Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What it is used for Atenza XL is used to treat ‘attention deficit hyperactivity disorder’ (ADHD).
• It is used in children aged 6 years and over and in adults.
• 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.
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 , adolescents or adults with behaviour problems. If you are an adult and have not been treated before, the specialist will carry out tests to confirm that you have had ADHD since childhood. 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
• to concentrate.
It is not their fault that they cannot do these things.
Many children and young people struggle to do these things. However, ADHD can cause problems with everyday life. Children and adolescents 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.
Adults with ADHD often find it hard to concentrate. They often feel restless, impatient and inattentive. They may have difficulty organising their private life and work.
Not all patients with ADHD need to be treated with medicine.
Do not take Atenza 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 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 un- inhibited.
Do not take methylphenidate if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you take methylphenidate. This is because methylphenidate can make these problems worse.
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
• are a girl and have started your periods (see the ‘Pregnancy, breast-feeding and contraception’ section below)
• have hard-to-control, repeated twitching of any parts of the body or you 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
• develop blurred vision or other visual disturbances contact your doctor. Your doctor may consider discontinuation of Atenza XL.
Other mental health problems include:
• mood swings (from being manic to being depressed - called ‘bipolar disorder’)
• feeling aggressive or hostile
• seeing, hearing or feeling things that are not there (hallucinations)
• believing things that are not true (delusions)
• feeling unusually suspicious (paranoia)
• feeling agitated, anxious or tense
• feeling depressed or guilty.
Tell your doctor or pharmacist if any of the above apply to you before starting treatment. This is because methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects you.
During treatment, boys and adolescents may unexpectedly experience prolonged erections. This may be painful and can occur at any time. It is important to contact your doctor straight away if your erection lasts for longer than 2 hours, particularly if this is painful.
Checks that your doctor will make before you start taking Atenza XL 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 are taking
• whether there is any family history of sudden unexplained death
• any other medical problems (such as heart problems) you or your family may have
• how you are feeling, such as feeling high or low, having strange thoughts or if you have had any of these feelings in the past
• whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the body or repeating sounds and words)
• any mental health or behaviour problems you or other family members have ever had. Your doctor will discuss whether you are at risk of having mood swings (from being manic to being depressed - called ‘bipolar disorder’). They will check your mental health history, and check if any of your family have a history of suicide, bipolar disorder or depression.
It is important that you provide as much information as you can. This will help your doctor decide if methylphenidate is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine. For adult patients that are new to Atenza XL, your doctor may refer you to a heart specialist.
Other medicines and Atenza XL Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take methylphenidate if you:
• are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in your blood pressure (see “Do not take Atenza XL”).
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).
Taking methylphenidate with these types of medicine could cause a life-threatening increase of ‘serotonin’ in the brain (serotonin syndrome), which may lead to feeling confused or restless, sweating, shivering, muscle jerks or fast heart beat. If you develop these side effects, see a doctor straight away.
If you are taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you are taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate:
• medicines for severe mental health problems
• medicines for Parkinson’s disease (such as levodopa)
• medicines for epilepsy
• medicines used to reduce or increase blood pressure
• some cough and cold remedies which contain medicines that can affect blood pressure. It is important to check with your pharmacist when you buy any of these products
• medicines that thin the blood to prevent blood clots.
If you are in any doubt about whether any medicines you are taking are included in the list above, ask your doctor or pharmacist before taking methylphenidate.
Please tell you doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Having an operation Tell your doctor if you are 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.
Atenza 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 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.
Available data do not suggest an increased risk of overall birth defects, whilst a small increase in the risk of malformations of the heart when used during the first three months of pregnancy could not be ruled out. Your doctor will be able to give you more information about this risk. Tell your doctor or pharmacist before using methylphenidate if you are
• having sex. Your doctor will discuss contraception with you
• pregnant or think you may be pregnant. Your doctor will decide whether you should take methylphenidate.
• breast-feeding or planning to breast-feed. Methylphenidate passes into breast milk. Therefore, your doctor will decide whether you 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.
