Patient Medication Information: uses, side effects, how to take - Auro-Rufinamide
ABOUT THIS MEDICATION
What the medication is used for:
Auro-Rufinamide is a prescription medication used with other antiepileptic drugs to treat seizures associated with Lennox-Gastaut syndrome in adults and children 4 years of age and older by decreasing the overall number and severity of seizures, and the number of drop attacks.
What it does:
The exact way in which Auro-Rufinamide controls seizures is not known.
When it should not be used:
You should not take Auro-Rufinamide if:
- You have a family history of a genetic condition called Familial Short QT syndrome that affects the electrical system of the heart.
- You are allergic to any of the ingredients in Auro-Rufinamide or to triazole derivatives.
You are breastfeeding.
Do not use Auro-Rufinamide for a condition for which it was not prescribed. Do not give Auro-Rufinamide to other people, even if they have the same symptoms as you. It may harm them.
What the medicinal ingredient is:
Rufinamide
What the non-medicinal ingredients are:
Colloidal Silicon Dioxide, Corn Starch, Croscarmellose sodium, Hypromellose Methocel E5 LV premium, Iron Oxide Red, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose, Polyethylene Glycol, Sodium Lauryl Sulfate, Talc and Titanium Dioxide,
What dosage forms it comes in:
Tablets: 200 mg and 400 mg
WARNINGS AND PRECAUTIONS
BEFORE you use Auro-Rufinamide talk to your doctor or pharmacist if you:
- Have heart problems
- Have liver problems
- Have other medical problems
- Have or have had suicidal thoughts or actions, depression or mood problems
- Are pregnant, or think you might be pregnant, or intend to become pregnant while taking Auro-Rufinamide. It is not known if Auro-Rufinamide can harm your unborn baby. Tell your doctor right away if you become pregnant while taking Auro-Rufinamide. You and your doctor will decide if you should take Auro-Rufinamide while you are pregnant.
Auro-Rufinamide may make certain types of birth control (i.e., hormonal contraceptives) less effective. Talk to your doctor about the best birth control methods for you while taking Auro-Rufinamide.
- If you become pregnant while taking Auro-Rufinamide, talk to your doctor 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.
- Are breast-feeding or plan to start breast-feeding while taking Auro-Rufinamide. Auro-Rufinamide may pass into your breast milk. You and your doctor should decide if you will take Auro-Rufinamide or breastfeed. You should not do both.
Like other antiepileptic drugs, Auro-Rufinamide may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. You should contact your doctor right away or go to the nearest hospital if you have any of these symptoms, especially if they are new, worse, or worry you:
- Attempt to commit suicide
- New or worse depression
- New or worse anxiety
- Feeling agitated or restless
- Panic attacks
- Trouble sleeping (insomnia)
- New or worse irritability
- Acting aggressive, being angry, or violent
- Acting on dangerous impulses
- An extreme increase in activity and talking(mania)
- Other unusual changes in behaviour or mood
- Suicidal thoughts or actions can be caused by
- hings other than medicines. If you have suicidal thoughts or actions, your doctor may check for other causes.
You should pay attention to any changes, especially sudden changes, in mood, behaviours, thoughts or feelings.
You should keep all follow-up visits with your doctor as scheduled and call your doctor between visits as needed, especially if you are worried about symptoms.
Do not stop Auro-Rufinamide without first talking to your doctor.
Stopping Auro-Rufinamide suddenly can cause serious problems. Stopping a seizure medication suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Auro-Rufinamide may cause you to feel sleepy, tired, weak, dizzy or have problems with coordination and walking. Do not drive, operate heavy machinery or do other dangerous activities until you know how Auro-Rufinamide affects you. Auro-Rufinamide can slow your thinking and motor skills.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Taking Auro-Rufinamide with certain other medications can cause side effects or affect how well they work.
Do not start or stop other medications without telling your doctor about all other medications you are taking e.g., when adding another antiepileptic drug to your treatment with Auro-Rufinamide. The other antiepileptic drug may change the concentration of Auro-Rufinamide. Your doctor will have to adjust the dosage of the new drug.
Know the medications you take. Keep a list of them to show your doctor and pharmacist each time you get a new medication.
Do not drink alcohol or take other medications that make you sleepy or dizzy while taking Auro-Rufinamide until you talk to your doctor.
Taking Auro-Rufinamide with alcohol or medications that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
PROPER USE OF THIS MEDICATION
USUAL STARTING DOSE:
Use in children and adults less than 30 kg: Treatment initiated
at 200 mg/day in two divided doses. Maximum recommended dose not over 1300 mg/day.
Use in adults, adolescents and children 30 kg or over: Treatment initiated at 400 mg/day in two divided doses. Maximum recommended dose as per the weight table. Safety of doses above 3200 mg/day has not been established.
Your doctor will adjust your dosage until a satisfactory control of seizures is obtained.
Weight Table
| Weight range | 30.0 to 50.0 kg | 50.1 to 70.0 kg | Equal to or more than 70.1 kg |
|---|---|---|---|
| Maximum recommended dose (mg/day) | 1800 | 2400 | 3200 |
Take Auro-Rufinamide exactly as your doctor tells you.
Do not change your dose of Auro-Rufinamide without talking to your doctor.
Do not stop Auro-Rufinamide without first talking to a doctor. Stopping Auro-Rufinamide suddenly can cause serious problems. Stopping a seizure medication suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Take Auro-Rufinamide with food.
Auro-Rufinamide can be swallowed whole, cut in half or crushed.
Overdose:
| If you think you, or a person you are caring for, have taken too much Auro-Rufinamide, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
A missed dose should be taken as soon as possible. However, if it is almost time for the next dose skip the missed dose and continue taking Auro-Rufinamide as normal. Do not take a double dose to make up for a forgotten dose. If you miss more than one dose, seek advice from your doctor.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects of Auro-Rufinamide include:
- headache
- dizziness
- tiredness
- sleepiness
- nausea
- vomiting
Auro-Rufinamide can also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Rare | Thoughts of suicide or hurting yourself | √ | ||
| Allergic reaction (symptoms include swelling in the eyes, lips, mouth, tongue, face and throat, itching, rash, hives) | √ | |||
Serious skin reactions that typically present with any combination of rash, redness, blistering of the lips, eyes or mouth, skin peeling, accompanied by fever, chills, headache, cough, body aches or swollen lymph nodes, joint pain, and may be associated with signs and symptoms involving other organs, e.g. liver. | √ | |||
| Very Rare | Liver disorder (symptoms include: nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine) | √ | ||
| Cardiac arrhythmias (potential symptoms: irregular pulse, slow pulse, rapid pulse, palpitations, shortness of breath, dizziness) | √ |
This is not a complete list of side effects. For any unexpected effects while taking Auro-Rufinamide, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15 - 30°C) in a dry place. Cap the bottle tightly immediately after use. Keep out of reach and sight of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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 Auro-Rufinamide
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Part III: Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648-6681.