Generic Medicines
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USES
Methylphenidate is used to treat attention disorders (attention
deficit hyperactivity disorder, or ADHD) as part of a total treatment plan
including psychological, educational and social measures. This medication
is also used to treat patients with narcolepsy (a disorder of sleep
regulation). When this medication is used to treat ADHD, patients may find
they have increased attention, decreased impulsiveness, and decreased
hyperactivity (see also Notes section). This medication is a mild
stimulant that works by affecting the levels of chemicals
(neurotransmitters) in the nervous system.This medication should not be
used to treat simple fatigue symptoms.OTHER This section contains uses of
this drug that are not listed in the approved professional labeling for
the drug but that may be prescribed by your health care professional. Use
this drug for a condition that is listed in this section only if it has
been so prescribed by your health care professional.This medication may
also be used for treating depression in certain cases.
HOW TO USE
Read the Medication Guide provided by your pharmacist before you start
using methylphenidate and each time you get a refill. If you have any
questions, consult your doctor or pharmacist.This medication is best taken
30 to 45 minutes before a meal or as directed by your doctor. If loss of
appetite occurs or if you experience stomach upset, it may be taken with
or after meals or snacks.Use this medication regularly in order to get the
most benefit from it. To help you remember, take it at the same time(s)
each day. It may take up to two weeks to notice an improvement while on
this drug.Use this medication exactly as prescribed. Dosage is based on
your medical condition and response to therapy. Your doctor may instruct
you to gradually increase or decrease your dose. Do not increase your
dose, use it more frequently or use it for a longer period of time than
prescribed because this drug can be habit-forming. Also, if used for a
long period of time, do not suddenly stop using this without first
consulting your doctor.This medication may cause withdrawal reactions,
especially if it has been used regularly for a long time or in high doses.
In such cases, withdrawal symptoms (such as severe depression and chronic
overactivity) may occur if you suddenly stop using this medication. To
prevent withdrawal reactions, your doctor may reduce your dose gradually.
Consult your doctor or pharmacist for more details, and report any
withdrawal reactions immediately.Though it is very unlikely to occur, this
medication can also result in abnormal drug-seeking behavior
(addiction/habit-forming). Do not increase your dose, take it more
frequently or use it for a longer period of time than prescribed. Properly
stop the medication when so directed. This will lessen the chances of
becoming addicted.When used for an extended period, this medication may
not work as well and may require different dosing. Talk with your doctor
if this medication stops working well.Inform your doctor if your condition
persists or worsens.
SIDE EFFECTS
Headache, stomach pain, loss of appetite, trouble sleeping, dizziness,
nausea, vomiting, lightheadedness, irritability, nervousness, blurred
vision, dry mouth, constipation or (rarely) drowsiness may occur. If any
of these effects persist or worsen, notify your doctor or pharmacist
promptly.Remember that your doctor has prescribed this medication because
he or she has judged that the benefit to you is greater than the risk of
side effects. Many people using this medication do not have serious side
effects.Tell your doctor immediately if any of these unlikely but serious
side effects occur: uncontrolled movements (motor tics or tremor), verbal
tics (e.g., Tourette's syndrome), weight loss, fast/pounding/irregular
heartbeat, mental/mood/behavior changes (e.g., agitation, aggression, mood
swings, depression, abnormal thoughts), difficulty urinating.Tell your
doctor immediately if any of these rare but very serious side effects
occur: signs of infection (e.g., fever, persistent sore throat), easy
bruising/bleeding.Seek immediate medical attention if any of these rare
but very serious side effects occur: shortness of breath, chest pain,
jaw/left arm pain, fainting, seizures, sudden vision changes, weakness on
one side of the body, slurred speech, confusion.A very serious allergic
reaction to this drug is unlikely, but seek immediate medical attention if
it occurs. Symptoms of a serious allergic reaction may include: rash,
itching/swelling (especially of the face/tongue/throat), severe dizziness,
trouble breathing.This is not a complete list of possible side effects. If
you notice other effects not listed above, contact your doctor or
pharmacist.In the US -Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada -
Call your doctor for medical advice about side effects. You may report
side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS
Before taking methylphenidate, tell your doctor or pharmacist if you
are allergic to it; or if you have any other allergies.This medication
should not be used if you have certain medical conditions. Before using
this medicine, consult your doctor or pharmacist if you have: severe
anxiety/tension, certain mental/mood conditions (e.g, agitation,
psychosis), heart/blood vessel disease (e.g., irregular heartbeat/rhythm,
coronary artery disease, angina, heart failure, cardiomyopathy), problems
with heart structure (e.g., valve problems), history of heart attack or
stroke, glaucoma, motor tics.Before using this medication, tell your
doctor or pharmacist your medical history, especially of: high blood
pressure (hypertension), family history of sudden death/irregular
heartbeat/rhythm, family/personal history of mental/mood disorders (e.g.,
bipolar disorder, depression, psychotic disorder, suicidal thoughts),
overactive thyroid (hyperthyroidism), seizures, verbal tics (diagnosis or
family history of Tourette's syndrome).This drug may make you dizzy,
lightheaded, (rarely) drowsy, or cause blurred vision. Do not drive, use
machinery, or do any activity that requires alertness or clear vision
until you are sure you can perform such activities safely. Limit alcoholic
beverages.Though uncommon, depression itself can lead to thoughts or
attempts of suicide. If you are being treated for depression, tell your
doctor immediately if you have any suicidal thoughts, or other mental/mood
changes. Keep all medical appointments so your doctor can monitor your
progress closely.Children younger than 6 years may be at greater risk for
the side effects of this medication.This drug may affect your child's
growth rate, weight, and final adult height, especially in children
younger than 6 years. To reduce the risk, the doctor may recommend
temporarily stopping the medication from time to time. Check your child's
weight and height, and consult your doctor or pharmacist for more
details.Methylphenidate should be used during pregnancy only when clearly
needed. Discuss the risks and benefits with your doctor.It is not known if
methylphenidate passes into breast milk. Consult your doctor before
breast-feeding.
