Equasym XL 30mg capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Methylphenidate hydrochloride
Available from:
CST Pharma Ltd
ATC code:
N06BA04
INN (International Name):
Methylphenidate hydrochloride
Dosage:
30mg
Pharmaceutical form:
Modified-release capsule
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 04040000; GTIN: 5055946804460

Package Leaflet: Information for the user

Equasym

®

XL 30mg Capsules

(methylphenidate hydrochloride)

The name of your medicine is Equasym XL 30mg Capsules but will

be referred to as Equasym XL throughout the leaflet, it contains

the active substance ‘methylphenidate hydrochloride’. This

product is also available in other strengths of 10mg and 20mg.

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. Do not pass it on

to others. It may harm them, even if their symptoms are the

same as yours.

If any of the side effects worry you, or if you notice any side

effects not listed in this leaflet, tell your doctor or

pharmacist.

The leaflet has been written in sections

:

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

‘your guardians’).

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

Before you take Equasym XL

How to take Equasym XL

Possible side effects

How to store Equasym XL

Further information

Information for children and young people

Now read the rest of this leaflet before you start

taking this medicine

.

1.

What Equasym XL is and what it is used

for

What it is used for

Equasym XL 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.

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 people.

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 includes:

psychological

educational and

social therapy.

It is prescribed only by doctors who have experience in children or

young people’s behaviour problems. 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.

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.

Before you take Equasym XL

Do not take methylphenidate if:

you are allergic (hypersensitive) to methylphenidate or any

of the other ingredients of Equasym XL (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 heartbeat, 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 (vasculitis)

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 hopeless

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

and un-inhibited.

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.

Check with your doctor or pharmacist before

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 disorder’)

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 you.

Checks that your doctor will make before you start

taking methylphenidate

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have

recently taken any other medicines, including medicines obtained

without a prescription.

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 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 are

taking are included in the list

above, ask your doctor or

pharmacist before taking methylphenidate.

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.

Taking 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.

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 methylphenidate.

Driving or using machines

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

sleepy or dizzy, or you may have problems focusing or have

blurred vision. If these happen it may be dangerous to do things

such as drive, use machines, ride a bike or horse or climb trees.

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

affects you.

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

drive.

However, you would not be committing an offence if:

A doctor has prescribed this medicine for you and

You have taken it according to his or her instructions,

or with the information in this leaflet 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.

Important information about some of the

ingredients of Equasym XL

This medicine 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.

Information for children and young people

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.

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 holiday.

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

this medicine worse.

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.

Some people need to talk to their doctor before

they start having this medicine

You need to talk to your doctor if:

you have epilepsy (fits)

you are pregnant or breastfeeding

you are taking other medicines – your doctor needs to know

about all the medicines you are taking.

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3.

How to take Equasym XL

How much to take

Always take Equasym XL 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 gradually 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 XL.

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 benefit.

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.

4.

Possible side effects

Like all medicines, methylphenidate 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 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

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 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

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, 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

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

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, pharmacist or

nurse. 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.

By reporting side effects, you can help provide more information

on the safety of this medicine.

5.

How to store Equasym XL

Keep out of the sight and reach of children.

Make sure you keep your medicine in a safe place, so that

no one else takes it, especially younger brothers or sisters.

Do not use Equasym XL 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.

Do not store above 25°C.

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

way.

If you notice any signs of discolouration or deterioration of

your medicine, please tell your Pharmacist immediately.

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.

6.

Further information

What Equasym XL contains

The active substance is methylphenidate hydrochloride.

Each capsule contains 30mg of methylphenidate hydrochloride

corresponding to 25.94mg of methylphenidate.

The other ingredients are:

Capsule content: Sugar spheres (sucrose, maize starch),

povidone K29 to K32, Opadry Clear YS-1-7006

(hypromellose, macrogol 400 and macrogol 8000),

ethylcellulose aqueous dispersion and dibutyl sebacate.

Capsule shell: Gelatin, titanium dioxide (E171),

indigio carmine aluminium (E132), red iron oxide (E172).

White printing ink: shellac, propylene glycol,

sodium hydroxide, povidone K16, titanium dioxide (E171).

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

propylene glycol, ammonium hydroxide solution 28%,

black iron black (E172).

What Equasym XL looks like and contents of the

pack

Equasym XL capsule has a reddish-brown opaque cap imprinted

with "S544" in white and a white opaque body imprinted with

"30mg" in black.

Equasym XL is available in blister packs containing 30 capsules

.

Manufacturer

Manufactured by: Shire Pharmaceuticals Ireland Limited,

Hampshire International Business Park, Chineham, Basingstoke,

Hampshire RG24 8EP, UK.

Procured from within the EU and repackaged by: Doncaster

Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,

Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0632

Equasym

XL is a registered trademark of UCB Pharma S.A.

The latest revision date is 23.04.15.

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 medicine

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 tablets

the next time. Just take one tablet 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

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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