Ritalin

Package Leaflet: Information for the User

Ritalin 10 mg tablets

Methylphenidate
The name of your medicine is Ritalin and it contains the active substance 'methylphenidate hydrochloride'. In this

The package leaflet also uses the name “methylphenidate”.

Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information you should know about your medicine
This medicine is used to treat ADHD

• The full name for ADHD is 'Attention Deficit Hyperactivity Disorder'.
• This medicine helps regulate your brain activity. It can help you improve attention, concentration, and reduce impulsiveness.
• You may need other treatments for ADHD in addition to this medicine. Read section 1 for further information. Before taking this medicine, inform your doctor if:
• You have heart, circulation, or mental health problems – you may not be able to take this medicine.
• You are taking any other medicines – because methylphenidate can affect how other medicines work. Read section 2 for further information. While taking this medicine:
• Visit your doctor regularly. Your doctor will want to monitor how the medicine is working.
• Do not stop taking the medicine without first consulting your doctor.
• If you have been taking the medicine for more than one year, your doctor may temporarily stop treatment to assess whether it is still needed.
• The most common side effects are nervousness, insomnia, or headache. Read sections 3 and 4 for further information.

Inform your doctor immediately if any of the following occur:

• Your mood or how you feel changes.
• You think you may have heart problems. Read section 4 for further information.

The remainder of this package leaflet contains further details and other important information
on the safe and effective use of this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed specifically for you. Never give it to others. It could be dangerous for other individuals, even if their symptoms are the same as yours.
• If any side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor.

Contents of this package leaflet:

• Sections numbered 1 to 6 are intended for parents and caregivers.
• The last section is a special section to be read by a child or adolescent. However, all sections are written so they can be read and understood by the child or adolescent taking this medicine. The sections are:
  1. What Ritalin is and what it is used for
  2. What you need to know before taking Ritalin
  3. How to take Ritalin
  4. Possible side effects
  5. How to store Ritalin
  6. Contents of the pack and other information Information for children and adolescents

1. What Ritalin is and what it is used for

What Ritalin is used for
Ritalin is used to treat 'Attention Deficit Hyperactivity Disorder' (ADHD).

• It is used in children and adolescents aged between 6 and 18 years.
• It is used only after trying non-medication treatments such as supportive therapy and behavioural therapy. Ritalin must not be used to treat ADHD in children under 6 years of age or in adults. It is not known whether Ritalin is safe or effective in these patient populations.

How Ritalin works
Ritalin improves the activity of certain brain areas that are less active. The medicine can help to
improve attention, concentration, and reduce impulsive behaviour.
The medicine is given as part of a comprehensive treatment programme which generally
includes:

• psychological therapy,
• educational therapy, and
• social therapy.

It is prescribed only by doctors experienced in managing behavioural disorders in children or adolescents. Although there is no cure for ADHD, it can be managed using comprehensive treatment programmes.

Information about ADHD
For children and adolescents with ADHD:

• it is difficult to sit still, and
• it is difficult to concentrate.
  It is not their fault if they cannot do these things. Many children and adolescents struggle hard to do them. However, having ADHD, they may experience problems in everyday life. Children and adolescents with ADHD may have difficulties in learning and doing schoolwork. It is difficult for them to behave appropriately at home, at school, or in other settings. ADHD does not affect a child's or adolescent's intelligence.

2. What you need to know before taking Ritalin

Do not take Ritalin if:

• you are allergic to methylphenidate or any of the excipients of this medicine (listed in section 6)
• you have a thyroid problem
• you have high pressure in the eye (glaucoma)
• you have a tumour of the adrenal gland (pheochromocytoma)
• you have an eating disorder when you are not hungry or when you want to eat, such as 'anorexia nervosa'
• you have very high blood pressure or have narrowing of the blood vessels, which may cause pain in the arms and legs
• you have previously had heart problems – such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or if you were born with a heart problem
• you have previously had problems with blood vessels in the brain – such as stroke, swelling and weakening of a part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• you are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) (see Other medicines and Ritalin)
• you have mental disorders such as:
• a 'psychopathic' or 'borderline' personality disorder
• abnormal thoughts, hallucinations, or a condition called 'schizophrenia'
• signs of severe mood disorders such as: suicidal thoughts, severe depression (feeling very sad, useless and desperate), or mania (feeling unusually excitable, hyperactive and uninhibited). If any of these conditions apply to you, do not take methylphenidate. If you are unsure, consult your doctor before taking methylphenidate. This is because methylphenidate may worsen these conditions.

