DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride tablet
Glenmark Pharmaceuticals, Inc.
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MEDICATION GUIDE Dexmethylphenidate Hydrochloride Tablets CII (dex-METH-il-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: • sudden death in patients who have heart problems or heart defects • stroke and heart attack in adults • increased blood pressure and heart rate 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: All Patients • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostility • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms 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?
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Who should not take dexmethylphenidate hydrochloride tablets: Dexmethylphenidate hydrochloride tablets should not be taken if you or your child:
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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: • heart problems, heart defects, high blood pressure • mental problems including psychosis, mania, bipolar illness, or depression • circulation problems in fingers or toes • if you are pregnant or plan to become pregnant. It is not known if dexmethylphenidate hydrochloride tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
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: • anti-depression medicines including MAOIs • blood pressure medicines (anti-hypertensive) Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. • You should not take dexmethylphenidate hydrochloride tablets on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation. Do not start any new medicine while taking dexmethylphenidate hydrochloride tablets without talking to your doctor first. |
How should dexmethylphenidate hydrochloride tablets be taken?
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What are the possible side effects of dexmethylphenidate hydrochloride tablets? Dexmethylphenidate hydrochloride tablets may cause serious side effects, including:
o fingers or toes may feel numb, cool, painful o fingers or toes may change color from pale, to blue, to red Tell your doctor if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
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? • Store dexmethylphenidate hydrochloride tablets in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). • Protect from light and moisture. • Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix dexmethylphenidate hydrochloride tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) dexmethylphenidate hydrochloride tablets in the household trash.
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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, silicified microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, and D&C Yellow #10 aluminum lake (5 mg tablets), FD&C Blue #2 aluminum lake (10 mg tablets) Manufactured by: Neolpharma, Inc. Caguas, Puerto Rico 00725, USA Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 For more information, call 1-888-721-7115. MG81701 |
This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: February 2019 |