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
Focusim XL is used to treat 'Attention Deficit Hyperactivity Disorder' (ADHD).
= itis used in children and adolescents between the ages of 6 and 18, and in adults
Focusim XL is not for use as a treatment for ADHD in children under 6 years of age. It is not known if itis safe or of benefit in children under 6 years of age
How it works
Focusim 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.
as part of a treatment programme, which usually includes:
= social therapy
Focus XL enst oly bead by, and wed under the supervision of «doce, speciale in the eaten of ADHD, each
sdiatrician, a child a r this doctor is required. twill carry out tests to confirm that you have had ADHD since
About ADHD
adolescents with ADHD find it hard:
= tosit still = to concentrate
fault that they cannot do these things.
n and adolescents struggle to do t
;s. However, ADHD can cause problems with everyday life. Children and at school
Other medicines and Focu: Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Do nat take methylphenidate f you o your cil ~ are taking a medicine called a 'monoamine oxidase inhibitor" (MAOD) used for depression, or have taken an MAOL in the lst 14 days. Taking an MAOL increase in blood pressure (see "Do not take Focusim XL")
If you or your child are taking ther medicines, 'methylphenidate may affect how wel hey work or cy ene side effet. tay
therefore sary t0 of the medicine or eatment alltogether. If you or your child are taking
any of the tllowing medion, check with your doctor or pharma before taking nchypenidate
© other medicines for de edivines for severe mental health problems (eg schizophrenia)
used to reduce or increase blood pressure 'which contain substances that can affect blood pressure. It is important to check with your
pharmacist when you buy any of these me '+ medicines that thin the blood to prevent blood clots
If you are in any doubt about whether any medicines you or your child are taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.
Having an operation
Tell your doctor that you or your child are being treated with Focusim XL if you or your child is going to have an operation Methylphenidate should not be taken on the day of surgery iffa certain type of anaesthetic is used. This is because there is a chance ofa sudden rise in blood pressure during the operation.
Focusim XL with food, drink and alcohol Taking methylphenidate with food may help to stop stomach pain, nausea and being sick.
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 fertility Available data does 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
Ask your doctor or pharmacist for advise before taking this medicine if you or your daughter are: sexually active. Your doctor will discuss contraceptio
~ preznant may be pregnant or are planning to become pregnant. Your doctor will decide whether you should take methylphenidate
= are breast-feeding or are planning to breast-feed. It is possible that methylphenidate is passed into breast milk. Therefore, your doctor will decide whether you should breast-feed while taking methylphenidate
No effects on fertility have been seen in animal tests.
riving and using machines You or your child may ec! dizzy or sleepy, have problems focussing or have blued vision, have hallucinations or other side effets afte central nervous sytem when taking methylphenidate I these happen, it may be dangerous to do things such as drive, tse machines, ride bike or horse climb
Dose Your doctor will usually start treatment with a low dose and increase it gradually as required.
Children (6 d adolescents
impatient and inattentive. They may ¢ life and work
Not all patients with ADHD need to be treated with medicine. For children, the decision to use a medicine must be based on a very
ent of the severity and chronic nature of the child's symptor
ADHD does not affect intelligence.
