Details for: APO-MODAFINIL
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02285398 | APO-MODAFINIL | MODAFINIL | 100 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
APO-MODAFINIL is used to treat adults who are very sleepy due to one of the following medical conditions:
- Narcolepsy: People who have this condition experience sudden attacks of sleep that cannot be controlled.
- Obstructive Sleep Apnea (OSA): People with this condition have breathing problems during sleep. You should talk with your healthcare professional about treatments for OSA before you start taking APO-MODAFINIL. APOMODAFINIL does not take the place of other treatments that your healthcare professional has prescribed for OSA. It is important that you continue to use these treatments as prescribed by your healthcare professional.
- Shift Work Disorder (SWD): People with this condition experience very strong feelings of sleepiness when they work in shifts or irregular schedules outside the normal sleep period. APO-MODAFINIL may help to reduce your sleepiness caused by SWD, but it may not help you to do your work better than you did before taking APO-MODAFINIL.
What it does
Exactly how APO-MODAFINIL works is unknown; however, it is thought to work in your brain like other medicines called “stimulants”. Stimulants cause the body to become more active.
When it should not be used
Do not use APO-MODAFINIL if you:
- are allergic to modafinil or to any of the non-medicinal ingredients in APO-MODAFINIL.
- have severe anxiety (feel very worried, nervous or stressed) or are very agitated.
- are pregnant or plan to become pregnant.
What the medicinal ingredient is
Modafinil
What the non-medicinal ingredients are
colloidal silicon dioxide croscarmellose sodium, magnesium stearate and Methylcellulose, .
What dosage form it comes in
Tablets: 100 mg.
Warnings and precautions
Serious Warnings and Precautions
APO-MODAFINIL may cause you to have a serious rash or a serious allergic reaction. Stop taking APO-MODAFINIL and call your healthcare professional right away or get immediate medical help if you have any of the following:
- skin rash, hives, sores in your mouth, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue or throat
- trouble swallowing or breathing
- hoarse voice.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-MODAFINIL. Talk about any health conditions or problems you may have, including if you:
- are using a hormonal birth control method, such as birth control pills, shots, implants, intrauterine devices (IUDs), or patches.
- have high blood pressure
- have heart problems, or have had a heart attack.
- have liver or kidney problems.
- have or had a mental health problem
- have abused medicines called “stimulants” or street drugs.
- are pregnant, or planning to become pregnant as APO-MODAFINIL may harm your unborn baby.
- are breast feeding.
- are under 18 years of age.
- Women who use certain types of birth control may have a higher chance of getting pregnant while taking APOMODAFINIL, and for two months after stopping APO-MODAFINIL. Talk to your healthcare professional about birth control methods that are right for you while using APO-MODAFINIL.
- Before you start APO-MODAFINIL, you should have a negative pregnancy test. It is recommended that you repeat pregnancy test as often as you or your doctor feel necessary to do so.
- Your healthcare professional may request a test for your heart called an electrocardiogram (ECG) before you start taking APO-MODAFINIL. You may also have your blood pressure and heart rate monitored while you are taking APOMODAFINIL.
- APO-MODAFINIL does not take the place of getting enough sleep. Follow your healthcare professional’s advice about good sleep habits.
- There is no proof that APO-MODAFINIL will help to increase your usual level of attention.
- APO-MODAFINIL may help to treat your strong feelings of sleepiness, but it may not stop all your sleepiness. Discuss your level of sleepiness with your healthcare professional at each visit.
- Do not drive a car or do other dangerous activities until you know how APO-MODAFINIL affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits without talking to your healthcare professional.
- Avoid drinking alcohol.
- While you are taking APO-MODAFINIL, continue your other prescribed treatments. For example, if you have breathing problems during sleep, it is very important for you to continue the treatment that you used before starting to take APOMODAFINIL.
- APO-MODAFINIL can be abused or lead to dependence.
Interactions with this medication
The following may interact with APO-MODAFINIL:
- medicines used to treat depression (such as clomipramine, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants, monoamine oxidase (MAO) inhibitors)
- antipyrine, used to treat ear infection pain
- cyclosporine, used to suppress the immune system
- medicines used to treat attention deficit hyperactivity disorder (ADHD) (such as dextroamphetamine, methylphenidate)
- sedatives (such as diazepam, triazolam)
- oral birth control (“the pill”)
- medicines used to treat epilepsy (such as phenytoin, S-mephenytoin)
- propranolol, used to treat heart problems
- warfarin, used to thin the blood and prevent clots
Proper use of this medication
How to take APO-MODAFINIL:
Take APO-MODAFINIL exactly as prescribed by your healthcare professional. Do not change your dose of APO-MODAFINIL
without talking to your healthcare professional.
Your healthcare professional will tell you the right time of day to take APO-MODAFINIL. Do not change the time of day you take
APO-MODAFINIL unless you have talked to your healthcare professional.
APO-MODAFINIL starts to work slowly. It may take an hour or so before you feel the effects.
Usual Dose
- Narcolepsy: The usual dose is 1 to 2 APO-MODAFINIL tablets in the morning and 1 to 2 tablets at noon. It is not recommended to take more than 4 tablets a day (400 mg).
- Obstructive Sleep Apnea: The usual dose is 2 APO-MODAFINIL tablets in the morning.
- Shift Work Disorder: The usual dose is 2 APO-MODAFINIL tablets about 1 hour before the start of the work shift.
Overdose
An overdose of APO-MODAFINIL can cause:
- trouble sleeping
- feeling restless or agitated
- feeling disoriented
- feeling confused
- feeling nervous or anxious
- feeling excited
- hearing, seeing, feeling or sensing things that are not really there (hallucination)
- nausea
- vomiting
- diarrhea
- fast or slow heartbeat
- increase in blood pressure
- chest pain
Missed Dose
If you forget to take your medication, take it when you remember, unless it is close to the time of your next dose. Taking your medication in the evening or the late afternoon may prevent you from falling asleep at your usual bedtime, and should, therefore, be avoided. If you take APO-MODAFINIL too close to your bedtime, you may find it harder to go to sleep.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking APO-MODAFINIL. If you experience any side effects not listed
here, contact your healthcare professional.
The most common side effects of APO-MODAFINIL are:
- headache
- difficulty falling asleep
- nervousness
- nausea
- stuffy nose
- diarrhea
- back pain
- anxiety
- upset stomach
- dizziness
- sleepiness or drowsiness
- high blood pressure (hypertension)
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Fast and/or abnormal heart beat | ✔ | ||
| Rare | |||
| Heart problems: chest pain | ✔ | ||
| Mental problems: depression, anxiety, hallucinations, thoughts of suicide, aggression, extreme increase in activity and talking (mania) | ✔ | ||
| Serious skin rash: hives, sores in the mouth, blistering and peeling skin | ✔ | ||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, hoarse voice | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
- Store at room temperature 15°C to 30°C.
- Do not use expired medication.
- Keep APO-MODAFINIL in a safe place to prevent misuse or abuse.
- Keep out of reach and sight of children
Reporting side effects
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 APO-MODAFINIL:
- 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800-667- 4708.
Date of Revision: September 24, 2019