Patient leaflet - XENIDATE XL 27 MG PROLONGED-RELEASE TABLETS

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Package leaflet: Information for the patient Xenidate XL 27 mg prolonged-release tablets Methylphenidate hydrochloride

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child’s ones.
If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Xenidate XL is and what it is used for
2. What you need to know before you or your child takes Xenidate XL
3. How to take Xenidate XL
4. Possible side effects
5. How to store Xenidate XL
6. Contents of the pack and other information

1. what xenidate xl is and what it is used for

What it is used for

Xenidate 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.

Xenidate XL is not for use as a treatment for ADHD in children under 6 years of age or for the initiation of treatment in adults. When treatment was started at a younger age, it might be appropriate to continue taking Xenidate XL when you become an adult. Your doctor will advise you about this.

How it works

Xenidate XL improves the activity of certain parts of the brain which are underactive. 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 therapy
educational therapy
social therapy.

It is prescribed only by doctors who have experience in children or young people’s behaviour problems. Although there is no cure for ADHD, it can be managed using treatment programmes.

About ADHD

Children and young people with ADHD find it hard:

to sit still
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. what you need to know before you or your child take xenidate xl

Do not take Xenidate XL if you or your child:

are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
have a thyroid problem
have increased pressure in the eye (glaucoma)
have a tumour of the adrenal gland (phaeochromocytoma)
have an eating problem when you or your child do not feel hungry or want to eat – such as ‘anorexia nervosa’
have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
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
have or 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)
are currently taking or have taken within the last

14 days an antidepressant (known as a monoamine oxidase inhibitor)- see ‘Other medicines and Xenidate XL’

have or have had 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 uninhibited.

Do not take methylphenidate if any of the above applies to you or your child. If you are not sure, talk to your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate can make these problems worse.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xenidate XL if you or your child

have liver or kidney problems
have a problem with swallowing or swallowing whole tablets
have a narrowing or blockage of the gut or food-pipe have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEG)
are female and have started having periods (see the ‘Pregnancy, breast-feeding and fertility’ section below)
have ever abused or been dependent on alcohol, prescription medicines or street drugs
have hard-to-control repeated twitching of any parts of the body or you repeat sounds and words (tics)
have high blood pressure
have a heart problem which is not mentioned in the section ‘Do not take Xenidate XL if you or your child…’
have a mental health problem which is not mentioned in the section ‘Do not take Xenidate XL if you or your child…’.

3. how to take xenidate xl

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Things your doctor will do when you or your child are on treatment

Your doctor will carry out some tests:

before you or your child start – to make sure that Xenidate XL is safe and will be of benefit
after you or your child 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 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 Xenidate XL.

Long-term treatment

Xenidate XL does not need to be taken forever. If you or your child take Xenidate 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.

Not using Xenidate XL properly

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 take more Xenidate XL than you or your child should

If you or your child have taken 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), 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 Xenidate XL

Do not take a double dose to make up for a forgotten dose. If you or your child have forgotten a dose, wait until the next dose.

If you or your child stop taking Xenidate XL

If you or your child 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 Xenidate XL.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although 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 (may affect up to 1 in 10 people):

uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality.

Uncommon (may affect up to 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 (may affect up to 1 in 1,000 people):

feeling unusually excited, over-active and uninhibited (mania).

Very rare (may affect up to 1 in 10,000 people):

heart attack
sudden death
suicidal attempt
fits (epileptic seizures, convulsions, epilepsy)
skin peeling or purplish red patches
inflammation or blocked arteries in the brain
muscle spasms which cannot be controlled affecting your eyes, head, neck, body and nervous system – due to a temporary lack of blood supply to the 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.

Not known (frequency cannot be estimated from the available data):

unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)
paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with the blood vessels in your brain)
prolonged erections, sometimes painful, or an increased number of erections.

Other side effects include the following. If they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people):

headache
feeling nervous
not being able to sleep.

