Active ingredient
- methylphenidate hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 11243/0002.
Medikinet Tablets
Package Leaflet: Information for the user
Medikinet 5 mg tablets
Medikinet 10 mg tablets
Medikinet 20 mg tablets
Methylphenidate hydrochloride
The name of your medicine is Medikinet, it contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used in the leaflet.
Important things you need to know about your medicine
This medicine is used to treat ADHD
Read section 1 for more information.
Before you take this medicine, talk to your doctor if:
Read section 2 for more information.
While taking this medicine:
Read sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
Read section 4 for more information.
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
See section 4.
The leaflet has been written in sections:
However, all sections are written as though the child or young person taking the medicine is reading them.
What is in this leaflet:
1. What Medikinet is and what is used for
2. What you need to know before you or your child takes Medikinet
3. How to take Medikinet
4. Possible side effects
5. How to store Medikinet
6. Contents of the pack and other information
Information for children and young people
Now read the rest of this leaflet before you start taking this medicine.
1. What Medikinet is and what is used for
What it is used for
MEDIKINET is used to treat ‘attention deficit hyperactivity disorder’ (ADHD).
MEDIKINET is not for use as a treatment for ADHD in children under 6 years of age or in adults. It is not known if it is safe or of benefit in these people.
How it works
MEDIKINET 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:
MEDIKINET treatment must only be initiated by, and used under the supervision of, a specialist in childhood and/or adolescent behavioural disorders. Although there is no cure for ADHD, it can be managed using treatment programmes.
About ADHD
Children and young people with ADHD find it:
It is not their fault that they cannot do these things.
Many children and young people struggle to do these things. However, with ADHD they can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places.
ADHD does not affect the intelligence of a child or young person.
2. What you need to know before you or your child takes Medikinet
Do not take MEDIKINET
If you or your child
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 you or your child takes methylphenidate. This is because methylphenidate can make these problems worse.
Warnings and precautions
Talk to your doctor before taking MEDIKINET if you or your child
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.
Checks that your doctor will make before you 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:
Your doctor will discuss whether you or your child is at risk of having mood swings (from being manic to being depressed - called ‘bipolar disorder’). They will check you 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.
During treatment, boys and adolescents may unexpectedly experience prolonged erections. This may be painful and can occur at any time. It is important to contact your doctor straight away if your erection lasts for longer than 2 hours, particularly if this is painful.
Drug testing
This medicine may give a positive result when testing for drug use.
Athletes must be aware that this medicinal product may cause a positive reaction to ‘anti-doping’ tests.
Other medicines and MEDIKINET
Please tell your doctor or pharmacist if you or your child is taking, has recently taken or may take any other medicines.
Do not take methylphenidate if you or your child:
If you or your child is taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you or your child is taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate:
If you are in any doubt about whether any medicines you or your child is taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.
Having an operation
Tell your doctor if you or your child is going to have an operation. Methylphenidate should not be taken on the day of surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in blood pressure during the operation.
Taking MEDIKINET with food and drink
Taking MEDIKINET with food may help to stop stomach pains, feeling sick or being sick.
Taking methylphenidate with alcohol
Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol.
Pregnancy and breast-feeding
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:
Driving and using machines
You or your child may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.
MEDIKINET contains lactose
If you or your child has been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicinal product.
3. How to take MEDIKINET
How much to take
You or your child should always take MEDIKINET exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The maximum daily dose is 60 mg.
Your doctor will do some tests
How to take
The medicinal product is intended for oral use.
You or your child should swallowed MEDIKINET tablets with a drink of water. If needed the tablets can be divided into halves. Take the tablets with or after a meal.
If you or your child does not feel better after 1 month of treatment
If you or your child does not feel better, tell your doctor. They may decide a different treatment is needed.
Long-term treatment
MEDIKINET does not need to be taken for ever. If you or your child takes MEDIKINET for more than a year, your doctor should stop treatment for a short time, this may happen during a school holiday. This will show if the medicine is still needed.
Not using MEDIKINET properly
If MEDIKINET 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.
If you or your child takes more MEDIKINET than you should
If you or your child takes too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken.
Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.
If you or your child forgets to take MEDIKINET
Do not take a double dose to make up for a forgotten dose. If you or your child forgets a dose, wait until it is time for the next dose.
If you or your child stops taking MEDIKINET
If you or your child suddenly stops taking this medicine, 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 MEDIKINET.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, but not everybody gets them. Your doctor will talk to you about these side effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight away:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from available data
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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from available data
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.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Medikinet
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 blister and the box after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What MEDIKINET contains:
The active substance is: methylphenidate hydrochloride
MEDIKINET 5 mg tablets
Each tablet contains 5 mg methylphenidate hydrochloride equivalent to 4.35 mg methylphenidate.
MEDIKINET 10 mg tablets
Each tablet contains 10 mg methylphenidate hydrochloride equivalent to 8.65 mg methylphenidate.
MEDIKINET 20 mg tablets
Each tablet contains 20 mg methylphenidate hydrochloride equivalent to 17.30 mg methylphenidate.
The other ingredients are:
Microcrystalline cellulose, Pregelatinised maize starch, Calcium hydrogen phosphate dihydrate, Lactose monohydrate, Magnesium stearate
What MEDIKINET looks like and contents of the pack:
MEDIKINET 5 mg tablets
Tablet (white, round) embossed with "S". The tablets can be divided into halves.
Pack sizes: 20, 30 or 50 tablets
Boxes containing tablets packed in blisters made of PVC/PE/PVdC aluminium foil.
MEDIKINET 10 mg tablets
Tablet (white, round) embossed with "M". The tablets can be divided into halves.
Pack sizes: 20, 30, 50 or 100 tablets
Boxes containing tablets packed in blisters made of PVC/PVdC aluminium foil.
MEDIKINET 20 mg tablets
Tablet (white, round) embossed with "L". The tablets can be divided into halves.
Pack sizes: 30 or 50 tablets
Boxes containing tablets packed in blisters made of PVC/PVdC aluminium foil.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany:
Medikinet 5 mg, 10 mg, 20 mg Tabletten
Denmark:
Medikinet 5 mg, 10 mg, 20 mg
Finland:
Medikinet 5 mg, 10 mg, 20 mg
Iceland:
Medikinet 5 mg, 10 mg, 20 mg tafla
Luxembourg:
Medikinet 5 mg, 10 mg, 20 mg
Netherlands:
Medikinet 5 mg, 10 mg, 20 mg
Norway:
Medikinet 5 mg, 10 mg, 20 mg
Poland:
Medikinet 5 mg, 10 mg, 20 mg
Spain:
Medicebran 5 mg, 10 mg, 20 mg
Sweden:
Medikinet 5 mg, 10 mg, 20 mg
United Kingdom:
Medikinet 5 mg, 10 mg, 20 mg tablets
This leaflet was last revised in 08/2020.
Information for children and young people
This info is to help you learn the main things about your medicine called MEDIKINET.
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’.
While you are taking this medicine
Some people cannot have this medicine
You cannot have this medicine if:
Some people need to talk to their doctor before they start having this medicine
You need to talk to your doctor if:
How do I take my medicine (tablets)?
Possible side effects
Side effects are the unwanted things that can happen when you take a medicine. If any of the following happen, tell an adult you trust straight away. They can then talk to your doctor. The main things that could affect you are:
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
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.
Marine House, Clanwilliam Place, Dublin 2, Republic of Ireland
+44 (0)1438 727822
+44 (0)1438 727822
+44 (0)1773 510 123
+44 (0)1438 727805
+44 (0)1438 727805