Lamictal (Lamotrigine)

Serious Warnings and Precautions—Serious Skin Rashes

Serious skin rashes requiring hospitalization have occurred with the use of LAMICTAL. 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 LAMICTAL 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 LAMICTAL talk to your doctor or pharmacist if you or your child:

• Ever had an unusual or allergic reaction to LAMICTAL.
• Are/is allergic to any component of LAMICTAL 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 LAMICTAL in the first few months of pregnancy. Taking folic acid when planning pregnancy and during early pregnancy may be considered. If you take LAMICTAL 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). LAMICTAL 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 LAMICTAL, watch your baby closely for symptoms such as trouble breathing, episodes of temporarily stopping breathing, sleepiness 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-the-counter medicine, including birth control pills or other female hormonal products.
• Have/has liver, kidney disease, heart problems or other medical conditions.
• Consume alcohol on a regular basis.

A small number of people taking LAMICTAL 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 LAMICTAL. Please read the Serious Side Effects, How Often They Happen and What to Do About Them section of this leaflet for more information.

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 LAMICTAL. If at any time you have these thoughts, contact your doctor immediately. Do not discontinue LAMICTAL on your own.

The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking LAMICTAL. 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 LAMICTAL, contact a doctor as soon as possible.

Do not stop taking/giving LAMICTAL unless directed by your doctor. Always check that you have an adequate supply of LAMICTAL. 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 LAMICTAL, 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 LAMICTAL. Dizziness, poor coordination, drowsiness, double vision and blurred vision have been reported in people taking LAMICTAL.

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

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 LAMICTAL.

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 LAMICTALand birth control pills or other female hormonal products.

LAMICTAL 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 LAMICTAL.

Drug-Drug Interactions:

Drugs that may interact with LAMICTAL 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.

Usual dose:

It is very important that you/your child take LAMICTAL 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 LAMICTAL.

Do not stop taking your medication abruptly, because your/your child’s seizures may increase. Speak to your doctor before stopping LAMICTAL.

It is important to keep your/your child’s appointments for medical checkups.

LAMICTAL may be taken with or without food.

LAMICTAL tablets should be swallowed whole and should not be chewed or crushed.

LAMICTAL Chewable/Dispersible tablets may be chewed, dissolved in liquid or swallowed whole. Do not split the tablets. If you/your child chew the tablet, make sure that you/your child drinks a little bit of water or diluted fruit juice to help swallow the tablet. To dissolve the tablet(s), place in a glass and add a small amount of water or diluted fruit juice (about 1 teaspoon or just enough liquid to cover the tablet(s)). Wait until the tablet(s) are dissolved (takes about 1 minute), swirl the solution and drink the entire amount immediately. Add a little more water to the glass and drink that as well, to make sure no medicine is left in the glass.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you/your child happens 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.