Warnings and precautions
Check with your doctor before starting treatment if:

• you have liver or kidney problems
• you have had seizures (epilepsy) or if any electroencephalogram (EEG) tests have been abnormal
• you have ever had episodes of substance abuse or have been dependent on alcohol, prescription medicines, or common drugs
• you are a girl who has already started menstruating (see section 'Pregnancy, breastfeeding and fertility' below)
• you have difficulty controlling yourself, have repeated muscle contractions in any part of your body, or repeat sounds and words
• you have high blood pressure
• you have heart problems not described above in the section 'Do not take Ritalin if'
• you have a mental health condition not described above in the section 'Do not take Ritalin if'. Other mental health problems include:
• mood swings (from manic to depressed – known as 'bipolar disorder')
• becoming aggressive or hostile, or worsening of existing aggression
• seeing, hearing or sensing things that are not there (hallucinations)
• believing things that are not true (delusions)
• feeling unusually suspicious (paranoia)
• feeling restless, anxious or tense
• feeling depressed or guilty. If any of these conditions apply to you, consult your doctor before starting treatment. This is because

methylphenidate may worsen these conditions. Your doctor will want to monitor how the
medicine affects you.
Checks your doctor will carry out before you start treatment with methylphenidate
These checks are to determine whether methylphenidate is the right medicine for you. Your doctor will
ask you about:

• any other medicines you are taking
• any cases of unexplained sudden death, ventricular arrhythmia, or psychiatric disorders in your family
• any other medical problems (such as heart problems) affecting you or your family
• how you feel, such as feeling up or down, having strange thoughts, or if you have previously experienced any of these feelings
• family history of 'tics' (repeated contractions of any part of the body or repetition of sounds and words that are difficult to control)
• any mental health or behavioural problems you or your family may have had. Your doctor will assess your risk of mood swings (from manic to depressed – known as 'bipolar disorder'). Your doctor will review your mental health history and check whether anyone in your family has a history of suicide, bipolar disorder or depression. It is important that you provide as much information as possible. This will help your doctor decide whether methylphenidate is the right medicine for you. Your doctor may consider that further tests are needed before starting this medicine.

Other medicines and Ritalin
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
Do not take methylphenidate if:

• you are taking a medicine called 'monoamine oxidase inhibitor' (MAOI) used for depression, or if you have taken an MAOI within the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure. If you are taking other medicines, methylphenidate may affect how they work or may cause unwanted effects. If you are taking any of the following medicines, consult your doctor before taking methylphenidate:
• other medicines for depression
• medicines for severe mental health problems
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies containing substances that may affect blood pressure. It is important to check with your pharmacist when purchasing any of these products
• medicines that thin the blood to prevent clots. If you are unsure whether any of the medicines you are taking are included in the list above, consult your doctor before taking methylphenidate.

Surgery
Inform your doctor if you are due to have surgery. You must not take methylphenidate
on the day of surgery if anaesthetics are to be used. This is because there is a risk of a
sudden increase in blood pressure and, in some cases, heart rate during
surgery.
Drug screening tests
This medicine may give a positive result in drug screening tests,
including tests performed in sports.
During treatment, boys and adolescents may unexpectedly experience prolonged erections that may be painful and can occur at any time. It is important to contact your doctor immediately if an erection lasts more than 2 hours, especially if it is painful.
Taking Ritalin with food and drink
Taking methylphenidate with food may help prevent stomach upset, nausea or vomiting.
Taking Ritalin with alcohol
Do not drink alcohol while taking this medicine. Alcohol may worsen the side effects of
this medicine. Remember that some foods and some medicines contain alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Available data do not indicate an increased overall risk of birth defects, but a small increase in the risk of cardiac malformations following use during the first three months of pregnancy cannot be ruled out. Your doctor can provide you with more information about this risk. Inform your doctor before taking the medicine if:

• you are sexually active. Your doctor will discuss contraceptive methods with you.
• you are pregnant or think you may be pregnant. Your doctor will assess whether you should take methylphenidate.
• you are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, your doctor will assess whether you should breastfeed while taking methylphenidate.

Driving and using machines
It may happen that when taking methylphenidate you feel dizzy, have difficulty focusing or blurred vision. If this occurs, it may be dangerous to carry out activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.
Important information about some excipients of Ritalin
This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with a sugar intolerance, contact him or her before taking this medicine.
This medicine contains wheat starch. If you suffer from chronic fatty diarrhoea (but not coeliac disease), you must not take Ritalin.

How much Ritalin to take
Always take Ritalin exactly as directed by your doctor. If you have any doubts, consult your doctor.

• Your doctor will usually start treatment with a low dose and gradually increase it as needed.
• The maximum daily dose is 60 mg.
• Take Ritalin once or twice daily (for example, at breakfast and/or lunchtime).
• Do not take Ritalin in the evening: there must be at least 4 hours between the last dose and bedtime. If you still experience disturbances in the evening, contact your doctor.
• The tablets should be swallowed with a glass of water.
• You may split the tablet to make swallowing easier.

If you do not feel well after 1 month of treatment
If you do not feel well, inform your doctor. Your doctor may decide that you need a different treatment.

