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Methylphenidate Safety and Warning Information

This document outlines the essential safety information and precautions associated with the use of methylphenidate. It's crucial to read and understand this information, and consult your healthcare provider with any concerns.

• Misuse and Dependence: Methylphenidate carries a risk of misuse and dependence. Using the drug in a manner not prescribed can lead to severe side effects, including rapid heartbeat, increased blood pressure, aggressive behavior, and even self-harm. If you have a history of substance or alcohol use disorder, or if you have ever used methylphenidate in higher doses than prescribed, discuss this with your doctor. Abruptly stopping this medication can also be harmful.

• Serious Heart Problems: Regular doses of methylphenidate may lead to severe heart issues, such as sudden death, stroke, or heart attack. This medication can also increase heart rate and blood pressure. Inform your healthcare provider about any history of heart conditions before starting methylphenidate. If you experience symptoms such as unexplained fainting, chest pain during physical activity, or irregular heartbeats, seek medical advice immediately.

• Behavioral and Mental Changes: Stimulants like methylphenidate may cause mental health issues, including hallucinations, abnormal thinking, and mania. They may also exacerbate existing mood disorders. If you notice new or worsening mental health symptoms, contact your healthcare provider immediately.

• Prolonged and Painful Erection: Some individuals may experience prolonged and painful erections, which could require surgical intervention. This condition often occurs after dosage increases but can also happen upon stopping the medication. Seek medical attention if you have an erection lasting more than four hours.

• Blood Circulation Problems: Methylphenidate might lead to poor blood circulation, such as Raynaud's phenomenon, causing symptoms like cold, numb, or painful fingers and toes. Inform your doctor if you experience these symptoms.

• Slowed Growth in Children: Some studies indicate that children taking methylphenidate may experience slowed growth in height and weight. This effect is typically temporary. Your child's healthcare provider will monitor growth and might adjust the treatment if necessary.

• Serotonin Syndrome: This rare but potentially deadly condition can occur when too much serotonin accumulates in the brain. The risk increases when methylphenidate is used with other serotonin-affecting medications. Be alert for symptoms such as rapid heart rate, sweating, muscle stiffness, high fever, and confusion. Seek immediate medical help if these occur.

• Drug Interactions: Methylphenidate can interact with various medications, potentially reducing their effectiveness or causing high blood pressure. Discuss all medications and supplements you are taking with your healthcare provider.

• Caution with Phenylketonuria (PKU): The chewable form of methylphenidate contains phenylalanine, which can be harmful to individuals with PKU. If you have PKU, inform your healthcare provider to receive a safer alternative.

Contraindications:

• Avoid methylphenidate if you have a severe allergy to its components.
• Do not use if you are currently taking or have recently taken monoamine oxidase inhibitors (MAOIs) within the last 14 days.

For any concerns or more information, consult with your healthcare provider.

Common side effects:

• headache
• nervousness
• trouble sleeping
• loss of appetite
• weight loss
• dizziness
• nausea
• dry mouth
• stomach pain
• increased sweating

Less common but important to monitor:

• high blood pressure
• fast or irregular heartbeat
• changes in mental health
• mood swings
• agitation
• thoughts of self-harm
• uncontrolled muscle movements
• sudden outbursts of words or sounds

Serious side effects:

• prolonged and painful erection
• severe allergic reactions
• rash
• itching
• swelling
• severe dizziness
• difficulty breathing
• heart-related issues
• heart attack
• stroke
• serotonin syndrome
• rapid heartbeat
• muscle spasms
• fever
• confusion

Interactions with high risk of serious adverse effects and should be avoided:

• MAO inhibitors (isocarboxazid, Linezolid, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, Tranylcypromine)
• Dexmethylphenidate

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Amifampridine
• Bupropion
• Desflurane
• Donepezil
• Enflurane
• Halothane
• Iobenguane I 131
• Isoflurane
• Risperidone
• Sevoflurane

Interactions with low risk that usually do not require a change in therapy:

• Carbamazepine