ACT-Methylphenidate ER

The dose of methylphenidate extended-release needs to be individualized according to the needs of the person taking the medication. The dose is usually started low and increased gradually to the dose that works best for the person.

For people who are not currently taking methylphenidate, the usual starting dose is 18 mg once daily in the morning with or without food.

For people currently taking another form of methylphenidate, the starting dose depends on the current dose being taken. Swallow this medication whole with water or other liquids. Do not crush, chew, or split the tablets. This medication is designed to be released into the body over time. When the tablet is broken, the medication is released into the body faster than it should be and may cause serious side effects.

You may notice the methylphenidate extended-release tablet in your stool. If your child is on this medication, you may notice the tablet in your child's stool. This is normal and occurs because the tablet does not completely dissolve after all the medication has been released in the body.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones above, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule.** Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.**

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

18 mg
Each yellow, film-coated, capsule-shaped tablet, imprinted with "2392" on one side contains 18 mg methylphenidate. *Nonmedicinal ingredients: *lactose monohydrate, hypromellose 2208, silica, colloidal anhydrous, magnesium stearate; copolymers of methacrylic acid and methyl methacrylate, triethyl citrate, talc, hypromellose 2910, and fumaric acid; Coating: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

27 mg
Each gray, film-coated, capsule-shaped tablet, imprinted with "2393" on one side, contains 27 mg methylphenidate. *Nonmedicinal ingredients: *lactose monohydrate, hypromellose 2208, silica, colloidal anhydrous, magnesium stearate; copolymers of methacrylic acid and methyl methacrylate, triethyl citrate, talc, hypromellose 2910, and fumaric acid; Coating: FD&C Blue No. 2, iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

36 mg
Each white, film-coated, capsule-shaped tablet, imprinted with "2394" on one side, contains 36 mg methylphenidate. *Nonmedicinal ingredients: *lactose monohydrate, hypromellose 2208, silica, colloidal anhydrous, magnesium stearate; copolymers of methacrylic acid and methyl methacrylate, triethyl citrate, talc, hypromellose 2910, and fumaric acid; Coating: hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin/glycerol triacetate.

54 mg
Each red-brown, film-coated, capsule-shaped tablet, imprinted with "2395" on one side, contains 54 mg methylphenidate. Nonmedicinal ingredients: lactose monohydrate, hypromellose 2208, silica, colloidal anhydrous, magnesium stearate; copolymers of methacrylic acid and methyl methacrylate, triethyl citrate, talc, hypromellose 2910, and fumaric acid; Coating: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to methylphenidate or any ingredients of the medication

• are taking a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days

• have advanced hardening of the arteries

• have glaucoma (increased pressure in the eye)

• have heart disease

• have moderate-to-severe high blood pressure

• have an overactive thyroid gland

• have a history of drug abuse

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea

• dizziness

• drowsiness

• dry mouth

• headache

• heartburn

• increased frequency of sinus infections or colds

• increased sweating

• loss of appetite

• nausea

• nosebleeds

• stomach pain

• tiredness

• trouble sleeping

• vomiting

• weight changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal blinking

• aggressive or hostile behaviour

• breast swelling (in males)

• blurred vision

• difficulty opening the mouth

• eyelid spasms

• fast heart rate

• feeling anxious or nervous

• inability to control urination

• new or worsening hallucinations (seeing or hearing things that aren't there)

• new or worsening signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• new or worsening symptoms of mania (e.g., decreased need for sleep, elevated or irritable mood, racing thoughts)

• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, brown or discoloured urine)

• swollen hands, ankles, or feet

• symptoms of heart problems (e.g., fast or uneven heartbeat, chest pain, difficulty breathing, fainting)

• symptoms of high blood pressure (e.g., shortness of breath, fatigue, dizziness or fainting, chest pain)

• symptoms of Raynaud's phenomenon (discolouration of fingers and toes, pain, sensation of cold or numbness)

• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

• tics or symptoms of Tourette's syndrome (e.g., involuntary, sudden body movements or uncontrolled vocal outbursts)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• long lasting (greater than 4 hours in duration) and painful erection

• seizures

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Behaviour or mood changes: There have been reports of agitation, hallucinations, symptoms of depression, and thoughts of self-harm in people taking this medication. If you notice these side effects in your child who is taking this medication, contact your doctor immediately. Your doctor will probably want you to monitor your child for emotional and behaviour changes while taking this medication.

If you have a history of depression or bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood pressure: Methylphenidate may increase blood pressure. If you have high blood pressure or heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Circulation problems: **Methylphenidate may cause Raynaud's disease, a blood circulation problem, usually affecting the fingers and toes. If you notice, or your child complains of unusual episodes of cold fingers or toes, or develop sores that aren't healing well, talk to your doctor.

Methylphenidate has also been reported to cause vasculitis, a condition which involves inflammation of blood vessels. This medication should be used with caution if you have a history of blood vessel disorder including vasculitis, aneurysm, or stroke. Contact your doctor immediately if your child develops symptoms such as severe headaches, weakness or paralysis, problems with coordination, vision, speaking, or memory.

Drug dependence: There does not appear to be an increased risk of dependence or addiction with the use of methylphenidate extended-release by children. However, abuse of methylphenidate extended-release is possible for certain individuals. Regular, long-term abuse can lead to high levels of tolerance and psychological dependence, and a wide range of abnormal behaviours. People with a history of drug or alcohol dependence should be carefully monitored by their doctors while using this medication.

Dizziness and vision changes: This medication may cause side effects including blurred vision, trouble focusing, and dizziness. These side effects may affect your ability to perform high-risk activities or drive. Ensure you are not experiencing these side effects before performing such activities.

Exercise: If your child participates in strenuous exercise or activities, consult their doctor before taking methylphenidate. Strenuous exercise combined with the effects of methylphenidate on the heart and blood pressure may increase the risk of sudden death.

Heart problems and blood pressure: This medication can increase heart rate and blood pressure. It may also increase the risk of sudden death for people with heart problems. This medication should generally not be used by children with known heart problems, including an irregular heartbeat, established structural heart abnormalities (such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart), or a family history of sudden death related to heart disease. Misuse of methylphenidate may also be associated with sudden death and other serious heart-related effects.

If you have a family history of stroke, irregular heartbeat or sudden death due to heart problems, talk to your child's doctor.

Long-term use: If your child will be using methylphenidate for a long period of time, your child's doctor will want them to have regular heart checkups, blood pressure checks and lab tests to check their liver and blood.

Phenylketonuria: This medication contains aspartame, an artificial sweetener which contains phenylalanine. The 20 mg extended-release chewable tablet contains 3 mg of phenylalanine; the 30 mg extended-release chewable tablet contains 4.5 mg of phenylalanine; and the 40 mg extended-release chewable tablet contains 6 mg of phenylalanine. People with phenylketonuria are unable to break phenylalanine down to get rid of it. If your child has phenylketonuria, talk to your doctor about other alternatives.

Priapism: This medication may cause priapism, which is a painful and persistent erection of the penis that is unrelieved by sexual activity. This condition can lead to damage to the penis or impotence if it is not treated quickly. If you are experiencing these symptoms, call your doctor or go to the emergency room as soon as possible.

**Seizures: **This medication may increase the risk of seizures. If your child has a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Serotonin toxicity: **Severe reactions are possible when methylphenidate is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations may cause muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

If your child is taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Check with your doctor before stopping this medication. Stopping the medication too quickly can cause symptoms of ADHD to return.

Suppression of growth: Growth suppression (i.e., less increase in height or weight than usual) has been reported for children using stimulants such as methylphenidate for long periods of time. It is not known if the medication causes the growth suppression. However, children who need long-term therapy should be carefully monitored for growth. Their doctor may also recommend a "drug holiday," where the medication is not given on weekends or during school holidays.

Vision changes: Rarely, methylphenidate extended-release has been reported to cause blurred vision and difficulty focusing. It has also been associated with increased pressure in the eyes. If you notice any changes in your child's vision, or they complain about vision changes, contact your doctor.

Children: This medication is intended to be used by children between the ages of 6 and 12 years. The safety and effectiveness of using this medication have not been established for children under 6 years of age or over 12 years of age.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/ACT-Methylphenidate-ER