Skip to Content

UK Edition. Click here for US version.

EQUASYM XL 50 MG MODIFIED-RELEASE CAPSULES HARD

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user
Tradename 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg modified-release capsules, hard
Methylphenidate hydrochloride
The name of this medicine is Tradename, it contains the active substance ‘methylphenidate hydrochloride’.
The name ‘methylphenidate’ will also be used in this leaflet.
Read all of this leaflet carefully before you or your child start taking this medicine because it contains
important information for you.
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 or your child. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
1.
What Tradename is and what it is used for
2.
What you need to know before you or your child takes Tradename
3.
How to take Tradename
4.
Possible side effects
5.
How to store Tradename
6.
Contents of the pack and other information
1.

What Tradename is and what it is used for

What it is used for
Tradename is used to treat ‘attention deficit hyperactivity disorder’ (ADHD).
it is used in children and young people between the ages of 6 and 18.
it is used only after trying treatments which do not involve medicines. Such as counselling and
behavioural therapy.
Tradename is not for use as a treatment for ADHD in children under 6 years of age or in adults. It is not
known if it is safe or of benefit in these people.
How it works
Tradename improves the activity of certain parts of the brain which are under-active. The medicine can help
improve attention (attention span), concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes:
psychological
educational and
social therapy
Methylphenidate treatment must only be started by, and used under the regular check-ups of, a
specialist in childhood and/or adolescent behavioural disorders.
ADHD can be managed using treatment programmes.
About ADHD
Children and young people with ADHD find it:
hard to sit still and
hard to concentrate
It is not their fault that they cannot do these things.

1

Many children and young people struggle to do these things. However, with ADHD they can cause problems
with everyday life. Children and young people with ADHD may have difficulty learning and doing
homework. They find it hard to behave well at home, at school or in other places.
ADHD does not affect the intelligence of a child or young person.
2.

What you need to know before you or your child takes Tradename

Do not take methylphenidate if you or your child:
is allergic to methylphenidate or any of the other ingredients of this medicine (listed in Section 6)
has a thyroid problem
has increased pressure in the eye (glaucoma)
has a tumour of the adrenal gland (phaeochromocytoma)
has an eating problem when you do not feel hungry or want to eat - such as ‘anorexia nervosa’
has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and
legs
has ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the
chest, heart failure, heart disease or were born with a heart problem
has had a problem with the blood vessels in the brain - such as a stroke, swelling and weakening of
part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood
vessels (vasculitis)
is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine
oxidase inhibitor) – see Taking other medicines
has mental health problems such as:
a ‘psychopathic’ or ‘borderline personality’ problem
abnormal thoughts or visions or an illness called ‘schizophrenia’
signs of a severe mood problem like:
- feeling like killing yourself
- severe depression, where you feel very sad, worthless and hopeless
- mania, where you feel unusually excitable, over-active, and un-inhibited.
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
Tell your doctor or pharmacist before taking treatment if you or your child:
has liver or kidney problems
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-control, repeated twitching of any parts of the body or you repeat sounds and words
has high blood pressure
has a heart problem which is not in the ‘Do not take’ section above
has a mental health problem which is not in the ‘Do not take’ section above. Other mental health
problems include:
mood swings (from being manic to being depressed - called ‘bipolar disorder’)
starting to be aggressive or hostile, or aggression gets worse
seeing, hearing or feeling things that are not there (hallucinations)
believing things that are not true (delusions)
feeling unusually suspicious (paranoia)
feeling agitated, anxious or tense
feeling depressed or guilty.
Tell your doctor or pharmacist if any of the above apply to you or your child before starting treatment. This
is because methylphenidate can make these problems worse. Your doctor will want to monitor how the
medicine affects you or your child.
2

