Strattera 100mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Atomoxetine hydrochloride

Saatavilla:

Eli Lilly and Company Ltd

ATC-koodi:

N06BA09

INN (Kansainvälinen yleisnimi):

Atomoxetine hydrochloride

Annos:

100mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04040000; GTIN: 5014602301057

Pakkausseloste

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 been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as y

Valmisteyhteenveto

OBJECT 1
STRATTERA 10MG HARD CAPSULES
Summary of Product Characteristics Updated 08-Jun-2015 | Eli Lilly and
Company Limited
1. Name of the medicinal product
STRATTERA* 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg hard capsules.
2. Qualitative and quantitative composition
Each hard capsule contains atomoxetine hydrochloride equivalent to
10mg, 18mg, 25mg, 40mg, 60mg,
80mg or 100mg of atomoxetine.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Capsule, hard.
STRATTERA 10 mg capsules: hard capsule, opaque white, imprinted with
“Lilly 3227“ and “10 mg“
in black ink, approximately 15.5-16.1 mm length.
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.
STRATTERA 25 mg capsules: hard capsule, opaque blue (cap) and opaque
white (body), imprinted with
“Lilly 3228“ and “25 mg“ in black ink, approximately 15.5-16.1 mm
length.
STRATTERA 40 mg capsules: hard capsule, opaque blue, imprinted with
“Lilly 3229“ and “40 mg“
in black ink, approximately 15.5-16.1 mm length.
STRATTERA 60 mg capsules: hard capsule, opaque blue (cap) and gold
(body), imprinted with “Lilly
3239“ and “60 mg“ in black ink, approximately 17.5-18.1 mm length.
STRATTERA 80 mg capsules: hard capsule, opaque brown (cap) and opaque
white (body), imprinted
with “Lilly 3250“ and “80 mg“ in black ink, approximately
17.5-18.1 mm length.
STRATTERA 100 mg capsules: hard capsule, opaque brown, imprinted with
“Lilly 3251“ and “100
mg“ in black ink, approximately 19.2-19.8 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 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 accord