Strattera 18 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atomoxetine hydrochloride

Available from:

Eli Lilly Nederland B.V.

ATC code:

N06BA; N06BA09

INN (International Name):

Atomoxetine hydrochloride

Dosage:

18 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Centrally acting sympathomimetics; atomoxetine

Authorization status:

Marketed

Authorization date:

2006-02-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
STRATTERA
® 10, 18, 25, 40, 60, 80 AND 100 MG HARD CAPSULES
ATOMOXETINE
IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE
THIS MEDICINE IS USED TO TREAT ADHD

The full name for ADHD is ‘Attention Deficit Hyperactivity
Disorder’.

The medicine helps with your brain activity. It can help improve your
attention, help you concentrate, and
make you less impulsive.

You need to have other help for ADHD as well as this medicine.
READ SECTION 1 FOR MORE INFORMATION.
BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF YOU:

have mental health problems

have a problem with your heart or blood circulation

have serious problems with the blood vessels in your brain such as a
stroke
READ SECTION 2 FOR MORE INFORMATION.
WHILE TAKING THIS MEDICINE:

See your doctor regularly. This is because your doctor will want to
check how the medicine is working.

Do not stop taking the medicine without first talking to your doctor.

Your doctor may stop your medicine to see if it is still needed, if
you take it for more than a year.

The most common side effects in children and young people are:

headache, stomach ache, not feeling hungry, feeling or being sick,
feeling sleepy, increased blood
pressure, increased heart rate (pulse).

The most common side effects in adults are:

feeling sick, dry mouth, headache, not feeling hungry, not being able
to sleep, increased blood pressure,
increased heart rate (pulse).
READ SECTIONS 3 AND 4 FOR MORE INFORMATION.
TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN:

your mood and how you feel changes

you feel any problems with your heart e.g. a fast or unusual heartbeat
rhythm
READ SECTION 2 AND 4 FOR MORE INFORMATION.
THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT
INFORMATION ON THE SAFE AND EFFECTIVE
USE OF THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has

Summary of Product characteristics

Health Products Regulatory Authority
18 October 2019
CRN009DQP
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strattera 18 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine hydrochloride equivalent to 18
mg of atomoxetine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
STRATTERA 18 mg capsules: hard capsule, gold (cap) and opaque white
(body), imprinted with “Lilly 3238” and “18 mg” in
black ink, approximately 15.5-16.1 mm length.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Strattera is indicated for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years
and older, in
adolescents and in adults aspart of a comprehensive treatment
programme. Treatment must be initiated by a specialist in the
treatment of ADHD, such as a paediatrician, child/adolescent
psychiatrist, or psychiatrist. Diagnosis should be made according
to current DSM criteria or the guidelines in ICD.
In adults, the presence of symptoms of ADHD that were pre-existing in
childhood should be confirmed. Third-party
corroboration is desirable and Strattera should not be initiated when
the verification of childhood ADHD symptoms is
uncertain. Diagnosis cannot be made solely on the presence of one or
more symptoms of ADHD. Based on clinical judgment,
patients should have ADHD of at least moderate severity as indicated
by at least moderate functional impairment in 2 or more
settings (for example, social, academic, and/or occupational
functioning), affecting several aspects of an individual’s life.
Additional information for the safe use of this product:
A comprehensive treatment programme typically includes psychological,
educational and social measures and is aimed at
stabilising patients with a behavioural syndrome characterised by
symptoms which may include chronic history of short
attention span, distractibility, emotional lability, impulsivity,
moderate to severe hyperactivity, minor n