Bio-Modafinil: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What is the most important information I should know about Bio-MODAFINIL?

Bio-MODAFINIL may cause you to have a serious rash or a serious allergic reaction. Stop Bio-MODAFINIL and call your doctor right away or get emergency treatment 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.

Bio-MODAFINIL is not approved for use in children.

What the medication is used for:

Bio-MODAFINIL is intended to relieve the excessive sleepiness due to medical conditions called narcolepsy (uncontrollable, brief episodes of sleep), obstructive sleep apnea (OSA) (breathing disorder during sleep) and circadian rhythm sleep disorder, shift work type (shift work disorder) (SWD). In narcolepsy, modafinil has no effect on cataplexy (sudden loss of muscular tone). In OSA, Bio-MODAFINIL should be used along with successful standard medical treatments for the breathing disorder. In SWD, Bio-MODAFINIL is intended to reduce your sleepiness but may not improve your work performance.

What it does:

As with many medicines affecting the brain, the mechanism of action of this medicine is not entirely known.

When it should not be used:

You should not take this medicine if you are already agitated or have severe anxiety.

You should not take this medication if you are allergic to modafinil, armodafinil (similar active ingredient in a product sold in the U.S.) or to any of the non-medicinal ingredients in it (see the paragraphs entitled ″What the medicinal ingredient is″ and ″What the important nonmedicinal ingredients are″ below).

The safety and efficacy of Bio-MODAFINIL in children under the age of 18 has not been established and therefore it should not be used in pediatric patients.

What the medicinal ingredient is:

Modafinil

What the important nonmedicinal ingredients are: Lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, mannitol and magnesium stearate.

What dosage forms it comes in:

Each tablet contains 100 mg of an active ingredient called modafinil.

Serious skin rashes have been reported in patients using modafinil. (See “What is the most important information I should know about Bio-MODAFINIL?”)

BEFORE you use Bio-MODAFINIL talk to your doctor or pharmacist if:

• you are using a hormonal birth control method. Women who use hormonal contraceptives such as birth control pills, shots, implants, intrauterine devices (IUDs), or patches, may have a higher chance for getting pregnant while taking Bio-MODAFINIL, and for one month after stopping Bio-MODAFINIL. Talk to your doctor about birth control methods that are right for you while using Bio-MODAFINIL.

• you have high blood pressure, you have heart problems, or have had a heart attack.
• you have liver or kidney problems.
• you have or had a mental problem.
• you have abused medicines called “stimulants” or street drugs.
• you are pregnant, breast feeding or planning to become pregnant. There is very limited information on the safety of modafinil in these conditions. Therefore, Bio-MODAFINIL is not recommended during pregnancy and breast feeding.

• you are taking other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements. Bio-MODAFINIL and many other medicines can interact with each other causing side effects. Bio-MODAFINIL may affect the way other medicines work, and other medicines may affect how Bio-MODAFINIL works. Keep a list of all the medicines you take. Your doctor will decide if you can take Bio-MODAFINIL with your other medicines.

  Special concerns:

  Your doctor may request an electrocardiogram (ECG) before starting you on Bio-MODAFINIL. You may also have your blood pressure and heart rate monitored while you are taking Bio-MODAFINIL.

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Bio-MODAFINIL should not be used for treatment of normal fatigue states. Bio-MODAFINIL does not take the place of getting enough sleep.

There is no evidence that normal levels of attention can be increased by Bio-MODAFINIL.

Bio-MODAFINIL may help treat the excessive sleepiness in most narcoleptic, OSA and SWD patients, but it may not stop all your sleepiness. Discuss your level of sleepiness with your doctor at each visit.

You should avoid driving a car, operating hazardous machinery or engage in any other potentially dangerous activity until you are certain of how Bio-MODAFINIL affects your sleepiness.

Avoid drinking alcohol.

It may be critical that you continue to take your previously prescribed treatments (e.g., patients with breathing disorder during sleep must also receive a standard medical treatment for the breathing disorder while taking Bio-MODAFINIL). Bio-MODAFINIL is not a replacement for your CPAP machine. It is important that you continue to use your CPAP machine while sleeping.

Some effects of Bio-MODAFINIL on the brain are similar to, but less than, other medications called “stimulants” that may be associated with the potential for abuse or misuse.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Bio-MODAFINIL include: antipyrine, clomipramine, cyclosporine, dextroamphetamine, diazepam, methylphenidate, monoamine oxidase (MAO) inhibitors, oral contraceptives, phenytoin, propanolol, selective serotonin reuptake inhibitors, S-mephenytoin, triazolam, tricyclic antidepressant, warfarin.

Bio-MODAFINIL and many other medicines, including prescription and non-prescription medicines, dietary supplements, and herbal remedies, can interact with each other causing side effects. Bio-MODAFINIL may affect the way other medicines work, and other medicines may affect how Bio-MODAFINIL works. Keep a list of all the medicines you take. Your doctor will decide if you can take Bio-MODAFINIL with your other medicines.

PROPER USE OF THIS MEDICATION

Usual dose:

Take as directed by your doctor.

Patients with narcolepsy usually take Bio-MODAFINIL as one (1) to two (2) tablets in the morning and one (1) to two (2) tablets at noon. Your doctor will try to adjust the dose to coincide with the periods of greatest sleepiness during the day. The second dose should normally be taken

at noon or early in the afternoon to prevent difficulties falling asleep at bedtime. Bio-MODAFINIL starts to work slowly. It may take an hour or so before you feel the effects.

It is not recommended to take more than 4 tablets a day (400 mg). Do not take more tablets or take more often than you are told.

Patients with OSA usually take Bio-MODAFINIL as two (2) tablets in the morning.

Patients with SWD usually take Bio-MODAFINIL as two (2) tablets about 1 hour before their work shift.

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. Make sure you take your medicine with you to show the doctor.

An overdose can cause insomnia, restlessness, disorientation, confusion, agitation, anxiety, excitation, hallucination, nausea, vomiting, diarrhea, an increase or decrease in heart rate, an increase in blood pressure and chest pain and can be fatal either alone or in combination with other drugs.

Missed Dose:

If you forget to take your medication, take it when you remember, unless it is close to the time for the 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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects reported with this medicine are:

• Headache
• Difficulty falling asleep
• Nervousness
• Nausea
• Stuffy nose
• Diarrhea
• Back pain
• Anxiety
• Upset stomach
• Dizziness
• Sommolence
• Hypertension

• Tachycardia and/or palpitations (fast and/or abnormal heart beat)

  These side effects tend to disappear after a few days or after a reduction of the dosage. Reaching the maximum daily dosage progressively over several days may prevent these side effects.

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Bio-MODAFINIL may cause serious side effects. Call

your doctor or get emergency help if you experience any

of the following infrequent side effects:

This is not a complete list of side effects. For any unexpected effects while taking Bio-MODAFINIL, contact your doctor or pharmacist.

HOW TO STORE IT

This medicine should be stored at room temperature between 15°C and 30°C, protect from moisture. If the medication has expired (the expiry date appears on the label of the preparation and/or the treatment pack) throw away your tablets.

Keep these tablets in a safe place, out of reach and sight of children.

REPORTING SUSPECTED 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, Ontario

    K1A 0K9

Postage paid labels and 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 Biomed Pharma

Biomed Pharma

100-5950, Ch. de la Côte de Liesse

Mont-Royal

Qc, H4T 1E2

Phone# (514) 731-2003; Fax: (514) 731-2004

Date of Preparation: June 4, 2015