METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet
Actavis Pharma, Inc.
Methylphenidate Hydrochloride Tablets, USP CII
(meth" il fen' i date hye" droe klor' ide)
Read the Medication Guide that comes with methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets.
What is the most important information I should know about methylphenidate hydrochloride tablets? The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.
3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red
• Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
What are methylphenidate hydrochloride tablets?
Methylphenidate hydrochloride tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Methylphenidate hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Methylphenidate hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Methylphenidate hydrochloride tablets are also used in the treatment of a sleep disorder called narcolepsy.
|Methylphenidate hydrochloride tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets?
Methylphenidate hydrochloride tablets should not be taken if you or your child:
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 methylphenidate hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients.
Methylphenidate hydrochloride tablets should not be used in children less than 6 years old because it has not been studied in this age group.
Methylphenidate hydrochloride tablets may not be right for you or your child. Before starting methylphenidate hydrochloride tablets 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)
circulation problems in fingers or toes
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can methylphenidate hydrochloride tablets be taken with other medicines?
Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets.
Your doctor will decide whether methylphenidate hydrochloride tablets can be taken with other medicines.
Especially tell your doctor if you or your child takes:
anti-depression medicines including MAOIs
blood thinner medicines
blood pressure 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 methylphenidate hydrochloride tablets without talking to your doctor first.
How should methylphenidate hydrochloride tablets be taken?
Take methylphenidate hydrochloride tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
Methylphenidate hydrochloride tablets are usually taken 2 to 3 times a day.
Take methylphenidate hydrochloride tablets 30 to 45 minutes before a meal.
From time to time, your doctor may stop methylphenidate hydrochloride tablets treatment for a while to check ADHD symptoms.
Your doctor may do regular checks of the blood, heart, and blood pressure while taking methylphenidate hydrochloride tablets. Children should have their height and weight checked often while taking methylphenidate hydrochloride tablets. Methylphenidate hydrochloride tablets treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much methylphenidate hydrochloride tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of methylphenidate hydrochloride tablets?
See “What is the most important information I should know about methylphenidate hydrochloride tablets?” for information on reported heart and mental problems.
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
painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
Common side effects include:
• stomach ache
• trouble sleeping
• decreased appetite
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 methylphenidate hydrochloride tablets?
Store methylphenidate hydrochloride tablets in a safe place. Do not store above 30°C (86°F). Protect from light.
Keep methylphenidate hydrochloride tablets and all medicines out of the reach of children.
General information about methylphenidate hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride tablets for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate hydrochloride tablets that was written for healthcare professionals. For more information about methylphenidate hydrochloride tablets call 1-800-272-5525.
What are the ingredients in methylphenidate hydrochloride tablets?
Active Ingredient: methylphenidate HCL
Inactive Ingredients: colloidal silicon dioxide, compressible sugar, lactose monohydrate and magnesium stearate. Additionally, the 5 mg contains FD&C Blue #2 and FD&C Red #40; the 10 mg contains FD&C Blue #2 and D&C Yellow #10; and the 20 mg contains FD&C Yellow #6.
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.
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised: October 2016