Patient Medication Information: uses, side effects, how to take - NTP-Methylphenidate ER-C
ABOUT THIS MEDICATION
What the medication is used for:
NTP-METHYLPHENIDATE ER-C 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 is 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 C
information, difficulty learning new things, irritability, lack of esteem and excessive effort to maintain some organization.
What it does:
Part of the NTP-METHYLPHENIDATE ER-C 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. NTP-METHYLPHENIDATE ER-C helps increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
When it should not be used:
You / your child should NOT take NTP-METHYLPHENIDATE ER-C if you / your child:
have significant anxiety, tension or
agitation because NTP-
METHYLPHENIDATE ER-C may make these conditions worse;
are allergic to methylphenidate
hydrochloride or any of the other ingredients in NTP-
METHYLPHENIDATE ER-C;
- have glaucoma, an eye disease;
have motion tics (hard-to-control, repeated
twitching of any parts of your body), verbal tics (hard-to-control repeating of sounds or words) or Tourette’s syndrome;
have a family history of motion tics, verbal
tics or Tourette’s syndrome;
- 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 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 nonmedicinal ingredients are:
NTP-METHYLPHENIDATE ER-C contains the following non-medicinal ingredients: hydroxypropyl methylcellulose, lactose monohydrate,
microcrystalline cellulose, polyvinyl alcohol-
polyethylene glycol copolymer and colloidal silica, simethicone and stearic acid.
Colourants present in the tablets are:
18 mg: D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
27 mg: iron oxide black, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
36 mg: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
54 mg: hydroxpropyl methylcellulose, iron oxide yellow, iron oxide red, polyethylene glycol and titanium dioxide.
What dosage forms 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 NTP-METHYLPHENIDATE ER-C 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
Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. NTP-
METHYLPHENIDATE ER-C generally should not be used in children, adolescents or adults with known structural heart abnormalities.
BEFORE you use NTP-METHYLPHENIDATE ER-C, talk to your doctor or pharmacist if you / your child:
- have structural heart abnormalities;
- have mental problems, including psychosis, mania, bipolar illness, or depression;
- have had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms);
- have mild high blood pressure;
- have a narrowing or blockage of your gastrointestinal tract (your oesophagus, 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; or
have or have had any disorder of the blood
vessels in the brain (e.g. aneurysm, stroke, vasculitis).
Tell your doctor immediately if you / your child develop any of the above conditions or symptoms while taking NTP-METHYLPHENIDATE ER-C. He/she will decide if you can start/continue taking NTP-METHYLPHENIDATE ER-C.
BEFORE taking NTP-METHYLPHENIDATE ER-C, tell your doctor if you are pregnant or plan to become pregnant.
Tell your doctor if you are nursing a baby. If you take NTP-METHYLPHENIDATE ER-C, it may be in your breast milk.
Your doctor will monitor your progress with NTP-METHYLPHENIDATE ER-C 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 NTP-
METHYLPHENIDATE ER-C with other medicines. These include:
- clonidine;
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 NTP-
METHYLPHENIDATE ER-C with monoamine oxidase (MAO) inhibitors.
While on NTP-METHYLPHENIDATE ER-C, do not start taking a new medicine or herbal remedy before checking with your doctor.
You should avoid alcoholic drinks while taking NTP-METHYLPHENIDATE ER-C.
NTP-METHYLPHENIDATE ER-C 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 NTP-METHYLPHENIDATE ER-C.
PROPER USE OF THIS MEDICATION
Do not chew, crush or divide the tablets. Swallow NTP-METHYLPHENIDATE ER-C tablets whole with water or other liquids, such as milk or juice.
Take NTP-METHYLPHENIDATE ER-C once each day in the morning with or without food.
NTP-METHYLPHENIDATE ER-C has not been studied and should not be used in children under six years of age. Methylphenidate hydrochloride extended release has not been studied in adults over 65 years of age.
NTP-METHYLPHENIDATE ER-C 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 NTP-METHYLPHENIDATE ER-C 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 the event of overdosage, contact your doctor hospital emergency department or regional Poison Control Centre.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
In the clinical studies with patients using methylphenidate extended release, the most common side effects were headache, stomach pain, sleeplessness, dry mouth, nausea (feeling sick) and decreased appetite. Other side effects seen with methylphenidate extended release, include vomiting, dizziness, nervousness, tics, allergic reactions, increased blood pressure, and abnormal thinking or hallucinations.
Tell your doctor if you / your child have blurred vision when taking NTP-METHYLPHENIDATE ER-C.
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 you / your child’s NTP-METHYLPHENIDATE ER-C 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 NTP-METHYLPHENIDATE ER-C does not adversely affect your / your child's ability to engage in such activities.
This is not a complete list of side effects. For any unexpected effects while taking NTP-
METHYLPHENIDATE ER-C, contact your doctor or pharmacist.
HOW TO STORE IT
NTP-METHYLPHENIDATE ER-C should be stored in a safe place at room temperature (between 15-30ºC). Do not store this medicine in hot, damp or humid places.
Keep out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
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Report online at
www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting
Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701C Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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 NT Pharma Canada at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@NT Pharma.com
Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.
NT Pharma Canada Limited
5691 Main Street
Stouffville, Ontario
Canada, L4A 1H5