Ratio-Atomoxetine: Uses, Side Effects and Dosage

What ratio-ATOMOXETINE is used for:

ratio-ATOMOXETINE is a medicine that is taken either once or twice a day for the treatment of Attention-

Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, and adults. ratio-ATOMOXETINE should not be used in children under 6 years of age.

ratio-ATOMOXETINE is a part of your overall treatment program for ADHD that may include other measures (psychological, educational, and social). Your doctor may also recommend other therapy.

ratio-ATOMOXETINE works differently from other

medicines used for the treatment of ADHD. ratio-

ATOMOXETINE is not a stimulant and studies have shown

that it has no potential for drug abuse or dependence.

What is ADHD:

ADHD has 3 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 3 types of symptoms.

Symptoms of ADHD in adults may include a lack of

organization, problems starting tasks, impulsive actions,

daydreaming, daytime drowsiness, slow processing of

information, difficulty learning new things, irritability, lack of

motivation, sensitivity to criticism, forgetfulness, low self-

esteem, and excessive effort to maintain some organization.

The symptoms shown by adults who primarily have attention

problems but not hyperactivity have been commonly

described as Attention-Deficit Disorder (ADD).

Many people have these symptoms from time to time.

However, people with ADHD have these symptoms most of

the time. Symptoms must be present for at least 6 months to

be certain of the diagnosis. In addition, the symptoms cause

problems in more than one area of life (home, school, work,

or social situations).

When it should not be used:

Do not take ratio-ATOMOXETINE if you:

• are taking, or have recently taken, an antidepressant

  medicine known as a monoamine oxidase inhibitor

  (MAOI). Some names of MAOI medicines are phenelzine

  sulfate (Nardil^®) and tranylcypromine sulfate (Parnate^®).

• have narrow angle glaucoma, an eye disease.

• are allergic to atomoxetine or any other ingredient of

  ratio-ATOMOXETINE.

• have symptomatic cardiovascular disease.
• have moderate to severe high blood pressure.
• have advanced arteriosclerosis (hardened arteries).

• have uncontrolled hyperthyroidism (an overactive thyroid

  gland).

What the medicinal ingredient is:

Atomoxetine Hydrochloride

What the important nonmedicinal ingredients are:

The capsules contain pregelatinized starch and dimeticone.

The capsule shell contains gelatin, titanium dioxide, yellow

iron oxide, red iron oxide and/or FD&C Blue #1.

What dosage forms it comes in:

Each capsule of ratio-ATOMOXETINE contains

atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg or 60 mg of atomoxetine.

WARNINGS AND PRECAUTIONS

Severe liver damage: Call your doctor right away if you or your child have the following signs of liver problems:

• dark urine
• yellow skin or eyes
• right upper belly pain
• itching
• unexplained flu-like symptoms

Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. Although ratio-ATOMOXETINE is not a stimulant drug, it generally should not be used in children, adolescents or adults with known structural heart abnormalities.

New or Worsened Emotional or Behavioural Problems: Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. 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.

During treatment with these types of medication it is

Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, dietary supplements, and herbal remedies. Your doctor will decide if you can take ratio-ATOMOXETINE with your other medicines. Also tell your doctor if there have been any changes in dosing with your other medicines. Certain medicines may change the way your body reacts to ratio-ATOMOXETINE. These include medicines used to treat depression, like paroxetine hydrochloride (Paxil^®) and fluoxetine hydrochloride (Prozac^®), and certain other medicines (like quinidine).

Your doctor may need to change your dose of ratio-ATOMOXETINE if you are taking it with these medicines. You should not take ratio-ATOMOXETINE if you are taking desipramine.

Usual dose:

Take ratio-ATOMOXETINE exactly as directed by your doctor. It is very important that you do not take a larger dose of ratio-ATOMOXETINE than prescribed by your doctor. Your doctor may tell you to take ratio-ATOMOXETINE once a day or twice a day (morning and late afternoon/early evening). To help you remember to take ratio-

ATOMOXETINE, you may want to take it at the same time every day.

Improvement of your ADHD symptoms is generally observed within 1 to 4 weeks of starting ratio-ATOMOXETINE. ratio-ATOMOXETINE may be taken with or without food.

You should not open ratio-ATOMOXETINE capsules, but if they are accidentally opened or broken, avoid contact with the powder and wash away any loose powder as soon as possible

with water. If any of the powder gets in your eyes you should rinse them with water immediately and contact your doctor.

Overdose:

If you take too much ratio-ATOMOXETINE by accident, call your doctor or pharmacist or contact your regional poison control centre, or contact/go to the nearest emergency centre immediately.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, take it as soon as possible, but do not take more than your total daily dose in any 24-hour period.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

All prescription medicines may cause side effects in some patients. If you have some side-effects such as upset stomach, nausea, sleepiness or tiredness, your doctor may ask you to take ratio-ATOMOXETINE twice a day with meals, or in the evening. Most side effects will disappear after the first few weeks.

Weight loss may occur after starting ratio-ATOMOXETINE, especially in the first few weeks. Growth rates (weight and height) after 2 years of treatment are near normal. It is not known if growth will be slowed in children who use ratio-ATOMOXETINE for a longer period of time. Your doctor will watch your weight and height. If you are not growing or gaining weight as expected, your doctor may change your treatment of ratio-ATOMOXETINE.

ratio-ATOMOXETINE can cause liver damage in rare cases. Call your doctor right away if you have dark urine, yellow skin/eyes, upper right-sided abdominal tenderness, or unexplained nausea, tiredness, itching or flu-like symptoms. Stop taking ratio-ATOMOXETINE and call your doctor right away if you get swelling or hives. ratio-ATOMOXETINE can cause a serious allergic reaction in rare cases.

New or Worsened Emotional or Behavioural Problems: A small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide. Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. See also the WARNINGS AND PRECAUTIONS section.

The following common side effects were reported in clinical trials with atomoxetine hydrochloride:

In teenagers and children over 6:

• upset stomach
• decreased appetite
• nausea or vomiting
• dizziness
• tiredness
• constipation
• low blood pressure

In Adults:

• constipation
• dry mouth
• nausea
• decreased appetite
• dizziness
• problems sleeping
• sexual side effects
• problems urinating
• menstrual cramps
• rapid or irregular heartbeat
• tiredness

ratio-ATOMOXETINE should be stored in a dry place between 15ºC - 30ºC, away from moisture and keep the bottle tightly closed. Capsules should not be removed from the blister or bottle until ready for administration.

Keep all medicines, including ratio-ATOMOXETINE, 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 a 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 0701E Ottawa, Ontario

    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 the sponsor, Teva Canada Limited at:

1-800-268-4127 ext.5005 (English);

1-877-777-9117 (French) or

druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: May 31, 2012