DRUG INTERACTIONS
Your healthcare professionals (e.g., doctor or pharmacist) may already
be aware of any possible drug interactions and may be monitoring you for
it. Do not start, stop or change the dosage of any medicine before
checking with them first.Avoid taking MAO inhibitors (e.g., furazolidone,
isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine,
rasagiline, selegiline, tranylcypromine) within 2 weeks before or after
treatment with this medication. In some cases, a serious, possibly fatal,
drug interaction may occur. If you are currently using any of these
medications, tell your doctor or pharmacist before starting this
medication.Before using this medication, tell your doctor or pharmacist of
all prescription and nonprescription/herbal products you may use,
especially of: "blood thinners" (e.g., warfarin), guanethidine,
phenylbutazone, drugs that can increase blood pressure (e.g.,
phenylephrine), anti-seizure drugs (e.g., phenobarbital, phenytoin,
primidone), tricyclic antidepressants (e.g., imipramine, desipramine),
SSRI antidepressants (e.g., fluoxetine, sertraline).Also report the use of
drugs which might increase seizure risk when combined with this medication
such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline,
or tricyclic antidepressants (e.g., amitriptyline), among others. Consult
your doctor or pharmacist for details.Check the labels on all your
medicines/herbal products (e.g., cough-and-cold products, diet aids)
because they may contain ingredients that could increase your heart rate
or blood pressure (e.g., pseudoephedrine, phenylephrine, ephedra/ma huang).
Ask your pharmacist about the safe use of these products.This document
does not contain all possible interactions. Therefore, before using this
product, tell your doctor or pharmacist of all the products you use. Keep
a list of all your medications with you, and share the list with your
doctor and pharmacist.
OVERDOSE
If overdose is suspected, contact your local poison control center or
emergency room immediately. US residents can call the US national poison
hotline at 1-800-222-1222. Canadian residents should call their local
poison control center directly. Symptoms of overdose may include:
confusion, agitation, sweating, flushing, wide pupils, persistent tremor,
muscle twitching, hallucinations, severe headache, severe vomiting,
seizures, loss of consciousness.
MISSED DOSE
If you miss a dose, take it as soon as you remember and take any
remaining doses at evenly spaced times. If it is near bedtime or near time
for the next dose, skip that dose and resume your regular dosing schedule.
Do not double the dose to catch up.
STORAGE
Store the US product at room temperature between 59-86 degrees F
(15-30 degrees C).Store the Canadian product between 36-86 degrees F (2-30
degrees C).Store the medication away from heat, moisture, and sunlight. Do
not store in the bathroom. Keep all medicines away from children and
pets.Do not flush medications down the toilet or pour them into a drain
unless instructed to do so. Properly discard this product when it is
expired or no longer needed. Consult your pharmacist or local waste
disposal company for more details about how to safely discard your
product.
WARNING: Misuse or abuse of
methylphenidate may result in serious (possibly fatal) heart and blood
pressure problems.
Methylphenidate should be given cautiously to emotionally unstable
patients, especially if there is a history of alcohol or drug abuse. These
patients may be more likely to unnecessarily increase their doses or take
this medication too often. Long-term overuse of this medication may lead
to reduced drug effect, drug dependence, and abnormal behavior.
Take this medication only by mouth. Serious mental/mood changes (e.g.,
psychosis) may occur, especially if this drug is abused.
If methylphenidate must be stopped, it should be stopped gradually over
time. Follow your doctor's instructions on how to gradually lower the
dose. In some patients, long-term monitoring may be required after the
medication is stopped.
Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.