Consumer Information for: APO-ATOMOXETINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-ATOMOXETINE is a medicine for the treatment of Attention- Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, and adults. APO-ATOMOXETINE should not be used in children under 6 years of age.

APO-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.

What it does

AAPO-ATOMOXETINE is a selective norepinephrine reuptake inhibitor medicine that increases the amount of noradrenaline, a natural chemical in the brain. APO-ATOMOXETINE may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

APO-ATOMOXETINE works differently from other medicines used for the treatment of ADHD. Atomoxetine is not a stimulant and is not addictive.

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 APO-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 and tranylcypromine.
  • have narrow angle glaucoma, an eye disease.
  • are allergic to atomoxetine or any other ingredient of APO-ATOMOXETINE.
  • have symptomatic cardiovascular disease.
  • have moderate to severe high blood pressure.
  • have advanced arteriosclerosis (hardened arteries).
  • have uncontrolled hyperthyroidism (an overactive thyroid gland).
  • have a tumour of the adrenal gland (phaeochromocytoma).
What the medicinal ingredient is

Atomoxetine Hydrochloride

What the non-medicinal ingredients are

The capsules also contain pregelatinized starch. The capsule shells are imprinted with black edible ink and contain the non-medicinal ingredient gelatin, and also contain one or more of the following: FD&C Blue No. 2, yellow iron oxide, red iron oxide, titanium dioxide.

What dosage form it comes in

Each APO-ATOMOXETINE capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine.

Warnings and precautions

The following have been reported with use of atomoxetine and also with stimulant medications:

1. Suicidal thoughts and actions in children and teenagers

Some children and teenagers may have a higher chance of having suicidal thoughts or actions. Tell your child or teenager’s doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)
  • had suicide thoughts or actions before starting atomoxetine.

The chance for suicidal thoughts and actions are higher:

  • early during atomoxetine treatment
  • during dose adjustments.

Prevent suicidal thoughts and action in your child or teenager by:

  • paying close attention to your child or teenager’s moods, behaviours, thoughts, and feelings during atomoxetine treatment
  • keeping all follow-up visits with your child or teenager’s doctor as scheduled.

Watch for the following signs in your child or teenager during atomoxetine treatment:

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts.

Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

Should any of the above signs also happen to you while taking APO-ATOMOXETINE, it is important that you talk to your doctor about how you are feeling.

2. Severe liver damage

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

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

3. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects as well as in patients without pre-existing cardiac disease
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

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 APO-ATOMOXETINE.

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

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, irregular heart rate, palpitations, shortness of breath, dizziness or fainting while taking APO-ATOMOXETINE.

4. New mental (psychiatric) problems in children and teenagers:

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.

Call your child or teenager’s doctor right away about any new mental symptoms. APO-ATOMOXETINE treatment may be stopped.

BEFORE you use APO-ATOMOXETINE, talk to your doctor or pharmacist if you:

  • have or had suicidal thoughts or actions;
  • have structural heart abnormalities;
  • inborn, acquired or family history of long QT interval;
  • have mental problems, including psychosis, mania, bipolar illness, or depression;
  • have had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms);
  • have or had any disorder of the blood vessels in the brain (e.g. aneurysm, stroke, vasculitis);
  • have a family history of sudden death or death related to heart problems;
  • do strenuous exercise;
  • take other drugs for ADHD;
  • have or had liver problems. You may need a lower dose;
  • have mild high blood pressure. Atomoxetine can increase blood pressure;
  • have problems with your heart or an irregular heartbeat. Atomoxetine can increase heart rate (pulse);
  • have low blood pressure. Atomoxetine can cause dizziness or fainting in people with low blood pressure;
  • are nursing, pregnant, or thinking of becoming pregnant;
  • have circulation problems in fingers and toes, including numbness; feeling cold or pain (Raynaud’s Phenomenon).

Do not drive a car or operate hazardous machinery until you know how APO-ATOMOXETINE affects you.

This medicine was prescribed for your use only. Do not let anyone else take your APO-ATOMOXETINE

Interactions with this medication

Tell your doctor about all the medicines you/your child take or plan to take, including prescription and non-prescription medicines, dietary supplements, and herbal remedies. Your doctor will decide if you can take 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 APO-ATOMOXETINE.

Drugs that may interact with atomoxetine include:

  • Anti-depression medicines: Your doctor may need to change your dose of APO-ATOMOXETINE if you are taking paroxetine, fluoxetine or certain other medicines like quinidine.

You should not take APO-ATOMOXETINE if you are taking desipramine.

Asthma medicines: Atomoxetine may change the way your body reacts to oral, intravenous, or nebulized salbutamol (or drugs with similar actions), but the effectiveness of these drugs will not be changed. Blood pressure medicines: APO-ATOMOXETINE should be used with caution if you are being treated with drugs for high blood pressure.

Proper use of this medication

Usual Dose

Take APO-ATOMOXETINE exactly as directed by your doctor. It is very important that you do not take a larger dose of atomoxetine than prescribed by your doctor.

Your doctor may tell you to take APO-ATOMOXETINE once a day or twice a day (morning and late afternoon/early evening). To help you remember to take APO-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 APO-ATOMOXETINE.

APO-ATOMOXETINE may be taken with or without food.

You should not open APO-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

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 APO-ATOMOXETINE twice a day with meals, or in the evening. Most side effects will disappear after the first few weeks.

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

In teenagers and children over 6:

  • upset stomach
  • decreased appetite
  • nausea or vomiting
  • dizziness
  • tiredness
  • constipation
  • low blood pressure
  • weight loss may occur especially in the first few weeks

In Adults:

  • constipation
  • dry mouth
  • nausea
  • decreased appetite
  • dizziness
  • problems sleeping
  • sexual side effects
  • problems urinating
  • menstrual cramps
  • rapid or irregular heartbeat
  • tiredness
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and seek immediate emergency help
Very Common
Heart-related problems: Blood pressure increased, heart rate increased. (see Warnings and Precautions)   ✔  
Common
Rare (in children)
Urinary retention: problem passing urine and emptying bladder   ✔  
Uncommon
Allergic Reaction: Swelling, hives, or difficulty breathing     ✔
Suicidal Behavior: Thoughts or actions about hurting or killing yourself. (see Warnings and Precautions)     ✔
New psychotic symptoms: Paranoia, delusions-hallucinations (seeing, feeling or hearing things that are not real)   ✔  
Aggressive Behavior or Hostility   ✔  
Rare
Liver Injury: Dark urine, yellow skin/ eyes, upper right-sided abdominal tenderness, or flu-like symptoms   ✔  
Priapism: Long-lasting (greater than 4 hours in duration) and painful erection of the penis     ✔
Raynau’s Phenomenon: discoloration of the fingers and toes, pain, sensations of cold and/ or numbness   ✔  
Unknown
Slowing of growth in children (height and weight)   ✔  
New manic symptoms: Mania (feeling unusually excited, overactive, or un-inhibited).   ✔  
This is not a complete list of side effects. For any unexpected effects while taking APO-ATOMOXETINE, contact your doctor or pharmacist.
How to store

APO-ATOMOXETINE Capsules should be stored at room temperature (15 to 30°C).

Keep all medicines, including APO-ATOMOXETINE Capsules, out of the reach of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffet;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Patient Side Effect Reporting Form and sending it by:
    • Fax toll-free to 1-866-678-6789, or
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffet.

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

More information

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at: 1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products. This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Date of Revision: January 8, 2016

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