What is APTENSIO XR?

• APTENSIO XR is not for use in children under 6 years of age.

• allergic to methylphenidate hydrochloride or any of the ingredients in APTENSIO XR. See the end of this Medication Guide for a complete list of ingredients in APTENSIO XR.
• taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

• have heart problems, heart disease, heart defects, or 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
• have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
• have or had repeated movements or sounds (tics) or Tourette's syndrome, or have a family history of tics or Tourette's syndrome
• are pregnant or plan to become pregnant. It is not known if APTENSIO XR will harm your unborn baby.
  • There is a pregnancy registry for females who are exposed to APTENSIO XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to APTENSIO XR and their baby. If you or your child becomes pregnant during treatment with APTENSIO XR, 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. APTENSIO XR passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with APTENSIO XR.

• Take APTENSIO XR exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Take APTENSIO XR by mouth 1 time each day in the morning.
• APTENSIO XR can be taken with or without food but take it the same way each time.
• Swallow APTENSIO XR capsules whole, or if APTENSIO XR 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 APTENSIO XR 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
• If a dose of APTENSIO XR 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.

• 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 APTENSIO XR.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with APTENSIO XR. APTENSIO XR treatment may be stopped if your child is not growing or gaining weight.
• Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
• New or worsening tics or worsening Tourette's syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette's syndrome during treatment with APTENSIO XR.

How should I store APTENSIO XR?

• Store APTENSIO XR at room temperature between 68°F to 77°F (20°C to 25°C).
• Store APTENSIO XR in a safe place, like a locked cabinet. Protect from moisture.
• Dispose of remaining, unused, or expired APTENSIO XR 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 APTENSIO XR 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 APTENSIO XR in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.