Equasym XL 20mg capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Methylphenidate hydrochloride
Available from:
CST Pharma Ltd
ATC code:
INN (International Name):
Methylphenidate hydrochloride
Pharmaceutical form:
Modified-release capsule
Administration route:
Schedule 2 (CD)
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 04040000; GTIN: 5055946804453

Package leaflet: Information for the user



XL 10mg capsules



XL 20mg capsules



XL 30mg capsules

(methylphenidate hydrochloride)

Important things you need to know about your medicine

The name of your medicine is Equasym XL 10mg, 20mg or 30mg

capsules, hard, but it will be referred to as Equasym XL throughout this

leaflet. Equasym XL contains the active substance ‘methylphenidate

hydrochloride’ which will be used as ‘methylphenidate’ in this leaflet.

Please note that this leaflet also contains information about other strengths

Equasym XL 40mg, 50mg and 60mg capsules.

Read all of this leaflet carefully before you start using this medicine

because it contains important information for you.

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. 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 your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet.

The leaflet has been written in sections:

Sections 1 to 6 are for parents and carers (sometimes called ‘your


The last section is a special section for a child or young person to read.

However, all sections are written as though the child or young person

taking the medicine is reading them.

The sections are:

What Equasym XL is and what it is used for

What you need to know before you take Equasym XL

How to take Equasym XL

Possible side effects

How to store Equasym XL

Contents of the pack and other information

Information for children and young people

Now read the rest of this leaflet before you start taking this medicine.

What it is used for

Equasym XL is used to treat ‘attention deficit hyperactivity disorder’


- 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 counseling and behavioural therapy.

Equasym XL 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


How it works

Equasym XL 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


- 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


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.

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.

Do not take methylphenidate if:

- you are allergic to methylphenidate or any of the other ingredients of this

medicine (listed in Section 6)

- you have a thyroid problem

- you have increased pressure in your eye (glaucoma)

- you have a tumour of your adrenal gland (phaeochromocytoma)

- you have an eating problem when you do not feel hungry or want to eat -

such as ‘anorexia nervosa’

- you have very high blood pressure or narrowing of the blood vessels,

which can cause pain in the arms and legs

- you have ever had heart problems - such as a heart attack, uneven

heart beat, pain and discomfort in the chest, heart failure, heart disease

or were born with a heart problem

- you have had a problem with the blood vessels in your 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


- is currently taking or has taken within the last 14 days an

antidepressant (known as a monoamine oxidase inhibitor) – see

Taking other medicines

- you have 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


- mania, where you feel unusually excitable, over-active, and


Do not take methylphenidate if any of the above apply to you. If you are not

sure, talk to your doctor or pharmacist before you take methylphenidate.

This is because methylphenidate can make these problems worse.

Warnings and precautions

Tell your doctor or pharmacist before taking treatment if:

- you have liver or kidney problems

- you have had fits (seizures, convulsions, epilepsy) or any abnormal brain

scans (EEGs)

- you have ever abused or been dependent on alcohol, prescription

medicines or street drugs

- you are a girl and have started your periods (see the ‘Pregnancy,

breast-feeding and contraception’ section below)

- you have hard-to-control, repeated twitching of any parts of the body or

you repeat sounds and words

- you have high blood pressure

- you have a heart problem which is not in the ‘Do not take’ section above

- you have 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


- starting to be aggressive or hostile, or your 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 before

starting treatment. This is because methylphenidate can make these

problems worse. Your doctor will want to monitor how the medicine affects


Checks that your doctor will make before you start taking


These checks are to decide if methylphenidate is the correct medicine for

you. Your doctor will talk to you about:

- any other medicines you 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 are feeling, such as feeling high or low, having strange thoughts

or if you have 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 or other family members

have ever had. Your doctor will discuss whether you are at risk of having

mood swings (from being manic to being depressed - called ‘bipolar

disorder’). They will check your 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.

Your doctor may decide that other medical tests are needed before you

start taking this medicine.

Other medicines and Equasym XL

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:

- are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI)

used for depression, or have taken an MAOI in the last 14 days. Taking

an MAOI with methylphenidate may cause a sudden increase in your

blood pressure.

If you are taking other medicines, methylphenidate may affect how well

they work or may cause side effects. If you are taking any of the following

medicines, check with your doctor or pharmacist before taking


- 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 are taking are

included in the list above, ask your doctor or pharmacist before taking


Having an operation

Tell your doctor if you are going to have an operation. You should not take

methylphenidate on the day of your 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 whilst taking this medicine. Alcohol may make the side

effects of this medicine worse. Remember that some foods and medicines

contain alcohol.

