PMS-Dextroamphetamine (Pharmascience, PM 00032315): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

pms-DEXTROAMPHETAMINE (dextroamphetamine sulfate), a drug in the class of amphetamines (central nervous system stimulant), is used along with other therapies, for the treatment of:

• narcolepsy (a disorder that caused excessive

  sleepiness during the day and frequent and uncontrollable episodes of falling asleep). • Attention-deficit Hyperactivity Disorder (ADHD) (a

  disorder characterized by a very short attention span, impulsiveness, and hyperactivity). pms-DEXTROAMPHETAMINE should be used as a part of a total treatment program for ADHD that may include counselling or other therapies.

What it does:

pms-DEXTROAMPHETAMINE causes a lessening of fatigue, an increase in mental activity, an elevation of mood, and a general feeling of well-being.

pms-DEXTROAMPHETAMINE helps increase attention (including the ability to follow directions and finish tasks) and decrease impulsiveness and hyperactivity in patients with ADHD.

When it should not be used:

You or your child should NOT take pms-DEXTROAMPHETAMINE if you or your child:

• have cardiovascular disease;

• have moderate to severe high blood pressure; • have advanced arteriosclerosis (hardened arteries); • have hyperthyroidism (an overactive thyroid gland); • have allergies to pms-DEXTROAMPHETAMINE or

  to any ingredient in the formulation or component of the container;

• are sensitive to, allergic to, or had a reaction to other

  stimulant medicines or sympathomimetic amines; • have glaucoma, an eye disease;

• have very anxious, tense, or agitated states; • have motor tics (hard to control, repeat twitching of

  any parts of the body) or verbal tics (hard to control

  repeating of sounds or words) or Tourette’s syndrome; • have relatives with motor tics or verbal tics or

  Tourette’s syndrome;

  • had taken medications from the group called monoamine oxidase inhibitors (MAOI) within the last 14 days, as administration of pms-DEXTROAMPHETAMINE may cause hypertensive crises;
  • have a history of drug abuse.

pms-DEXTROAMPHETAMINE is not recommended for use in children under 6 years of age.

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

What the medicinal ingredient is:

pms-DEXTROAMPHETAMINE contains dextroamphetamine sulfate as the medicinal ingredient.

What the important nonmedicinal ingredients are:

pms-DEXTROAMPHETAMINE 5 mg tablets contain the following nonmedicinal ingredients: calcium sulfate, gelatin, lactose, FD&C Yellow no.6, FD&C Yellow no.5, starch, stearic acid, sucrose and talc.

What dosage forms it comes in:

pms-DEXTROAMPHETAMINE is available as 5 mg tablets.

WARNINGS AND PRECAUTIONS

The following have been reported with use of pms-DEXTROAMPHETAMINE and other medicines used to treat ADHD:

1. 1. Heart-related problems:
2. • sudden death in patients who have heart problems and heart defects
3. • stroke and heart attack in adults
4. • 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. pms-DEXTROAMPHETAMINE 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 pms-DEXTROAMPHETAMINE.

Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with pms-DEXTROAMPHETAMINE.

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 pms-DEXTROAMPHETAMINE.

1. 2. Mental (Psychiatric) problems:

All patients

• new or worse behaviour and thought problems • new or worse bipolar illness
• 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.

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

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

Amphetamines may impair the ability to perform potentially hazardous activities such as operating machinery or driving.

BEFORE you use pms-DEXTROAMPHETAMINE talk to your doctor or pharmacist if you or your child:

• have mild high blood pressure;

• have a family history of sudden death or death

  related to heart problems;

• have heart disease or structural heart abnormalities; • have mental problems including psychosis, mania,

  bipolar illness, depression, or a family history of suicide;

• have tics or Tourette’s syndrome;
• have thyroid problems;

• have seizures or have had an abnormal brain wave

  test (EEG);

• do strenuous exercise;
• take other drugs for ADHD;
• have diabetes mellitus;

• have an allergy to tartazine (FD & C Yellow no. 5) or

  aspirin;

• is pregnant or plans to become pregnant; • is breast feeding or plans to breastfeed; • if you or your child have (or have a family history of)

  ever abused or been dependent on alcohol, prescription medicines or street drugs.

Amphetamines have been subject to extensive abuse. Tolerance, extreme psychological dependence, and severe social disability can occur. It is important that pms-

DEXTROAMPHETAMINE be taken only as directed by your doctor.

INTERACTIONS WITH THIS MEDICATION

It is important to tell your doctor or pharmacist about all medicines that you or your child are taking including other medicines that a doctor has prescribed, medicines that you buy yourself without a prescription, and any herbal remedies that you or your child are taking, especially:

• anti-depression medicines including MAOIs • blood pressure medicines
• antacids
• seizure medicines

While on pms-DEXTROAMPHETAMINE do not start taking a new medicine or herbal remedy before checking with your doctor.

PROPER USE OF THIS MEDICATION

Usual dose:

In order to receive the most benefit from pms-DEXTROAMPHETAMINE, it is important that pms-DEXTROAMPHETAMINE be taken only as directed by your doctor. The doctor may adjust the amount of drug taken by your or your child until it is right for you or your child. From time to time, the doctor may interrupt treatment to check you or your child’s symptoms while you or your child are not taking the drug.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking pms-DEXTROAMPHETAMINE. Children should have their height and weight checked often while taking pms-DEXTROAMPHETAMINE. pms-DEXTROAMPHETAMINE treatment may be stopped if a problem is found during these check-ups.

Overdose:

Call the doctor immediately if you or your child takes more than the amount of pms-DEXTROAMPHETAMINE prescribed by the doctor.

Missed Dose:

If you forget to take your medicine, take it as soon as you remember. Then continue as before. Do not take a double dose to make up for forgotten individual doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its desired effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, talk to your or your child’s doctor.

Some of the side effects observed during treatment with stimulant medications such as pms-DEXTROAMPHETAMINE were slowing of growth (height and weight) in children, seizures (mainly in patients with a history of seizures), eye sight changes, tremors, headache, dizziness, loss of appetite, dry mouth, stomach upset, difficulty falling asleep, high blood pressure, irregular heartbeat, and irritability.

This is not a complete list of side effects. For any unexpected effects while taking pms-DEXTROAMPHETAMINE, contact your doctor or pharmacist.

HOW TO STORE IT

pms-DEXTROAMPHETAMINE tablets should be stored at 15-30°C.

Do not take your medicine after the expiry date shown on the bottle.

As with all medicines keep out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Pharmascience Inc. At, 1-888-550-6060.

Pharmascience Inc.

Montreal, Quebec

H4P 2T4

www.pharmascience.com

Last revised: October 15, 2015

.