a person you are caring for, have taken too much LAMOTRIGINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose, take it as soon as you remember. However, if your next dose is less than 4 hours away, skip the missed dose and take the next dose at the normal time. Do not try to make up for it by doubling up on the next dose. Try not to miss any more doses. Ask your healthcare professional for advice on how to start taking it again, even if you only stop for a few days.
What are possible side effects from using LAMOTRIGINE?
These are not all the possible side effects you may have when taking LAMOTRIGINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of LAMOTRIGINE include:
- double vision, blurred vision;
- headache;
- tremor, poor coordination;
- dizziness;
- nausea, vomiting, upset stomach;
- chest pain;
- pain in your neck, abdomen, or joints;
- feeling of weakness or tiredness (fatigue);
- sleepiness/drowsiness;
- difficulty sleeping (insomnia);
- nasal congestion;
- skin rash;
- aggression, agitation or irritability;
- anxiety;
- nightmares.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Skin rashes or redness | √ | ||
| COMMON | |||
| Worsening seizures: seizures happening more often in people who already have epilepsy | √ | ||
| UNCOMMON | |||
| Photosensitivity reaction: increased sensitivity of the skin to sunlight, exaggerated sun burn | √ | ||
| RARE | |||
| Aseptic meningitis (inflammation of the protective lining of the brain): fever, nausea, vomiting, sudden | √ | ||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| headache or stiff neck and extreme sensitivity to bright light | |||
| Choreoathetosis (a movement disorder): abnormal uncontrollable muscle movements that may involve the face, eyes, nose, mouth/tongue, neck, trunk, arms or legs | √ | ||
| Conjunctivitis (eye infection): itchy, red eyes with discharge, swelling and crusty eyelids | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blisters or crust in the center; possibly swollen lips, mild itching or burning | √ | ||
| Severe skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body | √ | ||
| VERY RARE | |||
| Blood problems: feeling very tired, fast heartbeat, shortness of breath, muscle weakness | √ | ||
| Haemophagocytic lymphohistiocytosis (HLH) (a serious overactive immune system condition that can lead to death): a high temperature (fever), skin rashes, trouble walking or seeing, and fits (seizures) for the first time or happening more often, enlarged liver and/or spleen with pain and/or tenderness in the region | √ | ||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| towards the top of the stomach, yellowing of the skin and/or eyes, swollen glands in the neck, armpit and/or groin, bleeding and/or bruising more easily; looking pale, feeling unusually tired | |||
| Hallucinations (seeing or hearing things that aren’t really there) | √ | ||
| Kidney problems: inflammation of the kidney felt as pain in the lower back and/or pain with urination (tubulointerstitial nephritis), which may occur with inflammation of the eye causing pain and/or visual disturbances (uveitis) | √ | ||
| Liver problems: yellowing of the skin and eyes, right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness, unexplained loss of appetite | √ | ||
| Lymphadenopathy (swollen lymph nodes): swelling of the face or swollen glands in the neck, armpits or groin | √ | ||
| Pseudolymphoma (a non-cancerous skin condition that looks like lymphoma): red nodules or patches on the skin | √ | ||
| Serious blood clotting disorder (where you develop small blood clots throughout your body): unexpected or prolonged bleeding, including from your gums or nose, swelling with redness or pain in the area, bruising, blood in urine | √ | ||
| UNKNOWN FREQUENCY | |||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (a serious skin reaction that can lead to death, it that may affect one or more organs): fever, severe rash, peeling skin, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine | √ | ||
| Multi-organ failure (failure of multiple organs such as the lungs, kidneys, heart, at the same time, this can lead to death): nausea or vomiting, less urine production, swelling of the ankles and feet, chest pain, difficulty breathing (at rest or with activity), seizures | √ | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle tenderness, weakness, red-brown (tea-coloured) urine | √ | ||
| Thoughts of suicide or hurting yourself | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
Store your LAMOTRIGINE tablets at room temperature (15°C to 30°C) in tight containers, in a dry place and protected from light. Cap the bottle tightly immediately after use.
Keep out of reach and sight of children.
If you want more information about LAMOTRIGINE:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting Pro Doc Ltée : 1-800-361-8559, www.prodoc.qc.ca, medinfo@prodoc.qc.ca.
Laval, Quebec, H7L 3W9