Pro-Atomoxetine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What PRO-ATOMOXETINE is used for:

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

PRO-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:

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

PRO-ATOMOXETINE works differently from other medicines used for the treatment of ADHD. PRO-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 PRO-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 PRO-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 dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following: FD&C Blue No. 1, FD&C Red No. 3, D&C Yellow No. 10, titanium dioxide.

What dosage forms it comes in:

Capsules of PRO-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 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)
• had suicidal thoughts or actions before starting PRO-ATOMOXETINE.

The chance for suicidal thoughts and actions are higher:

• early during PRO-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 PRO-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 PRO-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 PRO-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 PRO-ATOMOXETINE.

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

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

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

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 PRO-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 PRO-ATOMOXETINE.

Drugs that may interact with PRO-ATOMOXETINE include:

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

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

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

Usual dose:

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

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

PRO-ATOMOXETINE may be taken with or without food.

You should not open PRO-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 PRO-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

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

HOW TO STORE IT

PRO-ATOMOXETINE should be stored at room temperature (15°C to 30°C). Protect from moisture. Keep bottle tightly closed. Capsules should not be removed from bottles until ready to use.

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

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION