Focalin

The proper way to use

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

This medicine may be taken with or without food.

You should take the extended-release capsule only one time each day and in the morning. If you take this medicine in the afternoon or evening, it might be harder for you to fall asleep. If your doctor tells you to take the medicine at a certain time, take it exactly as directed.

The extended-release capsule should be swallowed whole and not crushed, divided, or chewed.

If you or your child are unable to swallow the capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce can not be stored for future use.

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 (extended-release capsules):
    • Adults:
      • Patients not taking dexmethylphenidate, methylphenidate, or patients taking stimulant medicines other than methylphenidate—10 milligrams (mg) one time a day in the morning. If needed, your doctor may increase the dose once a week by 5 mg a day until symptoms improve or a maximum dose of 20 mg is reached.
      • Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, one time a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 20 mg one time a day.
    • Children 6 years of age and older:
      • Patients not taking dexmethylphenidate, methylphenidate, or patients taking stimulant medicines other than methylphenidate—5 milligrams (mg) one time a day in the morning. If needed, your doctor may increase the dose once a week by 5 mg a day until symptoms improve or a maximum dose of 20 mg is reached.
      • Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, one time a day. If needed, your doctor will adjust your dose once a week to a maximum dose of 20 mg one time a day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults, teenagers, and children 6 years of age and older:
      • Patients not taking methylphenidate or patients taking stimulant medicines other than methylphenidate—2.5 milligrams (mg) two times a day, at least 4 hours apart. If needed, your doctor may increase the dose once a week by 2.5 or 5 mg a day until symptoms improve or a maximum dose of 10 mg two times a day is reached.
      • Patients taking methylphenidate—The dose per day will be half the dose of methylphenidate you are taking now, divided and taken two times a day, at least 4 hours apart. If needed, your doctor will adjust your dose once a week to a maximum dose of 10 mg two times a day.
    • 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.