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 and what it is used for Addepta XL is used to treat ‘Attention Deficit Hyperactivity Disorder’ (ADHD). It contains the active substance methylphenidate.
• It is used in children and adolescents between the ages of 6 and 18 years.
• It is used only after treatments which do not involve medicine, such as counselling and behavioural therapy, have been insufficient.
Addepta XL improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention span and concentration, and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes psychological, educational and social therapy.
Using treatment programmes as well as medicine helps to manage ADHD.
Treatment must only be initiated by, and used under the supervision of a doctor specialised in the treatment of ADHD, such as an expert paediatrician or a child and adolescent psychiatrist. Careful examination and monitoring during treatment by a specialist doctor is required.
About ADHD Children and adolescents with ADHD find it hard to:
• sit still
• concentrate
It is not their fault that they cannot do these things.
Many children and adolescents struggle to do these things. However ADHD 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 intelligence.
Do not take Addepta 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 your eye (glaucoma)
• have a tumour of your adrenal gland (phaeochromocytoma)
• have an eating problem where 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 an inherent 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)
• is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) – see other medicines and Addepta XL
• have mental health problems such as: • a psychopathic or borderline personality problem
• abnormal thoughts or hallucinations, or an illness called schizophrenia
• signs of a severe mood problem like: • suicidal thoughts • severe depression, where you feel very sad, worthless and hopeless
• mania, where you feel unusually excitable, over-active, and uninhibited.
Do not take methylphenidate if any of the above applies to you or your child. If you are not sure, talk to your doctor or pharmacist before taking methylphenidate. This is because methylphenidate can make these problems worse.
Warnings and precautions Talk to your doctor or pharmacist before taking Addepta XL if you or your child:
• have liver or kidney problems
• have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEG)
• have ever abused or been dependent on alcohol, prescription medicines or street drugs
• are female and have started having periods (see section ‘Pregnancy and breast-feeding below)
• 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 Addepta XL ”
• have a mental health problem which is not mentioned in the section “Do not take Addepta XL ”. Other mental health problems include: • mood swings (from being manic to being depressed, - known as bipolar disorder)
• aggressive or hostile behaviour, or aggression which 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.
• develop blurred vision or other visual disturbances contact your doctor. Your doctor may consider discontinuation of Addepta XL
Tell your doctor or pharmacist if any of the above applies 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 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 or your child are feeling, such as feeling high or low, having strange thoughts, or if you or your child have had any of these feelings in the past
• whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the body, or repeating sounds and words)
• any mental health or behaviour problems you, your child or other family members have or have ever had. Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to being depressed, - known as bipolar disorder). Your doctor will check your or your child’s mental health history, and check if any of your family has a history of suicide, bipolar disorder or depression.
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 start taking this medicine.
Having an operation
Tell your doctor if you or your child are going to have an operation. Methylphenidate should not be taken on the day of your 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.
Prolonged erections
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 or your child’s erection lasts for longer than 2 hours, particularly if this is painful.
Drug testing
This medicine may give a positive result when testing for drug use.
Children and adolescents Addepta XL is not for use as a treatment for ADHD in children under 6 years of age. It is not known if it is safe or of benefit in children under 6 years of age.
Adults and elderly Addepta XL is not for use as a treatment for ADHD in adults and the elderly above the age of 18 years. It is not known if it is safe or of benefit in adults and elderly.
Other medicines and Addepta XL Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Do not take methylphenidate if you or your child:
• are taking a medicine called a monoamine oxidase inhibitor (MAOI) used for depression, or have taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure.
If you or your child are taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you or your child are taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate:
• other medicines for depression
• medicines for severe mental health problems
• medicines for epilepsy
• medicines used to reduce or increase blood pressure
• some cough and cold remedies which contain substances that can affect blood pressure. It is important to check with your pharmacist when you buy any of these medicines
• medicines that thin the blood to prevent blood clots.
If you are in any doubt about whether medicines you or your child are taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.
Methylphenidate with alcohol Do not drink alcohol whilst 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 or pharmacist for advice before taking this medicine.
