Mydayis

• Shire US Inc.

Amphetamine and dextroamphetamine are central nervous system stimulants that affect chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Amphetamine and dextroamphetamine is a combination medicine used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).

Amphetamine and dextroamphetamine may also be used for purposes not listed in this medication guide.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amphetamine and dextroamphetamine combination to treat ADHD in children. However, safety and efficacy have not been established in children younger than 3 years of age for Adderall® tablets, in children younger than 6 years of age for Adderall XR® extended-release capsules, and in children younger than 13 years of age for Mydayis™ extended-release capsules.

Geriatric

Appropriate studies on the relationship of age to the effects of Adderall® tablets and Adderall XR® extended-release capsules have not been performed in the geriatric population.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Mydayis™ extended-release capsules in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Acetazolamide
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cinacalcet
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Ketobemidone
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Remifentanil
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Guanethidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitation, severe or
• Anxiety, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Coronary artery disease or
• Drug abuse, history of or
• Glaucoma or
• Heart attack, recent or
• Heart or blood vessel disease (eg, cardiomyopathy), severe or
• Heart rhythm problems (eg, ventricular arrhythmia) or
• Hypertension (high blood pressure), moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of or
• Tension, severe—Should not be used in patients with these conditions.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Depression, or a family history of or
• Heart rhythm problems (eg, arrhythmia), or a family history of or
• Hypertension (high blood pressure), mild or
• Mania, history of or
• Psychosis (mental illness), history of or
• Raynaud disease or
• Seizures, history of or
• Tachycardia (fast heart rate) or
• Tourette syndrome (tics), or a family history of—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain dextroamphetamine and amphetamine. It may not be specific to Mydayis. Please read with care.

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Talk to your doctor or pharmacist if you have any questions.

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose and check with your doctor.

Take the regular tablet in the morning and early afternoon. If you take the tablet in the evening, you may have trouble falling asleep at night.

If you are using the extended-release capsule:

• Swallow the capsule whole with water or other liquids. Do not crush, break, or chew it.
• Take the capsule in the morning right after you wake up. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
• You may take the capsule with or without food, but make sure to take it the same way each time.
• If you cannot swallow the capsule, carefully open it and sprinkle the small beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use. Do not crush or chew the beads from the capsule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For attention deficit hyperactivity disorder (ADHD):
  • For oral dosage form (Adderall XR® extended-release capsules):
    • Adults—20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
    • Children 13 to 17 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed.
    • Children 6 to 12 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 30 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (Mydayis™ extended-release capsules):
    • Adults—At first, 12.5 milligrams (mg) once a day in the morning right after you wake up. Your doctor may adjust your dose if needed. However, the dose is usually not more than 50 mg per day.
    • Children 13 to 17 years of age—At first, 12.5 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 25 mg per day.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (Adderall® tablets):
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) given 1 or 2 times a day. Your doctor may adjust your dose if needed.
    • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.
    • Children younger than 3 years of age—Use is not recommended.
• For narcolepsy:
  • For oral dosage form (Adderall® tablets):
    • Adults and children 12 years of age and older—At first, 10 milligrams (mg) per day, divided and given into 2 doses. Your doctor may adjust your dose if needed.
    • Children 6 to 12 years of age—At first, 5 mg per day. Your doctor may adjust your dose if needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• lower back or side pain

• Cold or flu-like symptoms
• cough or hoarseness
• fever or chills

• Blistering, peeling, or loosening of the skin
• chest pain or discomfort
• confusion
• dark-colored urine
• diarrhea
• difficulty breathing
• difficulty with speaking
• difficulty with swallowing
• dizziness
• double vision
• faintness
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching, skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of bladder control
• muscle cramps or spasms
• muscle pain or stiffness
• muscle spasm or jerking of all extremities
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• seizures
• slow speech
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sudden loss of consciousness
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• uncontrolled repeated movements (tics)
• uncontrolled vocal outbursts
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Anxiety
• dry mouth
• lack or loss of strength
• stomach pain
• weight loss

• Constipation
• decreased interest in sexual intercourse
• false or unusual sense of well-being
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (Mydayis) affects you.
• If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (Mydayis) stops working well. Do not take more than ordered.
• This medicine may be habit-forming with long-term use.
• If you have been taking this medicine for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine (Mydayis).
• You may have some heart tests before starting this medicine. Talk with your doctor.
• This medicine may cause high blood pressure.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (Mydayis).
• Do not take antacids with this medicine.
• Do not switch between this product and other products that have the same drugs in them without checking with the doctor.
• New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this medicine (Mydayis). Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Different brands of this medicine (Mydayis) may be for use in different ages of children. Talk with the doctor before giving this medicine to a child.
• Avoid drinking alcohol while taking this medicine (Mydayis).
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017