DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride tablet
Sun Pharmaceutical Industries, Inc.
Dexmethylphenidate Hydrochloride Tablets, CII
(dex meth ill FEN i date hye" droe klor'ide)
What is the most important information I should know about dexmethylphenidate hydrochloride tablets?
Dexmethylphenidate hydrochloride tablets are a federal controlled substance (CII) because it can be abused or lead to dependence. Keep dexmethylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate hydrochloride tablets 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 dexmethylphenidate hydrochloride tablets.
Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride tablets.
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 dexmethylphenidate hydrochloride tablets.
2. Mental (Psychiatric) problems:
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 dexmethylphenidate hydrochloride tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What are dexmethylphenidate hydrochloride tablets?
Who should not take dexmethylphenidate hydrochloride tablets:
Dexmethylphenidate hydrochloride tablets should not be taken if you or your child:
Dexmethylphenidate hydrochloride tablets may not be right for you or your child. Before starting dexmethylphenidate hydrochloride tablets, 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. Dexmethylphenidate 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 dexmethylphenidate hydrochloride tablets.
Your doctor will decide whether dexmethylphenidate hydrochloride tablets 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 dexmethylphenidate hydrochloride tablets without talking to your doctor first.
How should dexmethylphenidate hydrochloride tablets be taken?
What are the possible side effects of dexmethylphenidate hydrochloride tablets?
Dexmethylphenidate hydrochloride tablets may cause serious side effects, including:
Common side effects include:
• abdominal pain • fever • anorexia • nausea
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store dexmethylphenidate hydrochloride tablets?
General information about the safe and effective use of dexmethylphenidate hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about dexmethylphenidate hydrochloride tablets that is written for healthcare professionals. Do not use dexmethylphenidate hydrochloride tablets for a condition for which it was not prescribed. Do not give dexmethylphenidate hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
What are the ingredients in dexmethylphenidate hydrochloride tablets?
Active ingredient: dexmethylphenidate hydrochloride
Inactive ingredients: lactose monohydrate, sodium starch glycolate, talc, magnesium stearate, and FD&C Blue No.1 aluminum lake (2.5 mg tablet), D&C Yellow No. 10 aluminum lake (5 mg tablet); the 10 mg tablet contains no dye.
For more information, call 1-800-406-7984.
This Medication Guide has been approved by the U.S. Food and Drug Administration