Concerta XL 27 mg prolonged-release tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Methylphenidate hydrochloride

可用日期:

Imbat Limited

ATC代码:

N06BA; N06BA04

INN（国际名称）:

Methylphenidate hydrochloride

剂量:

27 milligram(s)

药物剂型:

Prolonged-release tablet

给药途径:

Oral use

每包单位数:

30 prolonged-release tablets

处方类型:

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

厂商:

Janssen Pharmaceutica NV

治疗组:

Centrally acting sympathomimetics

治疗领域:

Centrally acting sympathomimetics; methylphenidate

疗效迹象:

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

授权状态:

Authorised

授权日期:

2015-04-02

资料单张

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONCERTA
® XL 27MG
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

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Concerta XL 27 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged release tablet contains 27 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 gray tablet printed with 'alza 27'
on one side in black ink.
4 CLINICAL PARTICULARS
As per PA0748/049/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/049/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Butylhydroxytoluene (E321)
Cellulose acetate
Hypromellose (E464)
Phosphoric acid 85%
Poloxamer 188
Macrogol 200 K and 7000 K
Povidone K29-32
Sodium chloride
Stearic acid
Succinic acid
Iron oxide black (E172)
Iron oxide yellow (E172)
Iron oxide red (E172)
FILM COAT:
Iron oxide black (E172)
Hypromellose (E464)
Lactose monohydrate
Titanium dioxide (E171)
Triacetin
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CLEAR COAT:
Carnauba wax
Hypromellose (E464)
Macrogol 400
PRINTING INK:
Iron oxide black (E172)
Hypromellose (E464)
Propylene glycol
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