Details for: AURO-LAMOTRIGINE
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02381354 | AURO-LAMOTRIGINE | LAMOTRIGINE | 25 MG | TABLET | ORAL |
| 02381362 | AURO-LAMOTRIGINE | LAMOTRIGINE | 100 MG | TABLET | ORAL |
| 02381370 | AURO-LAMOTRIGINE | LAMOTRIGINE | 150 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AURO-LAMOTRIGINE has been prescribed to you/your child to control your/their epilepsy. Please follow your doctor's recommendations carefully.
What it does
AURO-LAMOTRIGINE affects chemicals in the brain that are involved in sending signals to the nerves. AURO-LAMOTRIGINE helps to control epileptic seizure.
When it should not be used
Do NOT take or use AURO-LAMOTRIGINE if you are hypersensitive (allergic) to lamotrigine or any of the other ingredients of AURO-LAMOTRIGINE tablets (see What the nonmedicinal ingredients are).
What the medicinal ingredient is
lamotrigine
What the non-medicinal ingredients are
AURO-LAMOTRIGINE contains Microcrystalline Cellulose, Lactose Monohydrate, Povidone, Sodium Starch Glycolate, Magnesium Stearate, FD& C Yellow No. 6 (100 mg tablet) and Ferric Oxide Yellow (150 mg tablet).
What dosage form it comes in
AURO-LAMOTRIGINE is available in 25 mg, 100 mg and 150 mg tablets.
Warnings and precautions
Serious Warnings and Precautions – Serious Skin Rashes
Serious skin rashes requiring hospitalization have occurred with the use of lamotrigine. Symptoms include blistering, peeling of the lips, eyes, mouth or genitals, swelling of the face and/or tongue, hives, swollen lymph nodes and fever. If you or your child develops these symptoms seek immediate medical help.
In children serious skin rashes can be mistaken for an infection. If your child develops a rash and fever while taking AURO-LAMOTRIGINE contact your doctor immediately.
Do NOT take more tablets than has been prescribed by your doctor. There is a higher chance of serious skin reactions occurring when more than the recommended number of tablets is taken.
There is a higher chance of developing a serious skin rash if you have a history of allergy or rash to other anti-epileptic drugs. If you or your child has had a serious skin reaction or allergy to another anti-epileptic drug you must tell your doctor.
BEFORE you use AURO-LAMOTRIGINE talk to your doctor or pharmacist if you or your child
- Ever had an unusual or allergic reaction to AUROLAMOTRIGINE.
- Are/is allergic to any component of AUROLAMOTRIGINE tablets.
- Have ever had a rash during previous treatment with lamotrigine or with any other antiepileptic drug.
- Have ever developed meningitis after taking lamotrigine.
- Are/is pregnant or are planning to become pregnant. There is a risk of malformations (e.g. cleft lip or cleft palate) associated with the use of AUROLAMOTRIGINE in the first few months of pregnancy. Taking folic acid when planning pregnancy and during early pregnancy may be considered. If you take AURO-LAMOTRIGINE while pregnant, you may register yourself at the North American Antiepileptic Drug Pregnancy Registry (see contact number at the end of this information).
- Are/is breast-feeding (nursing). AUROLAMOTRIGINE passes into breast milk and may cause side-effects in a breast-fed baby. If the decision by you and your healthcare provider is to breast-feed while taking AURO-LAMOTRIGINE, watch your baby closely for symptoms such as trouble breathing, episodes of temporarily stopping breathing, sleepiness, rash, poor weight gain or poor sucking. Call your baby’s healthcare provider right way if you see any of these problems.
- Are/is taking any other prescription or over-thecounter medicine, including birth control pills or other female hormonal products.
- Have/has liver, kidney disease, heart problems or other medical conditions.
- Have a family history of sudden cardiac death or suffer from a condition called Brugada syndrome (a genetic disease that affects the heart).
- Consume alcohol on a regular basis.
- Have/has repeated infections.
- Are/is allergic to a yellow dye called FD&C Yellow No. 6 lake.
A small number of people taking AUROLAMOTRIGINE get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems such as organ failure if not treated. You need to know the symptoms to look out for while you are taking AURO-LAMOTRIGINE. Please read the Serious Side Effects, How Often Do They Happen and What to do About Them section of this leaflet for more information.
A very small number of patients taking AUROLAMOTRIGINE may experience a serious condition (haemophagocytic lymphohistiocytosis or HLH), in which part of the body that fights disease is overactive. If you have any of the side effects, contact your doctor immediately because, if not recognized early, this condition can be life-threatening. Please read the Serious Side Effects, How Often Do They Happen and What to do About Them table in this leaflet for more information and list of side effects.
There have been a small number of reports of suicidal behaviour (including suicidal thoughts and suicide attempts) in patients being treated with anti-epileptic medicines such as AURO-LAMOTRIGINE. If at any time you have these thoughts, contact your doctor immediately. Do not discontinue AUROLAMOTRIGINE on your own.
The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking AURO-LAMOTRIGINE. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often or if you experience a more severe seizure while you’re taking AURO-LAMOTRIGINE, contact a doctor as soon as possible
Do not stop taking/giving AURO-LAMOTRIGINE unless directed by your doctor. Always check that you have an adequate supply of AURO-LAMOTRIGINE. Remember that this medicine was prescribed only for you/your child; never give it to anyone else.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for AURO-LAMOTRIGINE, make sure you can read it clearly and talk to your pharmacist to check that you are given the correct medicine.
Driving and using machines: Patients with uncontrolled epilepsy should not drive or operate machinery. Before doing tasks which require special attention, wait until you know how you respond to AURO-LAMOTRIGINE. Dizziness, poor coordination, drowsiness, double vision and blurred vision have been reported in people taking AURO-L
Interactions with this medication
Consult your doctor before taking/giving your child any other medication, including over-the-counter medicines, herbal and alternative medicines. Some drugs can produce various side effects when they are used in combination with AURO-LAMOTRIGI
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 AURO-LAMOTRIGINE and birth control pills or other female hormonal products.
AURO-LAMOTRIGINE may interfere with some laboratory tests to detect other drugs. If you require a laboratory test, tell your doctor or hospital that you are taking AURO-LAMOTRIGINE.
Drug-Drug Interactions
Drugs that may interact with AURO-LAMOTRIGINE include:
- Valproic acid (valproate)
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
- Risperidone
- Rifampin
- Procainamide
- Metformin
- Combination of lopinavir and ritonavir, or atazanavir and ritonavir
- Birth control pills or other female hormonal products.
- Acetaminophen (rarely, cases of seizure have been reported)
Proper use of this medication
Usual Dose
It is very important that you/your child take AUROLAMOTRIGINE exactly as your doctor instructed.
Your doctor may increase or decrease your/your child’s
medication according to your/their specific needs.
Carefully follow the instructions you were given. Do not
change the dose yourself.
If you plan to start or stop taking hormonal
contraceptives or other female hormonal products, your
doctor will give you specific instructions on the dose of
AURO-LAMOTRIGINE.
Do not stop taking your medication abruptly, because your/your child’s seizures may increase. Speak to your doctor before stopping AURO-LAMOTRIGINE.
It is important to keep your/your child’s appointments for medical checkups.
AURO-LAMOTRIGINE may be taken with or without food.
AURO-LAMOTRIGINE tablets should be swallowed whole and should not be chewed or crushed.
Overdose
If you think you have taken too much AUROLAMOTRIGINE contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you/your child happen to miss a dose, take it as soon as you remember. 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 doctor for advice on how to start taking it again, even if you only stop for a few days.
Side effects and what to do about them
Side effects include:
- double vision, blurred vision
- headache
- tremor, poor coordination
- dizziness
- nausea, vomiting, stomach upset
- 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
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
| Skin rashes or redness | ✔ | ||
| Rare | |||
| Severe Skin Reactions: skin rashes or redness developing into wide spread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals, sore mouth or eyes, a high temperature (fever), flu-like symptoms or drowsine | ✔ | ||
| Choreoathetesis: abnormal uncontrollable muscle movements that may involve the face, eyes (nystagmus), neck, trunk, arms or legs. | ✔ | ||
| Conjunctivitis: itchy eyes with discharge and crusty eyelids | ✔ | ||
| Aseptic meningitis: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light | ✔ | ||
| Very Rare | |||
| Hallucinations: seeing or hearing things that aren’t really there | ✔ | ||
| Nightmares | ✔ | ||
| Liver and blood problems: yellowing of the skin, itching, abdominal pain and/or tenderness, feeling very tired, unexpected bleeding or bruising or the fingers turning blue, a sore throat or more infections (such as colds) than usual | ✔ | ||
| Lymphadenopathy: swelling of the face or swollen glands in the neck, armpits or groin | ✔ | ||
| Serious blood clotting disorder: unexpected or prolonged bleeding, including from your gums or nose; blood in your urine; and unexpected bruising, including in the form of small dots on the skin. | ✔ | ||
| Serious immune system condition: (haemophagocytic lymphohistiocytosis or HLH): 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 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 | ✔ | ||
| 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) | ✔ | ||
| Not known | |||
| Thoughts of suicide or hurting yourself | ✔ | ||
| Seizures happening more often in people who already have epilepsy | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AUROLAMOTRIGINE contact your doctor or pharmacist.
How to store
- Stored in at room temperature between 15-30°C.
- Keep all medicines out of the sight and reach of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about AUROLAMOTRIGINE:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this consumer information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648- 6681.
This leaflet was prepared by Auro Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada.
Date of revision: August 26, 2020