Checks that your doctor will make before you or your child starts taking methylphenidate
These checks are to decide if methylphenidate is the correct medicine for you or your child. Your doctor
will talk to you about:
any other medicines you or your child are taking
whether there is any family history of sudden unexplained death
any other medical problems (such as heart problems) you or your family may have
how you or your child is feeling, such as feeling high or low, having strange thoughts or if you or your
child has had any of these feelings in the past
whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the body
or repeating sounds and words)
any mental health or behaviour problems you, your child or other family members have ever had.
Your doctor will discuss whether you or your child is at risk of having mood swings (from being
manic to being depressed - called ‘bipolar disorder’). They will check you or your child’s mental
health history, and check if any of your family have a history of suicide, bipolar disorder or
depression.
It is important that you provide as much information as you can. This will help your doctor decide if
methylphenidate is the correct medicine for you or your child. Your doctor may decide that other medical
tests are needed before you start taking this medicine.
Other medicines and Tradename
Tell your doctor or pharmacist if you are taking or have recently taken or might use any other medicines.
Do not take methylphenidate if you or your child:
is taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or has taken
an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in
blood pressure.
If you or your child is taking other medicines, methylphenidate may affect how well they work or may cause
side effects. If you or your child is taking any of the following medicines, check with your doctor or
pharmacist before taking methylphenidate:
other medicines for depression
medicines for severe mental health problems
medicines for epilepsy
medicines used to reduce or increase blood pressure
some cough and cold remedies which contain medicines that can affect blood pressure. It is important
to check with your pharmacist when you buy any of these products
medicines that thin the blood to prevent blood clots
If you are in any doubt about whether any medicines you or your child is taking are included in the list
above, ask your doctor or pharmacist before taking methylphenidate.
Please tell your doctor or pharmacist if you or your child is taking or has recently taken any other medicines,
including medicines obtained without a prescription.
Having an operation
Tell your doctor if you or your child is going to have an operation. Methylphenidate should not be taken on
the day of surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise
in blood pressure during the operation.
Drug testing
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Methylphenidate with alcohol
Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse.
Remember that some foods and medicines contain alcohol.
3

Pregnancy, breast-feeding and fertility
It is not known if methylphenidate will affect an unborn baby. Tell your doctor or pharmacist before using
methylphenidate if you or your daughter is:
having sex. Your doctor will discuss contraception
pregnant or may be pregnant. Your doctor will decide whether methylphenidate should be taken
breast-feeding or planning to breast-feed. It is possible that methylphenidate is passed into human
breast milk. Therefore, your doctor will decide whether you or your daughter should breast-feed while
taking methylphenidate.
Prolonged erections
During treatment, boys and adolescents may unexpectedly experience prolonged erections. This may be
painful and can occur at any time. It is important you or your child contact your doctor straight away if an
erection lasts for longer than 2 hours, particularly if this is painful.
Driving or using machines
You or your child may feel dizzy, have problems focussing or have blurred vision when taking
methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike
or horse or climb trees.
Tradename contains sucrose (a type of sugar).
If you or your child has an intolerance to some sugars, talk to your doctor before taking this medicine.
3.

How to take Tradename

How much to take
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
Tradename is a “modified release” form of methylphenidate which releases the medicine gradually
over a time period corresponding to the school day (8 hours). It is intended to take the place of the
same total daily dose of traditional (immediate release) methylphenidate taken at breakfast and
lunchtime.
If you or your child is already taking traditional (immediate release) methylphenidate, your doctor
may prescribe an equivalent dose of Tradename instead.
If you or your child has not taken methylphenidate before, your doctor will normally start treatment
with traditional (immediate release) methylphenidate tablets. If your doctor feels it is necessary
methylphenidate treatment may be started with Tradename 10 mg once daily before breakfast.
Your doctor will usually start treatment with a low dose and increase it gradually as required.
The maximum daily dose is 60 mg.
How to take
Tradename should be given in the morning before breakfast. The capsules may be swallowed whole
with a drink of water, or alternatively, may be opened and the capsule contents sprinkled onto a small
amount (tablespoon) of applesauce and taken/given immediately and not stored for future use. If the
medicine is taken/given with soft food, some fluids, e.g. water, should be taken afterwards.
If you or your child does not feel better after 1 month of treatment
If you or your child does not feel better, tell your doctor. They may decide you need a different treatment.
Not using Tradename properly
If Tradename is not used properly, this may cause abnormal behaviour. It may also mean that you or your
child starts to depend on the medicine. Tell your doctor if you or your child has ever abused or been
dependent on alcohol, prescription medicines or street drugs.