Common (may affect up to 1 in 10 people):

joint pain
blurred vision
tension headache
dry mouth, thirst
trouble falling asleep
high temperature (fever)
problems with sex drive
unusual hair loss or thinning
muscle tightness, muscle cramps
loss of appetite or decreased appetite
inability to develop or maintain an erection
itching, rash or raised red itchy rashes (hives)
feeling unusually sleepy or drowsy, feeling tired
excessive teeth grinding (bruxism) feeling of panic
tingling feeling, prickling, or numbness of the skin
increased alanine aminotransferase (liver enzyme) level in your blood
cough, sore throat or painful nose and throat irritation, upper respiratory tract infection, sinus infection
high blood pressure, fast heart beat (tachycardia)
dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable tense, jittery and abnormal behaviour
upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick.

Uncommon (may affect up to 1 in 100 people):

dry eyes
constipation
chest discomfort
blood in the urine
listlessness
shaking or trembling
increased need to pass urine
muscle pain, muscle twitching
shortness of breath or chest pain
feeling hot
increases in liver test results (seen in a blood test)
anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems sleeping.

Rare (may affect up to 1 in 1,000 people):

feeling disorientated, confusion
trouble seeing or double vision
swelling of the breasts in men
excessive sweating, redness of the skin, red raised skin rash.

Very rare (may affect up to 1 in 10,000 people):

muscle cramps
small red marks on the skin
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
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’).

Not known (frequency cannot be estimated from the available data):

migraine
dilated pupils
very high fever
slow, fast or extra heart beats
a major fit (‘grand mal convulsion’)
believing things that are not true
severe stomach pain, often with feeling and being sick
inability to control the excretion of urine (incontinence)
spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
stuttering

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 a lack of weight gain or height growth
your doctor will carefully watch your or your child’s height and weight, as well as how well you or your child are eating
if you or your child are not growing as expected, then treatment with methylphenidate may be stopped for a short time.

Reporting of side effects

If you or your child 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: 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.

5. how to store xenidate xl

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 bottle label and the carton box after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. However, the prolonged-release tablets should be stored in the original, child-resistant container.

Do not use this medicine if you notice that a tablet is damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Xenidate XL contains

The active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 27 mg methylphenidate hydrochloride equivalent to 23.35 mg methylphenidate.

The other ingredients are:

Tablet core: Sugar spheres (sucrose (see

section 2, ‘Xenidate XL contains sucrose’), maize starch), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, hypromellose acetate succinate, carmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, hydrochloric acid (pH adjustment).

Tablet coating: Polyvinyl alcohol, macrogol 3350, talc, yellow iron oxide (E172), hydrochloric acid (pH adjustment).

What Xenidate XL looks like and contents of the pack

Xenidate XL 27 mg prolonged-release tablets are yellow, oblong, biconvex, film coated tablets of 10.3 × 4.8 mm with a break line on both sides. The tablet can be divided into equal doses.

The prolonged-release tablets are available in bottles with child-resistant screw caps.

Pack sizes:

30 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan

Potters Bar, Hertfordshire

EN6 1TL

United Kingdom

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

McDermott laboratories t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Generics [UK] Limited,

Station Close,

Potters Bar,

EN6 1TL,

United Kingdom.

Mylan UK Healthcare Limited

Building 20

Station Close

Potters Bar

EN6 1TL

United Kingdom

This leaflet was last revised in 09/2020

2266594

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Package leaflet: Information for the patient Xenidate XL 27 mg prolonged-release tablets Methylphenidate hydrochloride

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child’s ones.
If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Xenidate XL is and what it is used for
2. What you need to know before you or your child takes Xenidate XL
3. How to take Xenidate XL
4. Possible side effects
5. How to store Xenidate XL
6. Contents of the pack and other information

1. what xenidate xl is and what it is used for

What it is used for

Xenidate 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.

How it works

Xenidate XL improves the activity of certain parts of the brain which are underactive. 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 therapy
educational therapy
social therapy.

It is prescribed only by doctors who have experience in children or young people’s behaviour problems. Although there is no cure for ADHD, it can be managed using treatment programmes.

About ADHD

Children and young people with ADHD find it hard:

to sit still
to concentrate.

It is not their fault that they cannot do these things.

ADHD does not affect the intelligence of a child or young person.

