Concerta XL 36 mg prolonged-release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
17-04-2015
Summary of Product characteristics
(SPC)
17-04-2015
Active ingredient:
Methylphenidate hydrochloride
Available from:
Imbat Limited
ATC code:
N06BA; N06BA04
INN (International Name):
Methylphenidate hydrochloride
Dosage:
36 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Administration route:
Oral use
Units in package:
30 prolonged-release tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Janssen Pharmaceutica NV
Therapeutic group:
Centrally acting sympathomimetics
Therapeutic area:
Centrally acting sympathomimetics; methylphenidate
Therapeutic indications:
It is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over
Authorization status:
Authorised
Authorization date:
2015-04-02
Patient Information leaflet
Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCERTA
® XL 36MG
PROLONGED-RELEASE TABLETS
(methylphenidate hydrochloride)
The name of your medicine is Concerta XL, it contains the active
substance ‘methylphenidate hydrochloride’.
The name ‘methylphenidate’ will also be used in this leaflet.
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 treatments 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 heart, circulation, or mental health problems - you
may not be able to take this medicine.
You are taking any other medicines - this is because
methylphenidate can affect how other medicines work.
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 are feeling nervous, not
being able to sleep or having a headache.
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.
Read Section 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
i
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Concerta XL 36 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 36 mg of methylphenidate
hydrochloride.
Excipients with known effect: contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
_Product imported from Germany:_
Capsule-shaped, white tablet with “alza 36” printed on one side in
black ink.
4 CLINICAL PARTICULARS
As per PA0748/049/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/049/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Butylhydroxytoluene (E321)
Cellulose acetate
Hypromellose (E464)
Phosphoric acid 85%
Poloxamer 188
Macrogol 200 000 and 7000 000,
Povidone K29-32
Sodium chloride
Stearic acid
Succinic acid
Iron oxide black (E172)
Iron oxide hydrate (E172)
FILM COAT:
Hypromellose (E464)
Lactose monohydrate
Titanium dioxide (E171)
Triacetin
CLEAR COAT:
Carnauba wax
Hypromellose (E464)
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Macrogol 400
PRINTING INK:
Iron oxide black (E172)
Hypromellose (E464)
Isopropyl alcohol
Propylene glycol
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
inner packaging and outer carton of the product as
marked in the c
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