Pregnancy, breast-feeding and contraception

It is not known if methylphenidate will affect an unborn baby. Tell your

doctor or pharmacist before using methylphenidate if you are:

- having sex. Your doctor will discuss contraception with you.

- pregnant or think you may be pregnant. Your doctor will decide whether

you should take methylphenidate.

- 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 should breast-feed while taking


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 to contact your doctor straight away if your an

erection lasts for longer than 2 hours, particularly if this is painful.

Driving or using machines

You may feel dizzy, have problems focusing 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.

The medicine can affect your ability to drive as it may make you sleepy or


Do not drive while taking this medicine until you know how it affects


It is an offence to drive if this medicine affects your ability to drive.

However, you would not be committing an offence if:

The medicine has been prescribed to treat a medical or dental

problem and

You have taken it according to the instructions given by the

prescriber or in the information provided with the medicine and

It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for

you to drive while taking this medicine.

Equasym XL contains sucrose (a type of sugar).

If you have been told by your doctor that you cannot tolerate or digest

some sugars, talk to your doctor before taking this medicine.


What Equasym XL is and what it is used for


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


This info is to help you learn the main things about your medicine called

Equasym 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.


Information for children and young people

Why have I been given this medicine?

This medicine can help children and young people with ‘ADHD’.

- ADHD can make you:

- run about too much

- not be able to pay attention

- act quickly without thinking about what will happen next (impulsive)

- It affects learning, making friends and how you think about yourself. It is

not your fault.

While you are taking this medicine

- As well as taking this medicine you will also get help with ways to cope with

your ADHD such as talking to ADHD specialists.

- This medicine should help you.

- You will need to go to your doctor several times a year for check ups. This

is to make sure the medicine is working and that you are growing and

developing OK.

- If you take the medicine for more than one year, your doctor may stop your

medicine to see if it is still needed. This will probably happen in a school


- Do not drink alcohol. Alcohol may make the side effects of this medicine


- Girls must tell their doctor straight away if they think they may be pregnant.

We do not know how this medicine affects unborn babies. If you are having

sex, please talk to your doctor about contraception.

Some people cannot have this medicine

You cannot have this medicine if:

- you have a problem with your heart

- you feel very unhappy, depressed or have a mental illness.

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.

- Equasym XL 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 are already taking traditional (immediate release) methylphenidate,

your doctor may prescribe an equivalent dose of Equasym XL instead.

- If you have 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 Equasym XL 10mg once daily before breakfast.

- Your doctor will usually start treatment with a low dose and increase it

grad ually as required.

- The maximum daily dose is 60mg.

How to take

- Equasym XL 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 immediately and not stored for

future use. If the medicine is taken with soft food, some fluids, e.g. water,

should be taken afterwards.

If you do not feel better after 1 month of treatment

If you do not feel better, tell your doctor. They may decide you need a

different treatment.

Not using Equasym XL properly

If Equasym XL is not used properly, this may cause abnormal behaviour. It

may also mean that you start to depend on the medicine. Tell your doctor if

you have ever abused or been dependent on alcohol, prescription

medicines or street drugs.

This medicine is only for you. Do not give this medicine to anyone else,

even if their symptoms seem similar.

If you take more Equasym XL than you should

If you take 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 forget to take Equasym XL

Do not take a double dose to make up for a forgotten dose. If you forget a

dose, wait until it is time for the next dose.

If you stop taking Equasym XL

If you suddenly stop 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 Equasym

If you have any further questions on the use of this medicine, ask your

doctor or pharmacist.

Things your doctor will do when you are on treatment

Your doctor will do some tests

- before you start - to make sure that Equasym XL is safe and will be of


- after you start - 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 your appetite

- measuring height and weight

- measuring blood pressure and heart rate

- checking whether you have any problems with your mood, state of

mind or any other unusual feelings. Or if these have got worse while

taking Equasym XL.

Long-term treatment

Equasym XL does not need to be taken for ever. If you take Equasym XL

for more than a year, your doctor should stop treatment for a short time,

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.

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


Some side effects could be serious. If you have any of the side effects

below, see a doctor straight away:

Common (affects less than 1 in 10 people)

- uneven heart beat (palpitations)

- mood changes or mood swings or changes in personality

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


- 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


- feeling aggressive, agitated, anxious, depressed, irritable and abnormal


- grinding of the teeth

Uncommon (affects less than 1 in 100 people)

- constipation

- chest discomfort

- blood in the urine

- 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


- 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 your height and weight, as well as how

well you are eating.

