Patient Medication Information: uses, side effects, how to take - Ratio-Lamotrigine
ABOUT THIS MEDICATION
What the medication is used for:
ratio-LAMOTRIGINE, the brand name for lamotrigine, has been prescribed to you/your child to control your/their epilepsy. Please follow your doctor's recommendations carefully.
What it does:
ratio-LAMOTRIGINE affects chemicals in the brain that are involved in sending signals to the nerves. ratio-LAMOTRIGINE helps to control epileptic seizures.
When it should not be used:
Do NOT take or use ratio-LAMOTRIGINE if you are hypersensitive (allergic) to lamotrigine or any of the other ingredients of ratio-LAMOTRIGINE Tablets (see What the nonmedicinal ingredients are).
What the medicinal ingredient is:
The medicinal ingredient in ratio-LAMOTRIGINE is lamotrigine.
What the nonmedicinal ingredients are:
cellulose, lactose, magnesium stearate, povidone, sodium starch glycolate, and the following coloring agents: 25 mg (white tablets) - none, 100 mg (peach tablets) - Sunset Yellow FCF Lake, 150 mg (cream tablets) - Ferric Oxide, Yellow
What dosage forms it comes in:
25, 100 and 150 mg tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use ratio-LAMOTRIGINE talk to your doctor or pharmacist if you or your child:
ever had an unusual or allergic reaction to ratio-LAMOTRIGINE.
are/is allergic to any component of ratio-
LAMOTRIGINE 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. One reason for this is that a study has reported a risk of cleft lip or cleft palate associated with the use of lamotrigine in the first few months of pregnancy. Intake of folic acid when planning pregnancy and during early pregnancy may also be considered you take ratio-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). ratio-
LAMOTRIGINE 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 ratio-LAMOTRIGINE, 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 away 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 or kidney disease, heart problems or other medical conditions.
- consume alcohol on a regular basis.
A small number of people taking ratio-LAMOTRIGINE get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems such as organ failure if not treated. Please read the Serious Side Effects, How Often Do 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 ratio-LAMOTRIGINE. If at any time you have these thoughts, contact your doctor immediately. Do not discontinue ratio-LAMOTRIGINE on your own.
The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking ratio-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 ratio-LAMOTRIGINE, contact a doctor as soon as possible.
Do not stop taking/giving ratio-LAMOTRIGINE unless directed by your doctor. Always check that you have an
| IMPORTANT: PLEASE READ |
adequate supply of ratio-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 ratio-LAMOTRIGINE, make sure you can read it clearly and talk to your pharmacist to check that you are given the correct medicine.
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 ratio-LAMOTRIGINE.
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 ratio-LAMOTRIGINE and birth control pills or other female hormonal products.
ratio-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 ratio-LAMOTRIGINE.
Drug-Drug Interactions
Drug that may interact with ratio-LAMOTRIGINE include:
- Valproic acid (valproate),
- Carbamazepine,
- Phenytoin,
- Phenobarbital,
- Primidone,
Birth control pills or other female hormonal
products.
Drug-Lifestyle Interactions
It is very important that you/your child do not
perform any hazardous tasks such as driving or operating machinery.
Usual dose:
It is very important that you/your child take ratio-LAMOTRIGINE 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 ratio-LAMOTRIGINE.
Do not stop taking your medication abruptly, because your/your child’s seizures may increase. Speak to your doctor before stopping ratio-LAMOTRIGINE.
ratio-LAMOTRIGINE may be taken with or without food.
It is important to keep your/your child’s appointments for medical checkups.
ratio-LAMOTRIGINE tablets should be swallowed whole and should not be chewed or crushed.
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, do not try to make up for it by doubling up on the dose next time. Just take/give the next regularly scheduled dose and try not to miss any more. 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
Like all medicines, ratio-LAMOTRIGINE can cause side effects, although not everybody gets them. The most common side effects include:
- double vision (diplopia), blurred vision
- tremor; poor coordination (ataxia)
- dizziness
- nausea; vomiting ; stomach upset
- pain in your neck, abdomen, or joints
- feeling of weakness or fatigue
- sleepiness/drowsiness (somnolence)
- difficulty sleeping (insomnia)
- nasal congestion (rhinitis)
- rash
- aggression, agitation or irritability
PROPER USE OF THIS MEDICATION
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| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist right away | Seek immediate emergenc y medical assistance | ||
Only if severe | In all cases | |||
Very Common | Skin rashes or redness | √ | ||
| Rare | Skin rashes or redness which develop into severe skin reactions including widespread 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 drowsiness | √ | ||
| Rare | Abnormal uncontrollable muscle movements (choreoathetosis) that may involve the face, eyes (nystagmus), neck, trunk, arms or legs | √ | ||
| Rare | Conjunctivitis: symptoms like itchy eyes with discharge and crusty eyelids | √ | ||
| Rare | 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 | √ | ||
| Very Rare | Liver and blood problems including liver failure [symptoms include 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] | √ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist right away | Seek immediate emergenc y medical assistance | ||
Only if severe | In all cases | |||
| Very Rare | Swelling of the face or swollen glands in the neck, armpits or groin (symptoms for lymphadenopathy) | √ | ||
| Very Rare | Serious blood clotting disorder with symptoms such as: 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 | √ | ||
Not known | Thoughts of suicide or hurting yourself | √ | ||
Not known | 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 ratio-LAMOTRIGINE, contact your doctor or pharmacist.
HOW TO STORE IT
Store your ratio-LAMOTRIGINE tablets at room temperature (15° to 30°C) in a dry place and protected from light. Cap the bottle tightly immediately after use. Keep out of sight and reach of children.
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Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
Online at MedEffect (http://hc-sc.gc.ca/dhp-
mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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
This document plus the full product monograph prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English);
1-877-777-9117 (French); or
druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada
M1B 2K9
North American Antiepileptic Drug (NAAED) Pregnancy Registry contact number: 1-888-233-2334.