Language selection

Search

Details for: ACT METHYLPHENIDATE ER

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02441934ACT METHYLPHENIDATE ERMETHYLPHENIDATE HYDROCHLORIDE18 MGTABLET (EXTENDED-RELEASE)ORAL
02441942ACT METHYLPHENIDATE ERMETHYLPHENIDATE HYDROCHLORIDE27 MGTABLET (EXTENDED-RELEASE)ORAL
02441950ACT METHYLPHENIDATE ERMETHYLPHENIDATE HYDROCHLORIDE36 MGTABLET (EXTENDED-RELEASE)ORAL
02441969ACT METHYLPHENIDATE ERMETHYLPHENIDATE HYDROCHLORIDE54 MGTABLET (EXTENDED-RELEASE)ORAL
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

ACT Methylphenidate ER is a once-a-day treatment for Attention Deficit Hyperactivity Disorder, or ADHD, in children 6 years of age or older, adolescents and adults. Methylphenidate hydrochloride extended-release tablets are a central nervous system stimulant that has been used to treat ADHD for more than 30 years.

ADHD has three main types of symptoms: inattention, hyperactivity and impulsiveness. Symptoms of inattention include not paying attention, making careless mistakes, not listening, not finishing tasks, not following directions and being easily distracted. Symptoms of hyperactivity and impulsiveness include fidgeting, talking excessively, running around at inappropriate times and interrupting others. Some patients have more symptoms of hyperactivity and impulsiveness while others have more symptoms of inattentiveness. Some patients have all three types of symptoms. Many people have symptoms like these from time to time, but patients with ADHD have these symptoms more than others their age. Symptoms must be present for at least 6 months to be certain of the diagnosis.

Symptoms of ADHD in adults may include a lack of organization, problems starting tasks, impulsive actions, daydreaming, slow processing of information, difficulty learning new things, irritability, lack of esteem and excessive effort to maintain some organization.

What it does

Part of the ACT Methylphenidate ER tablet dissolves right after you / your child swallow it in the morning, giving you / your child an initial dose of medication. The rest of the medication is slowly released during the day to keep improving the symptoms of ADHD. ACT Methylphenidate ER helps increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

When it should not be used

You / your child should NOT take ACT Methylphenidate ER if you / your child:

  • are allergic to methylphenidate hydrochloride or any of the other ingredients in ACT Methylphenidate ER;
  • have glaucoma, an eye disease;
  • have symptomatic cardiovascular disease;
  • have moderate to severe high blood pressure;
  • have advanced arteriosclerosis (hardened arteries);
  • have hyperthyroidism (an overactive thyroid gland); or
  • are taking or have taken within the past 14 days monoamine oxidase inhibitors (a type of drug, see INTERACTIONS WITH THIS MEDICATION).

Talk to your doctor if you believe any of these conditions apply to you / your child.

What the medicinal ingredient is

methylphenidate hydrochloride

What the non-medicinal ingredients are

Lactose Monohydrate, Hypromellose 2208, Silica, Colloidal Anhydrous, Magnesium Stearate; copolymers of methacrylic acid and methyl methacrylate, Triethyl Citrate, Talc, Hypromellose 2910, and Fumaric acid.
The coating of the 18 mg tablet contains: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

The coating of the 27 mg tablet contains: FD&C Blue #2, iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

The coating of the 36 mg tablet contains: hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin/glycerol triacetate.

The coating of the 54 mg tablet contains: iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

What dosage form it comes in

extended-release tablets: 18 mg, 27 mg, 36 mg and 54 mg

Warnings and precautions

Serious Warnings and Precautions

Drug Dependence

Abuse of ACT Methylphenidate ER can lead to dependence. Tell your doctor if you have ever abused or been dependent on alcohol or drugs, or if you are now abusing or dependent on alcohol or drugs

The following have been reported with use of ACT Methylphenidate ER and other medicines used to treat ADHD.

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. ACT Methylphenidate ER generally should not be used in children, adolescents or adults with known structural heart abnormalities.

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor may wish to check you or your child carefully for heart problems before starting ACT Methylphenidate ER.

Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with ACT Methylphenidate ER.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking ACT Methylphenidate ER.

2. Mental (Psychiatric) problems:

  • New or worse thoughts or feelings related to suicide (thinking about or feeling like killing oneself) and suicide actions (including suicide attempt, suicidal ideation and completed suicide)
  • new or worse symptoms of bipolar illness, characterized by extreme mood swings, with periods of mania (unusually excited, over-active or uninhibited) alternating with periods of depression (feelings of sadness, worthlessness or hopelessness)
  • new or worse aggressive behaviour or hostility
  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

These new or worse mental symptoms may be more likely to occur if you/your child have mental disorders that you may or may not know about. Tell your doctor about any mental problems or about any personal or family history of suicide, bipolar illness, or depression you or your child have.

A small number of patients taking ADHD drugs may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of suicide, self-harm or harm to others. Those suicidal thoughts or behaviors may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping ACT Methylphenidate ER. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking ACT Methylphenidate ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

BEFORE you or your child use ACT Methylphenidate ER, talk to your doctor or pharmacist if you / your child:

  • have structural heart abnormalities;
  • Have tics (movements or sounds that you cannot control) or Tourette’s syndrome, or if someone in your family has tics or Tourette’s syndrome;
  • have eye problems, such as:
    • increased pressure in the eye
    • far-sightedness (difficulty seeing near objects)
  • have mental problems or family history of mental problems, including psychosis, mania, bipolar illness, depression or suicide;
  • become aggressive, anxious or agitated, or feel more aggressive, anxious or agitated than usual;
  • have mild high blood pressure;
  • take blood pressure medications;
  • take cold, allergy or other drugs that can affect blood pressure;
  • have a narrowing or blockage of your gastrointestinal tract (your esophagus, stomach, or small or large intestine);
  • have a family history of sudden death or death related to heart problems;
  • do strenuous exercise;
  • take other drugs for ADHD;
  • have or have had any disorder of the blood vessels in the brain (e.g., aneurysm, stroke, vasculitis), or
  • have circulation problems in fingers and toes, including numbness; feeling cold or pain. (This is also known as Raynaud’s).

Tell your doctor immediately if you / your child develop any of the above conditions or symptoms while taking ACT Methylphenidate ER. He/she will decide if you can start/continue taking ACT Methylphenidate ER.

BEFORE taking ACT Methylphenidate ER, tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are nursing a baby. Methylphenidate passes into breast milk. If you take ACT Methylphenidate ER, it can be in your breast milk. You should consult with your doctor to determine whether you should stop breast-feeding or discontinue ACT Methylphenidate ER

Your doctor will monitor your progress with ACT Methylphenidate ER and may require you to do occasional tests to ensure your health and safety.

Interactions with this medication

Tell your doctor about all medicines that you / your child are taking. Your doctor should decide whether you / your child can take ACT Methylphenidate ER with other medicines. These include:

  • type of medicine for depression or anxiety called a ‘selective serotonin reuptake inhibitor’ (SSRI) or a ‘serotonin and norepinephrine reuptake inhibitor’ (SNRI).
  • clonidine;
  • type of medication called an “antipsychotic”;
  • other medicines that a doctor has prescribed;
  • medicines that you buy yourself without a prescription;
  • any herbal remedies that you /your child may be taking.

You / your child should not take ACT Methylphenidate ER with monoamine oxidase (MAO) inhibitors.

While on ACT Methylphenidate ER, do not start taking a new medicine or herbal remedy before checking with your doctor.

You should avoid alcoholic drinks while taking ACT Methylphenidate ER.

ACT Methylphenidate ER may change the way your / your child’s body reacts to certain medicines. These include medicines used to treat depression (e.g., amitriptyline, imipramine and fluoxetine), prevent seizures (e.g., phenobarbitone, phenytoin, carbamazepine and primidone) or prevent blood clots (commonly called “blood thinners”, e.g., warfarin). Your doctor may need to change your / your child’s dose of these medicines if you / your child are taking them with ACT Methylphenidate ER.

