Patient leaflet - Methylphenidate Hydrochloride 5 mg tablets
1. What Methylphenidate is and what it is used for
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 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'). They will check your or your child's mental health history, and check if any of your family have a history of suicide, bipolar disorder, or depression.
It is important that you provide as much information as you can. This will help your doctor decide if
methylphenidate is the correct medicine for you or your child. Your doctor may decide that other medical tests are needed before you or your child start taking this medicine.
If you or your child have or have had heart problems before starting treatment or develop heart symptoms during treatment with Methylphenidate, tell your doctor immediately, who will refer you to a heart specialist.
Methylphenidate contains the active substance 'methylphenidate hydrochloride'. It belongs to a group of medicines known as psychostimulants.
What it is used for
Methylphenidate is used to treat 'Attention Deficit Hyperactivity Disorder' (ADHD).
It is used in children and young people 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 and which have been insufficient.
During treatment, boys and men 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 the erection lasts for longer than 2 hours, particularly if this is painful. Other medicines and Methylphenidate
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.
Methylphenidate is not for use as a treatment for ADHD in children under 6 years of age or in patients older than 60 years. It is not known if it is safe or of benefit in these age groups.
How it works
Methylphenidate 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.
Methylphenidate 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, a child and adolescent psychiatrist or a psychiatrist. A thorough examination is necessary. 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. Using treatment programmes as well as medicine helps to manage ADHD.
Contact your doctor if you or your child do not feel any improvement or if you or your child feel worse.
If you or your child are taking other medicines, methylphenidate may affect how well they work or may cause side effects. It may therefore be necessary to adjust the dosage of the medicine or to stop taking it altogether. 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 (e.g. to treat
schizophrenia)
- medicines for epilepsy
- medicines used to reduce or increase blood pressure
some cough and cold remedies which contain medicines
that can affect blood pressure. It is important to check with your pharmacist when you buy any of these products
- medicines that thin the blood to prevent blood clots If you are in any doubt about whether any medicines you or your child are taking are included in the list above, ask your doctor or pharmacist before taking methylphenidate.
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 surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.
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, with ADHD they can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places.
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.
ADHD does not affect intelligence.
Not all patients with ADHD need to be treated with medicine and the decision to treat with Methylphenidate requires a very thorough assessment of the severity and duration of the patient's symptoms in relation to age.
Examinations during treatment with Methylphenidate
Your doctor will regularly check your (or your child's) health while being treated with Methylphenidate (please read carefully section 3, 'Things your doctor will do when you or your child are on treatment').
2. What you need to know before you take Methylphenidate
Do not take Methylphenidate if you or your child:
are allergic (hypersensitive) to methylphenidate or any of the
other ingredients of this medicine (listed in section 6)
are taking a medicine called a 'monoamine oxidase inhibitor'
(MAOI) used for depression, or have taken an MAOI in the last 14 days (see 'Other medicines and Methylphenidate')
- have a thyroid problem
- have increased pressure in the eye (glaucoma)
- have a tumour of the adrenal gland (phaeochromocytoma)
have an eating problem when not feeling hungry or wanting
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 the brain - such
as a stroke, swelling and
weakening of part of a blood vessel (aneurysm), narrow or
blocked blood vessels, or inflammation
- of the blood vessels (vasculitis)
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:
o feeling like killing yourself
o severe depression, where you feel very sad,
worthless, and hopeless
o mania, where you feel unusually excitable, over-
active, and un-inhibited.
o severe (type 1) bipolar disorder (switch between
depression and mania) that is not well controlled.
Do not take methylphenidate if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before taking methylphenidate. This is because methylphenidate can make these problems worse.
Drug testing
This medicine may give a positive result when testing for drug use.
Methylphenidate with food, drink and alcohol
Methylphenidate may be taken with or without food. Taking this medicine with food may help to stop stomach pains, feeling sick or being sick. If you or your child notice a decrease in appetite while taking this medication, try to avoid taking it just before a meal. Instead, try taking it with food or after finishing eating.
Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 or your daughter are:
having sex. Your doctor will discuss contraception with you
or your daughter.
