What is Relexxii?
Relexxii is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults less than 65 years of age and children 6 years of age and older. Relexxii may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if Relexxii is safe and effective in children under 6 years of age.
Relexxii has not been studied in adults older than 65 years of age.
Relexxii 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 Relexxii in a safe place to protect it from theft. Never give your Relexxii to anyone else because it may cause death or harm them. Selling or giving away Relexxii may harm others and is against the law.
What is the most important information I should know about Relexxii?
Relexxii can cause serious side effects, including:
- Abuse and dependence. Relexxii, 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 Relexxii.
- Tell your healthcare provider if you or your child has 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 related problems or defects
- increased blood pressure and heart rate
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Relexxii. 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 healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with Relexxii.
Call your healthcare provider, or go to 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 Relexxii.
- 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 Relexxii, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
Who should not take Relexxii?
Do not take Relexxii if you or your child are:
- allergic to methylphenidate or any of the ingredients in Relexxii. See below for a complete list of ingredients in Relexxii.
- taking, or have stopped taking within the past 14 days, a medicine called a monoamine oxidase inhibitor (MAOI).
What should I tell my healthcare provider before taking Relexxii?
Before taking Relexxii tell your healthcare provider about all your medical conditions, including if you or your child:
- have heart problems, heart defects, or high blood pressure
- have mental problems including psychosis, mania, bipolar illness, or depression, or 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 Relexxii will harm the unborn baby.
- Pregnancy Exposure Registry: There is a pregnancy registry for women who are exposed to Relexxii during pregnancy. The purpose of the registry is to collect information about the health of women exposed to Relexxii and their baby. If you or your child becomes pregnant during treatment with Relexxii, 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. Relexxii passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Relexxii.
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Relexxii 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 Relexxii. Your healthcare provider will decide whether Relexxii can be taken with other medicines.
Especially tell your healthcare provider if you or your child take:
- blood pressure medicines (anti-hypertensive)
Know the medicines that you take or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist. Do not start any new medicine during treatment with Relexxii without first talking to your healthcare provider.
How should I take Relexxii?
- Take Relexxii exactly as prescribed by your healthcare provider.
- Your healthcare provider may change the dose or tell you to stop taking Relexxii if needed.
- Take Relexxii 1 time each day in the morning with or without food.
- Swallow Relexxii whole with water or other liquids. Do not chew, crush, or divide the tablets. Tell your healthcare provider if you or your child cannot swallow Relexxii whole. A different medicine may need to be prescribed.
- Relexxii does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.
- Your healthcare provider may sometimes stop Relexxii treatment for a while to check ADHD symptoms.
If you or your child take too much Relexxii, call your healthcare provider or poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects of Relexxii?
Relexxii can cause serious side effects, including:
- See "What is the most important information I should know about Relexxii?"
- Painful and prolonged erections (priapism). Priapism that may require surgery 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 or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Relexxii.
- Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Relexxii. Relexxii treatment may be stopped if your child is not growing or gaining weight.
- Possible blockage of the intestine. Because the Relexxii tablet does not change in shape in the intestines (GI tract), Relexxii should not be taken by people with severe intestinal problems (preexisting severe gastrointestinal narrowing).
The most common side effects of Relexxii in adults include:
- decreased appetite
- dry mouth
- trouble sleeping (insomnia)
- weight loss
- increased sweating
The most common side effects of Relexxii in children 6 to 17 years of age was stomach pain.
These are not all the possible side effects of Relexxii.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Relexxii
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Relexxii for a condition for which it was not prescribed. Do not give Relexxii to other people, even if they have the same symptoms that you have. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Relexxii that was written for healthcare professionals.
How should I store Relexxii?
- Store Relexxii at room temperature between 68°F to 77°F (20°C to 25°C).
- Store Relexxii in a safe place, like a locked cabinet. Protect from light and moisture.
- Dispose of remaining, unused, or expired Relexxii 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 Relexxii 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 Relexxii in the household trash.
Keep Relexxii and all medicines out of the reach of children.
What are the ingredients in Relexxii?
Active Ingredient: methylphenidate hydrochloride
Inactive Ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, and triacetin.
27 mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake
45 mg tablets contain: FD&C Red #40 Aluminum Lake
54 mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake
63 mg tablets contain: iron oxide red, iron oxide yellow
72 mg tablets contain: FD&C Blue #1 Aluminum Lake
For more information, go to www.verticalpharma.com or call 1-800-444-5164