Proper use of this medication

Do not chew, crush, or divide the tablets. Swallow ACT Methylphenidate ER tablets whole with water or other liquids, such as milk or juice.

Take ACT Methylphenidate ER once each day in the morning with or without food.

ACT Methylphenidate ER has not been studied and should not be used in children under six years of age. Methylphenidate hydrochloride extended-release tablet has not been studied in adults over 65 years of age.

ACT Methylphenidate ER may be a part of your / your child’s overall treatment for ADHD. Your doctor may also recommend that you / your child have counselling or other therapy.

As with all medicines, never share ACT Methylphenidate ER with anyone else.

Usual dose

Take the dose prescribed by your doctor. Your doctor may adjust the amount of drug you / your child take until it is right for you / your child. From time to time, your doctor may interrupt your / your child’s treatment to check your / your child’s symptoms while you / your child are not taking the drug.

Overdose

In case of a drug overdose, immediately go to the nearest emergency room even if you do not feel sick. Make sure you take your medicine bottle with you to show the doctor.

Side effects and what to do about them

Refer to the beginning of this leaflet for information on reported heart-related and mental (psychiatric) problems.

In the clinical studies with patients using methylphenidate hydrochloride extended-release tablets, the very common side effects (may affect more than 1 in 10 people) were headache, stomach pain, sleeplessness, dry mouth, nausea (feeling sick) and decreased appetite. Other side effects commonly seen with methylphenidate hydrochloride extended-release tablets (may affect up to 1 in 10 people) include vomiting, fast heart rate, weight loss, anxiety, irritability, and increased sweating, dizziness, nervousness, tics, increased blood pressure. Tell your doctor if you / your child have blurred vision when taking ACT Methylphenidate ER.

Slower growth (weight gain and/or height) has been reported with long-term use of methylphenidate hydrochloride in children. Your doctor will be carefully watching your child’s height and weight. If you / your child are not growing or gaining weight as your doctor expects, your doctor may stop your / your child’s ACT Methylphenidate ER treatment.

Stimulants may impair your / your child's ability to operate potentially hazardous machinery or vehicles. You should exercise caution until you are reasonably certain that ACT Methylphenidate ER does not adversely affect your / your child's ability to engage in such activities.

Serious side effects and what to do about them
Symptom / effect Call your doctor right away Only if severe Call your doctor right away In all cases Stop taking drug and seek immediate emergency medical help
Very Rare
Signs of heart problems, such as chest pain, shortness of breath, or fainting    
Convulsions (seizures)    
Persistent (greater than 4 hours in duration) and painful erections (priapism)    

New or worsening psychotic or manic symptoms:

  • Paranoia, delusions
  • Hallucinations: seeing, feeling or hearing things that are not real
  • Mania: feeling unusually excited, over-active, or uninhibited

(see Warnings and Precautions)

   

Suicidal behaviour:
Thoughts or actions about hurting or killing yourself.
(see Warnings and Precautions)

   
Liver damage or sudden liver failure. Symptoms may include yellowing of the whites of the eyes, or of the skin, dark urine, bleeding, mental clouding (feeling like you’re in a fog), confusion.    
Problem with blood vessels in the brain (such as inflamed blood vessels, stroke caused by a burst blood vessel or blocked blood supply to the brain). Symptoms may include severe headaches, weakness or paralysis of any body part, or problems with coordination, vision, speaking, finding words or with your memory.    
Rare
Symptoms of allergic reaction, such as itching, skin rash, swelling of the mouth, face, lips, or tongue, or shortness of breath.    
Common
Aggressive behaviour or hostility    
Unknown
Raynaud’s Phenomenon:
discoloration of the fingers and toes, pain, sensations of cold and/or numbness
   

This is not a complete list of side effects. For any unexpected effects while taking ACT Methylphenidate ER, contact your doctor or pharmacist.

How to store

ACT Methylphenidate ER should be stored in a safe place at room temperature (between 15-30°C). Protect from moisture. Do not store this medicine in hot, damp or humid places.

Keep out of the reach of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full Product Monograph prepared for health professionals can be found by contacting
Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada

www.tevacanada.com

Revised on: February 26, 2020

Date modified: