ADDEPTA XL 20 MG MODIFIED-RELEASE HARD CAPSULES - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Addepta XL is and what it is used for

• 2. What you need to know before you or your child take Addepta XL

• 3. How to take Addepta XL

• 4. Possible side effects

• 5. How to store Addepta XL

• 6. Contents of the pack and other information

– any mental health or behaviour problems you, your child or other family members have or have ever had. Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to being depressed, -known as bipolar disorder). Your doctor will check your or your child’s mental health history, and check if any of your family has a history of suicide, bipolar disorder or depression.

It is important that you provide as much information as you can. This will help your doctor decide if methylphenidate is the correct medicine for you or your child. Your doctor may decide that other medical tests are needed before you start taking this medicine.

Having an operation

Tell your doctor if you or your child are going to have an operation. Methylphenidate should not be taken on the day of your surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden rise in blood pressure during the operation.

Prolonged erections

Duringtreatmen­t,boysand adolescents may unexpectedly experience prolonged erections. This may be painful and can occur at any time. It is important to contact your doctor straight awayif youror your child’s erection lasts for longer than2 hours,particularly if this is painful.

Drug testing

This medicine may give a positive result when testing for drug use.

Children and adolescents

Addepta XL is not for use as a treatment for ADHD in children under 6 years of age. It is not known if it is safe or of benefit in children under 6 years of age.

Adults and elderly

Addepta XL is not for use as a treatment for ADHD in adults and the elderly above the age of 18 years. It is not known if it is safe or of benefit in adults and elderly.

Other medicinesandAddepta XL

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

Do not take methylphenidate if you or your child:

• – are taking a medicine called a monoamine oxidase inhibitor (MAOI) used for depression, or have taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate may affect how well they work or may cause side effects. If you or your child are taking any of the following medicines, check with your doctor or pharmacist before taking methylphenidate: – other medicines for depression

• – medicines for severe mental health problems

• – medicines for epilepsy

• – medicines used to reduce or increase blood pressure

• – some cough and cold remedies which contain substances that can affect blood pressure. It is important to check with your pharmacist when you buy any of these medicines

• – medicines that thin the blood to prevent blood clots.

If you are in any doubt about whether medicines you or your child are taking are included in the list above, ask your doctor or pharmacist for advice before taking methylphenidate.

Methylphenidate with alcohol

Do not drink alcohol whilst taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol.

Do not take Addepta XL if you or your child:

• – are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)

• – have a thyroid problem

• – have increased pressure in your eye (glaucoma)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be

– have a tumour of your adrenal gland (phaeochromocytoma)

pregnant or are planning to have a baby, ask your doctor or

• – have an eating problem where you do not feel hungry or want to eat (such as anorexia nervosa)

• – have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs

• – have ever had heart problems such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease or an inherent heart problem

• – have had a problem with the blood vessels in your brain such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis)

• – is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) – see other medicines and Addepta XL

• – have mental health problems such as:

• – a psychopathic or borderline personality problem

• – abnormal thoughts or hallucinations, or an illness called schizophrenia

• – signs of a severe mood problem like:

• – suicidal thoughts

• – severe depression, where you feel very sad, worthless and hopeless

• – mania, where you feel unusually excitable, over-active, and uninhibited.

Do not take methylphenidate if any of the above applies to you or your child. If you are not sure, talk to your doctor or pharmacist before taking methylphenidate. This is because methylphenidate can make these problems worse.

Warnings and precautions

Talk to your doctor or pharmacist before taking Addepta XL if you or your child:

• – have liver or kidney problems

• – have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEG)

• – have ever abused or been dependent on alcohol, prescription medicines or street drugs

• – are female and have started having periods (see section ‘Pregnancy and breast-feeding below)

• – have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words (tics)

• – have high blood pressure

• – have a heart problem which is not mentioned in the section “Do not take Addepta XL ”

• – have a mental health problem which is not mentioned in the section “Do not take Addepta XL ”. Other mental health problems include:

• – mood swings (from being manic to being depressed, -known as bipolar disorder)

• – aggressive or hostile behaviour, or aggression which gets worse

• – seeing, hearing or feeling things that are not there (hallucinations)

• – believing things that are not true (delusions)

• – feeling unusually suspicious (paranoia)

• – feeling agitated, anxious or tense

• – feeling depressed or guilty.