2. what you need to know before you or your child take xenidate xl

Do not take Xenidate XL if you or your child:

are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
have a thyroid problem
have increased pressure in the eye (glaucoma)
have a tumour of the adrenal gland (phaeochromocytoma)
have an eating problem when you or your child do not feel hungry or want to eat – such as ‘anorexia nervosa’
have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
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
have or 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)
are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor)- see ‘Other medicines and Xenidate XL’
have or have had 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 uninhibited.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xenidate XL if you or your child

have liver or kidney problems
have a problem with swallowing or swallowing whole tablets
have a narrowing or blockage of the gut or food-pipe
have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEG)
are female and have started having periods (see the ‘Pregnancy, breast-feeding and fertility’ section below)
have ever abused or been dependent on alcohol, prescription medicines or street drugs
have hard-to-control repeated twitching of any parts of the body or you repeat sounds and words (tics)
have high blood pressure
have a heart problem which is not mentioned in the section ‘Do not take Xenidate XL if you or your child
have a mental health problem which is not mentioned in the section ‘Do not take Xenidate XL if you or your child.’. 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.

Checks that your doctor will make before you or your child start 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, your child or your family may have
how you or your child are feeling, such as feeling high or low, having strange thoughts or if you or your child 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 your child or other family members have or have ever had. Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to being depressed – called ‘bipolar disorder’). Your doctor will check your or your child’s mental health history, and check if any of your family has a history of suicide, bipolar disorder or depression.

Other medicines and Xenidate XL

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

Do not take methylphenidate if you or your child:

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 or your child’s blood pressure.

Tell your doctor or pharmacist if you are taking any of the following medicines for depression or anxiety:

tricyclic antidepressant
selective serotonin reuptake inhibitor (SSRI)
serotonin and norepinephrine reuptake inhibitor’ (SNRI).

If you or your child are taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you or your child 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 or your child are taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.

Please tell your doctor or pharmacist ifyou or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Having an operation

Drug testing/anti-doping testing

This medicine may give a positive result when testing for drug use.

This includes testing used in sport.

Xenidate XL 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 fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Tell your doctor or pharmacist before using methylphenidate if you or your daughter:

are having sex. Your doctor will discuss contraception
are pregnant or think might be pregnant. Your doctor will decide whether methylphenidate should be taken
are breast-feeding or planning to breastfeed. 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.

Driving and using machines

You may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate. Ifthese happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.

Xenidate XL contains sucrose and sodium

If you or your child have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take xenidate xl

How much to take

You or your child should always take this medicine exactly as your doctor or phrmacist has told you. Check with your doctor or pharmacist if you are not sure:

your doctor will usually start treatment with a low dose and increase it gradually as required
the maximum recommended daily dose is 54 mg
you or your child should take Xenidate XL once each day in the morning with a glass of water. The tablet can be divided into equal doses. The tablet (or half tablet) must not be chewed or crushed. The tablet may be taken with or without food.

If you or your child do not feel better after 1 month of treatment

If you or your child do not feel better, tell your doctor. They may decide a different treatment is needed.

Things your doctor will do when you or your child are on treatment

Your doctor will carry out some tests

before you or your child start – to make sure that Xenidate XL is safe and will be of benefit
after you or your child 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 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 Xenidate XL.

Long-term treatment

Not using Xenidate XL properly

If Xenidate XL is not used properly, this may cause abnormal behavior. It may also mean that you or your child star to depend on the medicine. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. 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 take more Xenidate XL than you or your child should

If you or your child have taken too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken.

If you or your child forget to take Xenidate XL Do not take a double dose to make up for a forgotten dose. If you or your child have forgotten a dose, wait until the next dose.

If you or your child stop taking Xenidate XL If you or your child 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 Xenidate XL.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible 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 (may affect up to 1 in 10 people):

uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality.
Uncommon (may affect up to 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 (may affect up to 1 in 1,000 people):

feeling unusually excited, over-active and uninhibited (mania).
Very rare (may affect up to 1 in 10,000 people): heart attack
sudden death
suicidal attempt
fits (epileptic seizures, convulsions, epilepsy)
skin peeling or purplish red patches
inflammation or blocked arteries in the brain
muscle spasms which cannot be controlled affecting your eyes, head, neck, body and nervous system – due to a temporary lack of blood supply to the 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.

Not known (frequency cannot be estimated from the available data):

unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)
paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with the blood vessels in your brain)
prolonged erections, sometimes painful, or an increased number of erections.