4

This medicine is only for you or your child. Do not give this medicine to anyone else, even if their
symptoms seem similar.
If you or your child takes more Tradename than you should
If you or your child takes too much medicine, talk to a doctor or call an ambulance straight away. Tell them
how much has been taken.
Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements,
muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or
hearing things that are not real (hallucinations or psychosis), sweating, flushing, headache, high fever,
changes in heart beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.
If you or your child forget to take Tradename
Do not take a double dose to make up for a forgotten dose. If you or your child forgets a dose, wait until it is
time for the next dose.
If you or your child stops taking Tradename
If you or your child suddenly stops taking this medicine, the ADHD symptoms may come back or unwanted
effects such as depression may appear. Your doctor may want to gradually reduce the amount of medicine
taken each day, before stopping it completely. Talk to your doctor before stopping Tradename. If you have
any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
Things your doctor will do when you or your child is on treatment
Your doctor will do some tests
before you or your child starts - to make sure that Tradename is safe and will be of benefit.
after you or your child starts - they will be done at least every 6 months, but possibly more often.
They will also be done when the dose is changed.
these tests will include:
checking appetite
measuring height and weight
measuring blood pressure and heart rate
checking problems with mood, state of mind or any other unusual feelings. Or if these have got
worse while taking Tradename.
Long-term treatment
Tradename does not need to be taken for ever. If you or your child takes Tradename for a longer time, your
doctor should stop treatment for some time, at least once a year, this may happen during a school holiday.
This will show if the medicine is still needed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, but not everybody gets them. Although some people
get side effects, most people find that methylphenidate helps them. Your doctor will talk to you about these
side effects.
Some side effects could be serious. If you or your child have any of the side effects below, see a doctor
straight away:
Common (affects less than 1 in 10 people)
uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality
5

Uncommon (affects less than 1 in 100 people)
thinking about or feeling like killing yourself
seeing, feeling, or hearing things that are not real, these are signs of psychosis
uncontrolled speech and body movements (Tourette’s)
signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other
parts of the body, shortness of breath, wheezing or trouble breathing
Rare (affects less than 1 in 1,000 people)
feeling unusually excited, over-active and un-inhibited (mania)
Very rare (affects less than 1 in 10,000 people)
heart attack
fits (seizures, convulsions, epilepsy)
skin peeling or purplish red patches
muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system due to a temporary lack of blood supply to the brain
paralysis or problems with movement and vision, difficulties in speech (these can be signs of
problems with the blood vessels in your brain)
decrease or increase in number of blood cells (red cells, white cells and platelets) which can make you
more likely to get infections, and make you bleed and bruise more easily
a sudden increase in body temperature, very high blood pressure and severe convulsions (‘Neuroleptic
Malignant Syndrome’). It is not certain that this side effect is caused by methylphenidate or other
drugs that may be taken in combination with methylphenidate.
Other side effects (how often they happen is not known)
unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)
If you have any of the side effects above, see a doctor straight away.
Other side effects include the following, if they get serious, please tell your doctor or pharmacist:
Very common (affects more than 1 in 10 people)
headache
feeling nervous
not being able to sleep.
Common (affects less than 1 in 10 people)
joint pain
dry mouth
high temperature (fever)
unusual hair loss or thinning
feeling unusually sleepy or drowsy
loss of appetite or decreased appetite
itching, rash or raised red itchy rashes (hives)
cough, sore throat or nose and throat irritation
high blood pressure, fast heart beat (tachycardia)
feeling dizzy, movements which you cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable and abnormal behaviour
grinding of the teeth
Uncommon (affects less than 1 in 100 people)
constipation
chest discomfort
blood in the urine
6

-

shaking or trembling
double vision or blurred vision
muscle pain, muscle twitching
shortness of breath or chest pain
increases in liver test results (seen in a blood test)
anger, feeling restless or tearful, excessive awareness of surroundings, problems sleeping.

Rare (affects less than 1 in 1,000 people)
changes in sex drive
feeling disorientated
dilated pupils, trouble seeing
swelling of the breasts in men
excessive sweating, redness of the skin, red raised skin rash.
Very rare (affects less than 1 in 10,000 people)
heart attack
sudden death
muscle cramps
small red marks on the skin
inflammation or blocked arteries in the brain
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
suicidal attempt, completed suicide, abnormal thinking, lack of feeling or emotion, doing things over
and over again, being obsessed with one thing
fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold
(‘Raynaud’s phenomenon’).
Other side effects (how often they happen is not known)
migraine
excessive talkativeness
very high fever
slow, fast or extra heart beats
a major fit (‘grand mal convulsions’)
believing things that are not true, confusion
severe stomach pain, often with feeling and being sick
prolonged erections, sometimes painful. or an increased number of erections, inability to develop or
maintain an erection
problems with the blood vessels of the brain (stroke, cerebral arteritis or cerebral occlusion).
Effects on growth
When used for more than a year, methylphenidate may cause reduced growth in some children. This affects
less than 1 in 10 children.
There may be lack of weight gain or height growth.
Your doctor will carefully watch you or your child’s height and weight, as well as how well you or
your child are eating.
If you or your child is not growing as expected, then your treatment with methylphenidate may be
stopped for a short time.
If you have any of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
7

5.