Tell your doctor or pharmacist if any of the above applies to you or your child before starting treatment. This is because methylphenidate can make these problems worse. Your doctor will want to monitor how the medicine affects you or your child.

Checks that your doctor will make before you or your child start taking methylphenidate

These checks are to decide if methylphenidate is the correct medicine for you or your child. Your doctor will talk to you about: – any other medicines you or your child are taking

• – whether there is any family history of sudden unexplained death

• – any other medical problems (such as heart problems) you or your family may have

• – how you or your child are feeling, such as feeling high or low, having strange thoughts, or if you or your child have had any of these feelings in the past

• – whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the body, or repeating sounds and words)

pharmacist for advice before taking this medicine.

Available data does not suggest an increased risk of overall birth defects, whilst a small increase in the risk of heart malformations when used during the first three months of pregnancy could not be ruled out. Your doctor will be able to give you more information about this risk.Tell your doctor or pharmacist before using methylphenidate if you or your daughter is:

• – having sex. Your doctor will discuss contraception

• – pregnant or might be pregnant. Your doctor will decide whether methylphenidate should be taken

• – breast-feeding or are planning to breast-feed. It is possible that methylphenidate is passed into breast milk, so your doctor will decide whether you or your daughter should breast-feed while taking methylphenidate.

Driving and using machines

You or your child may feel dizzy, have problems focusing or have blurred vision when taking methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• – Addepta XL is a modified release form of methylphenidate which releases the medicine gradually over a time period of 8 hours. It is intended to take the place of the same total daily dose of traditional (immediate release) methylphenidate taken at breakfast and lunchtime

• – If you or your child have not taken methylphenidate before, your doctor will normally start treatment with traditional (immediate release) methylphenidate tablets. If your doctor feels it is necessary methylphenidate treatment may be started with Addepta XL 10 mg once daily before breakfast

• – Your doctor will usually start treatment with a low dose and increase it gradually as required

• – The maximum daily dose is 60 mg.

Long-term treatment

Addepta XL does not need to be taken for ever. If you or your child takes Addepta XL for more than a year, your doctor will stop treatment for a short time, e.g. during a school holiday. This will show if the medicine is still needed.

If you do not feel better after 1 month of treatment

If you or your child do not feel better, tell your doctor. They may decide you need a different treatment.

Not using Addepta XL properly

If Addepta XL is not used properly, this may cause abnormal behaviour. It may also mean that you or your child start to depend on the medicine. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Things your doctor will do during treatment

Your doctor will do some tests

– before you or your child start treatment, to make sure that Addepta XL is safe and will be of benefit

• – after you or your child has started treatment, at least every 6 months, but possibly more often. They will also be done when the dose is changed

• – these tests will include:

• – checking your appetite

• – measuring height and weight

• – measuring blood pressure and heart rate

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– checking whether you have any problems with your mood, state of mind or any other unusual feelings, or if these have got worse while taking Addepta XL.

If you or your child take more Addepta XL than you should If you or your child take too much medicine, talk to a doctor or call an ambulance straight away. Tell them how much has been taken.

Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or hearing things that are not real (hallucinations or psychosis), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.

• – There may be lack of weight gain or height increase.

• – Your doctor will carefully monitor you or your child’s height and weight, as well as how well you or your child are eating.

• – If you or your child are not growing as expected, then treatment with methylphenidate may be stopped for a short time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

If you or your child forget to take Addepta XL

Do not take a double dose to make up for a forgotten dose. If you or your child forget a dose, wait until it is time for the next dose.

If you or your child stop taking Addepta XL

If you or your child suddenly stop taking this medicine, the ADHD symptoms may come back or unwanted effects such as depression may appear. Your doctor may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Talk to your doctor before stopping Addepta XL.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Keep the bottle tightly closed in order to protect from moisture.

Do not use this medicine if the capsules look damaged in any way.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protecttheenvi­ronment.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Althoughsome people get side effects, most people find that methylphenida­tehelps them. Your doctor will talk to you about these side effects.