Other side effects include the following. If they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people):

headache
feeling nervous
not being able to sleep.

Common (may affect up to 1 in 10 people):

joint pain
blurred vision
tension headache
dry mouth, thirst
trouble falling asleep
high temperature (fever)
problems with sex drive
unusual hair loss or thinning
muscle tightness, muscle cramps
loss of appetite or decreased appetite
inability to develop or maintain an erection
itching, rash or raised red itchy rashes (hives)
feeling unusually sleepy or drowsy, feeling tired
excessive teeth grinding (bruxism), feeling of panic
tingling feeling, prickling, or numbness of the skin
increased alanine aminotransferase (liver enzyme) level in your blood
cough, sore throat or painful nose and throat irritation, upper respiratory tract infection, sinus infection
high blood pressure, fast heart beat (tachycardia)
dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable tense, jittery and abnormal behaviour
upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick.

Uncommon (may affect up to 1 in 100 people):

dry eyes
constipation
chest discomfort
blood in the urine
listlessness
shaking or trembling
increased need to pass urine
muscle pain, muscle twitching
shortness of breath or chest pain
feeling hot
increases in liver test results (seen in a blood test)
anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems sleeping.

Rare (may affect up to 1 in 1,000 people):

feeling disorientated, confusion
trouble seeing or double vision
swelling of the breasts in men
excessive sweating, redness of the skin, red raised skin rash.

Very rare (may affect up to 1 in 10,000 people):

muscle cramps
small red marks on the skin
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
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’).

Not known (frequency cannot be estimated from the available data):

migraine
dilated pupils
very high fever
slow, fast or extra heart beats
a major fit (‘grand mal convulsion’)
believing things that are not true
severe stomach pain, often with feeling and being sick
inability to control the excretion of urine (incontinence)
spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
stuttering

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 a lack of weight gain or height growth
your doctor will carefully watch your or your child’s height and weight, as well as how well you or your child are eating
if you or your child are not growing as expected, then treatment with methylphenidate may be stopped for a short time.

Reporting of side effects

5. how to store xenidate xl

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 bottle label and the carton box after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. However, the prolonged-release tablets should be stored in the original, child-resistant container.

Do not use this medicine if you notice that a tablet is damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Xenidate XL contains

The active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 27 mg methylphenidate hydrochloride equivalent to 23.35 mg methylphenidate.

The other ingredients are:

Tablet core: Sugar spheres (sucrose

(see section 2, ‘Xenidate XL contains sucrose’), maize starch), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, hypromellose acetate succinate, carmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, hydrochloric acid (pH adjustment).

Tablet coating: Polyvinyl alcohol, macrogol 3350, talc, yellow iron oxide (E172), hydrochloric acid (pH adjustment).

What Xenidate XL looks like and contents of the pack

Xenidate XL 27 mg prolonged-release tablets are yellow, oblong, biconvex, film coated tablets of 10.3 × 4.8 mm with a break line on both sides. The tablet can be divided into equal doses.

The prolonged-release tablets are available in bottles with child-resistant screw caps.

Pack sizes:

30 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan

Potters Bar, Hertfordshire

EN6 1TL

United Kingdom

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

McDermott laboratories t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Generics [UK] Limited,

Station Close,

Potters Bar,

EN6 1TL,

United Kingdom.

Mylan UK Healthcare Limited

Building 20

Station Close

Potters Bar

EN6 1TL

United Kingdom

This leaflet was last revised in 09/2020

2266594

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Package leaflet: Information for the patient Xenidate XL 27 mg prolonged-release tablets Methylphenidate hydrochloride

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child’s ones.
If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Xenidate XL is and what it is used for
2. What you need to know before you or your child takes Xenidate XL
3. How to take Xenidate XL
4. Possible side effects
5. How to store Xenidate XL
6. Contents of the pack and other information

1. what xenidate xl is and what it is used for

What it is used for

Xenidate 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.

How it works

Xenidate XL improves the activity of certain parts of the brain which are underactive. 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 therapy
educational therapy
social therapy.

It is prescribed only by doctors who have experience in children or young people’s behaviour problems. Although there is no cure for ADHD, it can be managed using treatment programmes.

About ADHD

Children and young people with ADHD find it hard:

to sit still
to concentrate.

