(methylphenidate hydrochloride) Extended-release Capsules
Read the Medication Guide that comes with RITALIN LA® before
you or your child starts taking it and each time you get a refill. There may be
new information. This Medication Guide does not take the place of talking to
your doctor about your or your child's treatment with RITALIN LA® .
What is the most important information I should know
about RITALIN LA®?
The following have been reported with use of
methylphenidate hydrochloride and other stimulant medicines.
1. Heart-related problems:
- sudden death in patients who have heart problems or
- stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child have any heart
problems, heart defects, high blood pressure, or a family history of these
Your doctor should check you or your child carefully for
heart problems before starting RITALIN LA® .
Your doctor should check your or your child's blood
pressure and heart rate regularly during treatment with RITALIN LA® .
Call your doctor right away if you or your child has
any signs of heart problems such as chest pain, shortness of breath, or
fainting while taking RITALIN LA® .
2. Mental (Psychiatric) problems:
- new or worse behavior and thought problems
- new or worse bipolar illness
- new or worse aggressive behavior or hostility
Children and Teenagers
- new psychotic symptoms (such as hearing voices,
believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your
child have, or about a family history of suicide, bipolar illness, or
Call your doctor right away if you or your child have
any new or worsening mental symptoms or problems while taking RITALIN LA®,
especially seeing or hearing things that are not real, believing things that
are not real, or are suspicious.
What Is RITALIN LA®?
RITALIN LA® is a central nervous system stimulant
prescription medicine. It is used for the treatment of Attention-Deficit
Hyperactivity Disorder (ADHD). RITALIN LA® may help increase attention and
decrease impulsiveness and hyperactivity in patients with ADHD.
RITALIN LA® should be used as a part of a total treatment
program for ADHD that may include counseling or other therapies.
RITALIN LA® is a federally controlled substance (CII)
because it can be abused or lead to dependence. Keep RITALIN LA® in a safe place
to prevent misuse and abuse. Selling or giving away RITALIN LA® may harm
others, and is against the law.
Tell your doctor if you or your child have (or have a
family history of) ever abused or been dependent on alcohol, prescription
medicines or street drugs.
Who should not take RITALIN LA®?
RITALIN LA® should not be taken if you or your
- are very anxious, tense, or agitated
- have an eye problem called glaucoma
- have tics or Tourette's syndrome, or a family history of
Tourette's syndrome. Tics are hard to control repeated movements or sounds.
- are taking or have taken within the past 14 days an
anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
- are allergic to anything in RITALIN LA® . See the end of
this Medication Guide for a complete list of ingredients.
RITALIN LA® should not be used in children less than 6
years old because it has not been studied in this age group.
RITALIN LA® may not be right for you or your
child. Before starting RITALIN LA® tell your or your child's doctor about all
health conditions (or a family history of) including:
- heart problems, heart defects, high blood pressure
- mental problems including psychosis, mania, bipolar
illness, or depression
- tics or Tourette's syndrome
- seizures or have had an abnormal brain wave test (EEG)
Tell your doctor if you or your child is pregnant,
planning to become pregnant, or breast-feeding.
Can RITALIN LA® be taken with other medicines?
Tell your doctor about all of the medicines that you
or your child take including prescription and nonprescription medicines,
vitamins, and herbal supplements. RITALIN LA® and some medicines may
interact with each other and cause serious side effects. Sometimes the doses of
other medicines will need to be adjusted while taking RITALIN LA® .
Your doctor will decide whether RITALIN LA® can be taken
with other medicines.
Especially tell your doctor if you or your child
- anti-depression medicines including MAOIs
- seizure medicines
- blood thinner medicines
- blood pressure medicines
- stomach acid medicines
- cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a
list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking RITALIN LA®
without talking to your doctor first.
How should RITALIN LA® be taken?
- Take RITALIN LA® exactly as prescribed. Your
doctor may adjust the dose until it is right for you or your child.
- Take RITALIN LA® once a day in the morning. RITALIN LA® is
an extended-release capsule. It releases medicine into your body throughout the
- Swallow RITALIN LA® capsules whole with water or other
liquids. If you cannot swallow the capsule, open it and sprinkle the medicine
over a spoonful of applesauce. Swallow the applesauce and medicine mixture
without chewing. Follow with a drink of water or other liquid. Never chew or
crush the capsule or the medicine inside the capsule.
- Ritalin LA should not be taken with alcohol. This may
result in a more rapid release of the dose of Ritalin LA
- From time to time, your doctor may stop RITALIN LA® treatment
for a while to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart,
and blood pressure while taking RITALIN LA® . Children should have their height
and weight checked often while taking RITALIN LA® . Â RITALIN LA® treatment may be
stopped if a problem is found during these check-ups.
- If you or your child takes too much RITALIN LA®
or overdoses, call your doctor or poison control center right away, or get
What are possible side effects of RITALIN LA®?
See “What is the most important information I should
know about RITALIN LA®” for information on reported heart and mental
Other serious side effects include:
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
Common side effects include:
- stomach ache
- decreased appetite
- trouble sleeping
Talk to your doctor if you or your child has side effects
that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask
your doctor or pharmacist for more information.
How should I store RITALIN LA®?
- Store RITALIN LA® in a safe place at room temperature, 59
to 86° F (15 to 30° C).
- Keep RITALIN LA® and all medicines out of the
reach of children.
General information about RITALIN LA®
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use RITALIN LA® for a condition
for which it was not prescribed. Do not give RITALIN LA® to other people, even
if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information
about RITALIN LA®. If you would like more information, talk with your doctor.
You can ask your doctor or pharmacist for information about RITALIN LA® that
was written for healthcare professionals. For more information about RITALIN LA®
What are the ingredients in RITALIN LA®?
Active Ingredient: methylphenidate HCL
Inactive Ingredients: ammonio methacrylate
copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic
acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only),
sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide
(10, 30, and 40 mg capsules).
Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S.
Food and Drug Administration.