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Alertec

(modafinil)

In this factsheet:
• How does Alertec work? What will it do for me?
• How should I use Alertec?
• What form(s) does Alertec come in?
• Who should NOT take Alertec?
• What side effects are possible with Alertec?
• Are there any other precautions or warnings for Alertec?
• What other drugs could interact with Alertec?

DIN (Drug Identification Number)

What side effects are possible with Alertec?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• anxiety
• appetite loss
• back pain
• diarrhea
• headache
• increased heart rate or palpitations
• nausea
• nervousness
• sleeping difficulties
• stuffy or runny nose
• upset stomach
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• dizziness or fainting
• mood swings
• ongoing sleepiness
• signs of depression (such as such as feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of harming oneself)
• signs of liver problems (such as yellow eyes or skin, abdominal pain, darkened urine)
• skin rash

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• signs of severe allergic reaction (such as swelling of face, eyes, lips, tongue; difficulty swallowing or breathing; hoarseness; chest tightness)
• signs of severe skin reaction (blistering rash with fever, sores in mouth, peeling skin)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Alertec?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Drowsiness/reduced alertness: Some people experience ongoing drowsiness or dizziness while taking modafinil. It may also cause overconfidence and over-stimulation, causing poor judgement. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Grapefruit juice: Grapefruit juice affects how modafinil is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. People should not drink grapefruit juice or eat grapefruit at anytime while taking this medication for treatment.

Heart disease: It is not known how modafinil will affect heart disease. There is some evidence that it may cause heart palpitations and chest pain. If you have a heart condition or history of heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: People with severe liver disease should take lower doses of modafinil because of an increased risk of accumulation of the medication in the body and side effects. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental illness: Modafinil may reactivate certain mental disorders or cause confusion and agitation. If you have a history of mental disorders such as depression, psychosis, or mania, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of agitation, depression or hallucination, or notice them in a family member who is taking this medication, contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking this medication.

Normal fatigue states: Modafinil should not be used to treat normal fatigue states (e.g., fatigue due to lack of sleep rather than narcolepsy), as it can lead to overconfidence in abilities without actually increasing performance. This could make it more dangerous to perform certain activities.

Seizure disorder: If you have a seizure disorder or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if modafinil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Serious reactions have been associated with the use of modafinil by children. The risks and benefits of modafinil have not been established for children. It is not recommended that children be given modafinil.

Seniors: Seniors may be more sensitive to the effects of modafinil. They should use lower starting doses.

What other drugs could interact with Alertec?

There may be an interaction between modafinil and any of the following:

amiodarone amphetamines appetite suppressants aprepitant aripiprazole atomoxetine "azole" antifungals (e.g., itraconazole, ketoconazole, posaconazole, voriconazole) birth control pills bosentan bosutinib caffeine carbamazepine cimetidine clobazam clopidogrel cocaine cyclosporine dasatinib delavirdine deferasirox dexamethasone diazepam diltiazem efavirenz fosphenytoin haloperidol

ifosfamide imatinib linezolid macrolide antibiotics (e.g., clarithromycin, erythromycin) methylphenidate metronidazole mifepristone moclobemide nasal decongestants nefazodone nevirapine nicardipine oxcarbazine phenobarbital phenytoin pimozide primidone protease inhibitors (e.g., indinavir, ritonavir, saquinavir) rifabutin rifampin SSRI antidepressants (e.g., citalopram, escitalopram, sertraline) St. John's wort tetracycline theophylline tricyclic antidepressants (e.g., amitriptyline, clomipramine, imipramine) verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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