METHYLPHENIDATE HYDROCHLORIDE - methylphenidate hydrochloride tablet, chewable
Rising Pharma Holdings, Inc.
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Methylphenidate Hydrochloride Chewable Tablets 2.5 mg, 5 mg, and 10 mg CII
Read the Medication Guide that comes with Methylphenidate Hydrochloride Chewable 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 healthcare provider about your or your child's treatment with Methylphenidate Hydrochloride Chewable Tablets.
What is the most important information I should know about Methylphenidate Hydrochloride Chewable Tablets?
Methylphenidate Hydrochloride Chewable Tablets may cause serious side effects, including:
Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your healthcare provider should check you or your child carefully for heart problems before starting Methylphenidate Hydrochloride Chewable Tablets.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Chewable Tablets.
Call your healthcare provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Methylphenidate Hydrochloride Chewable Tablets.
Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking Methylphenidate Hydrochloride Chewable Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
Call your healthcare provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride.
What Are Methylphenidate Hydrochloride Chewable Tablets?
Methylphenidate Hydrochloride Chewable Tablets are a central nervous system stimulant prescription medicine. Methylphenidate Hydrochloride Chewable Tablets are tablets that are made to be chewed and swallowed.
They are used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). Methylphenidate Hydrochloride Chewable Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Methylphenidate Hydrochloride Chewable Tablets should be used as a part of a total treatment program for ADHD that may include counseling or other
therapies.
Methylphenidate Hydrochloride Chewable Tablets are also used in the treatment of a sleep disorder called narcolepsy.
Methylphenidate Hydrochloride Chewable Tablets are a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Methylphenidate Hydrochloride Chewable Tablets in a safe place to protect it from theft. Never give your Methylphenidate Hydrochloride Chewable Tablets to anyone else, because it may cause death or harm them. Selling or giving away Methylphenidate Hydrochloride Chewable Tablets may harm others, and is against the law.
Who should not take Methylphenidate Hydrochloride Chewable Tablets?
Methylphenidate Hydrochloride Chewable Tablets should not be taken if you or your child:
Methylphenidate Hydrochloride Chewable Tablets should not be used in children less than 6 years old because they have not been studied in this age group.
Methylphenidate Hydrochloride Chewable Tablets may not be right for you or your child. Before taking Methylphenidate Hydrochloride Chewable Tablets, tell your healthcare provider about all health conditions (or a family history of) including:
• heart problems, heart disease, heart defects, or 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 and toes
Tell your healthcare provider if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Methylphenidate Hydrochloride Chewable Tablets be taken with other medicines?
Tell your healthcare provider about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.
Methylphenidate Hydrochloride Chewable 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 Chewable Tablets.
Your healthcare provider will decide whether Methylphenidate Hydrochloride Chewable Tablets can be taken with other medicines.
Especially tell your healthcare provider if you or your child takes:
• antidepression medicines including MAOIs
• seizure medicines
• 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 healthcare provider and pharmacist.
Do not start any new medicine while taking Methylphenidate Hydrochloride Chewable Tablets without talking to your healthcare provider first.
How should Methylphenidate Hydrochloride Chewable Tablets be taken?
• Take Methylphenidate Hydrochloride Chewable Tablets exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child.
• Methylphenidate Hydrochloride Chewable Tablets are usually taken 2 to 3 times a day.
• Take Methylphenidate Hydrochloride Chewable Tablets 30 to 45 minutes before a meal.
• Chew Methylphenidate Hydrochloride Chewable Tablets well and swallow with at least 8 ounces (a full glass) of water or other liquid. Methylphenidate Hydrochloride Chewable Tablets can swell and cause choking if enough liquid is not taken with them. Get emergency medical care if you have chest pain, vomiting, or trouble swallowing, or breathing after taking a Methylphenidate Hydrochloride Chewable Tablet.
If you or your child take too much Methylphenidate Hydrochloride Chewable Tablets , call your healthcare provider or Poison Help line, at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects of Methylphenidate Hydrochloride Chewable Tablets?
See "What is the most important information I should know about Methylphenidate Hydrochloride Chewable Tablets?" for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Talk to your healthcare provider 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 healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to Rising Pharmaceuticals, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088.
How do I store Methylphenidate Hydrochloride Chewable Tablets?
General information about Methylphenidate Hydrochloride Chewable Tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate Hydrochloride Chewable Tablets for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride Chewable 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 Chewable Tablets. If you would like more information, talk with your healthcare provider . You can ask your healthcare provider or pharmacist for information about Methylphenidate Hydrochloride Chewable Tablets that is written for healthcare professionals. For more information, please contact Rising Pharmaceuticals, Inc. at 1-844-874-7464.
What are the ingredients in Methylphenidate Hydrochloride Chewable Tablets?
Active Ingredient: methylphenidate hydrochloride USP
Inactive Ingredients: microcrystalline cellulose, grape flavor, guar gum, maltose, stearic acid, and sucralose.
Manufactured for:
Rising Pharmaceuticals, Inc.
East Brunswick, NJ 08816
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 09/2023
MGR22301-02