Cotempla Xr-Odt

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as blood pressure, complete blood count, height/weight monitoring in children) may be done while you are taking this medication. Keep all medical and lab appointments.

There are different brands and forms of this medication available. Not all have the same effects. Do not change brands or forms without consulting your doctor or pharmacist.

Misuse or abuse of methylphenidate can cause serious (possibly fatal) heart and blood pressure problems.

This medication can be habit-forming and people who have mental/mood disorders or a substance use disorder (such as overuse of or addiction to drugs/alcohol) should use it cautiously. Before using this medication, tell your doctor if you have a personal or family history of a substance use disorder. Do not increase your dose, use it more often, or use it for a longer time or in a different way than prescribed. Doing so may cause the drug to work less well, or cause drug dependence or abnormal thoughts/behavior.

Your doctor may monitor you for a while after the medication is stopped, especially if you have taken this drug for a long time or in high doses. (See also How to Use section.)

Read the Medication Guide provided by your pharmacist before you start taking methylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily in the morning. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. Taking this medication late in the day may cause trouble sleeping (insomnia).

Keep the medication in the original package until you are ready to take a dose. Dry your hands before handling the medication. Peel back the foil layer of the blister pack to remove a tablet. Do not push the tablet through the foil because it may get damaged. Place the tablet on your tongue, allow it to dissolve, and swallow with your saliva. You do not need to take this medication with water or other liquid. Do not crush or chew the tablet.

The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used methylphenidate for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not get better or if it gets worse.

Nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts, thoughts of suicide), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control, vision changes (such as blurred vision).

Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or to dexmethylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood circulation problems (such as Raynaud's disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal/family history of uncontrolled muscle movements (motor tics, Tourette's syndrome), overactive thyroid (hyperthyroidism), seizure disorder.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If used for a long time, this drug may affect a child's growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child's weight and height regularly, and consult your doctor or pharmacist for more details.

During pregnancy, methylphenidate should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Avoid alcohol while using this medication because it may cause the medication to be released too quickly and increase the risk of side effects.

Methylphenidate is very similar to dexmethylphenidate. Do not use medications containing dexmethylphenidate while using methylphenidate.

This medication may interfere with certain medical/lab tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, agitation, confusion, sweating, flushing, muscle twitching, hallucinations, seizures, loss of consciousness.

If you miss a dose, take it as soon as you remember. If it is near bedtime or near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.