Available data does not suggest an increased risk of overall birth defects, whilst a small increase in the risk of heart malformations 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 or your daughter is:
• having sex. Your doctor will discuss contraception
• pregnant or might be pregnant. Your doctor will decide whether methylphenidate should be taken
• breast-feeding or are planning to breast-feed. It is possible that methylphenidate is passed into breast milk, so 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 focusing 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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Addepta XL is a modified release form of methylphenidate which releases the medicine gradually over a time period of 8 hours. It is intended to take the place of the same total daily dose of traditional (immediate release) methylphenidate taken at breakfast and lunchtime.
• If you or your child have not taken methylphenidate before, your doctor will normally start treatment with traditional (immediate release) methylphenidate tablets. If your doctor feels it is necessary methylphenidate treatment may be started with Addepta XL 10 mg once daily before breakfast
• Your doctor will usually start treatment with a low dose and increase it gradually as required
• The maximum daily dose is 60 mg.
How to take Addepta XL is for oral use. It should be given in the morning before breakfast. The capsules may be swallowed whole with a drink of water, or alternatively, may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of soft food (e.g. applesauce) and taken immediately, and not stored for future use. If the medicine is taken with soft food some fluid, e.g. water, should be taken afterwards. The capsules and the capsule contents must not be crushed or chewed.
Long-term treatment Addepta XL does not need to be taken for ever. If you or your child takes Addepta XL for more than a year, your doctor will stop treatment for a short time, e.g. during a school holiday. This will show if the medicine is still needed.
If you do not feel better after 1 month of treatment If you or your child do not feel better, tell your doctor. They may decide you need a different treatment.
Not using Addepta XL properly If Addepta 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 or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Things your doctor will do during treatment Your doctor will do some tests
• before you or your child start treatment, to make sure that Addepta XL is safe and will be of benefit
• after you or your child has started treatment, 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 Addepta XL.
If you or your child take more Addepta XL than you should If you or your child take 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 or psychosis), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.
If you or your child forget to take Addepta XL Do not take a double dose to make up for a forgotten dose. If you or your child forget a dose, wait until it is time for the next dose.
If you or your child stop taking Addepta 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 Addepta XL .
If you have any further questions on the use of this medicine, 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 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, mood swings or changes in personality.
Uncommon (may affect up to 1 in 100 people)
• thinking about or feeling like killing yourself
• seeing, feeling, or hearing things that are not real - these are signs of psychosis
• uncontrolled speech and body movements (Tourette’s)
• signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
Rare (may affect up to 1 in 1,000 people)
• feeling unusually excited, over-active and uninhibited (mania).
Very rare (may affect up to 1 in 10,000 people)
• heart attack
• fits (seizures, convulsions, epilepsy)
• skin peeling or purplish red patches
• 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
• paralysis or problems with movement and vision, difficulties in speech - these can be signs of problems with the blood vessels in your 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 medicines 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.
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
• dry mouth
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy
• loss of appetite or decreased appetite
• itching, rash or raised red itchy rash (hives)
• cough, sore throat or nose and throat irritation
• high blood pressure, fast heart beat (tachycardia)
• feeling dizzy, movements which you cannot control, being unusually active
• feeling aggressive, agitated, anxious, depressed, irritable and behaving abnormally
• excessive teeth grinding (bruxism).
Uncommon (may affect up to 1 in 100 people)
• constipation
• chest discomfort
• blood in the urine
• double vision or blurred vision
• muscle pain, muscle twitching
• increases in liver test results (seen in a blood test)
• anger, feeling restless or tearful, excessive awareness of surroundings, problems sleeping
• tremor
• dry eye
Rare (may affect up to 1 in 1,000 people)
• changes in sex drive
• feeling disorientated
• dilated pupils, trouble seeing
• swelling of the breasts in men
• excessive sweating, redness of the skin, raised red 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)
• sudden death
• muscle cramps
• small red marks on the skin
• inflammation or blocked arteries in the brain
• abnormal liver function including liver failure and coma
• changes in test results including liver and blood tests
• suicidal attempt, suicide, 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
• excessive talkativeness
• very high fever
• slow, fast or extra heart beats
• a major fit (grand mal convulsions)
• believing things that are not true, confusion
• severe stomach pain, often with feeling and being sick
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• inability to control urination (incontinence)
• prolonged erections, sometimes painful, or an increased number of erections, inability to develop or maintain an erection
• problems with the blood vessels of the brain (stroke, cerebral arteritis or cerebral occlusion)
• 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 one 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 increase.