This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected.
Atenza XL contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Atenza XL contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially ‘sodium- free’.
How much to take 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 the daily dose by 9 mg and/or 18 mg no sooner than once a week if necessary. The aim should be the lowest dose that is effective for you. Your doctor will decide the maximum daily dose for you or your child.
• 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. 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.
Use in children 6 years and over
• the recommended starting dose of Atenza XL is 18 mg once daily for children who are not currently taking methylphenidate, or for children who are switching from another stimulant to methylphenidate,
• the maximum daily dose is 54 mg
Use in adults
For adults who have taken Atenza XL before:
• if you have already taken Atenza XL as a child or adolescent, the same daily dosage (mg/day) can be used; your doctor will check regularly to see if any adjustment is required.
• adult patients may require a higher daily dosage but the doctor will aim to give you the lowest dose that is effective.
For adults who have not taken Atenza XL before:
• the recommended starting dose is 18 mg daily.
• The maximum daily dose in adults is 72 mg.
If you do not feel better after 1 month of treatment If you or your child does not feel better after 1 month of treatment, 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 start to depend on the medicine. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
This medicine is only for you. Do not give this medicine to anyone else, even if their symptoms seem similar.
If you take more Atenza XL than you should If you take too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken. Medical treatment might be needed.
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 forget 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 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 are on treatment
Your doctor will do some tests
• before you start - to make sure that Atenza XL is safe and will be of benefit.
• after you start - they will be done at least every 6 months, but possibly more often. They will also be done when the dose is changed.
• these tests will include:
• checking your appetite
• measuring height and weight
• measuring blood pressure and heart rate
• checking whether you have any problems with your mood, state of mind or any other unusual feelings. Or if these have got worse while taking 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.
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 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
• 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)
• 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 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 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 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
• weight decreased.
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)
• problems with sex drive
• feeling disorientated or confused
• trouble seeing or double vision
• swelling of the breasts in men
• redness of the skin, red raised skin rash
• obsessive-compulsive disorder (OCD) (including irresistible urge to pull out body hair, skin picking, having repeated unwanted thoughts, feelings, images or urges in your mind (obsessive thoughts), performing repeated behaviours or mental rituals (compulsions)).
Very rare (may affect up to 1 in 10,000 people)
• 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
• 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
• problems with the blood vessels of the brain (stroke, cerebral arteritis or cerebral occlusion)
• inability to control the excretion of urine (incontinence)
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• stuttering
• nosebleed
• increased pressure in the eye
• eye diseases which may cause decreased vision due to damage to the eye nerve (glaucoma).
Effects on growth When used for more than a year, methylphenidate may cause reduced growth in some children. This affects less than 1 in 10 children.
• there may be lack of weight gain or height growth.
• your doctor will carefully watch your height and weight, as well as how well you are eating.
• if you are not growing as expected, then your treatment with methylphenidate may be stopped for a short time.
Reporting of side effects
If you get any side effects talk to your doctor 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: www.mhra.gov.uk/yellowcard 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.
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.
What Atenza XL contains The active substance is methylphenidate hydrochloride
• Each tablet contains 45 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), indigo carmine (E132).
What Atenza XL looks like and contents of the pack • 45 mg: Round, biconvex, blue 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 (2x30) and 90 tablets (3x30).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Exeltis Healthcare, S.L.
Avenida Miralcampo, 7
Polígono Industrial Miralcampo
19200, Azuqueca de Henares
Guadalajara
Spain
Laboratorios Liconsa, S.A.
Calle Dulcinea S/n. Alcalá De Henares.
28805 – Madrid
Spain
This leaflet was last revised in November 2025
Exeltis – PL 44081/0043
Exeltis UK Ltd
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Atenza XL 45 mg prolonged release tablets comes as tablet containing 45 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Atenza XL 45 mg prolonged release tablets is methylphenidate hydrochloride.
