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This document provides crucial safety and warning information regarding the use of methylphenidate and its extended-release form (Methylphenidate ER). Understanding these details is essential for safe usage, so please review them carefully and consult your healthcare provider if you have any questions or concerns.

• Misuse and Dependence: Methylphenidate can be habit-forming and may lead to misuse or dependence. Misuse occurs when the drug is used differently from the prescribed manner, which increases the risk of serious side effects such as rapid heartbeat, elevated blood pressure, aggressive behavior, and thoughts of self-harm. Individuals with a history of substance or alcohol use disorder should be particularly cautious. It is important not to exceed the prescribed dose, frequency, or duration of use, as this can lead to reduced effectiveness, dependence, or abnormal behavior.

• Cardiovascular Risks: There have been reports of sudden death, stroke, and heart attack in individuals taking methylphenidate, even at regular doses. This medication can also increase blood pressure and heart rate. If you have a history of heart problems, notify your healthcare provider before using this medication. Seek immediate medical attention if you experience unexplained fainting, chest pain during physical activity, or an irregular heartbeat.

• Behavioral and Thought Changes: Stimulants like methylphenidate can cause mental health issues, including hallucinations, unclear thinking, and mania. These effects may worsen existing mood-related problems or occur even in individuals without previous issues. If you notice any mood or behavior changes, contact your healthcare provider immediately.

• Prolonged and Painful Erection: Some individuals may experience prolonged and painful erections, a condition that could require surgical intervention. This is often linked to dose increases or cessation of the medication. Seek urgent medical attention if an erection lasts longer than four hours.

• Blood Circulation Problems: Methylphenidate ER may be associated with Raynaud's phenomenon, leading to poor blood circulation, especially in fingers and toes. Symptoms include skin discoloration, coldness, numbness, or pain. In rare cases, it can lead to sores or ulcers. Inform your healthcare provider if these symptoms occur.

• Growth Suppression in Children: Long-term use of stimulants like methylphenidate ER may temporarily slow growth in children, as shown in studies where affected children experienced reduced growth in height and weight. Your child's growth will be closely monitored, and treatment may be paused or halted if growth concerns arise.

• Serotonin Syndrome: This rare but potentially fatal condition is due to excess serotonin in the brain. The risk increases when methylphenidate ER is taken with medications affecting serotonin levels, like certain antidepressants and migraine medications. Symptoms include rapid heartbeat, sweating, muscle stiffness, fever, and confusion. Immediate medical help is needed if these symptoms appear.

• Drug Interactions: Methylphenidate ER can interact with various medications, particularly blood pressure medications, potentially reducing their effectiveness. Combining this medication with monoamine oxidase inhibitors (MAOIs) can significantly increase blood pressure. Always inform your healthcare provider and pharmacist about all medications and supplements you are taking.

• Contraindications: Avoid methylphenidate if you have:

  • Severe allergies to methylphenidate products.
  • Used an MAOI in the past 14 days.
  • Inherited problems with sugar digestion (specific to capsules containing sucrose).
  • Marked anxiety, tension, and distress (Relexxi brand).
  • Glaucoma (Relexxi brand).
  • Motor tics or a personal/family history of Tourette syndrome.

In case of overdose, seek emergency medical attention immediately. Always follow your healthcare provider's guidance and report any side effects or concerns promptly.

When taking this medication, some people may encounter mild side effects such as headaches, trouble sleeping, low appetite, stomach pain, dizziness, nausea, vomiting, or dry mouth. These symptoms are generally harmless, but if they persist or worsen, it is advisable to consult a healthcare professional for guidance. Occasionally, users might also experience anxiety or irritability. It's important to monitor your blood pressure regularly, as this medication can cause an increase.

In more serious cases, there are several side effects that warrant immediate medical attention. These include symptoms indicative of heart problems such as a racing heart, high blood pressure, or chest pain, which might suggest a heart attack. Similarly, symptoms like weakness, trouble speaking, or sudden vision changes could be signs of a stroke. Mental health changes such as agitation, mood swings, or abnormal thoughts also require urgent care.

Very rarely, some males, including boys and teenagers, might experience a painful or prolonged erection lasting four or more hours. This condition needs immediate medical intervention to prevent long-term issues. Additionally, severe allergic reactions, though uncommon, can occur and include symptoms like rash, hives, or difficulty breathing. If you notice these signs, seek emergency medical help right away.

If you experience any other unusual effects not listed here, contact your healthcare provider for advice.

When taking Methylphenidate, it is important to be aware of potential interactions with other medications. Methylphenidate should not be used in combination with MAO inhibitors, as this can lead to severe, and possibly fatal, interactions. Avoid using MAO inhibitors such as isocarboxazid, Linezolid, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, and Tranylcypromine while on this medication. It is also advised to wait at least two weeks after stopping any MAO inhibitors before starting methylphenidate. Consult your doctor for guidance on when to begin or discontinue this medication.

Additionally, methylphenidate is similar to Dexmethylphenidate, and these should not be used together.

Be aware that methylphenidate may affect the results of certain medical tests, including brain scans for Parkinson’s disease. Inform your healthcare provider and lab personnel that you are taking methylphenidate to prevent any misinterpretation of test results.

Furthermore, using methylphenidate with medications such as furazolidone, iproniazid, and nialamide is not recommended, and your doctor may adjust your treatment plan accordingly. If necessary, some medications like amifampridine and bupropion might be used alongside methylphenidate under close medical supervision. In some cases, taking methylphenidate with Carbamazepine can increase side effects, but this combination may be appropriate with adjusted dosages. Always keep your doctor and pharmacist informed about all medications and supplements you are taking.