METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet, extended release
Amneal Pharmaceuticals LLC
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MEDICATION GUIDE Methylphenidate (meth” il fen’ i date) HCl Extended-Release Tablets, USP CII |
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What is the most important information I should know about methylphenidate HCl extended-release tablets?
Methylphenidate HCl extended-release tablets may cause serious side effects, including:
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with methylphenidate HCl extended-release tablets. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with methylphenidate HCl extended-release tablets.
Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate HCl extended-release 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 during treatment with methylphenidate HCl extended-release tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. |
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What are methylphenidate HCl extended-release tablets?
Methylphenidate HCl extended-release tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in children 6 years of age and older and adults up to 65 years of age. Methylphenidate HCl extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. It is not known if methylphenidate HCl extended-release tablets are safe and effective in children under 6 years of age. Methylphenidate HCl extended-release tablets have not been studied in adults older than 65 years of age. Methylphenidate HCl extended-release 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 HCl extended-release tablets in a safe place to protect it from theft. Never give your methylphenidate HCl extended-release tablets to anyone else because it may cause death or harm them. Selling or giving away methylphenidate HCl extended-release tablets may harm others and is against the law. |
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Do not take methylphenidate HCl extended-release tablets if you or your child:
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Before taking methylphenidate HCl extended-release tablets, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Methylphenidate HCl extended-release tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with methylphenidate HCl extended-release tablets. Your healthcare provider will decide whether methylphenidate HCl extended-release tablets can be taken with other medicines. Especially tell your healthcare provider if you or your child take:
Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine. Do not start any new medicine during treatment with methylphenidate HCl extended-release tablets without first talking to your healthcare provider. |
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How should methylphenidate HCl extended-release tablets be taken?
If you or your child take too much methylphenidate HCl extended-release tablets, call your healthcare provider or Poison Help line at 1-800-222- 1222 or go to the nearest hospital emergency room right away. |
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What are the possible side effects of methylphenidate HCl extended-release tablets?
Methylphenidate HCl extended-release tablets may cause serious side effects, including:
Signs and symptoms may include:
Tell your healthcare provider if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with methylphenidate HCl extended-release tablets.
The most common side effect of methylphenidate HCl extended-release tablets in children is upper stomach-area (abdominal) pain. The most common side effects of methylphenidate HCl extended-release tablets in adults include: |
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These are not all the possible side effects of methylphenidate HCl extended-release tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Amneal Pharmaceuticals at 1-877-835-5472. |
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How should I store methylphenidate HCl extended-release tablets?
Keep methylphenidate HCl extended-release tablets and all medicines out of the reach of children. |
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General information about the safe and effective use of methylphenidate HCl extended-release tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate HCl extended-release tablets for a condition for which it was not prescribed. Do not give methylphenidate HCl extended-release tablets to other people, even if they have the same condition. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about methylphenidate HCl extended-release tablets that is written for healthcare professionals. For more information about methylphenidate HCl extended-release tablets call 1-877-835-5472. |
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What are the ingredients in methylphenidate HCl extended-release tablets?
Active Ingredient: methylphenidate HCl, USP Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, fumaric acid, hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium chloride, stearic acid, talc, titanium dioxide and triethyl citrate. The 18 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 27 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 54 mg extended-release tablet also contains iron oxide red. This Medication Guide has been approved by the U.S. Food and Drug Administration. Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 |