Pregnant, think you may be pregnant, or are planning to
become pregnant. Your doctor will decide whether you or your daughter should take methylphenidate.
breast-feeding or planning to breast-feed. It is possible that
methylphenidate is passed into human breast milk. Therefore, your doctor will decide whether you or your daughter should breast-feed while taking methylphenidate.
Driving and using machines
You or your child may feel dizzy or drowsy, have problems focusing the eyes or have blurred vision, or have hallucinations or other central nervous system side effects 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.
Important information about some of the ingredients of Methylphenidate
Lactose and Sodium:
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
3. How to take Methylphenidate
Always take Methylphenidate exactly as your doctor has told. Check with your doctor or pharmacist if you are not sure.
How much to take
Your doctor will usually start treatment with a low dose and
increase it gradually as required.
The last doses should, in general, not be given within 4 hours before bedtime in order to prevent disturbances in falling asleep
- Children and adolescents : the maximum daily dose is 60 mg.
- Adults: the maximum daily dose is 80 mg.
At the beginning of treatment, Methylphenidate is taken
once or twice daily (e.g. at breakfast or/and lunchtime). As your treatment continues, your doctor may ask you to take it more often (e.g. 2-3 times daily).
Warnings and precautions
Check with your doctor or pharmacist before taking Methylphenidate if you or your child:
- have liver or kidney problems
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 female and have started your periods (see the
'Pregnancy and breast-feeding' 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. Other mental health problems include:
mood swings (from being manic to being depressed -
called 'bipolar disorder')
starting to be aggressive or hostile, or your aggression
gets worse
seeing, hearing or feeling things that are not there
(hallucinations)
- believing things that are not true (delusions)
- feeling unusually suspicious (paranoia)
- feeling agitated, anxious or tense
feeling depressed or guilty.
How to take Methylphenidate
- Methylphenidate can be taken with or without food.
- The tablets should be swallowed with a drink of water.
The break line is only there to help you break the tablet if you
have difficulty swallowing it whole [10 mg/20 mg only].
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. They may decide you or your child need a different treatment.
Things your doctor will do when you are on treatment Your doctor will do some tests and checks
before you or your child start treatment - to make sure that
Methylphenidate is safe and will be of benefit.
after you or your child have started treatment - the tests will
be done at least every 6 months, but possibly more often. They will also be done when the dose is changed.
these tests and checks will include the following:
- checking appetite
measuring the height and weight of children and
adolescents
- recording the weight of adults
- measuring blood pressure and heart rate
checking whether there are any problems with mood,
state of mind or any other unusual feelings. Or if these have got worse while taking Methylphenidate.
Tell your doctor or pharmacist if any of the above apply to you or your child before starting treatment. This is because methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects you or your child.
If you or your child develop blurred vision or other visual disturbances contact your doctor. Your doctor may consider discontinuation of Methylphenidate.
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,
your child or your family may have
how you or your child are feeling, such as feeling high or low,
having strange thoughts or if you have had any of these feelings in the past
Long-term treatment
Methylphenidate does not need to be taken forever. If you or your child take Methylphenidate for more than a year, your doctor should stop treatment at least once per year for a short time. For children and adolescents, this may happen during a school holiday. This will show if the medicine is still needed.
Not using Methylphenidate properly
Attention should be paid to the risk of diversion, misuse and abuse of this medicine. Long-term abuse of Methylphenidate may lead to a lack of efficacy of usual doses (tolerance), psychological dependence, abnormal behaviour or psychotic episodes (hallucinations, delusions). It may also mean that you or your child become dependent on the medicine. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
This medicine is only for you or your child. Do not give this medicine to anyone else, even if symptoms seem similar.
If you or your child take more Methylphenidate 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. You or your child may need medical treatment
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, dry nose and
mouth, muscle spasms, fever, red-brown urine which could be possible signs of abnormal breakdown of muscles (rhabdomyolysis).
If you or your child forget to take Methylphenidate
Do not take a double dose to make up for a forgotten dose. If you or your child have missed a dose, wait until it is time for the next dose.
If you or your child stop taking Methylphenidate
If you or your child suddenly stop taking this medicine, the ADHD symptoms may come back or unwanted effects such as depression may occur. Talk to your doctor before stopping Methylphenidate.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Although
some people get side effects, most people find that methylphenidate helps them. Your doctor will talk to you about these side effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight away:
Common (affects less than 1 in 10 people)
- uneven/irregular heartbeat (palpitations,arrhythmia)
- changes in personality
Uncommon (affects less than 1 in 100 people)
- thinking about or feeling like killing yourself
- mood changes or mood swings
feeling or hearing things that are not real(hallucinations),
these are signs of psychosis
- uncontrolled speech and body movements (tics,Tourette's)
- heart murmur (detected by auscultation of the heart)
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 (affects less than 1 in 1,000 people)
- feeling unusually excited, over-active and un-inhibited (mania)
Very rare (affects less than 1 in 10,000 people)
- heart attack (with risk of sudden death)
- fits (seizures, convulsions)
- skin peeling or purplish red patches
- suicidal attempt (including completed suicide)
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
- inflammation or blocked arteries in the brain
a sudden increase in body temperature, very high blood
pressure and severe convulsions ('Neuroleptic Malignant Syndrome'). It is not certain that this side effect is caused by methylphenidate or other drugs that may be taken in combination with methylphenidate.
Not known (how often they happen is not known)
- unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath (these
can be signs of heart problems)
problems with blood vessels in the brain (stroke, cerebral
arteritis, or cerebral occlusion)
- a major fit ('grand mal convulsions')
- dependence on methylphenidate
Other side effects include the following, if they get serious, please tell your doctor or pharmacist:
Very common (affects more than 1 in 10 people)
- decreased appetite
- headache
- feeling nervous
- not being able to sleep.
- feeling sick
- dry mouth
Common (affects less than 1 in 10 people)
- joint pain
- high temperature (fever)
- unusual hair loss or thinning
- feeling unusually sleepy or drowsy
- loss of appetite
reduced weight gain and growth retardation during
prolonged use in children
- weight loss in adults
- panic attack
- decrease in sex drive
- toothache
- itching, rash or raised red itchy rashes (hives)
- excessive sweating
cough, sore throat or nose and throat irritation ,shortness of
breath
changes in blood pressure (usually high blood pressure),
fast heart beat (tachycardia)
- cold hands and feet
shaking or trembling, feeling dizzy, movements which you
cannot control, feeling jittery, being unusually active
feeling aggressive, agitated, restless, anxious, depressed,
stressed,irritable and abnormal behavior, problems sleeping, tiredness
stomach pain, diarrhoea, stomach discomfort, indigestion,
thirst,and being sick
- excessive teeth grinding (bruxism)
Uncommon (affects less than 1 in 100 people)
- constipation
- chest pain
- blood in the urine
- double vision or blurred vision
- muscle pain, muscle twitching, muscle tightness
- increases in liver test results (seen in a blood test)
anger, feeling tearful, excessive awareness of
surroundings,tension
stomach pain, often with nausea, vomiting, and diarrhoea
(gastroenteritis)
- a compelling need to move (akathisia)
- dry eye
Rare (affects less than 1 in 1,000 people)
- changes in sex drive
- feeling disorientated
- dilated pupils, trouble seeing
- swelling of the breasts in men (gynaecomastia)
- 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 (affects less than 1 in 10,000 people)
- muscle cramps
- small red marks on the skin
- abnormal liver function including liver failure and coma
- changes in test results – including liver and blood tests
- abnormal thinking, lack of feeling or emotion
fingers and toes feeling numb, tingling, and changing colour
(from white to blue, then red) when cold ('Raynaud's phenomenon')
Not known(how often they happen is not known):
- migraine
- very high fever
- chest discomfort
- slow, fast or extra heart beats
- believing things that are not true (delusions), confusion
- excessive uncontrolled talking
- erectile dysfunction
prolonged erections, sometimes painful, or an increased
number of erections
- 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 child's height and weight, as well as how well your child is eating.
- If your child is not growing as expected, then treatment with methylphenidate may need to be stopped.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Methylphenidate
Make sure you keep your medicine in a safe place, so that no one else takes it, especially younger brothers or sisters.