fou need to know before you take Focusim XL
Do not take Focusim XL if you or your child:
c to methylphenidate or any of the other ingredients of this medicine (listed in section 6). If you think you are k your doctor for advice thyroid problem
= take a medicine called 'monoamine oxidase inhibitor" (MAOI) used for depression, or if you took an MAOI in the past 14 days = have ine
sed pressure in your eye (glaucoma) tumour of your adrenal gland (phacochromocytoma) cating problem where you do not feel hungry or want to
(such as anorexia nervosa)
= have very high blood pressure or narrowing ofthe plod vessels, which can cause pain inthe arms and leg hav
id heart problems such as a heart attack, uneven heartbeat, inthe ches, heat failure, heart or an inherent
heart problem
swelling and weakening of part of a blood vessel 1s, or inflammation of the blood vessels (vasculitis)
fe mental health problems such as: "psychopathic" or 'borderline per
ity' problem
= abnormal thoughts or hallucination, or an iliness called "schizophrenia' ~ signs of severe mood problem like fe If
feeling like killing your severe depression, where you feel very sad, worthless and hopeless 'mania, where you feel unusually excitable, over-active, and uninhibited from depression to mania
'mood chang
Do not take methylphenidate if any of the above applies fo you or your child. Ifyou are not sure, talk to your doctor or pharmacist
before
have liv
- tave had fits (seizu
= are female and have started having
This is make the
'Warnings and precautions Talk to your doctor or pharmacist befre taking Focus XL if you o your hil
er or kidney probl
~ develop bined vison or other visual disturbances contact your doctor. Your doctor may consider discontinuation of Focusim
. convulsions, epilepsy) or any abnormal brain scans (EEG) sn dependent on alcohol, prescription medici treet drugs periods (see section "Pregnancy, breast-feeding and fertility' below)
+ abused oF b
It is important
These checks
suicide,
this medicine.
During treatment, boys and men may unexpectedly experien
any other medicines
= whether there is any family history of sudden unexplained death
= any other medical heart problems) you, your ¢
= how you or your child are
these feelings in the past
= whether there is a family history of ties" (hard-to-control, repeated twitching of any parts of the body or repeating sounds and words)
= any mental health or behaviour problems you or your child or other family members have or have ever had. Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to being depressed - called "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
Its important that you provide as much information as you can. This will help your doctor d 'medicine for you or your child. Your doctor may decide that other medical tests are needed before you or your child start taking
d p 1g 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 th = have a mental health problem which is not mentioned in the section "Do not take Focusim XL". Other mental health problems include "mood swings (rom being mani o beng depressed - ale 'bipolar disorder')
tion "Do not take Foe
im XL"
ting to be aggressive or hostile, or aggression which g¢ . hearing or feeling things that are not there thaluinaions)
- ising things that are not true (delusions)
Tell your doctor oF 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.
t 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 or your child start taking methylphenidate the
are to de 3 you or your child. talk to you about
you or your child are takin
hil hav cling, such as feeling high o low, having strange thoughts of you or you child have had any
bipolar disorder or depression
id
f methylphenidate is the corr
Drug testing/anti-doping testing This medicine may give a positive result when testing for drug use. This includes testing used in sport.
prolonged erections. This may be painful and can occur at any time.
The recommended starting dose is 20 mg once daily. At the discretion of the doctor, treatment with Focusim XL can also be started
at a dose of 10 mg. The maximum daily dose is 60 mg. Focusim XL is taken once daily in the morning in patients younger than
18 years of age
Adults
The maximum daily dose is 80 mg
= Ifyou take Focusim XL for the first time, your doctor will start treatment at a dose of 20 mg once daily and, if required, will inerease the dose gradually at weekly small increments
= Ifyou were with a formulation or any preparation with a similar release sytem incildhood and nd yon have jst tue 18, your doctor ey coatins teament with he ene dase. you were treated with an immediate-release formulation in childhood, your doctor will prescribe the equivalent dose of Focusim XL.
ements, different strengths of this medicine and other methylphenidate-containing medicines may
four doctor will do when you or your child is on treatment
Year ctor wl da some txts
= before you or your child starts —to make sure that Focusim XL is safe and will be of benefit (Listed in se your doctor will make before you or your child start taking methylphenidate")
= 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
3s that
ion "Chet
These tests will include: cking appetite
= measuring height and weight for children,
= measuring weight for adults,
= measuring blood pressure and heart rate
ckng for problems with moad, sate of mind or any ober unusual feelings orf these have become worse while aking Focusim X!
Method of Administration Focusim XL is for oral u take Focusim XL once daily with or without food. Focusim XL should not be taken to lat in the morning a it may cause disturbances in sleep the capsule should be swallowed whole, with a dink of water = donot crush, chew or divide the capsule or the contents
you or your child are wna to swallow Focusim XL you can sprinkle the contents on a small amount of food, as follows: carefully open the capsule and sprinkle the pellets over a small amount of soft food (c.g. apple sauce)
= the fod should not be warm because this could aect the special propentics ofthe pellets
= donot crush or chew the pellets.
~ immediately cat all of the drug/food mixture
Do not store any drug/food mixture for future use
Long-term treatment
Focusim XL should not and does not need to be taken forever. If you or your child takes Focusim XL for more than one year, your doctor should stop treatment for a short time at least once a year (in children, this may happen during a school holiday). This will show if the medicine is still needed.
If you or your child do not feel better after 1 month of treatment If you or your child do not feel better, tell your doctor. He may decide that you or your child need a different treatment.
Not using Focusim XL properly If Focusim XL is not used properly, this may cause abnormal behaviour. It may also mean that you or your child starts to depend (on the medicine. Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines or street drugs,
This medicine is only for you or your child. Do not give this medicine to anyone else, even if their symptoms seem similar,
If you or your child take more Focusim XL than you should
Ifyou your child have alan too many eapaneg, talk toa doc rel an ambulance sight away, Tell hem how noch has taken. Medical treatment might be needed.
Sioa of overdone nay fc being sch feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by cor very happy, being confused, seein; or hearing things that are not real (hallucinations), sweating, fushing, headache high fever, changes in heartbeat (slow, fst or uneven) high bloodpressure, dilated pupils and ry nose and mouth,
If you or your child forget to take Focusim 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 Focusim XL.
If you or your child suddenly stop the ADHD symp some back or such as depression may appear. Your doctor may wan to gradually reduce the amount of medicine taken each day before stoppin it completely. Talk to your doctor before stopping Focusim 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 helps them. talk to you about
Some side effects could be serious. If you or your child experience any of the side effects below, see a doctor straight away: Common (may affect up to 1 in 10 people)
NON PRINTING COLOUR as CMO - ARTWORK DETAIL LABEL [ MFG. LOCATION [ Konapharma AG PRODUCT Focusim XL Modified-Release Hard Capsules 10,20,30,40 mg SPUK [COMPONENT | Outsert DIMENSION 625 x 397 mm [PACK NEW ITEM CODE | 1052635 [OLD ITEM CODE | 1051290 COLOUR SHADES [No.of Colours | 1 Change Control No.| PO-SPU/2025/021 - Record Number: 468793 [Artwork Version| 2.0 Design'Style Front & Back Side printing Substrate {As per CMO Specification Special Instructions | PRINTING CLARITY TO BE CLEAR AND SHARP. 'Rutocaronator | yyy Requirements Caution to ease ensure that th ig exaelly in ine with APPROVED ARTWORK pros a your est ay FONTSSESI ae -matengu he APPROVED ARTWORK plese inom SCM/ PD fe hte ect, DO NOT MAKE ANY CHANGE TO THE ARTWORK WITHOUT
Front Side
P/\ SE RLAUE
8Z_K_2P_2W_12
SAP-FALZCODE
16.12.2015
PRIMABRITE 40G/M
12001608_000_01
AUGUST FALLER KG, KT-NR
s
70.0 X 36.6 X 0.0 MM , MATERIAL
= uneven heartbeat (palpitations)
Keep this medicine out of the sight and reach of children.
Make sure to store the medicine in a secure place so that nobody el Other things to remember
ath take it lake sure you keep your medicine ina safe lass so that no one else takes it, especially younger brothers or sisters.
Do not use this medicine after the expiry date, which is stated on the carton box and bottle after {EXP}. The expiry date refers to. The medicine is special for you~ do not et anyone ese have it tay help you, butt cul hur someone the last day of that month, = IF you forget to take don the next time, Just time. 'This medicine does not require any special storage conditions, {yeu do tate too much medicine, tll your mun, dad or caer ag away.
= It is important not to take too much medicine or you will get ill.
Do not throw away any medicines via wastewater or houschold waste. Ask your pharmacist how to throw away medicines youn ont stop taking your medicine until your doctor says it's OK.
longer use. These measures will help protect the environment. 8 Who should I ask if there is anything I don't understand? g 'Your mum, ded, carer, doctor, nurse or pharmacist will be able to help you. & Back Side NON PRINTING COLOUR as CMO - ARTWORK DETAIL LABEL [ MFG. LOCATION [ Konapharma AG PRODUCT Focusim XL Modified-Release Hard Capsules 10,20,30,40 mg SPUK [COMPONENT | Outsert DIMENSION 625 x 397 mm [PACK NEW ITEM CODE | 1052635 [OLD ITEM CODE | 1051290 COLOUR SHADES [No.of Colours | 1 Change Control No.| PO-SPU/2025/021 - Record Number: 468793 [Artwork Version| 2.0 Design'Style Front & Back Side printing Substrate {As per CMO Specification Special Instructions | PRINTING CLARITY TO BE CLEAR AND SHARP. 'Rutocaronator | yyy Requirements Caution to ease ensure that th ig exaelly in ine with APPROVED ARTWORK pros a your est ay FONTSSESI ae -matengu he APPROVED ARTWORK plese inom SCM/ PD fe hte ect, DO NOT MAKE ANY CHANGE TO THE ARTWORK WITHOUT
= mood changes, mood swings or changes in personality What Focusim XL contains
Uncommon (may affect up to 1 in 100 people) The active substance is methylphenidate hydrochloride.
= thinking about or feeling like killing yourself Focusim XL 10 mg modified-release hard capsules
- ng, eling ot hearing things tat re not el thexe are sigs of psychos Each
= uncontrolled sp body movements Toure' 's) Focusim XL 20 mg modified-release hard capsules Each 173
= Sians of allergy such as rash, ching or hives onthe skin, swelling of the fice lips, tongue or other pars ofthe boy, wh 1s
. Shortness of bath eezing or trouble breathiny Focusim XL 30 mg modified-release hard capsules Each 25.95 30 mg Rare (may affect up to 1 in 1,000 people) Focusim XL 40 mg modified-release hard capsules fecling unusually excited, over-active and uninhibited (mania) Each Very rare (may affect up to 1 in 10,000 people) The other excipients are: unexplained fining, chest pai, shorines of breath these can be signs of heat problems (ine, heat tack) Capsule contents: ~ fits (ee, convulsions epilepsy) Cellulose, hypromellose, tale, methacrylic acid-methyl ymer (1:1), triethyl citrate,
ethylcellulose, hydroxypropyicellulose
= muscle spasms which you cannot contol alfecting Your eyes, head ne 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
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
= assudden 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 What Focusim XL looks like and contents of the pack
yellowing eyes/skin (jaundice), abdominal pain and swelling in the legs and ankles — these may be the signs of liver failure Modified-release hard capsules
land can lead to coma
. body and nervous system - due to a temporary lack
Copsale shel
" atin, avium dioxide {EID ton oxide yellow (E172) susim XL 20 mg modified-release hard capsules
- de ine titanium dioxide (E171)
Printed ink: Shellac glaze, Iron oxide black (E172), Propylene glycol
Focusim XL 10 mg modified-release hard capsule: Not known (frequency cannot be estimated from the available data) Opaque hard gelatine capsule (size 3) with rich Byelow sap and white body imprinted "10" with black ink, filled with white to off- - unwanted thoughts that keep coming back white spherical pellets. Capsule length: 15.9 m
= prolonged erections, sometimes painful, or an increased number of erections
Focusim XL 20 mg modified-retease hard capsule: Other side effects include the following, if they get serious, please tell your doctor or pharmacist: Opaque hard gelatine capsule (size 3) with white cap and white body, imprinted
" with black ink, filled with white to off-white
Yery common (may aet more than 1in 10 people spherical pellets. Capsule length: 15.9 mm. creased appetite Focusim XL 30 mg modified-release hard capsule: - headache 'Opaque hard gelatine capsule (size 2) with ivory cap and ivory body, imprinted "30" with black ink, filled with white to off-white - feeling nervous spherical pellets. Capsule length: 18 mm. = not being able to sleep = feeling sick Focusim XL 40 mg modified-release hard capsules
= dry mout Opaque hard gelatine eapsule (size 1) with rich yellow cap and rich yellow body, imprinted "40" with black ink, filled with white to off-white spherical pellets. Capsule length: 19.4 mm.
'Common (may affect up to 1 in 10 people)
= joint pain
= high temperature (fever)
= unusual hair loss or thinning
= feeling unusually sleepy or drowsy
Focusim XL modified-release hard capsules are available in: HDPE bottles with child-resistant closure (PP)
Or Child-resistant aluminium/PVC/PE/PYDC blisters 10, 28, 30, 40, 50, 56, 60, 84, 100 modified-retease hard capsules
= loss of app = weight decrease in adults Not all pack sizes may be marketed. Shanice ive Marketin: isation Holder and 2 teatacke Marketing Authorisation Holder
= excessive teeth grinding (bruxism) Strides Pharma UK Limited
= itching, rash or raised red itchy rashes (hives) entre Dwight Road, = excessive sweating
= cough, sore throat or nose and throat irritation, shortness of breath or chest pain United Kingdom
= changes in blood pressure (mainly high blood pressure, fast heart beat (tachycardia), cold hands and feet Manufacturer = shaking or trembling, feeling dizzy, movements which you cannot control, feeling jittery, being unusually active 'A&O Pharma GmbH, Am Sattel 17, D-79588, Efringen-Kirchen,
= feeling aggressive, agitated, restless, anxious, depressed, stressed, irritable and abnormal behaviour, problems sleeping, iredness " ° pe 'This leaflet was last revised in 09/2025.
= stomach pain, diarrhoea, stomach discomfort, indigestion, thirst and being sick.
'These side eff ally occur at the start of be reduced by taking the medicine with food.
Information for children and young people Uncommon (may affect up to 1 in 100 people) constipation
This info is to help you learn the main things about your medicine called Focusim XL. = chest discomfort ip y gs ys
= double vision or blurred vision Ifyou don't enjoy reading, someone like your mum, dad or carer (sometimes called "your guardian') can read it to you and answer = muscle pain, muscle twitching, muscle tightness any questions. = increases in liver test results (Seen in a blood test) - anger, feeling tearful, excessive awareness of surroundings, tension It may help if you read small bits at a time. - dry ey i fs icine? Why have I been given this medicine? Rare (ay afect up tn 1,000 people) This medicine can help children and young people with "ADHD". changes in - ADHD can make you: feeling sont = runabout too much = dilated pupils, trouble seeing = not be able to pay attention = welling oft the beens ine = act quickly without thinking about what will happen next (impulsive). = edness of the skin, red raised skin rash : jects learning, making friends and how you think about yourself. It is not your fault.
= 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))
While you are taking this medi well as taking this medicine you wil ls get help with ways to cope wih your ADHD such stalking to ADHD 10,000 people) = Pismedcine should help you. = You will ne to your doctor several times a year for check ups. This is to make sure the medicine is working and that you are growing and developing O} - Ifyou take the medicine for more than one year, your doctor may stop your medicine to see if itis still needed. This will probably happen in a school holiday. ~ Donot drink alcohol. Alcohol may make the side effects of this medicine worse. ~ Girls must tell their doctor straight away if they think they may be pregnant. We do not know how this medicine affects phenomenon' ) unborn babies. If you are having sex, please talk to your doctor about contraception.
'Not known (frequency cannot be estimated from the available data)
Very rare (may affect up to ~~ muscle eramps
= small red marks on the skin = changes in test results including liver and blood te: _ shuormal inking, lack of fecting or emotion
= fingers ing numb, tingling and changing colour from white to blue, then red when cold ('Raynaud's
Some people cannot have this medicine You cannot have this medicine if:
= you have a problem with your heart
= you feel very unhappy, depressed or have a mental illness.
~ very high fever
~ slow, fast or extra heart beats
= amajor fit 'grand mal convulsions')
= believing things that are not true, confusion 'Some people need to talk to their doctor before they start having this medicine stomach pain, often with feeling and being sick You need to talk to your doctor if:
= erectile dysfunction = you have epilepsy (fits) = inability to control the excretion of urine (incontinence) = you are pregnant or breastfeedin, = spasm ofthe jv muscles tha makes i diieult to open the mouth (isms) = you are taking other medicines
= stuttering = your doctor needs to know about all the medicines you are taking,
How do I take my medicine (capsules)? +" Swallow your medicine wi water and food, {Your doctor will tll you how many des a day you should take your medicine
~ increased pressure in th = eye diseases which may
decreased vision due to damage to the eye nerve (glaucoma)
Effects on growth in children = Donot stop taking the medicine without talking to your doctor first. 'When used for more than one year, methylphenidate may cause reduced growth in some children. This affects less than 1 in 10 children oslo ide fects sfc
= there may be lack of weight gain or height increase = your doctor will carefully monitor height and weight, as well as how well your child is eating = ifyour child is not growing as expected, then treatment with methylphenidate may be stopped for a short time
me the unwanted things that can happen when you take a medicine, Many ofthe following tppen, tell n adult you trust straightaway. They can then talk to your doctor The main things tat could affect you ar Fe
. eine very depressed and unhappy or wanting to hurt yourself Reporting of side effects Having diferent moods than wen, not being able to gett seep Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You shes, bruising easily, getting out of bre can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow ©The medicine can also make you fel sleepy I ou feel sloop, itis important nt todo outdoor sports like riding abo Card' in the Google Play or Apple App Store You could huirt yourself and others.
- Your heart beating faster than usual
By reporting side effects you can help provide more information on the safety of this medicine.
Focusim XL-40 mg modified-release hard capsules comes as capsule containing 40 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 Focusim XL-40 mg modified-release hard capsules is methylphenidate hydrochloride.
Medicines with the same active substance include: Addepta XL 10 mg Modified-release capsule, Addepta XL 30 mg Modified-release capsule, 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. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Focusim XL-40 mg modified-release hard capsules, 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)
Methylphenidate 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 a psychiatrist.
Special diagnostic considerations for ADHD in children
Diagnosis should be made according to DSM criteria or the guidelines in ICD 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.
Special diagnostic considerations for ADHD in adults
Diagnosis should be made according to DSM criteria or the guidelines in ICD and should be based on a complete history and evaluation of the patient.
The specific aetiology 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 pre-existence of childhood ADHD is required and has to be determined retrospectively (by patients' records or if not available by appropriate and structured instruments/interviews). Third-party corroboration is desirable and Focusim XL 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 a psychiatrist.
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 (in children only) and weight on a growth chart (see sections 4.3 and 4.4).
Ongoing monitoring
Growth (in children/adolescents), weight (in adults), 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 (children), 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.
Posology
The specific galenics of Focusim XL simulate twice daily administration of an immediate-release methylphenidate formulation. About 50% of the total amount of the active substance is available in unretarded, immediate-release form, while the remaining 50% are released after approximately 4 hours.
Dose titration
Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose If symptoms do not improve after dose titration over a period of one month, the medicinal product should be discontinued.
If symptoms worsen or other adverse effects occur, the dose should be reduced or, if necessary, the medicinal product discontinued.
The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
Long-acting methylphenidate should not be taken too late in the morning as it may cause disturbances in sleep.
For the treatment of hyperkinetic disorders/ADHD the time of methylphenidate intake should be chosen in such a way that the effect concurs with the time of the largest school (in children) and social problems as well as behavioural abnormalities of the patient.
Other strengths of this medicinal product and other methylphenidate-containing products may be available.
Children (6 years and over)
Focusim XL is taken once daily in the morning. The recommended starting dose is 20 mg. When in the judgment of the clinician a lower initial dose is appropriate, the patient may begin treatment with 10 mg, alternatively it is recommended to start with conventional short-acting methylphenidate 10 mg and continuously increase according to the recommendation for this formulation.. The maximum daily dose of methylphenidate is 60 mg.
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.
Adults
Focusim XL is taken once daily usually in the morning. The time of the intake may be adapted according to the patient's individual needs, but intake should not be too late in the morning in order to prevent sleep disturbances. The dose should be titrated individually. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. Only the modified-release formulation of methylphenidate should be used for the treatment of ADHD in adults. A maximum daily dose of 80 mg should not be exceeded.
Patients new to methylphenidate (see section 5.1)
The recommended starting dose of Focusim XL in patients who are not currently taking methylphenidate is 20 mg once daily. Focusim XL dose may be adjusted at weekly intervals in 20 mg increments for adults. For lower doses or smaller increments, other strengths of Focusim XL or other methylphenidate-containing medicinal products are available.
Patients transitioning from childhood methylphenidate treatment to adulthood
Treatment may be continued with the same daily dose. If the patient was previously treated with an immediate-release formulation, a conversion to an appropriate recommended dose of Focusim XL should be made (see below “Switching patient's treatment to Focusim XL”).
Periodic assessment of the treatment in ADHD
Focusim XL should be discontinued periodically to assess the patient's condition. Improvement may continue when the medicinal product is temporarily or permanently discontinued. Treatment may be restarted as appropriate to control the symptoms of ADHD.
Medicinal product treatment should not, and need not, be indefinite. When used in children with ADHD, treatment can usually be discontinued during or after puberty.
Special populations
Elderly
Focusim XL should not be used in the elderly. Safety and efficacy has not been established in ADHD patients older than 60 years.
Hepatic impairment
Focusim XL has not been studied in patients with hepatic impairment. Caution should be exercised in these patients.
Renal impairment
Focusim XL has not been studied in patients with renal impairment. Caution should be exercised in these patients.
Children under 6 years of age
Focusim XL should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Switching patient's treatment to Focusim XL
Focusim XL, administered as a single dose, provides comparable overall exposure (AUC) of methylphenidate compared to the same total dose of immediate-release methylphenidate administered twice daily.
The recommended dose of Focusim XL should be equal to the total daily dose of the immediate-release formulation not exceeding a total dose of 60 mg in children and 80 mg in adults.
The recommended dose of Focusim XL for patients switched from an immediate-release formulation or a modified-release formulation to Focusim XL is as follows:
Table 1
| Previous methylphenidate dose | Recommended Focusim XL dose | |
| IR* | MR* | |
| 5 mg methylphenidate twice daily. | 10 mg modified-release methylphenidate | 10 mg per day |
| 10 mg methylphenidate twice daily. | 20 mg modified-release methylphenidate | 20 mg per day |
| 15 mg methylphenidate twice daily. | 30 mg modified-release methylphenidate | 30 mg per day |
| 20 mg methylphenidate twice daily. | 40 mg modified-release methylphenidate | 40 mg per day |
| 30 mg methylphenidate twice daily. | 60 mg modified-release methylphenidate | 60 mg per day |
* IR: immediate-release, MR: modified-release
The maximum daily dose of methylphenidate is 60 mg for treatment of ADHD in children and 80 mg for treatment of ADHD in adults.
For other methylphenidate regimens, clinical judgment should be used when selecting the starting dose. Focusim XL dose for treatment of ADHD in children may be adjusted at weekly intervals in 10 mg increments.
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 in children and adolescents. The long term safety of methylphenidate has not been systematically evaluated in controlled clinical trials in adults. Methylphenidate treatment should not and need not, be indefinite. In children and adolescents with 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 patient's condition (for children, 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
Only the modified-release formulation is licensed for use in adults with ADHD. Safety and efficacy of other formulations have not been established in this age group.
Method of administration
Focusim XL is for oral use.
Focusim XL modified-release hard capsules may be administered with or without food. They may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of food.
Focusim XL modified-release hard capsules must not be crushed, chewed, or divided.
Administration by sprinkling capsule contents on food
For ease of intake, the modified-release capsules may be carefully opened and the pellets sprinkled over soft food (e.g. apple sauce). The food should not be warm because this could affect the modified-release properties of this formulation. The mixture of medicinal product and food should be consumed immediately in its entirety. The medicinal product and food mixture should not be stored for future use. The pellets sprinkled over food (e.g. apple sauce) should not be chewed or crushed.
- 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 effect 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, primodone) 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)
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 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 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. 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, (see section 4.8). 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.
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 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 Focusim XL-40 mg modified-release hard capsules. 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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