Medicines with the same active substance include: Affenid XL 18 mg prolonged release tablets, Affenid XL 27 mg prolonged release tablets, Affenid XL 36 mg prolonged release tablets, Affenid XL 54 mg prolonged release tablets, Ambinet XL 10 mg modified-release hard capsules, Ambinet XL 20 mg modified-release hard capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Atenza XL 45 mg prolonged release tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Attention-Deficit/Hyperactivity Disorder (ADHD)
Atenza XL is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over and adults when remedial measures alone prove insufficient.
Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or an adult psychiatrist.
Special Diagnostic Considerations for ADHD in children
Diagnosis should be made according to the current DSM criteria or ICD guidelines and should be based on a complete history and evaluation of the patient. Third-party corroboration is desirable and diagnosis cannot be made solely on the presence of one or more symptom.
The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources.
A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.
Atenza XL treatment is not indicated in all children with ADHD and the decision to use the medicine must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age.
Appropriate educational placement is essential, and psychosocial intervention is generally necessary.
Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms.
The use of methylphenidate should always be used in this way according to the licensed indication and according to prescribing/diagnostic guidelines.
Special Diagnostic Considerations for ADHD in adults
Diagnosis should be made according to the current DSM criteria or ICD guidelines, and should be based on a complete history and evaluation of the patient.
The specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adults with ADHD have symptom patterns characterised by restlessness, impatience, and inattentiveness. Symptoms such as hyperactivity tend to diminish with increasing age, possibly due to adaptation, neurodevelopment and self-medication. Inattentive symptoms are more prominent and have a greater impact on adults with ADHD. Diagnosis in adults should include a structured patient interview to determine current symptoms. The preexistence of childhood ADHD is required and has to be determined retrospectively (by patient's records or, if not available, by appropriate and structured instruments/interviews). Third-party corroboration is desirable and treatment should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis should not be made solely on the presence of one or more symptoms. The decision to use a stimulant in adults must be based on a very thorough assessment and diagnosis should include moderate or severe functional impairment in at least 2 settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life.
Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or an adult psychiatrist.
Pre-treatment screening
In adults new to Atenza XL, and if required by national practice, cardiologist advice is needed prior to treatment initiation in order to check the absence of cardiovascular contraindications.
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4).
Ongoing monitoring
Growth, psychiatric and cardiovascular status should be continuously monitored (see also section 4.4).
▪ Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
▪ Height, weight and appetite in children should be recorded at least 6 monthly with maintenance of a growth chart;
▪ Weight should be recorded for adults regularly;
▪ Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Dose titration
Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose. A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages.
Other strengths of this medicinal product and other methylphenidate-containing products may be available.
Dosage may be adjusted in 9 mg and/or 18 mg increments In general, dosage adjustment may proceed at approximately weekly intervals.
The maximum daily dosage of Atenza XL is 54 mg in children.
The maximum daily dosage of Atenza XL is 72 mg in adults.
Posology
Children
Children New to Methylphenidate: Atenza XL may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat children new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of Atenza XL for children who are not currently taking methylphenidate, or for children who are on stimulants other than methylphenidate, is 18 mg once daily.
Adults
Adults New to Methylphenidate: Atenza XL may not be indicated in all adults with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat adults new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of Atenza XL for adults who are not currently taking methylphenidate, or for adults who are on stimulants other than methylphenidate, is 18 mg once daily.
Patients Currently Using Methylphenidate: The recommended dose of Atenza XL for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.
TABLE 1
Recommended Dose Conversion from Other methylphenidate Hydrochloride Regimens, where available, to Atenza XL
| Previous methylphenidate Hydrochloride Daily Dose | Recommended Atenza XL Dose |
| 5 mg methylphenidate three times daily | 18 mg once daily |
| 10 mg methylphenidate three times daily | 36 mg once daily |
| 15 mg methylphenidate three times daily | 54 mg once daily |
| 20 mg methylphenidate three times daily | 72 mg once daily |
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Long-term (more than 12 months) use
The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. In children and adolescents methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in patients with ADHD should periodically re-evaluate the long-term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy. It is recommended that methylphenidate is de-challenged at least once yearly to assess the patient's condition (for children preferable during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Dose reduction and discontinuation
Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.
