Methylphenidate Hydrochloride (Page 6 of 7)

17 PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients that Methylphenidate Hydrochloride Extended-Release Capsules is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give Methylphenidate Hydrochloride Extended-Release Capsules to anyone else. Advise patients to store Methylphenidate Hydrochloride Extended-Release Capsules in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired Methylphenidate Hydrochloride Extended-Release Capsules by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1, 9.2, and 9.3)].

Dosage and Administration Instructions

Advise patients that Methylphenidate Hydrochloride Extended-Release Capsules can be taken with or without food and that they should establish a routine pattern of taking Methylphenidate Hydrochloride Extended-Release Capsules with regard to meals. For patients who take Methylphenidate Hydrochloride Extended-Release Capsules sprinkled over applesauce, the contents of the entire capsule should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. When initiating treatment with Methylphenidate Hydrochloride Extended-Release Capsules, provide dosage escalation and administration instructions [see Dosage and Administration (2.2)].

Serious Cardiovascular Risks

Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with Methylphenidate Hydrochloride Extended-Release Capsules use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Blood Pressure and Heart Rate Increases

Instruct patients that Methylphenidate Hydrochloride Extended-Release Capsules can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3)].

Psychiatric Risks

Advise patients that Methylphenidate Hydrochloride Extended-Release Capsules, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Priapism

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]

Instruct patients beginning treatment with Methylphenidate Hydrochloride Extended-Release Capsules about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate Hydrochloride Extended-Release Capsules. Further clinical evaluation (e.g. rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Suppression of Growth

Advise patients that Methylphenidate Hydrochloride Extended-Release Capsules may cause slowing of growth and weight loss [see Warnings and Precautions (5.7)].

Alcohol

Advise patients to avoid alcohol while taking Methylphenidate Hydrochloride Extended-Release Capsules. Consumption of alcohol while taking Methylphenidate Hydrochloride Extended-Release Capsules may result in a more rapid release of the dose of methylphenidate [see Clinical Pharmacology (12.3)].

Marketed by:
Rhodes Pharmaceuticals L.P.
Coventry, RI 02816

Manufactured by:
Patheon Manufacturing Services LLCGreenville, North Carolina 27834

This product is covered by US patents including US Patents No. 6,419,960, 7,083,808, 7,247,318, 8,580,310, 9,066,869 and 9,801,823.

305286-0B

Revised: 06/2021

MEDICATION GUIDEMethylphenidate (METH-il-FEN-i-date) Hydrochloride Extended-Release Capsules, CII
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2019

What is the most important information I should know about Methylphenidate Hydrochloride Extended-Release Capsules?

