PACKAGE LEAFLET: INFORMATION FOR THE USER

Afyna XL 18 mg Prolonged Release Tablets Afyna XL 36 mg Prolonged Release Tablets Afyna XL 54 mg Prolonged Release Tablets methylphenidate hydrochloride

The name of this medicine is Afyna XL, it contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used in this leaflet.

What is in this leaflet:

1.    What Afyna XL is and what it is used for

2.    What you need to know before you or your child takes Methylphenidate

3.    How to take Afyna XL

4.    Possible side effects

5. How to store Afyna XL

6.    Contents of the pack and other information

1. What Afyna XL is and what it is used for

What it is used for

Afyna 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.

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

How it works

Afyna 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. 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 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.

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

Do not take methylphenidate if you or your child:

•    is allergic to methylphenidate or any of the other ingredients of this medicine (listed in Section 6)

•    has a thyroid problem

•    has increased pressure in the eye (glaucoma)

•    has a tumour of the adrenal gland (phaeochromocytoma)

•    has an eating problem when you do not feel hungry or want to eat - such as ‘anorexia nervosa’

•    has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs

•    has ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease or was born with a heart problem

•    has had a problem with the blood vessels in the brain - such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis)

•    is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) - see Taking other medicines

•    has mental health problems such as:

-    a ‘psychopathic’ or ‘borderline personality’ problem

-    abnormal thoughts or visions or an illness called ‘schizophrenia’

-    signs of a severe mood problem like:

o feeling like killing yourself

o severe depression, where you feel very sad, worthless and hopeless o mania, where you feel unusually excitable, over-active, and un-inhibited.

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

Warnings and precautions

Talk to your doctor before taking Afyna XL if you or your child:

•    has liver or kidney problems

•    has problems with swallowing or swallowing whole tablets

•    has a narrowing or blockage of the gut or food-pipe

•    has had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)

•    has ever abused or been dependent on alcohol, prescription medicines or street drugs

•    is female and has started having periods (see the ‘Pregnancy and breast-feeding’ section below)

•    has hard-to-control, repeated twitching of any parts of the body or repeats sounds and words

•    has high blood pressure

•    has a heart problem which is not in the ‘Do not take’ section above

•    has a mental health problem which is not in the ‘Do not take’ section above. Other mental health problems include:

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

-    starting to be aggressive or hostile, or aggression gets worse

-    seeing, hearing or feeling things that are not there (hallucinations)

-    believing things that are not true (delusions)

-    feeling unusually suspicious (paranoia)

-    feeling agitated, anxious or tense

-    feeling depressed or guilty.

Tell your doctor or pharmacist if any of the above apply to you or your child before starting treatment. This is because methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects you or your child.

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 is taking

•    whether there is any family history of sudden unexplained death

•    any other medical problems (such as heart problems) you or your family may have

•    how you or your child is feeling, such as feeling high or low, having strange thoughts or if you or your child has had any of these feelings in the past

•    whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the body or repeating sounds and words)

•    any mental health or behaviour problems you or your child or other family members have ever had. Your doctor will discuss whether you or your child is at risk of having mood swings (from being manic to being depressed - called ‘bipolar disorder’). They will check yours or your child’s mental health history, and check if any of your family have a history of suicide, bipolar disorder or depression.

It is important that you provide as much information as you can. This will help your doctor decide if methylphenidate is the correct medicine for you or your child. Your doctor may decide that other medical tests are needed before you or your child start taking this medicine.

Other medicines and Afyna XL

Tell your doctor 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:

•    is taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or has taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure.

If you or your child is taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you or your child is taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate:

•    other medicines for depression

•    medicines for severe mental health problems

•    medicines for epilepsy

•    medicines used to reduce or increase blood pressure

•    some cough and cold remedies which contain medicines that can affect blood pressure. It is important to check with your pharmacist when you buy any of these products

•    medicines that thin the blood to prevent blood clots.

If you are in any doubt about whether any medicines you or your child is taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.

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

Having an operation

Tell your doctor if you or your child is going to have an operation. Methylphenidate should not be taken on the day of surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in blood pressure during the operation.

Drug testing

This medicine may give a positive result when testing for drug use. This includes testing used in sport. Afyna 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 and breast-feeding

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.

