Xenidate Xl 18 Mg Prolonged-Release Tablets

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Package leaflet: Information for the patient

Xenidate XL 18 ma prolonged-release tablets

Methylphenidate hydrochloride

Read all of this leaflet carefully before you or

your child starts taking this medicine because

it contains important information for you.

• Keep this leaflet. You may need to read it again.

• Ifyou 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.

• Ifyou 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 Xenidate XL 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 under6years of age orforthe 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 Xenidate XL 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,

• educational, and

• social therapy

Methylphenidate must only be initiated by, and used under the supervision of, a specialist in childhood/and or adolescent behavioral.

Using medicine in combination with treatment programmes helps to manage ADHD.

About ADHD

Children and young people with ADHD find it hard:

• to sit still, and

• 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 takes methylphenidate

Do not take methylphenidate ifyou 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 oryour 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, unevenheartbeat, 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 oran 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 oryour child. Ifyou 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 ifyou oryour 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),

• is female and have started having periods (see the 'Pregnancy and breast-feeding'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 ifyou oryour child ...',

• have a mental health problem which is not mentioned in the section'Do not take Xenidate XL ifyou oryourchild ...'.

Checks that your doctor will make before you or your child start taking Xenidate XL

These checks are to decide if methylphenidate is the correct medicine for you or your child. Your doctor will talktoyou about:

• any other medicines you oryour child are taking,

• whether there is any family history of sudden unexplained death,

• any other medical problems (such as heart problems) you, your child oryour family may have,

• how you oryour 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 oryour child are at risk of having mood swings (from being manic to being depressed - called 'bipolar disorder¹). 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.

It is important that you provide as much information asyou can.This will help your doctor decide if methylphenidate is the correct medicine for you oryour child. Your doctor may decide that other

medical tests are needed before you oryour child start taking this medicine.

Other medicines and Xenidate XL

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

Do not take methylphenidate if you oryour 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.

Ifyou oryour child are taking other medicines, methylphenidate may affect how well they work or may cause side effects. Ifyou oryour 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.

Ifyou are in any doubt about whether any medicines you oryour child are taking are included in the list above, askyour doctor or pharmacist for advice before taking methylphenidate

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

Having an operation

Tell your doctor ifyou are oryour child is going to have an operation. Methylphenidate should not be taken on the day of a 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/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 contraception

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

It is not known if methylphenidate will affect an unborn baby.Tell your doctor or pharmacist before using methylphenidate ifyou oryour daughter:

• is having sex. Your doctor will discuss contraception

• is pregnant or think might be pregnant. Your doctor will decide whether methylphenidate should be taken.

• is 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 oryour 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. 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 dizzy.

• 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:

* 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. Talkto yourdoctoror pharmacist if you are not sure whether it is safe foryou to drive while taking this medicine.

Xenidate XL contains sucrose

Ifyou oryour child have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Xenidate XL

Before you oryour child start treatment, at every change of dose and then at least every 6 months or every visit your doctor will conduct various tests to make sure that methylphenidate is still acceptably safe and beneficial. These will include:

• Measuring blood pressure and heart rate and recording these on a chart

• Measuring height, weight and appetite recording these on a chart

• Assessing psychiatric symptoms

Dose adjustment

Careful dose adjustment is necessary at the start of treatment with methylphenidate.The dose should be started at the lowest possible dose and increased as recommended by your doctor.

How much to take

You oryour child should always take this medicine exactly as your doctor or pharmacist 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 oryour child should take Xenidate XL once each day in the morning with a glass of water.

The tablet must be swallowed whole and not chewed, broken 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 oryour child do not feel better, tell your doctor. They may decide a different treatment is needed.

Long-term treatment

Xenidate XL does not need to be taken forever. If you oryour child takes 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

If Xenidate XL is not used properly, this may cause abnormal behavior. It may also mean that you or your child starts to depend on the medicine. Tell your doctor if you oryour child has everabused or been dependent on alcohol, prescription medicines or street drugs.

This medicine is only foryou oryour 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 oryour child have taken too much medicine, talk to a doctor or call an ambulance straightaway. 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 fora forgotten dose. If you oryour child have forgotten a dose, wait until the next dose.

If you or your child stop taking Xenidate XL

If you oryour 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, askyour 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 un-inhibited (mania).

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

• heart attack,

• 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,

• 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).

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 oryour child's height and weight, as well as how well you oryour child are eating.

• if you oryour child are not growing as expected, then treatment with methylphenidate may be stopped for a short time.

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

666308

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),

• decreased interest in sex,

• unusual hair loss orthinning,

• 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

• clenching or grinding your teeth, 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, excessive talkativeness, 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,

• diluted pupils

• very high fever,

• slow, fast or extra heart beats.

• a major fit ('grand mal convulsions'),

• believing things that are not true,

• severe stomach pain, often with feeling and being sick.

Reporting of side effects

Ifyou getany side effects,talktoyourdoctor, 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.m h ra .g o v. u k/ye 11 owca rd 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 ifyou notice that the tablet is damaged.

Do not throw away any medicines via wastewater or household waste. Askyour 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 18 mg methylphenidate hydrochloride equivalent to 15.57 mg methylphenidate.

The other ingredients are:

Tablet core: Sugar spheres (sucrose, maize starch), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, hypromellose acetate succinate, carmellose sodium, cellulose, microcrystalline, magnesium stearate, silica, colloidal anhydrous, hydrochloric acid (pH adjustment).

Tablet coating: Titanium dioxide (E171), hypromellose, macrogol (6000), talc, iron oxide, yellow (El 72), hydrochlorid acid (pH adjustment).

What Xenidate XL looks like and contents of the pack

Xenidate XL 18 mg are yellowish to yellow, round, biconvex tablets of 6.3 mm.

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

Pack sizes: 28 or 30 prolonged-release tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK.

Manufacturer

Develco Pharma GmbH, Grienmatt 42,79650 Schopfheim, Germany.

Gerard Laboratories, 35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

This leaflet was last revised in 05/2015

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