Methylphenidate Hydrochloride Extended-Release Capsules can cause serious side effects, including:
  • Abuse and dependence. Methylphenidate Hydrochloride Extended-Release Capsules, other methylphenidate containing medicines, and amphetamines have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Methylphenidate Hydrochloride Extended-Release Capsules.
    • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
    • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Heart-related problems, including:
    • sudden death, stroke, and heart attack in adults
    • sudden death in children who have heart problems or heart defects
    • increased blood pressure and heart rate
    Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Methylphenidate Hydrochloride Extended-Release Capsules. Tell your healthcare provider 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’s blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Extended-Release Capsules.Call your healthcare provider or go 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 Hydrochloride Extended-Release Capsules.
  • Mental (psychiatric) problems, including:
    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    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 Hydrochloride Extended-Release Capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
What is Methylphenidate Hydrochloride Extended-Release Capsules?
Methylphenidate Hydrochloride Extended-Release Capsules is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Methylphenidate Hydrochloride Extended-Release Capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
  • Methylphenidate Hydrochloride Extended-Release Capsules is not for use in children under 6 years of age.
  • Methylphenidate Hydrochloride Extended-Release Capsules is 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 Hydrochloride Extended-Release Capsules in a safe place to protect it from theft. Never give your Methylphenidate Hydrochloride Extended-Release Capsules to anyone else, because it may cause death or harm them. Selling or giving away Methylphenidate Hydrochloride Extended-Release Capsules may harm others and is against the law.
Do not take Methylphenidate Hydrochloride Extended-Release Capsules if you or your child are:
  • allergic to methylphenidate hydrochloride or any of the ingredients in Methylphenidate Hydrochloride Extended-Release Capsules. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate Hydrochloride Extended-Release Capsules.
  • taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Before taking Methylphenidate Hydrochloride Extended-Release Capsules tell your healthcare provider about all medical conditions, including if you or your child:
  • have heart problems, heart defects, high blood pressure
  • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
  • have circulation problems in fingers and toes
  • are pregnant or plan to become pregnant. It is not known if Methylphenidate Hydrochloride Extended-Release Capsules will harm your unborn baby.
    • There is a pregnancy registry for females who are exposed to Methylphenidate Hydrochloride Extended-Release Capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Methylphenidate Hydrochloride Extended-Release Capsules and their baby. If you or your child becomes pregnant during treatment with Methylphenidate Hydrochloride Extended-Release Capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
  • are breastfeeding or plan to breastfeed. Methylphenidate Hydrochloride Extended-Release Capsules passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Methylphenidate Hydrochloride Extended-Release Capsules.
Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Methylphenidate 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 changed during treatment with Methylphenidate Hydrochloride Extended-Release Capsules. Your healthcare provider will decide whether Methylphenidate Hydrochloride Extended-Release Capsules can be taken with other medicines.
Especially tell your healthcare provider if you or your child take a medicine used to treat depression called monoamine oxidase inhibitor (MAOI).
Know the medicines that you or your child take. Keep a list of the medicines with you to show your healthcare provider and pharmacist. Do not start any new medicine during treatment with Methylphenidate Hydrochloride Extended-Release Capsules without talking to your healthcare provider first.
How should Methylphenidate Hydrochloride Extended-Release Capsules be taken?
  • Take Methylphenidate Hydrochloride Extended-Release Capsules exactly as prescribed by your healthcare provider.
  • Your healthcare provider may change the dose if needed.
  • Take Methylphenidate Hydrochloride Extended-Release Capsules by mouth 1 time each day in the morning.
  • Methylphenidate Hydrochloride Extended-Release Capsules can be taken with or without food but take it the same way each time.
  • Swallow Methylphenidate Hydrochloride Extended-Release Capsules whole, or if Methylphenidate Hydrochloride Extended-Release Capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto a tablespoonful of applesauce. Make sure to sprinkle all the medicine onto the applesauce. The Methylphenidate Hydrochloride Extended-Release Capsules dose should not be divided.
    • swallow all the applesauce and medicine mixture without chewing right away or within 10 minutes
    • do not chew the applesauce and medicine mixture
    • do not store applesauce and medicine mixture
  • Your healthcare provider may sometimes stop Methylphenidate Hydrochloride Extended-Release Capsules treatment for a while to check ADHD symptoms.
  • If a dose of Methylphenidate Hydrochloride Extended-Release Capsules is missed, do not take the dose later in the day or take an extra dose to make up for the missed dose, wait until the next morning to take the next scheduled dose.
  • In case of poisoning call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What should be avoided during treatment with Methylphenidate Hydrochloride Extended-Release Capsules?
Avoid drinking alcohol during treatment with Methylphenidate Hydrochloride Extended-Release Capsules. This may cause a faster release of the Methylphenidate Hydrochloride Extended-Release Capsules medicine.
What are possible side effects of Methylphenidate Hydrochloride Extended-Release Capsules?
Methylphenidate Hydrochloride Extended-Release Capsules can cause serious side effects, including:
See What is the most important information I should know about Methylphenidate Hydrochloride Extended-Release Capsules?
  • Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
    • fingers or toes may feel numb, cool, painful
    • fingers or toes may change color from pale, to blue, to red
    Tell your healthcare provider if you have or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.Call your healthcare provider right away if you have or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Methylphenidate Hydrochloride Extended-Release Capsules.
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Methylphenidate Hydrochloride Extended-Release Capsules. Methylphenidate Hydrochloride Extended-Release Capsules treatment may be stopped if your child is not growing or gaining weight.
The most common side effects of Methylphenidate Hydrochloride Extended-Release Capsules in children 6 to 17 years of age include stomach pain, decreased appetite, headache, trouble sleeping.
These are not all the possible side effects of Methylphenidate Hydrochloride Extended-Release Capsules.
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 Rhodes Pharmaceuticals L.P. at 1-888-827-0616.
How should I store Methylphenidate Hydrochloride Extended-Release Capsules?
  • Store Methylphenidate Hydrochloride Extended-Release Capsules at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store Methylphenidate Hydrochloride Extended-Release Capsules in a safe place, like a locked cabinet. Protect from moisture.
  • Dispose of remaining, unused, or expired Methylphenidate Hydrochloride Extended-Release Capsules by a medication 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 Methylphenidate 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 Methylphenidate Hydrochloride Extended-Release Capsules in the household trash.
Keep Methylphenidate Hydrochloride Extended-Release Capsules and all medicines out of the reach of children.
General information about the safe and effective use of Methylphenidate Hydrochloride Extended-Release Capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate Hydrochloride Extended-Release Capsules for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride Extended-Release Capsules to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your doctor or pharmacist for information about Methylphenidate Hydrochloride Extended-Release Capsules that was written for healthcare professionals.
What are the ingredients in Methylphenidate Hydrochloride Extended-Release Capsules?
Active Ingredient: methylphenidate hydrochloride
Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate.
Manufactured by: Patheon Manufacturing Services LLC, Greenville, North Carolina 27834
For more information call Rhodes Pharmaceuticals L.P. (the distributor for Methylphenidate Hydrochloride Extended-Release Capsules) at 1-888-827-0616.

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