Step-by-step Guidance on Taking
Cotempla XR-ODT

Your child should take Cotempla XR-ODT once daily in the morning. Your child’s doctor may adjust the dose until it is right for your child.

The following brief instructions will guide you on: opening the blister pack, taking the medication, routine monitoring and proper storage.

Opening the Blister Pack

Do not remove the tablet from the blister pack until your child is ready to take it. Your child should take the tablet as soon as you open the blister pack.
Use dry hands to open the blister pack.
Remove the tablet by peeling back the foil on the blister pack. Do not push the tablet through the foil.

Taking Cotempla XR-ODT

Place the whole tablet on your child’s tongue.
The tablet will dissolve in your child’s saliva so that it can be swallowed. No liquid is needed to take the tablet.
Your child should not crush or chew the tablet.
The tablet should be taken consistently either with food or without food.

Routine Monitoring While Taking Cotempla XR-ODT

Your child’s doctor may sometimes stop Cotempla XR-ODT treatment for a while to check your child’s ADHD symptoms.
Your child’s doctor may do regular checks of your child’s heart rate and blood pressure while taking Cotempla XR-ODT.
Children should have their height and weight checked often during treatment with Cotempla XR-ODT. The medication may be stopped if your child is not gaining weight and height.

If your child takes too much Cotempla XR-ODT, call your healthcare provider or go to the nearest hospital emergency room right away.

Storing Cotempla XR-ODT

To keep your child’s medication safe, be sure to store Cotempla XR-ODT according to the following directions:

At room temperature between 68°F and 77°F (20°C and 25°C).
In a safe place, like a locked cabinet.
In the blister packaging until you are ready to give it to your child.
Store Cotempla XR-ODT blister packages in the reusable travel case after removal from the carton.
Always keep Cotempla XR-ODT and all medicines out of reach from children.

Possible side effects of Cotempla XR-ODT

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Already have a prescription for Cotempla XR-ODT?

Important Safety Information

Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.

Who should not take Cotempla XR-ODT?

Do not give Cotempla XR-ODT to your child if they are:

allergic to methylphenidate or any ingredients in Cotempla XR-ODT.
taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.

What is the most important information I should know about Cotempla XR-ODT?

Cotempla XR-ODT can cause serious side effects. Tell your healthcare provider about health conditions, including if your child:

has ever abused or been dependent on alcohol, prescription medicines, or street drugs. Cotempla XR-ODT has a high chance for abuse and can cause physical and psychological dependence.
has any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects. Increased blood pressure and heart rate have been reported. Your healthcare provider should check for heart problems prior to prescribing Cotempla XR-ODT and will check your child’s blood pressure and heart rate regularly during treatment. Call the healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while during treatment.
has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because the following could occur: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (hearing voices, or seeing or believing things that are not real) or new manic symptoms. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.
develops painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. Get medical help right away if your child develops priapism.
has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, and/or change color from pale, to blue, to red. Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in their fingers or toes. Call the healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Cotempla XR-ODT.
is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Cotempla XR-ODT. Treatment may be stopped if your child is not gaining weight or height.
is pregnant or plans to become pregnant. It is not known if Cotempla XR-ODT will harm the unborn baby. If your child becomes pregnant during treatment with Cotempla XR-ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants.
is breastfeeding, or plans to breastfeed. You and your healthcare provider should decide if your child will take Cotempla XR-ODT or breastfeed.
takes any medicines, including prescription and over-the-counter medicines (especially for depression, including MAOIs), vitamins, and herbal supplements. Cotempla XR-ODT and some medicines may interact with each other and cause serious side effects, or sometimes the dose of the other medicine will need to be adjusted.

Do not start any new medicine while taking Cotempla XR-ODT without talking to your healthcare provider first.

What should I avoid during treatment with Cotempla XR-ODT?

You should avoid drinking alcohol during treatment with Cotempla XR-ODT.

Common side effects of Cotempla XR-ODT include:

Decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure.

These are not all the possible side effects of Cotempla XR-ODT. Call your healthcare provider for medical advice about side effects.

What is Cotempla XR-ODT?

Cotempla XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. Cotempla XR-ODT 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 Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.

For additional safety information, click here for Medication Guide and Full Prescribing Information and discuss with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Step-by-step Guidance on Taking Cotempla XR-ODT

Important Safety Information

Step-by-step Guidance on Taking
Cotempla XR-ODT