How to store Tradename

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The
expiry date refers to the last day of that month.
Store below 25°C.
Do not use this medicine if the capsules look damaged in any way.
Do not throw away any medicines via wastewater of household waste. Ask your pharmacist how to throw
away medicines you no longer use. The measures will help to protect the environment.
6.

Contents of the pack and other information

What Tradename contains
The active substance is methylphenidate hydrochloride.
Each 10 mg capsule contains 10 mg methylphenidate hydrochloride corresponding to 8.65 mg
methylphenidate.
Each 20 mg capsule contains 20 mg methylphenidate hydrochloride corresponding to 17.30 mg
methylphenidate.
Each 30 mg capsule contains 30 mg methylphenidate hydrochloride corresponding to 25.94 mg
methylphenidate.
Each 40 mg capsule contains 40 mg methylphenidate hydrochloride corresponding to 34.59 mg
methylphenidate.
Each 50 mg capsule contains 50 mg methylphenidate hydrochloride corresponding to 43.24 mg
methylphenidate.
Each 60 mg capsule contains 60 mg methylphenidate hydrochloride corresponding to 51.89 mg
methylphenidate.
The other ingredients are:
Capsule content: Sugar spheres (sucrose and maize starch), povidone K29 to K32, Opadry Clear Ys1-7006 (hypromellose, macrogol 400 and macrogol 8000), ethylcellulose aqueous dispersion and
dibutyl sebacate
Capsule shell: Gelatin, Titanium dioxide (E171).
The 10 mg capsule also contains Indigo carmine (E132), Yellow iron oxide (E172)
The 20 mg capsule also contains Indigo carmine (E132)
The 30 mg capsule also contains Indigo carmine (E132), Red iron oxide (E172)
The 40 mg capsule also contains yellow iron oxide (E172)
The 50 mg capsule also contains indigo carmine (E132) and red iron oxide (E172)
White printing ink (10,20,30 and 50 mg capsules only): shellac, propylene glycol, sodium
hydroxide, povidone K16 and titanium dioxide (E171)
Black ink contains shellac glaze 45% (20% esterified) in ethanol, propylene glycol, ammonium
hydroxide 28% and iron oxide black (E172)
What Tradename looks like and contents of the pack
Modified-release capsules, hard
The 10 mg modified-release capsules, hard have a dark green opaque cap imprinted with “S544” in white
and white opaque body imprinted with “10 mg” in black.
The 20 mg modified-release capsules, hard have a blue opaque cap imprinted with “S544” in white and
white opaque body imprinted with “20 mg” in black.
8

The 30 mg modified-release capsules, hard have a reddish-brown opaque cap imprinted with “S544” in
white and white opaque body imprinted with “30 mg” in black.
The 40 mg modified-release capsules, hard have a yellow ivory opaque cap imprinted with “S544” in black
and a white opaque body imprinted with “40 mg” in black.
The 50 mg modified-release capsules, hard have a purple opaque cap imprinted with “S544” in white and a
white opaque body imprinted with “50 mg” in black.
The 60 mg modified-release capsules, hard have a white opaque cap imprinted with “S544” in black and a
white opaque body imprinted with “60 mg” in black.
Pack sizes: 10, 28, 30, 60 or 100* modified-release capsules, hard. (*10 mg and 20 mg capsules only)
28 or 30 modified-release capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
Ireland
Tel: +44(0)1256 894 959
E-mail: medinfoEMEA@shire.com

This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium
Denmark
Finland
France
Germany
Iceland
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Spain
United Kingdom

Equasym XR
Equasym Depot
Equasym Retard
Quasym
Equasym Retard
Equasym Depot
Equasym XL
Equasym
Equasym XR
Equasym XL
Equasym Depot
Quasym
Equasym
Equasym XL

This leaflet was last revised in mm/yyyy.
<[To be completed nationally]>
Other information sources

<---------------------------------------------------------------------------------------------------------------------------->

9

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide