Mylan-Atomoxetine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What MYLAN-ATOMOXETINE is used for:

MYLAN-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. MYLAN-ATOMOXETINE should not be used in children under 6 years of age.

MYLAN-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:

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

MYLAN-ATOMOXETINE works differently from other medicines used for the treatment of ADHD. MYLAN-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 MYLAN-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 MYLAN-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 also contain magnesium stearate, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate. The capsule shells contain gelatine, titanium dioxide and FD&C Blue #2 (25 mg, 40 mg and 60 mg); Iron Oxide Yellow (18 mg, 60 mg, 80 mg and 100 mg); Iron Oxide Red (80 mg and 100 mg).

What dosage forms it comes in:

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

The following have been reported with use of atomoxetine hydrochloride 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)

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

• had suicide thoughts or actions before starting MYLAN-ATOMOXETINE.

The chance for suicidal thoughts and actions are higher:

• early during MYLAN-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 MYLAN-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 MYLAN-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 MYLAN-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 MYLAN-ATOMOXETINE.

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

1. 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. MYLAN-ATOMOXETINE treatment may be stopped.

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

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

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 MYLAN-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 MYLAN-ATOMOXETINE.

Drugs that may interact with MYLAN-ATOMOXETINE include:

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

  You should not take MYLAN-ATOMOXETINE if

  you are taking desipramine.

• Asthma medicines: MYLAN-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: MYLAN-ATOMOXETINE should be used with caution if you are being treated with drugs for high blood pressure.

USE

Usual dose:

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

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

MYLAN-ATOMOXETINE may be taken with or without food.

You should not open MYLAN-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 MYLAN-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 hydrochloride:

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

SIO

INTERACTIONS WITH MEDICATION

PROPER USE OF MYLAN-ATOMOXETINE

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

MYLAN-ATOMOXETINE should be stored at room temperature (15 to 30°C). Protect from light and moisture.

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

M

Reporting Side Effects

HOW TO STORE IT

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Revised on: January 7, 2016

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca

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