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

•    is having sex. Your doctor will discuss contraception

•    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 or your daughter should breast-feed while taking methylphenidate.

Driving and using machines

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

Afyna XL contains lactose

This medicine contains lactose (a type of sugar). If you or your child has an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Afyna XL

How much to take

You or your child should always take this medicine exactly as your doctor 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 daily dose is 54 mg.

•    you or your child should take Afyna XL once each day in the morning with a glass of water. The tablet should be swallowed whole and not chewed, broken, or crushed. The tablet may be taken with or without food.

The tablet does not dissolve completely after all of the drug has been released and sometimes the tablet shell may appear in the stools. This is normal.

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

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

Not using Afyna XL properly

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

This medicine is only for you or your child. Do not give this medicine to anyone else, even if their symptoms seem similar.

If you or your child takes more Afyna XL than you should

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

Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or hearing things that are not real (hallucinations), 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 forgets to take Afyna XL

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

If you or your child stops taking Afyna XL

If you or your child suddenly stops taking this medicine, 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 Afyna XL.

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

Things your doctor will do when you or your child is on treatment Your doctor will do some tests

•    before you or your child starts - to make sure that Afyna XL is safe and will be of benefit.

•    after you or your child starts - they will be done at least every 6 months, but possibly more often. They will also be done when the dose is changed.

•    these tests will include:

-    checking appetite

-    measuring height and weight

-    measuring blood pressure and heart rate

-    checking problems with mood, state of mind or any other unusual feelings. Or if these have got worse while taking Afyna XL.

Long-term treatment

Afyna XL does not need to be taken forever. If you or your child takes Afyna 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.

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 has 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

•    sudden death

•    suicidal attempt

•    fits (seizures, convulsions epilepsy)

•    skin peeling or purplish red patches

•    inflammation or blocked arteries in the brain

•    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

•    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)

If you or your child has 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 (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 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

•    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 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 eye

•    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 or confused

•    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 convulsions’)

•    believing things that are not true

•    severe stomach pain, often with feeling and being sick

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 or your child’s height and weight, as well as how well you or your child is eating.

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 Afyna 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 label. The expiry date refers to the last day of that month.

Keep the bottle tightly closed in order to protect from moisture. Do not store above 30°C.

The pack contains one or two silica gel pouches. These pouches are used to keep the tablets dry and should not be eaten.

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 to protect the environment.

6. Contents of the pack and other information

What Afyna XL contains

The active substance is methylphenidate hydrochloride

•    Afyna XL contains 18 mg of methylphenidate hydrochloride.

•    Afyna XL contains 36 mg of methylphenidate hydrochloride.

•    Afyna XL contains 54 mg of methylphenidate hydrochloride.

The other ingredients are:

•    butylhydroxytoluene (E321), cellulose acetate, hypromellose (E464), phosphoric acid concentrated, poloxamer 188, polyethylene oxides 200K and 7000K, povidone K29-32, sodium chloride, stearic acid, succinic acid, iron oxide black (E172), iron oxide yellow (E172), and iron oxide red (E172, 54 mg tablet only).

•    Film coat: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, iron oxide yellow (E172, 18 mg and 54 mg tablets only), iron oxide red (E172, 54 mg tablet only) and stearic acid (18 mg tablet only).

•    Clear coat: carnauba wax, hypromellose (E464), macrogol 400.

•    Printing ink: iron oxide black (E172), hypromellose (E464), isopropyl alcohol, propylene glycol, and purified water.

What Afyna XL looks like and contents of the pack

Afyna XL is available in four strengths: 18 mg, 27 mg, 36 mg and 54 mg. Each capsule shaped tablet is individually marked to aid identification:

•    18 mg: Yellow, with ‘alza 18’ printed on one side in black ink

•    27 mg: Grey with ‘alza 27’ printed on one side in black ink.

•    36 mg: White with ‘alza 36’ printed on one side in black ink.

•    54 mg: Brownish-red with ’alza 54’ printed on one side in black ink.

The medicinal product is available in bottles containing 28 or 30 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

JANSSEN-CILAG LIMITED - C242 50-100 HOLMERS FARM WAY HIGH WYCOMBE BUCKINGHAMSHIRE HP12 4EG

UNITED KINGDOM

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 08/2013