STRATTERA 10 mg CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Eli Lilly (S.A.) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS ATOMOXETINE HYDROCHLORIDE EQUIVALENT TO ATOMOXETINE 10,0 mg

Authorization status:

Registered

Authorization date:

2005-03-06

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S5
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
STRATTERA 10 mg (capsules)
STRATTERA 18 mg (capsules)
STRATTERA 25 mg (capsules)
STRATTERA 40 mg (capsules)
STRATTERA 60 mg (capsules)
STRATTERA 80 mg (capsules)
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
STRATTERA (ATOMOXETINE) INCREASED THE RISK OF SUICIDAL IDEATION IN
CHILDREN OR ADOLESCENTS.
PATIENTS STARTED ON THERAPY SHOULD BE CLOSELY MONITORED.
_ _
Each capsule contains ATOMOXETINE hydrochloride equal to 10 mg, 18 mg,
25 mg, 40 mg, 60 mg or
80 mg atomoxetine.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR A CHILD IN YOUR
CARE START TAKING STRATTERA (STRA-TAIR-A)

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or
your pharmacist.
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
STRATTERA has been prescribed for you personally or a
child in your care and you should not share this medicine with
other people. It may harm them, even if their symptoms are
the same as yours or a child in your care.
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WHAT STRATTERA CONTAINS
The active substance is atomoxetine.
The other ingredients are black ink, dimethicone, FD&C blue 2 (25 mg,
40 mg and 60 mg only),
gelatin, pregelatinised starch, red iron oxide (80 mg only), sodium
laurilsulfate, titanium dioxide,
yellow iron oxide (18 mg, 60 mg and 80 mg only).
LACTOSE FREE.
WHAT STRATTERA IS USED FOR
STRATTERA is used to treat Attention-Deficit/ Hyperactivity Disorder
(ADHD) in children 6 years
of age or older, adolescents and adults.
BEFORE YOU TAKE STRATTERA OR GIVE STRATTERA TO A CHILD IN YOUR CARE
DO NOT TAKE OR GIVE STRATTERA TO A CHILD IN YOUR CARE IF YOU OR A
CHILD IN YOUR CARE:

are allergic to atomoxetine or any of the other ingredients of
STRATTERA;

took a medicine known as a monoamine oxidase inhibitor (MAOI), for
example phenelzine,
in the last two weeks. An MAOI is sometimes used for depression and
other mental-health
problems; taking STRATTERA with an MAOI could cause seriou

Summary of Product characteristics

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SCHEDULING STATUS
S5
PROPRIETARY NAME AND DOSAGE FORM
STRATTERA 10 mg (Capsules)
STRATTERA 18 mg (Capsules)
STRATTERA 25 mg (Capsules)
STRATTERA 40 mg (Capsules)
STRATTERA 60 mg (Capsules)
STRATTERA 80 mg (Capsules)
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
STRATTERA (ATOMOXETINE) INCREASED THE RISK OF SUICIDAL IDEATION IN
SHORT-TERM STUDIES IN
CHILDREN
OR
ADOLESCENTS
WITH
ATTENTION-DEFICIT/HYPERACTIVITY
DISORDER
(AHDH).
ANYONE
CONSIDERING THE USE OF STRATTERA IN A CHILD OR ADOLESCENT MUST BALANCE
THIS RISK WITH THE
CLINICAL NEED. CO-MORBIDITIES OCCURRING WITH ADHD MAY BE ASSOCIATED
WITH AN INCREASE IN THE
RISK OF SUICIDAL IDEATION AND/OR BEHAVIOUR. PATIENTS WHO ARE STARTED
ON THERAPY SHOULD BE
MONITORED CLOSELY FOR SUICIDALITY (SUICIDAL THINKING AND BEHAVIOUR),
CLINICAL WORSENING, OR
UNUSUAL CHANGES IN BEHAVIOUR.
FAMILIES
AND
CAREGIVERS
SHOULD
BE
ADVISED
OF
THE
NEED
FOR
CLOSE
OBSERVATION
AND
COMMUNICATION WITH THE PRESCRIBER. STRATTERA IS APPROVED FOR ADHD IN
PAEDIATRIC AND
ADULT PATIENTS. STRATTERA IS NOT APPROVED FOR MAJOR DEPRESSIVE
DISORDER.
COMPOSITION
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Each capsule contains atomoxetine hydrochloride equal to 10 mg, 18 mg,
25 mg, 40 mg, 60 mg or
80 mg atomoxetine.
STRATTERA capsules contain the following inactive ingredients: black
ink, dimethicone, FD&C blue
2 (25 mg, 40 mg and 60 mg only), gelatin, pregelatinised starch, red
iron oxide (80 mg only), sodium
laurilsulfate, titanium dioxide, yellow iron oxide (18 mg, 60 mg and
80 mg only).
Lactose Free.
PHARMACOLOGICAL CLASSIFICATION
A1.2 Psychoanaleptics
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Atomoxetine is a selective inhibitor of the presynaptic norepinephrine
transporter, without directly
affecting the serotonin or dopamine transporters. Atomoxetine has
minimal affinity for other
noradrenergic receptors or for other neurotransmitter transporters or
receptors.
PHARMACOKINETIC PROPERTIES
The pharmacokinetics of atomoxetine in children and adolescents are
similar to those in