Strattera Capsules Atomoxetine

1. What STRATTERA is and what it is used for

STRATTERA capsules are opaque blue (cap) and opaque white (body), with “Lilly 3228” on the cap and “25 mg” black ink on the body. Each box contains 28 capsules.

STRATTERA contains atomoxetine, which increases the amount of noradrenaline in the brain. This substance, a chemical naturally produced in the brain, increases attention and reduces impulsiveness and hyperactivity in patients with ADHD. This medication has been prescribed to control ADHD symptoms. STRATTERA has not been shown to be addictive.

STRATTERA is a non-stimulant drug used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older and as part of a broader treatment program that includes psychological, educational and social measures in adolescents.

After you start using STRATTERA, it may take several weeks for your symptoms to completely improve.

It may be appropriate for people who start treatment at a young age to continue using STRATTERA when they become adults. Your specialist doctor will advise you on this issue.

2.How to use STRATTERA?

Instructions for proper use and dose/frequency of administration

Always use STRATTERA as prescribed by your doctor. This is usually 1 or 2 capsules a day, taken in the morning and late afternoon or evening.

Your doctor will tell you how much STRATTERA you should use, based on your weight. Your doctor will normally start you at a lower dose before increasing the dose of STRATTERA according to the following instructions:

Children and adolescents 6 years and older:

– Body weight up to 70 kg: STRATTERA should be started at approximately 0.5 mg/kg body weight per day and this dose should be continued for at least 7 days. Your doctor may then increase this to a follow-up dose of approximately 1.2 mg/kg body weight per day.

– Those with a body weight over 70 kg: STRATTERA should be started at a daily dose of 40 mg and this dose should be continued for at least 7 days. Your doctor may then increase this to a continuing dose of 80 mg daily. The highest dose your doctor can prescribe you per day is 100 mg.

A child using STRATTERA may lose some weight after starting treatment. Your doctor will keep track of your child’s height and weight. If your child is not growing and gaining weight as expected, your doctor may change the dose your child will use or stop using STRATTERA for a while.

Application route and method

STRATTERA is for oral use. Swallow your capsule whole with water.

• You can take STRATTERA on an empty stomach or on a full stomach.

Use in the elderly

Special use cases

There is no data.

Liver failure:

If you have a problem with your liver, your doctor may prescribe a lower dose of your medicine.

Your doctor will tell you how long your treatment with STRATTERA will last. Do not stop your treatment early.

If you have the impression that the effect of STRATTERA is too strong or too weak, talk to your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in STRATTERA.

Side effects in this leaflet are listed as shown in the following categories. Very common Common

Uncommon Rare Very rare

If any of the following occur, stop using STRATTERA and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:

Although uncommon, STRATTERA can cause serious allergic reactions.

• Swelling of the face and throat

• Difficulty in breathing

• Hives (small bumps on the skin in patches)

These are all very serious side effects. If you have any of these, you have a serious allergy to STRATTERA. You may need emergency medical attention or hospitalization.

It can be seen in at least 1 in 10 patients.

It may be seen less than 1 in 10 patients, but more than 1 in 100 patients. It may occur in less than 1 in 100 patients, but more than 1 in 1,000 patients. It may occur in less than 1 in 1,000 patients. It may occur in less than 1 in 10,000 patients.

If you notice any of the following, tell your doctor immediately or go to the nearest hospital emergency department:

• Darkness of the urine

• Yellowing of the skin and eyes

• Abdominal pain (tenderness) when you press the lower right side of your ribs with your hand

• Feeling unexplainedly sick (nausea)

• Tiredness

• Itching

• The feeling of falling into bed with the flu

Liver damage has been reported very rarely.

All these are serious side effects. Emergency medical attention may be required.

Tell your doctor if you notice any of the following:

Patients under the age of 18 have an increased risk of side effects such as:

• Thoughts of suicide

• Enmity (usually aggression, oppositional behavior and anger)

• Emotional lability