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 methylphenidate extended-release 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

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.

• agitation, nervousness, or anxiety

• dizziness

• dry mouth

• headache

• increased sweating

• irritability

• loss of appetite

• nervousness

• nausea

• slowed growth

• stomach pain

• trouble sleeping

• vomiting

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 any of the following side effects occur:

• abnormal thoughts or behaviour

• aggressive or hostile behaviour

• difficulty opening your mouth

• fast heart rate

• hallucinations (hearing, seeing, or feeling things that are not actually there)

• inability to control urine elimination

• increased blood pressure

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• symptoms of depression (e.g., losing interest in your usual activities, feeling sad, having thoughts of suicide)

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

• symptoms of muscle damage (e.g., muscle weakness, pain, spasms, red-brown-coloured urine)

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

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

• vision changes

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

• convulsions (seizures)

• long-lasting (greater than 4 hours) and painful erection of the penis

• signs of a serious allergic reaction (difficulty breathing; hives; swelling of the face, lips, eyes, mouth, or throat)

• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

• sudden signs of heart problems (e.g., fast heartbeat, palpitations, chest pain, shortness of breath, fainting)

• thoughts of suicide or harming yourself

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 taking 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 take this medication.

Behaviour or mood changes: Stimulant medications such as methylphenidate may make behavior and thought disturbances worse for people who have mental health conditions. They may also cause symptoms of psychosis and mania to develop in people who have not had these symptoms before.

There have been reports of agitation, hallucinations, symptoms of depression, and thoughts of self-harm and suicide in people taking this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

**Circulation problems: **Methylphenidate may cause Raynaud's disease, a blood circulation problem, usually affecting the fingers and toes. If you notice 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 of you develop symptoms such as severe headaches, weakness or paralysis, problems with coordination, vision, speaking, or with your memory.

Blood pressure: This medication can increase blood pressure. If you have high blood pressure or heart problems, talk to your doctor before taking this medication.

Drowsiness/reduced alertness: Methylphenidate extended-release may cause dizziness, which could affect your ability to drive or operate machinery. Avoid activities requiring alertness until you have determined how this medication affects you.

Drug dependence: There does not appear to be an increased risk of dependence or addiction with the use of methylphenidate by children and adolescents. However, abuse of methylphenidate is possible by certain individuals. Regular, long-term abuse can lead to high levels of tolerance and psychological dependence, and a wide range of abnormal behaviours. If you have a history of drug or alcohol dependence, you should be closely monitored by your doctor while using this medication.

Exercise: If you participate in strenuous exercise or activities, consult your doctor before taking methylphenidate extended-release. 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 people with known 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 or cardiac death. Methylphenidate may also increase the risk of stroke, particularly for people who have already had a stroke or are at risk of having a stroke.

People taking more than one stimulant medication for ADHD should be closely monitored by their doctor.

Misuse of methylphenidate may also be associated with sudden death and other serious heart-related effects.

Long-term use: If you will be using methylphenidate extended-release for a long period of time, your doctor will want you to have regular heart checkups, blood pressure checks and lab tests to monitor your liver and blood.

Serotonin toxicity: Severe reactions are possible when methylphenidate extended-release is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, which are medications used to treat depression. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

Stomach and intestinal problems: This medication should not be used by people with certain stomach or intestinal problems (e.g., narrowing of the intestines, "short gut" syndrome, a history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckels' diverticulum).

Stopping the medication: Check with your doctor before stopping this medication. Suddenly stopping the medication may cause mental conditions or hyperactivity to return.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

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 methylphenidate extended-release causes growth suppression in children (i.e., less increase in height or weight than usual). Children who need long-term treatment 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.

**Tics: **This medication may cause tics or worsening of motor or verbal tics. If you have Tourette's syndrome or develop tics while on this medication, 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.

Vision: Rarely, people taking methylphenidate extended-release have experienced vision changes. If you notice any changes in your vision, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are sbreast-feeding and are taking methylphenidate extended-release, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 6 years of age. Methylphenidate extended-release should not be used by children in this age group.

There may be an interaction between methylphenidate extended-release and any of the following:

• alcohol

• aliskiren

• alpha blockers (e.g., doxazosin, silodosin, tamsulosin)

• angiotensin receptor blockers (e.g., candesartan, irbesartan, losartan, telmisartan, valsartan)

• angiotensin-converting enzyme inhibitors (e.g., enalapril, lisinopril, perindopril, ramipril)

• antipsychotics (e.g., cariprazine, chlorpromazine, haloperidol, quetiapine, risperidone)

• atomoxetine

• beta-agonists (e.g., formoterol, salbutamol, salmeterol)

• beta-adrenergic blockers (e.g., atenolol, bisoprolol, metoprolol)

• bupropion

• caffeine

• calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)

• cannabis

• carbamazepine

• clonidine

• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)

• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)

• diuretics (e.g., chlorthalidone, furosemide, hydrochlorothiazide)

• epinephrine

• eplerenone

• esketamine

• fentanyl

• general anesthetics (medications to put you to sleep for surgery)

• guanfacine

• hydralazine

• levothyroxine

• linezolid

• lithium

• mirtazapine

• monoamine oxidase (MAO) inhibitors (e.g., moclobemide, phenelzine, selegiline, tranylcypromine)

• other medications for ADHD

• nabilone

• ozanimod

• phenobarbital

• primidone

• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin)

• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)

• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)

• sodium phosphates

• spironolactone

• theophyllines (e.g., aminophylline, theophylline)

• tramadol

• trazodone

• tricyclic antidepressants (e.g., amitriptyline, imipramine, nortriptyline)

• tryptophan

If you are taking any of these 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. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than the ones listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that 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