It is not their fault that they cannot do these things.

ADHD does not affect the intelligence of a child or young person.

2. what you need to know before you or your child take xenidate xl

Do not take Xenidate XL if you or your child:

are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
have a thyroid problem
have increased pressure in the eye (glaucoma)
have a tumour of the adrenal gland (phaeochromocytoma)
have an eating problem when you or your child do not feel hungry or want to eat – such as ‘anorexia nervosa’
have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
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
have or 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)
are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor)- see ‘Other medicines and Xenidate XL’
have or have had 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 uninhibited.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xenidate XL if you or your child

have liver or kidney problems
have a problem with swallowing or swallowing whole tablets
have a narrowing or blockage of the gut or food-pipe
have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEG)
are female and have started having periods (see the ‘Pregnancy, breast-feeding and fertility’ section below)
have ever abused or been dependent on alcohol, prescription medicines or street drugs
have hard-to-control repeated twitching of any parts of the body or you repeat sounds and words (tics)
have high blood pressure
have a heart problem which is not mentioned in the section ‘Do not take Xenidate XL if you or your child
have a mental health problem which is not mentioned in the section ‘Do not take Xenidate XL if you or your child.’. 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.

Checks that your doctor will make before you or your child start 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, your child or your family may have
how you or your child are feeling, such as feeling high or low, having strange thoughts or if you or your child 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 your child or other family members have or have ever had. Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to being depressed – called ‘bipolar disorder’). Your doctor will check your or your child’s mental health history, and check if any of your family has a history of suicide, bipolar disorder or depression.

Other medicines and Xenidate XL

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

Do not take methylphenidate if you or your child:

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 or your child’s blood pressure.

Tell your doctor or pharmacist if you are taking any of the following medicines for depression or anxiety:

tricyclic antidepressant
selective serotonin reuptake inhibitor (SSRI)
serotonin and norepinephrine reuptake inhibitor’ (SNRI).

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 are taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.

Please tell your doctor or pharmacist ifyou or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Having an operation

Drug testing/anti-doping testing

This medicine may give a positive result when testing for drug use.

This includes testing used in sport.

Xenidate XL 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 fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Tell your doctor or pharmacist before using methylphenidate if you or your daughter:

are having sex. Your doctor will discuss contraception
are pregnant or think might be pregnant. Your doctor will decide whether methylphenidate should be taken
are breast-feeding or planning to breastfeed. 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.

Driving and using machines

You may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate. Ifthese happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.

Xenidate XL contains sucrose and sodium

If you or your child have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take xenidate xl

How much to take

You or your child should always take this medicine exactly as your doctor or phrmacist has told you. Check with your doctor or pharmacist if you are not sure:

your doctor will usually start treatment with a low dose and increase it gradually as required
the maximum recommended daily dose is 54 mg
you or your child should take Xenidate XL once each day in the morning with a glass of water. The tablet can be divided into equal doses. The tablet (or half tablet) must not be chewed or crushed. The tablet may be taken with or without food.

If you or your child do not feel better after 1 month of treatment

If you or your child do not feel better, tell your doctor. They may decide a different treatment is needed.

Things your doctor will do when you or your child are on treatment

Your doctor will carry out some tests

before you or your child start – to make sure that Xenidate XL is safe and will be of benefit
after you or your child 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 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 Xenidate XL.

Long-term treatment

Not using Xenidate XL properly

If you or your child take more Xenidate XL than you or your child should

If you or your child have taken too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken.

If you or your child forget to take Xenidate XL Do not take a double dose to make up for a forgotten dose. If you or your child have forgotten a dose, wait until the next dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible 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 (may affect up to 1 in 10 people):

uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality.
Uncommon (may affect up to 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 (may affect up to 1 in 1,000 people):

feeling unusually excited, over-active and uninhibited (mania).
Very rare (may affect up to 1 in 10,000 people): heart attack
sudden death
suicidal attempt
fits (epileptic seizures, convulsions, epilepsy)
skin peeling or purplish red patches
inflammation or blocked arteries in the brain
muscle spasms which cannot be controlled affecting your eyes, head, neck, body and nervous system – due to a temporary lack of blood supply to the 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.

