Strattera 4mg/1ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atomoxetine hydrochloride

Available from:

Eli Lilly and Company Ltd

ATC code:

N06BA09

INN (International Name):

Atomoxetine hydrochloride

Dosage:

4mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04040000; GTIN: 5014602500764

Patient Information leaflet

1
STRATTERA
®
atomoxetine
oral solution
INSTRUCTIONS FOR USE
YOUR STEP-BY-STEP GUIDE FOR USING STRATTERA
WHEN USING STRATTERA, READ AND CAREFULLY FOLLOW THE STEP-BY-STEP
INSTRUCTIONS.
WARNING:
The adaptor represents a CHOKING HAZARD – small parts. Do not attach
the
syringe to the adaptor until the adaptor is fully inserted into the
bottle. It must be inserted completely
into the bottle for safe use. Use only under adult supervision.
GUIDE TO PARTS
PLUNGER
SYRINGE
TIP
CHILD-RESISTANT
CAP
ADAPTOR
MEDICINE
ORAL DOSING
SYRINGE
MEDICINE
BOTTLE
2
IMPORTANT
DO NOT
let your child take the medicine without your help.
DO NOT
use the medicine if it has expired. (Check the expiration date on the
label.)
DO NOT
use the medicine more than 45 days after the first time you open the
bottle. See the
DISPOSAL
section to find out what to do with the medicine you don’t use.
DO NOT
wash the oral dosing syringe with soap or detergent.
DO NOT
put the syringe in the
dishwasher. If you do, the syringe may not work as well as it should.
Please see steps N through P for
cleaning instructions.
It is not recommended to mix STRATTERA oral solution with food or
water since it may affect the
taste or prevent a full dose.
STRATTERA
causes irritation of the eye.
AVOID CONTACT WITH THE EYE
. If the medicine gets in the eye,
flush the eye immediately with water and contact a doctor. Wash hands
and surfaces that may have
come in contact with the medicine as soon as possible.
3
STEP 1 INITIAL BOTTLE PREPARATION
Prior to first use only, push the adaptor
ALL THE WAY DOWN
into the
opening of the bottle. Do not attach the syringe to the adaptor until
the
adaptor is fully inserted into the bottle.
DO NOT
twist the adaptor. WARNING:
The adaptor represents a CHOKING HAZARD –
small parts. It must be inserted completely into the bottle for safe
use.
STEP 2 GET READY
Gather the items you will need:

Medicine bottle

Oral dosing syringe
Wash your hands with soap and water.
Write your child’s dose here:
________ mL
Be sure to use the exact dose tha

Summary of Product characteristics

OBJECT 1
STRATTERA 4 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 08-Jun-2015 | Eli Lilly and
Company Limited
1. Name of the medicinal product
STRATTERA* 4 mg/mL oral solution.
2. Qualitative and quantitative composition
Each mL of oral solution contains atomoxetine hydrochloride equivalent
to 4 mg of atomoxetine.
For the full list of excipients, see section 6.1.
Excipient with known effect: contains 32.97 mg of sorbitol per mL
3. Pharmaceutical form
Oral solution
Clear, colourless
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 as part 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 neurological signs and abnormal EEG.
Learning may or may not