RITALIN- methylphenidate hydrochloride tablet
Novartis Pharmaceuticals Corporation
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: November 2019 | ||||
MEDICATION GUIDE RITALIN® (rit-ah-lin) (methylphenidate hydrochloride) tablets CII |
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What is the most important information I should know about RITALIN?
RITALIN is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep RITALIN in a safe place to prevent misuse and abuse. Selling or giving away RITALIN may harm others and is against the law. Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or street drugs. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines: 1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting RITALIN. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with RITALIN. 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. 2. Mental (psychiatric) problems: All Patients
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
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What is RITALIN?
It is not known if RITALIN is safe and effective in children under 6 years of age. |
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Who should not take RITALIN? RITALIN should not be taken if you or your child:
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RITALIN may not be right for you or your child. Before starting RITALIN, tell your or your child’s doctor about all health conditions (or a family history of), including:
Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements. RITALIN 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. Your doctor will decide whether RITALIN can be taken with other medicines. Especially tell your doctor if you or your child takes:
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 without talking to your doctor first. |
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How should RITALIN be taken?
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What are the possible side effects of RITALIN?
RITALIN may cause serious side effects, including:
Common side effects include: |
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• fast heart beat • sweating a lot | • abnormal heartbeat (palpitations) • decreased appetite | • headache • dry mouth | • trouble sleeping • nausea | • nervousness • stomach pain |
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store RITALIN?
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General information about the safe and effective use of RITALIN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about RITALIN that is written for healthcare professionals. Do not use RITALIN for a condition for which it was not prescribed. Do not give RITALIN to other people, even if they have the same symptoms that you have. It may harm them and it is against the law. |
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What are the ingredients in RITALIN?
Active ingredient: methylphenidate HCl Inactive ingredients: D&C Yellow No.10 (5-mg and 20-mg tablets), FD&C Green No.3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets) Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis For more information and request for additional copies of the Medication Guide, call 1-888-669-6682. T2019-127 |
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: November 2019 | ||||
MEDICATION GUIDE RITALIN-SR® (rit-ah-lin) (methylphenidate hydrochloride) extended-release tablets CII |
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What is the most important information I should know about RITALIN-SR?
RITALIN-SR is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep RITALIN-SR in a safe place to prevent misuse and abuse. Selling or giving away RITALIN-SR may harm others, and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines: 1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting RITALIN-SR. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with RITALIN-SR. 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-SR. 2. Mental (psychiatric) problems: All Patients
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN-SR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
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What is RITALIN-SR?
It is not known if RITALIN-SR is safe and effective in children under 6 years of age. |
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Who should not take RITALIN-SR? RITALIN-SR should not be taken if you or your child:
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RITALIN-SR may not be right for you or your child. Before starting RITALIN-SR, tell you or your child’s doctor about all health conditions (or a family history of), including:
Tell your doctor about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RITALIN-SR 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-SR. Your doctor will decide whether RITALIN-SR can be taken with other medicines. Especially tell your doctor if you or your child takes:
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-SR without talking to your doctor first. |
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How should RITALIN-SR be taken?
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What are the possible side effects of RITALIN-SR?
RITALIN-SR may cause serious side effects, including: What are possible side effects of RITALIN-SR?
Common side effects include: |
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• fast heart beat • sweating a lot | • abnormal heartbeat (palpitations) • decreased appetite | • headache • dry mouth | • trouble sleeping • nausea | • nervousness • stomach pain |
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store RITALIN-SR?
|
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General information about the safe and effective use of RITALIN-SR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about RITALIN-SR that is written for healthcare professionals. Do not use RITALIN-SR for a condition for which it was not prescribed. Do not give RITALIN-SR to other people, even if they have the same symptoms. It may harm them and it is against the law. |
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What are the ingredients in RITALIN-SR?
Active ingredient: methylphenidate HCl, USP Inactive ingredients: Cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis For more information, call 1-888-669-6682. T2019-128 |