Not known (frequency cannot be estimated from the available data):

unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)
paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with the blood vessels in your brain)
prolonged erections, sometimes painful, or an increased number of erections.

Other side effects include the following. If they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people):

headache
feeling nervous
not being able to sleep.

Common (may affect up to 1 in 10 people):

joint pain
blurred vision
tension headache
dry mouth, thirst
trouble falling asleep
high temperature (fever)
problems with sex drive
unusual hair loss or thinning
muscle tightness, muscle cramps
loss of appetite or decreased appetite
inability to develop or maintain an erection
itching, rash or raised red itchy rashes (hives)
feeling unusually sleepy or drowsy, feeling tired
excessive teeth grinding (bruxism), feeling of panic
tingling feeling, prickling, or numbness of the skin
increased alanine aminotransferase (liver enzyme) level in your blood
cough, sore throat or painful nose and throat irritation, upper respiratory tract infection, sinus infection
high blood pressure, fast heart beat (tachycardia)
dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable tense, jittery and abnormal behaviour
upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick.

Uncommon (may affect up to 1 in 100 people):

dry eyes
constipation
chest discomfort
blood in the urine
listlessness
shaking or trembling
increased need to pass urine
muscle pain, muscle twitching
shortness of breath or chest pain
feeling hot
increases in liver test results (seen in a blood test)
anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems sleeping.

Rare (may affect up to 1 in 1,000 people):

feeling disorientated, confusion
trouble seeing or double vision
swelling of the breasts in men
excessive sweating, redness of the skin, red raised skin rash.

Very rare (may affect up to 1 in 10,000 people):

muscle cramps
small red marks on the skin
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
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’).

Not known (frequency cannot be estimated from the available data):

migraine
dilated pupils
very high fever
slow, fast or extra heart beats
a major fit (‘grand mal convulsion’)
believing things that are not true
severe stomach pain, often with feeling and being sick
inability to control the excretion of urine (incontinence)
spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
stuttering

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 a lack of weight gain or height growth
your doctor will carefully watch your or your child’s height and weight, as well as how well you or your child are eating
if you or your child are not growing as expected, then treatment with methylphenidate may be stopped for a short time.

Reporting of side effects

5. how to store xenidate xl

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 bottle label and the carton box after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. However, the prolonged-release tablets should be stored in the original, child-resistant container.

Do not use this medicine if you notice that a tablet is damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Xenidate XL contains

The active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 27 mg methylphenidate hydrochloride equivalent to 23.35 mg methylphenidate.

The other ingredients are:

Tablet core: Sugar spheres (sucrose

Tablet coating: Polyvinyl alcohol, macrogol 3350, talc, yellow iron oxide (E172), hydrochloric acid (pH adjustment).

What Xenidate XL looks like and contents of the pack

Xenidate XL 27 mg prolonged-release tablets are yellow, oblong, biconvex, film coated tablets of 10.3 × 4.8 mm with a break line on both sides. The tablet can be divided into equal doses.

The prolonged-release tablets are available in bottles with child-resistant screw caps.

Pack sizes:

30 prolonged-release tablets.

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation Holder

Mylan

Potters Bar, Hertfordshire

EN6 1TL

United Kingdom

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

McDermott Laboratories t/a Gerard

Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Generics [UK] Limited

Station Close

Potters Bar

EN6 1TL

United Kingdom

Mylan UK Healthcare Limited

Building 20

Station Close

Potters Bar

EN6 1TL

United Kingdom

This leaflet was last revised in 09/2021

2481041

XENIDATE XL 27 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - XENIDATE XL 27 MG PROLONGED-RELEASE TABLETS

1. what xenidate xl is and what it is used for

2. what you need to know before you or your child take xenidate xl

3. how to take xenidate xl

4. possible side effects

5. how to store xenidate xl

6. contents of the pack and other information

1. what xenidate xl is and what it is used for

2. what you need to know before you or your child take xenidate xl

3. how to take xenidate xl

4. possible side effects

5. how to store xenidate xl

6. contents of the pack and other information

1. what xenidate xl is and what it is used for

What it is used for

2. what you need to know before you or your child take xenidate xl

3. how to take xenidate xl

4. possible side effects

5. how to store xenidate xl

6. contents of the pack and other information