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 01883/0361.
Xaggitin XL 18mg, 27mg, 36mg, 54mg prolonged-release tablets
INFORMATION FOR THE USER
Xaggitin XL 18mg, 27mg, 36mg, 54mg prolonged-release tablets
methylphenidate hydrochloride
The name of your medicine is Xaggitin XL, it contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used in this 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.
The rest of this leaflet includes more detail and other important information on the safe and effective use of this medicine.
It may harm them, even if their symptoms are the same as yours.
Read Section 4 for more information.
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.
The sections are:
1. What Xaggitin XL is and what it is used for
2. What you need to know before you take Xaggitin XL
3. How to take Xaggitin XL
4. Possible side effects
5. How to store Xaggitin XL
6. Contents of the pack and further information
Information for children and young people
Now read the rest of this leaflet before you start taking this medicine
1. What Xaggitin XL is and what it is used for
What it is used for
Xaggitin XL is used to treat ‘attention deficit hyperactivity disorder’(ADHD).
Xaggitin XL is not for use as a treatment for ADHD in children under 6 years of age or for initiation of treatment in adults. When treatment was started at a younger age, it might be appropriate to continue taking Xaggitin XL when you become an adult. Your doctor will advise you about this.
How it works
Xaggitin XL improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes:
It is prescribed only by doctors who have experience in children or adolescents’ behaviour problems. Although there is no cure for ADHD, it can be managed using treatment programmes.
About ADHD
Children and adolescents with ADHD find it:
It is not their fault that they cannot do these things.
Many children and adolescents struggle to do these things. However, with ADHD they can cause problems with everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places.
ADHD does not affect the intelligence of a child or adolescent.
2. What you need to know before you take Xaggitin XL
Do not take Xaggitin XL if you
Do not take methylphenidate if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take methylphenidate. This is because methylphenidate can make these problems worse.
Warnings and precautions
Talk to your doctor before taking Xaggitin XL if you:
Other mental health problems include:
Tell your doctor or pharmacist if any of the above apply to you before starting treatment. This is because methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects you.
During treatment, boys and adolescents may unexpectedly experience prolonged erections. This may be painful and can occur at any time. It is important to contact your doctor straight away if your erection lasts for longer than 2 hours, particularly if this is painful.
Checks that your doctor will make before you start taking Xaggitin XL.
These checks are to decide if methylphenidate is the correct medicine for you. Your doctor will talk to you about:
Your doctor will discuss whether you are at risk of having mood swings (from being manic to being depressed - called ‘bipolar disorder’). They will check your mental health history, and check if any of your family has a history of suicide, bipolar disorder or depression.
It is important that you provide as much information as you can. This will help your doctor decide if methylphenidate is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine.
Other medicines and Xaggitin XL
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take methylphenidate if you:
Tell your doctor or pharmacist if you or your child are taking any of the following medicines for depression or anxiety:
Taking methylphenidate with these type of medicine could cause a life threatening increase of ‘serotonin’ in the brain (serotonin syndrome), which may lead to feeling confused or restless, sweating, shivering, muscle jerks or fast heartbeat. If you or your child develop these side effects, see a doctor straight away.
If you are taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you are taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate:
If you are in any doubt about whether any medicines you are taking are included in the list above, ask your doctor or pharmacist before taking methylphenidate.
Having an operation
Tell your doctor if you are going to have an operation. You should not take methylphenidate on the day of your surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in blood pressure during the operation.
Drug testing/anti-doping testing
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Xaggitin XL with alcohol
Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol.
Pregnancy, breast-feeding and contraception
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Available data do not suggest an increased risk of overall birth defects, whilst a small increase in the risk of malformations of the heart when used during the first three months of pregnancy could not be ruled out.
Your doctor will be able to give you more information about this risk. Tell your doctor or pharmacist before using methylphenidate if you or your daughter:
Driving and using machines
You may feel dizzy, have problems focussing or have blurred vision when taking methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Xaggitin XL contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Xaggitin XL
How much to take
Always take medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The tablet should be swallowed whole and not chewed, broken, divided or crushed. The tablet may be taken with or without food.
