DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride capsule, extended release
Granules Pharmaceuticals Inc.
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Dispense with Medication Guide available at:
https://granulespharma.com/product/dexmethylphenidate-er-cap/
MEDICATION GUIDE
for oral use, CII |
What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules? Dexmethylphenidate hydrochloride extended-release capsules may cause serious side effects, including: • Abuse, misuse, and addiction. Dexmethylphenidate hydrochloride extended-release capsules has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of dexmethylphenidate hydrochloride extended-release capsules or when it is used in ways that are not approved, such as snorting or injection.
Your healthcare provider should check you or your child carefully for heart problems before starting dexmethylphenidate hydrochloride extended-release capsules. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
• Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules. • Mental (psychiatric) problems:
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 dexmethylphenidate hydrochloride extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
What are dexmethylphenidate hydrochloride extended-release capsules?
Dexmethylphenidate hydrochloride extended-release capsule is a federally controlled substance (CII) because it contains dexmethylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep dexmethylphenidate hydrochloride extended-release capsules in a safe place to protect it from theft. Never give your dexmethylphenidate hydrochloride extended-release capsules to anyone else because it may cause death or harm them. Selling or giving away dexmethylphenidate hydrochloride extended-release capsules may harm others and is against the law. |
Who should not take dexmethylphenidate hydrochloride extended-release capsules?
Dexmethylphenidate hydrochloride extended-release capsules should not be taken if you or your child: • are allergic to methylphenidate hydrochloride, or any of the ingredients in dexmethylphenidate hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in dexmethylphenidate hydrochloride extended-release capsules. • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI). |
Dexmethylphenidate hydrochloride extended-release capsules may not be right for you or your child. Before starting dexmethylphenidate hydrochloride extended-release capsules, tell your or your child's healthcare provider about all health conditions (or a family history of), including:
• have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules.
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How should dexmethylphenidate hydrochloride extended-release capsules be taken?
• Take dexmethylphenidate hydrochloride extended-release capsules exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child. • Take dexmethylphenidate hydrochloride extended-release capsule once each day in the morning. Dexmethylphenidate hydrochloride extended-release capsules is an extended-release capsule. • Dexmethylphenidate hydrochloride extended-release capsules can be taken with or without food. Taking dexmethylphenidate hydrochloride extended-release capsules with food may slow the time it takes for the medicine to start working. • Swallow dexmethylphenidate hydrochloride extended-release capsules whole with water or other liquids. Do not chew, crush, or divide the capsules or the beads in the capsule. If you or your child cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing. • Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking dexmethylphenidate hydrochloride extended-release capsules. • Children should have their height and weight checked often while taking Dexmethylphenidate hydrochloride extended-release capsules. Dexmethylphenidate hydrochloride extended-release capsules treatment may be stopped if a problem is found during these check-ups. If you or your child take too much dexmethylphenidate hydrochloride extended-release capsules, 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 dexmethylphenidate hydrochloride extended-release capsules? Dexmethylphenidate hydrochloride extended-release capsules may cause serious side effects, including: • see " What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules?" for information on reported heart and mental problems.
Tell your healthcare provider if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
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How should I store dexmethylphenidate hydrochloride extended-release capsules?
• Store dexmethylphenidate hydrochloride extended-release capsules in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). • Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride extended-release capsules by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicine. • Keep dexmethylphenidate hydrochloride extended-release capsules and all medicines out of the reach of children. |
General information about the safe and effective use of dexmethylphenidate hydrochloride extended-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about dexmethylphenidate hydrochloride extended-release capsules that is written for healthcare professionals. Do not use dexmethylphenidate hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules?
Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, sugar spheres (which contain sucrose and starch), talc, titanium dioxide, and triethyl citrate. The 5 mg, 25 mg and 35 mg capsule also contains D&C red #28. The 15 mg and 40 mg capsule also contains D&C yellow #10. The 5 mg, 15 mg, 25 mg, 35 mg, and 40 mg capsule also contains FD&C blue #1. The 10 mg, 30 mg and 35 mg capsule also contains FD&C yellow #6. In addition, capsule imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.
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This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2023 |