Some side effects could be serious. If you or your child have any of the side effects below, see a doctor straight away:

Common (may affect up to 1 in 10 people)

• – uneven heartbeat (palpitations)

• – mood changes, mood swings or changes in personality.

Uncommon (may affect up to 1 in 100 people)

• – thinking about or feeling like killing yourself

• – seeing, feeling, or hearing things that are not real – these are signs of psychosis

• – uncontrolled speechandbody movements (Tourette’s)

• – signs of allergy suchasrash, itching orhives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Rare (may affect up to 1 in 1,000 people)

• – feeling unusually excited, over-active and uninhibited (mania).

Very rare (may affect up to 1 in 10,000 people)

• – heart attack

• – fits (seizures, convulsions, epilepsy)

• – skin peeling or purplish red patches

• – muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system – due to a temporary lack of blood supply to the brain

• – paralysis or problems with movement and vision, difficulties in speech – these can be signs of problems with the blood vessels in your brain

• – decrease in number of blood cells (red cells, white cells and platelets) which can make you more likely to get infections, and make you bleed and bruise more easily

• – a sudden increase in body temperature, very high blood pressure and severe convulsions (‘Neuroleptic Malignant Syndrome’). It is not certain that this side effect is caused by methylphenidate or other medicines that may be taken in combination with methylphenidate.

Not known (frequency cannot be estimated from the available data)

• – unwanted thoughts that keep coming back

• – unexplained fainting, chest pain, shortness of breath -these can be signs of heart problems.

If you have any of the side effects above, see a doctor straight away.

Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people)

• – headache

• – feeling nervous

• – not being able to sleep.

Common (may affect up to 1 in 10 people)

• – joint pain

• – dry mouth

• – high temperature (fever)

• – unusual hair loss or thinning

• – feeling unusually sleepy or drowsy

• – loss of appetite or decreased appetite

• – itching, rash or raised red itchy rash (hives)

• – cough, sore throat or nose and throat irritation

• – high blood pressure, fast heart beat (tachycardia)

• – feeling dizzy, movements which you cannot control, being unusually active

• – feeling aggressive, agitated, anxious, depressed, irritable and behaving abnormally

• – excessive teeth grinding (bruxism).

Uncommon (may affect up to 1 in 100 people)

• – constipation

• – chest discomfort

• – blood in the urine

• – double vision or blurred vision

• – muscle pain, muscle twitching

• – increases in liver test results (seen in a blood test)

• – anger, feeling restless or tearful, excessive awareness of surroundings, problems sleeping

• – tremor.

What Addepta XL contains

• – The active substance is methylphenidate hydrochloride. Addepta XL 10 mg modified-release hard capsules contain 10 mg methylphenidate hydrochloride equivalent to 8.65 mg methylphenidate.

Addepta XL 20 mg modified-release hard capsules contain 20 mg methylphenidate hydrochloride equivalent to 17.3 mg methylphenidate.

Addepta XL 30 mg modified-release hard capsules contain 30 mg methylphenidate hydrochloride equivalent to 25.95 mg methylphenidate.

• – The other excipients are:

Capsuleconten ts: microcrystalline cellulose, hypromellose, ethylcellulose, hydroxypropyl­cellulose, dibutyl sebacate, povidone, talc(E553b), hydrochloric acid (E507-for pH adjustment)

Capsule shell : hypromellose, titanium dioxide (E171), iron oxide yellow (E172) (additionally in Addepta XL 20 mg, 30 mg modified-release hard capsules)

• - Printing ink : shellac (E904), iron oxide black (E172), propylene glycol (E1520), potassium hydroxide (E525)

Sweden:

Metylfenidat Amdipharm kapslar med modifierad frisattning, harda 10 mg Metylfenidat Amdipharm kapslar med modifierad frisattning, harda 20 mg Metylfenidat Amdipharm kapslar med modifierad frisattning, harda 30 mg

This leaflet was last revised in 09/2021

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Rare (may affect up to 1 in 1,000 people)

• – changes in sex drive

• – feeling disorientated

• – dilated pupils, trouble seeing

• – swelling of the breasts in men

• – excessive sweating, redness of the skin, raised red skin rash.