- If you are not growing as expected, then your treatment with

methylphenidate may be stopped for a short time.

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 Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store.

By reporting side effects you can help provide more information on the

safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not take the capsule after the expiry date which is stated on the carton

and blister labels after ‘Exp’. The expiry date refers to the last day of that


Do not use Equasym XL if the capsules look damaged in any way.

If the capsules become discoloured or show any signs of deterioration,

seek the advice of your pharmacist.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

What Equasym XL contains

The active ingredient in Equasym XL is methylphenidate hydrochloride.

Each 10mg capsule contains 10mg methylphenidate hydrochloride

corresponding to 8.65mg methylphenidate.

Each 20mg capsule contains 20mg methylphenidate hydrochloride

corresponding to 17.30mg methylphenidate

Each 30mg capsule contains 30mg methylphenidate hydrochloride

corresponding to 25.94mg methylphenidate

The other ingredients are:

Capsule content: sugar spheres (sucrose and maize starch),

povidone K 29-32, ethylcellulose in aqueous dispersion, dibutyl sebacate,

Opadry Ys-1-7006 (hypromellose, macrogol 400 and macrogol 8000).

Capsule shell: gelatine, indigo carmine aluminium salt (E132), titanium

dioxide (E171). The 10mg capsule also contains yellow iron oxide (E172)

and the 30mg capsules also contains red iron oxide (E172).

White printing ink: shellac, propylene glycol, sodium hydroxide,

povidone K 16 and titanium dioxide (E171).

Black print ink: shellac glaze 45% (20% esterified) in ethanol, propylene

glycol, ammonium hydroxide 28%, black iron oxide.

What Equasym XL looks like and contents of the pack

The 10mg modified-release hard capsules, have a dark green opaque cap

imprinted with ‘S544’ in white and a white opaque body imprinted with

'10mg' in black.

The 20mg modified-release hard capsules, have a blue opaque cap

imprinted with ‘S544’ in white and a white opaque body imprinted with

'20mg' in black.

The 30mg modified-release hard capsules, have a reddish-brown opaque

cap imprinted with ‘S544’ in white and a white opaque body imprinted with

‘30mg’ in black.

Equasym XL are available as blister packs of 30 capsules.

Manufactured by: Shire Pharmaceuticals Limited, Hampshire International

Business Park, Chineham, Basingstoke, United Kingdom

Procured from within the EU and repackaged by the Product Licence

holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,

HA4 0NU, UK.



XL 10mg capsules; PL 18799/2572



XL 20mg capsules; PL 18799/2573



XL 30mg capsules; PL 18799/2574

Leaflet date: 12.07.2019

Equasym is a registered trademark of Shire Pharmaceuticals Ireland


Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the

leaflet in a format suitable for you.


How to take Equasym XL


Possible side effects


How to store Equasym XL


Contents of pack and other information



Some people need to talk to their doctor before they start having this


You need to talk to your doctor if:

- you have epilepsy (fits)

- you are pregnant or breast-feeding

- you are taking other medicines – your doctor needs to know about all the

medicines you are taking.

How do I take my medicine (capsules)?

- Swallow your medicine with water and food.

- Your doctor will tell you how many times a day you should take your


- Do not stop taking the medicine without talking to your doctor first.

Possible side effects

Side effects are the unwanted things that can happen when you take a

medicine. If any of the following happen, tell an adult you trust straight away.

They can then talk to your doctor. The main things that could affect you are:

- Feeling worried or nervous

- Feeling dizzy, or getting headaches

- Being very depressed and unhappy or wanting to hurt yourself

- Having different moods than usual, not being able to get to sleep

- Skin rashes, bruising easily, getting out of breath

- The medicine can also make you feel sleepy. If you feel sleepy, it is

important not to do outdoor sports like riding a horse or bike, swimming or

climbing trees. You could hurt yourself and others

- Your heart beating faster than usual.

If you feel unwell in any way while you are taking your medicine please

tell an adult you trust straight away.

Other things to remember

- Make sure you keep your medicine in a safe place, so that no one else

takes it, especially younger brothers or sisters.

- The medicine is special for you - do not let anyone else have it. It may help

you, but it could hurt someone else.

- If you forget to take your medicine don’t take two capsules the next time.

Just take one capsule at the next normal time.

- If you do take too much medicine, tell your mum, dad or carer right away.

- It is important not to take too much medicine or you will get ill.

- Don’t stop taking your medicine until your doctor says it’s OK.

Who should I ask if there is anything I don’t understand?

Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.

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