Do not use Methylphenidate after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Keep this medicine out of sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Methylphenidate contains
The active substance is methylphenidate hydrochloride. Each tablet contains 5 mg or 10 mg or 20 mg of methylphenidate hydrochloride.
The other ingredients are: lactose monohydrate, maize starch, sodium starch glycolate (type A), hypromellose, citric acid monohydrate, silica, colloidal anhydrous and magnesium stearate.
What Methylphenidate looks like and contents of the pack
5 mg: White to off white, circular, flat bevelled edged tablets engraved with '5' on one side and '73' on the other side.
10 mg: White to off-white, circular, flat bevelled edged tablets with a breakline, engraved “10” on one side and “73” on the other side.
20 mg: White to off-white, circular, flat bevelled edged tablets with a breakline, engraved “20” on one side and “73” on the other side.
The medicinal product is available in blister pack containing 10, 30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Limited.
Micro House,
Bury Street,
Ruislip, HA4 7TL,
United Kingdom.
This leaflet was last revised in 03/2026.
Information for children and young people with ADHD
This info is to help you learn the main things about your medicine called Methylphenidate.
If you don't enjoy reading, someone like your mum, dad or carer (sometimes called 'your guardian') can read it to you and answer any questions.
It may help if you read small bits at a time.
Why have I been given this medicine?
This medicine can help children and young people with 'ADHD'.
ADHD can make you:
o run about too much
o not be able to pay attention
o act quickly without thinking about what will happen next
(impulsive).
- It affects learning, making friends and how you think about yourself. It is not your fault.
While you are taking this medicine
- As well as taking this medicine you will also get help with ways to cope with your ADHD such as talking to ADHD specialists.
- This medicine should help you. But it does not cure ADHD.
- You will need to go 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 OK.
- If you take the medicine for more than one year, your doctor may stop your medicine to see if it is still needed. This will probably happen in a school holiday.
- If you take this medicine more than once a day, you may have to remember to take it at school or college. You or your mum, dad or carer will need to find out what the school rules are about this.
- Do not 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 unborn babies. If you are having sex, please talk to your doctor about contraception.
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.
Some people need to talk to their doctor before they start having this medicine
You need to talk to your doctor if:
- you have epilepsy (fits)
- you are pregnant or breastfeeding
- you are taking other medicines – your doctor needs to know about all the medicines you are taking.
How do I take my medicine (tablets)?
- Swallow your medicine with water.
- Your doctor will tell you how many times a day you should take your medicine
- Do not stop taking the medicine without talking to your doctor first.
Possible side effects
Side effects are the unwanted things that can happen when you take a medicine. If any of the following happen or if you have any concerns about other possible side effects tell an adult you trust straight away. They can then talk to your doctor. The main things that could affect you are:
- Feeling or being sick, having tummy pains or having a dry mouth. These may only happen when you first start taking the medicine. It is best to take the medicine with food
- Feeling worried or nervous
- Feeling shaky, trembling or being unusually active
- Feeling dizzy, or getting head aches
- Being very depressed and unhappy or wanting to hurt yourself
- Being very sweaty
- Having different moods than usual, not being able to get to sleep
- Skin rashes, bruising easily, getting out of breath or chest pains
- The medicine can also make you feel sleepy. If you feel sleepy, it is important not to do outdoor sports like riding a horse or bike, swimming or climbing trees. You could hurt yourself and others.
- Your heart beating faster than usual.
If you feel unwell in any way while you are taking your medicine please tell an adult you trust straight away.
Other things to remember
- Make sure you keep your medicine in a safe place, so that no one else takes it, especially younger brothers or sisters.
- The medicine is special for you - do not let anyone else have it. It may help you, but it could hurt someone else.
- If you forget to take your medicine don't take two tablets the next time. Just take one tablet at the next normal time.
- If you do take too much medicine, tell your mum, dad or carer right away.
- It is important not to take too much medicine or you will get ill.
- Don't stop taking your medicine until your doctor says it's OK.
Who should I ask if there is anything I don't understand?
Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.