AG-Atomoxetine: Uses, Side Effects and Dosage

What AG-Atomoxetine is used for:

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

AG-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:

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

AG-Atomoxetine works differently from other medicines used for the treatment of ADHD. AG-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 AG-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 AG-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

What the nonmedicinal ingredients are:

The capsules contain pregelatinized starch and colloidal silicon dioxide. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following: FD&C Blue No. 2, iron oxide red, synthetic yellow iron oxide, titanium dioxide.

What dosage forms it comes in:

Capsules of AG-Atomoxetine contain 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 capsules and also with stimulant medications:

1. 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 suicidal thoughts or actions before starting AG-Atomoxetine.

The chance for suicidal thoughts and actions are higher: ABOUT THIS MEDICATION

• early during AG-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 AG-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 AG-Atomoxetine treatment:

• anxiety
• agitation
• panic attacks
• trouble sleeping
• irritability
• hostility
• aggressiveness
• impulsivity
• restlessness
• mania
• depression
• suicidal 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 AG-Atomoxetine, it is important that you talk to your doctor about how you are feeling.

1. 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
• 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 AG-Atomoxetine.

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

1. 4. New mental (psychiatric) problems in children and teenagers:
2. • 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. AG-Atomoxetine treatment may be stopped.

BEFORE you use AG-Atomoxetine, talk to your doctor or pharmacist if you or your child:

• 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. AG-

  Atomoxetine can increase blood pressure;

• have problems with your heart or an irregular heartbeat. AG-Atomoxetine can increase heart rate (pulse);
• have low blood pressure. AG-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 AG-Atomoxetine affects you.

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

INTERACTIONS WITH THIS MEDICATIONS

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 AG-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 AG-Atomoxetine.

Drugs that may interact with AG-Atomoxetine include:

• Anti-depression medicines: Your doctor may need to

  change your dose of AG-Atomoxetine if you are taking paroxetine, fluoxetine, or certain other medicines like quinidine.

  You should not take AG-Atomoxetine if you are taking desipramine.

• Asthma medicines: AG-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: AG-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 AG-Atomoxetine exactly as directed by your doctor. It is very important that you do not take a larger dose of AG-Atomoxetine than prescribed by your doctor.

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

AG-Atomoxetine may be taken with or without food.

You should not open AG-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:

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.

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 AG-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 capsules:

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If you think you have taken too much AG- Atomoxetine contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Very common

Heart-related

problems: Blood pressure increased, heart rate increased. (see Warnings and Precautions)

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SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

AG-Atomoxetine should be stored at room temperature (15 to 30°C).

Keep all medicines, including AG-Atomoxetine, out of the reach and sight of children.

MORE INFORMATION

If you want more information about AG-Atomoxetine:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); or by contacting the sponsor, Angita Pharma Inc., at: 450-449-9272.

HOW TO STORE IT

REPORTING SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to

Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect- canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Boucherville, Québec

J4B 5H3

Last Revised: November 26, 2020