• Your doctor will carefully monitor you or your child’s height and weight, as well as how well you or your child are eating.
• If you or your child are not growing as expected, then treatment with methylphenidate may be stopped for a short time.
Reporting of side effects If you 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 and 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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture.
Do not use this medicine if the capsules look damaged in any way.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Addepta XL contains • The active substance is methylphenidate hydrochloride.
Addepta XL 10 mg modified-release hard capsules contain 10 mg methylphenidate hydrochloride equivalent to 8.65 mg methylphenidate.
Addepta XL 20 mg modified-release hard capsules contain 20 mg methylphenidate hydrochloride equivalent to 17.3 mg methylphenidate.
Addepta XL 30 mg modified-release hard capsules contain 30 mg methylphenidate hydrochloride equivalent to 25.95 mg methylphenidate.
• The other excipients are:
Capsule contents: microcrystalline cellulose, hypromellose, ethylcellulose, hydroxypropylcellulose, dibutyl sebacate, povidone, talc(E553b), hydrochloric acid (E507-for pH adjustment)
Capsule shell: hypromellose, titanium dioxide (E171), iron oxide yellow (E172) (additionally in Addepta XL 20 mg, 30 mg modified-release hard capsules)
• Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520), potassium hydroxide (E525)
What Addepta XL looks like and contents of the pack Modified-release hard capsule
Addepta XL 10 mg modified-release hard capsules
Opaque oblong hard capsule with white cap and white body imprinted “10” with black ink on body filled with white to off-white spherical pellets. Capsule length: 16 mm.
Addepta XL 20 mg modified-release hard capsules
Opaque oblong hard capsule with ivory cap and white body imprinted “20” with black ink on body filled with white to off-white spherical pellets. Capsule length: 16 mm.
Addepta XL 30 mg modified-release hard capsules
Opaque oblong hard capsule with yellow cap and white body imprinted “30” with black ink on body filled with white to off-white spherical pellets. Capsule length: 18 mm.
Addepta XL 10 mg/20 mg/30 mg modified-release hard capsules are available in:
HDPE bottles with child-resistant PP screw caps containing a desiccant
Pack sizes: 28, 30, 50, 60, 100 modified-release hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder Mercury Pharmaceuticals Ltd
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom
Manufacturer Develco Pharma GmbH
Grienmatt 27
79650 Schopfheim
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Sweden: Metylfenidat Amdipharm kapslar med modifierad frisättning, hårda 10 mg
Metylfenidat Amdipharm kapslar med modifierad frisättning, hårda 20 mg
Metylfenidat Amdipharm kapslar med modifierad frisättning, hårda 30 mg
This leaflet was last revised in October 2025.
ADVANZ Pharma
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Addepta XL 30 mg Modified-release capsule comes as capsule containing 30 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 Addepta XL 30 mg Modified-release capsule 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 Addepta XL 30 mg Modified-release capsule, 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.
Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children from 6 years of age when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders.
Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. 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.
Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the medicinal product 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. Methylphenidate should always be used in this way according to the licensed indication and according to prescribing/diagnostic guidelines.
Posology
Addepta XL consists of an immediate release component (30% of the dose) and a modified release component (70% of the dose). Hence Addepta XL 10 mg yields an immediate-release dose of 3 mg and an extended release dose of 7 mg methylphenidate hydrochloride. The extended-release portion of each dose is designed to maintain a treatment response through the afternoon without the need for a midday dose. It is designed to deliver therapeutic plasma levels for a period of approximately 8 hours, which is consistent with the school day rather than the whole day (see section 5.2). For example, 20 mg of Addepta XL is intended to take the place of 10 mg at breakfast and 10 mg at lunchtime of immediate release methylphenidate hydrochloride.