If you do not feel better after 1 month of treatment
If you do not feel better, tell your doctor. They may decide you need a different treatment.
Things your doctor will do when you are on treatment
Your doctor will do some tests
Long-term treatment
Xaggitin XL does not need to be taken forever. If you take Xaggitin XL for more than a year, your doctor should stop treatment for a short time, this may happen during a school holiday. This will show if the medicine is still needed.
Not using Xaggitin XL properly
If Xaggitin XL is not used properly, this may cause abnormal behaviour. It may also mean that you start to depend on the medicine. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
This medicine is only for you. Do not give this medicine to anyone else, even if their symptoms seem similar.
If you take more Xaggitin XL than you should
If you take too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken.
Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.
If you forget to take Xaggitin XL
Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until it is time for the next dose.
If you stop taking Xaggitin XL
If you suddenly stop taking this medicine, the ADHD symptoms may come back or unwanted effects such as depression may appear. Your doctor may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Talk to your doctor before stopping Xaggitin XL.
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, although not everybody gets them. Although some people get side effects, most people find that methylphenidate helps them. Your doctor will talk to you about these side effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight away
Common (may affect up to 1 in 10 people)
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 the 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 the 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 Xaggitin XL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the label after ‘EXP’. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
Shelf life after first opening the bottle:
18 mg tablets: 3 months
27 mg tablets: 6 months
36 mg tablets: 6 months
54 mg tablets: 6 months
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use
These measures will help protect the environment.
6. Contents of the pack and other information
What Xaggitin XL contains
The active substance is methylphenidate hydrochloride.
Xaggitin XL 18mg: Each prolonged-release tablet contains 18mg of methylphenidate hydrochloride equivalent to 15.6 mg of methylphenidate.
Xaggitin XL 27mg: Each prolonged-release tablet contains 27mg of methylphenidate hydrochloride equivalent to 23.3 mg of methylphenidate.
Xaggitin XL 36mg: Each prolonged-release tablet contains 36mg of methylphenidate hydrochloride equivalent to 31.1 mg of methylphenidate.
Xaggitin XL 54mg: Each prolonged-release tablet contains 54mg of methylphenidate hydrochloride equivalent to 46.7 mg of methylphenidate.
The other ingredients are:
Tablet core:
Lactose monohydrate, hypromellose, silica (colloidal anhydrous), magnesium stearate, fumaric acid, methacrylic acid–methyl methacrylate copolymer (1:1), methacrylic acid–methyl methacrylate copolymer (1:2), triethyl citrate, talc.
Tablet coating:
18mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
27mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171), iron oxide yellow (E172), Indigo carmine aluminium lake (E132), iron oxide black (E172).
36mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171).
54mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171), iron oxide red (E172).
Printing ink:
Shellac glaze, iron oxide black (E172), propylene glycol.
What Xaggitin XL looks like and contents of the pack
18mg Tablet: Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9 mm, with “2392” printed on one side in black ink.
27mg Tablet: Capsule-shaped, biconvex, grey tablet, 6.7 mm x 12.0 mm, with “2393” printed on one side in black ink.
36mg Tablet: Capsule-shaped, biconvex, white tablet, 6.7 mm x 12.0 mm, with “2394” printed on one side in black ink.
54mg Tablet: Capsule-shaped, biconvex, red-brown tablet, 6.8 mm x 12.0 mm, with “2395” printed on one side in black ink.
Xaggitin XL is available in bottles with child-resistant closure, with silica gel desiccant integrated into the closure, containing 28, 30 or 90 prolonged-release tablets (18 mg tablets) or 28, 30 or 100 prolongedrelease tablets (27 mg, 36 mg and 54 mg tablets). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in September 2020
Information for children and young people
This info is to help you learn the main things about your medicine called Xaggitin XL. 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’.
It is not your fault.
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
D50204
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