Medikinet XL 50mg capsules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Methylphenidate hydrochloride

Dostupno od:

Medice UK Ltd

ATC koda:

N06BA04

INN (International ime):

Methylphenidate hydrochloride

Doziranje:

50mg

Farmaceutski oblik:

Modified-release capsule

Administracija rute:

Oral

Razred:

Schedule 2 (CD)

Tip recepta:

Caution - AMP level prescribing advised

Proizvod sažetak:

BNF: 04040000; GTIN: 5060106551344

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDIKINET
® XL 50MG
MODIFIED-RELEASE CAPSULES, HARD
(METHYLPHENIDATE HYDROCHLORIDE)
The name of your medicine is Medikinet
®
XL 50mg modified-release
capsules, hard but will be referred to as Medikinet XL in this
leaflet.
It contains the active substance ‘methylphenidate hydrochloride’.
The name ‘methylphenidate’ will also be used in the leaflet.
Medikinet XL is also available in other strengths.
WHAT IT IS USED FOR
Medikinet XL is used to treat ‘attention deficit hyperactivity
disorder’ (ADHD).

it is used in children aged 6 years and over and in adults.

it is used only after treatments have been tried which do not involve
medication e.g. counselling and behavioural therapy and which have
been insufficient.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE
This info is to help you learn the main things about your medicine
called
Medikinet XL. If you don’t enjoy reading, someone like your mum, dad
or
carer (sometimes called ‘your guardian’) can read it to you and
answer any
questions.
It may help if you read small bits at a time.
WHY HAVE I BEEN GIVEN THIS MEDICINE?
This medicine can help children and young people with ‘ADHD’.
INFORMATION FOR CHILDREN AND YOUNG PEOPLE
Do not take methylphenidate if any of the above apply to you or your
child.
If you are not sure, talk to your doctor or pharmacist before you or
your child
takes methylphenidate. This is because methylphenidate can make these
problems worse.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Medikinet XL if you or your child

has liver or kidney problems

has problems with swallowing or swallowing whole tablets

has a narrowing or blockage of the gut or food-pipe

has had fits (seizures, convulsions, epilepsy) or any abnormal brain
scans (EEGs)

has ever abused or been dependent on alcohol, prescription medicines
or
street drugs

is female and has started having periods (see the ‘Pregnancy and
breast-feeding’ section below)

has hard-to-cont

Svojstava lijeka

OBJECT 1
MEDIKINET XL 10 MG MODIFIED-RELEASE CAPSULES,
HARD
Summary of Product Characteristics Updated 09-Feb-2018 | Flynn Pharma
Ltd
1. Name of the medicinal product
MEDIKINET XL 5 MG modified-release capsules, hard
MEDIKINET XL 10 MG modified-release capsules, hard
MEDIKINET XL 20 MG modified-release capsules, hard
MEDIKINET XL 30 MG modified-release capsules, hard
MEDIKINET XL 40 MG modified-release capsules, hard
MEDIKINET XL 50 MG modified-release capsules, hard
MEDIKINET XL 60 MG modified-release capsules, hard
2. Qualitative and quantitative composition
MEDIKINET XL 5 MG modified-release capsules, hard
Each modified-release capsule, hard contains 5 mg methylphenidate
hydrochloride, equivalent to 4.35 mg
methylphenidate.
Excipient with known effect: 63.57 mg – 72.71 mg
sucrose/modified-release capsule, hard
MEDIKINET XL 10 MG modified-release capsules, hard
Each modified-release capsule, hard contains 10 mg methylphenidate
hydrochloride, equivalent to 8.65
mg methylphenidate.
Excipient with known effect: 127.14 mg – 145.42 mg
sucrose/modified-release capsule, hard
MEDIKINET XL 20 MG modified-release capsules, hard
Each modified-release capsule, hard contains 20 mg methylphenidate
hydrochloride, equivalent to 17.30
mg methylphenidate.
Excipient with known effect: 114.65 mg – 131.13 mg
sucrose/modified-release capsule, hard
MEDIKINET XL 30 MG modified-release capsules, hard
Each modified-release capsule, hard contains 30 mg methylphenidate
hydrochloride, equivalent to 25.95
mg methylphenidate.
Excipient with known effect: 69.60 mg – 79.61 mg
sucrose/modified-release capsule, hard
MEDIKINET XL 40 MG modified-release capsules, hard
Each modified-release capsule, hard contains 40 mg methylphenidate
hydrochloride, equivalent to 34.60
mg methylphenidate.
Excipient with known effect: 92.80 mg – 106.14 mg
sucrose/modified-release capsule, hard
MEDIKINET XL 50 MG modified-release capsules, hard
Each modified-release capsule, hard contains 50 mg methylphenidate
hydrochloride, equivalent to 43.25
mg methylphe