Paediatric population (Children (aged 6 years and over) and adolescents):
Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Pre-treatment screening
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 comorbid 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, weight, psychiatric and cardiovascular status should be continuously monitored (see 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 should be recorded at least 6 monthly with maintenance of a growth chart;
- 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. This is usually accomplished by using an immediate-release formulation divided into multiple doses. The recommended initial dose is 5 mg once or twice daily (for example for breakfast and lunch). If necessary, the daily dose may be increased weekly in increments of 5 - 10 mg, depending on the tolerability and the observed degree of effectiveness. Instead of twice daily administration of an immediate release methylphenidate hydrochloride 5 mg formulation, Addepta XL 10 mg may be used from the beginning of treatment if the treating physician determines that twice daily dosing is appropriate at baseline but twice daily dosing is not feasible.
The maximum daily dose of methylphenidate hydrochloride is 60 mg.
For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate-containing products are available.
Patients currently using methylphenidate
Patients established on an immediate release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of Addepta XL.
Addepta XL should be given in the morning before breakfast.
Addepta XL should not be taken too late in the morning as it may cause disturbances in sleep. If the effect of the medicinal product wears off too early in the late afternoon or evening, disturbed behaviour and/or inability to go to sleep may recur. A small dose of immediate-release methylphenidate late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate-release methylphenidate regimen. The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered.
Treatment should not continue with long-acting methylphenidate if an additional late dose of immediate-release methylphenidate is required, unless it is known that the same extra dose was also required for a conventional immediate-release regimen at equivalent breakfast/lunchtime dose. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
Long-term (more than 12 months) use in children (>6 years of age) and adolescents (<18 years of age)
The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials in children and adolescents. Methylphenidate treatment should not and need not, be indefinite. ADHD 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 child's condition (preferably 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 dose adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dose should be reduced or discontinued.
Adults
Addepta XL is not approved for the treatment of adults with ADHD. Safety and efficacy have not been demonstrated in this age group.
Special populations
Elderly
Addepta XL should not be used in the elderly. Safety and efficacy in this age group has not been established.
Children under 6 years of age
Addepta XL should not be used in children under the age of 6 years. Safety and efficacy in this age group have not been established.
Method of administration
For oral use.
The capsules may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of soft food (e.g. applesauce) and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed.
- Hypersensitivity to the active substance 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 substances, due to 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 pectoris, 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 interactions
It is not known how methylphenidate may affect plasma concentrations of concomitantly administered medicinal products. Therefore, caution is recommended at combining methylphenidate with other medicinal products, 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 (e.g. phenobarbitol, 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 dose of these medicinal products already being taken and establish substance plasma concentrations (or for coumarin, coagulation times).
Pharmacodynamic interactions
Anti-hypertensive medicinal products
Methylphenidate may decrease the effectiveness of medicinal products used to treat hypertension.
Use with medicinal products that elevate blood pressure
Caution is advised in patients being treated with methylphenidate with any other active substances 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 effects of psychoactive medicinal products, including methylphenidate. It is therefore advisable for patients to abstain from alcohol during treatment. In case of very high alcohol concentrations the kinetic profile may change towards a more immediate-release-like pattern.
Use with halogenated anaesthetics
There is a risk of sudden blood pressure 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 with concomitant use with clonidine. The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.
Use with dopaminergic substances
Caution is recommended when administering methylphenidate with dopaminergic substances, including antipsychotics.
Because a predominant action of methylphenidate is to increase extracellular 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 only 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 has been found in the breast-milk of a woman treated with methylphenidate.
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 breast-fed 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. In animal studies, no clinically relevant effects on fertility were observed.
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.
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.
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 overdose.
Treatment consists of appropriate supportive measures.
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine be given before performing gastric lavage.
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 Addepta XL 30 mg Modified-release capsule. 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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