Special populations
Elderly
Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group. Methylphenidate has not been studied in ADHD in patients older than 65 years.
Hepatic impairment
Methylphenidate has not been studied in patients with hepatic impairment.
Renal impairment
Methylphenidate has not been studied in patients with renal impairment.
Children under 6 years of age
Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Method of administration
Atenza XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (see section 4.4).
This medicinal product may be administered with or without food (see section 5.2).
Atenza XL is for oral use once daily in the morning.
• Hypersensitivity to methylphenidate or to any of the excipients listed in section 6.1
• Glaucoma
• Phaeochromocytoma
• During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to the risk of hypertensive crisis (see section 4.5)
• Hyperthyroidism or Thyrotoxicosis
• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
• Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
• Pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)
• Pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Pharmacokinetic interaction
It is not known how methylphenidate may effect plasma concentrations of concomitantly administered drugs. Therefore, caution is recommended at combining methylphenidate with other drugs, especially those with a narrow therapeutic window.
Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics. Conversely, the d- and l- enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.
However, there are reports indicating that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). When starting or stopping treatment with methylphenidate, it may be necessary to adjust the dosage of these drugs already being taken and establish drug plasma concentrations (or for coumarin, coagulation times).
Pharmacodynamic interactions
Anti-hypertensive drugs
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Use with drugs that elevate blood pressure
Caution is advised in patients being treated with methylphenidate with any other drug that can also elevate blood pressure (see also sections on cardiovascular and cerebrovascular conditions in section 4.4).
Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 4.3).
Use with alcohol
Alcohol may exacerbate the adverse CNS effect of psychoactive medicinal products, including methylphenidate. In-vitro data suggest that alcohol concentrations higher than 10% increase the cumulative release of MPH from methylphenidate tablets. The clinical relevance of this finding on the MPH exposure after oral ingestion of methylphenidate in combination with alcohol is not known. It is therefore advisable for patients to abstain from alcohol during treatment.
Use with serotonergic medicinal products
There have been reports of serotonin syndrome following coadministration of methylphenidate with serotonergic medicinal products. If concomitant use of methylphenidate with a serotonergic medicinal product is warranted, prompt recognition of the symptoms of serotonin syndrome is important (see section 4.4). Methylphenidate must be discontinued as soon as possible if serotonin syndrome is suspected.
Use with halogenated anaesthetics
There is a risk of sudden blood pressure and heart rate increase during surgery. If surgery is planned, methylphenidate treatment should not be used on the day of surgery.
Use with centrally acting alpha-2 agonists (e.g. clonidine)
Serious, adverse events, including sudden death, have been reported in concomitant use of methylphenidate and clonidine. The long-term safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.
Use with dopaminergic drugs
Caution is recommended when administering methylphenidate with dopaminergic drugs, including antipsychotics. Because a predominant action of methylphenidate is to increase extracelluar dopamine levels, methylphenidate may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) or with dopamine antagonists including antipsychotics.
Pregnancy
Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was a small increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95 % CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non- exposed pregnancies.
Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous case reports.
Studies in animals have shown evidence of reproductive toxicity at maternally toxic doses (see section 5.3).
Methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy.
Breast-feeding
Methylphenidate is excreted in human milk. Based on reports of breast milk sampling from five mothers, methylphenidate concentrations in human milk resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage, and a milk to maternal plasma ratio ranging between 1.1 and 2.7.
There is one case report of an infant who experienced an unspecified decrease in weight during the period of exposure but recovered and gained weight after the mother discontinued treatment with methylphenidate. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from methylphenidate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
No human data on the effect of methylphenidate on fertility are available. There were no relevant effects observed in the non-clinical studies.
Methylphenidate can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. It may have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It may be an offence to drive while under the influence of this medicine.
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.
Signs and Symptoms
Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Treatment
There is no specific antidote to methylphenidate overdosage.
Treatment consists of appropriate supportive measures.
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. The efficacy of activated charcoal has not been established.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.
Ask anything about Atenza XL 45 mg prolonged release tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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