ATENZA XL 18 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Patient leaflet - ATENZA XL 18 MG PROLONGED-RELEASE TABLETS

Read all of this leaflet carefully before you or your child starts 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 only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

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

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

Atenza 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.

Atenza 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 Atenza XL when you become an adult. Your or your child’s doctor will advise you about this.

How it works

Atenza 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.

2. what you need to know before you take atenza xl do not 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 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 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 Atenza XL’
have mental health problems such as:
– a ‘psychopathic’ or ‘borderline personality’ problem
– abnormal thoughts or visions or an illness called ‘schizophrenia’
– signs of a severe mood problem like:

■ feeling like killing yourself
■ severe depression, where you feel very sad, worthless and hopeless
■ mania, where you feel unusually excitable, over-active, and uninhibited.

Do not take methylphenidate if any of the above apply to you. If youare not sure, talk to you or your child 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 before taking Atenza XL if you or your child:

have liver or kidney problems
have problems 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 (EEGs)
have ever abused or been dependent on alcohol, prescription medicines or street drugs
ia a woman or girl and have started the periods (see the ‘Pregnancy, breast-feeding and contraception’ section below)
have hard-to-control, repeated twitching of any parts of the body or you or your child repeat sounds and words
have high blood pressure
have a heart problem which is not in the ‘Do not take’ section above
have a mental health problem which is not in the ‘Do not take’ section above.

3. how to take atenza xlalways 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 should take Atenza XL once each day in the morning with a glass of water.

The tablet should be swallowed whole and not chewed, broken, or crushed since it may affect how the medicine works in the body. The tablet may be taken with or without food.

The tablet does not dissolve completely after all of the medicine 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 Atenza XL properly

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

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

If you or your child take more Atenza 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 Atenza XL

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

If you or your child stop taking Atenza 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 Atenza XL.

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 Atenza 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:
– checkingappetite
– measuring height and weight
– measuring blood pressure and heart rate
– checking problems withmood, state of mind or any other unusual feelings. Or if these have got worse while taking Atenza XL.

Long-term treatment

Atenza XL does not need to be taken for ever. If you take Atenza XL for more than a year, your doctor should stop treatment for a short time, this may happen during a school holiday. This will show if the medicine is still needed.

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

4. possible side effects

Like all medicines, 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 e ffects could be serious. If you or your child has any of the side e ffects below, see a doctor straight away:

Common (may a

uneven heartbeat (palpitations)
mood changes or mood swings or changes in personality
excessive teeth grinding (bruxism)

Uncommon (may a

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 a

feeling unusually excited, over-active and un-inhibited (mania)

Very rare (may a

heart attack
sudden death
suicidal attempt
fits (seizures, convulsions epilepsy)
skin peeling or purplish red patches
inflammation or blocked arteries in the brain
temporary paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with the blood vessels in your brain)
muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system
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 medicinal products 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.

If you have any of the side effects above, see a doctor straight away.

Other side e

headache
feeling nervous
not being able to sleep.

Common (may a

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
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.
excessive sweating.

Uncommon (may a

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 a

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

Very rare (may a

muscle cramps
small red marks on the skin
abnormal liver function including sudden 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
inability to control the excretion of urine (incontinence)
spasm of the jaw muscles that makes it difficult to open the mouth (trismus).

When used for more than a year, methylphenidate may cause reduced growth in some children. This affects less than 1 in 10 children.

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

Reporting side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: 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.

By reporting side effects you can help provide more information on the safety of the medicine.

5. how to store atenza 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.

This medicine does not require any special temperature storage conditions

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 informationthe active substance is methylphenidate hydrochloride

Each tablet contains 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride.

The other ingredients are:

Tablet core: hypromellose, macrogol, succinic acid, magnesium stearate, sodium chloride, silica colloidal anhydrous, black iron oxide (E172).
Film coating: cellullose acetate, macrogol.
Clear coating: hypromellose, macrogol, phosphoric acid (for pH adjustments).
Colour coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172) (18 mg), red iron oxide, (E172) (18mg, 27mg, 54mg), black iron oxide (E172) (27mg).

What Atenza XL looks like and contents of the pack

18 mg: Round, biconvex, yellow film-coated tablets of approximately 9 mm of diameter with a small hole in one side of the tablet.
27 mg: Round, biconvex, grey film-coated tablets of approximately 9 mm of diameter with a small hole in one side of the tablet.
36 mg: Round, biconvex, white film-coated tablets of approximately 10 mm of diameter with a small hole in one side of the tablet.
54 mg: Round, biconvex, pink film-coated tablets of approximately 10 mm of diameter with a small hole in one side of the tablet

The medicinal product is available in a plastic bottle, including 2 desiccant canisters, with plastic child resistant cap. The desiccant canisters are used to keep the tablets dry and should not be eaten.

Pack sizes are: 30 tablets; 60 tablets (2×30) and 90 tablets (3×30).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Calle Dulcinea S/n. Alcala De Henares.

28805 – Madrid

Spain

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

Sweden: Atenza XL 18 mg; 27 mg; 36 mg; 54 mg depottablett

United Kingdom: Atenza XL XL 18 mg, 27 mg, 36 mg, 54 mg prolonged release tablets

Spain: Atenza 18 mg; 27 mg; 36 mg; 54 mg comprimidos de liberation prolongada

Poland: Atenza

This leaflet was last revised in 2021–11–29