Misuse of Ritalin
If Ritalin is not used correctly, abnormal behaviour may occur. It may also mean that you are becoming dependent on this medicine. Inform your doctor if you have ever had episodes of substance abuse or have been dependent on alcohol, prescription medicines, or illicit drugs.
This medicine is intended only for you. Do not give it to others, even if their symptoms appear similar.

If you take more Ritalin than you should
If you take too much medicine, contact a doctor immediately or call an ambulance. Inform them how much medicine you have taken.
Signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, muscle twitching, seizures (sometimes followed by coma), feelings of euphoria, confusion, seeing, hearing, or sensing things that are not real (hallucinations), sweating, hot flushes, headache, high fever, changes in heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth; muscle spasms (sudden, involuntary muscle contractions), fever, red-brown discoloration of the urine, which may be signs of abnormal muscle tissue breakdown (rhabdomyolysis).

If you forget to take Ritalin
Do not take a double dose to make up for a missed dose. If you forget a dose, wait until the next scheduled dose.

If you stop taking Ritalin
If you have any doubts about using Ritalin, consult your doctor.
If you stop treatment with Ritalin abruptly, ADHD symptoms may return or you may experience unwanted effects such as depression. Your doctor may decide it is advisable to gradually reduce the daily dose before stopping treatment completely. Inform your doctor before stopping Ritalin treatment.

What your doctor will do during treatment with Ritalin
Your doctor will carry out some checks

• before starting treatment – to ensure Ritalin is safe and beneficial for you.
• after starting treatment – checks should be carried out at least every 6 months, but preferably more frequently. They will also be performed whenever the dose is changed.
• these checks will include:
• monitoring of appetite
• measurement of height and weight
• measurement of blood pressure, heart rate, and possible electrocardiogram (ECG)
• monitoring for the onset or worsening, during treatment with Ritalin, of any problems related to mood, mental state, or any other unusual sensations.

Long-term treatment
It is not necessary to take Ritalin indefinitely. If you have been taking Ritalin for more than one year, your doctor should interrupt treatment for a short period, which may coincide with a school holiday. This will help determine whether you still need to take the medicine.

If you have any doubts about using Ritalin, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will provide you with information about these side effects.
Some side effects can be serious. If you experience any of the side effects listed below, contact a doctor immediately:

Common (affects less than 1 in 10 people)

• irregular heartbeat (palpitations)
• mood changes or mood swings or changes in personality

Uncommon (affects less than 1 in 100 people)

• thoughts of suicide or suicidal ideation
• perceiving or sensing things that are not real – these are symptoms of psychosis
• uncontrolled speech and body movements (Tourette’s syndrome)
• signs of allergy such as skin rash, itching or hives, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing

Rare (affects less than 1 in 1,000 people)

• feeling unusually excited, hyperactive and disinhibited (mania)

Very rare (affects less than 1 in 10,000 people)

• heart attack
• seizures (epilepsy)
• skin peeling or appearance of red-purple spots
• uncontrolled muscle contractions of the eyes, head, neck, body and nervous system – this may be due to a temporary lack of blood supply to the brain
• paralysis or movement and vision problems, difficulty speaking (these may be signs of problems with cerebral blood vessels)
• decrease in blood cell counts (red blood cells, white blood cells and platelets), which may increase the risk of infections and make bleeding and bruising more likely
• sudden increase in body temperature, very high blood pressure and severe seizures (‘Neuroleptic Malignant Syndrome’). It is unclear whether these side effects are caused by methylphenidate or by other medicines that may be taken in combination with methylphenidate.

Other side effects (frequency not known)

• unwanted thoughts that keep recurring
• fainting without reason, chest pain, shortness of breath (these may be signs of heart problems)
• prolonged erections, sometimes painful, or increased frequency of erections

If you experience any of the side effects described above, contact a doctor immediately.

Other side effects: if these become severe, inform your doctor:

Very common (affects more than 1 in 10 people)

• headache
• nervousness
• inability to fall asleep

Common (affects less than 1 in 10 people)

• joint pain
• dry mouth
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or sluggish
• loss or decrease in appetite
• itching, skin rash or raised, red, itchy skin rash (urticaria)
• cough, sore throat or nasal and throat irritation
• high blood pressure, fast heartbeat (tachycardia)
• dizziness, uncontrolled movements, being unusually active
• feelings of aggression, restlessness, anxiety, depression, irritability and abnormal behaviour
• stomach pain, diarrhoea, nausea, gastric discomfort and vomiting. These usually occur at the beginning of treatment and may be reduced by taking the medicine with food
• excessive teeth grinding (bruxism)

Uncommon (affects less than 1 in 100 people)

• constipation
• chest discomfort
• blood in the urine
• jerking or tremors
• double or blurred vision
• muscle pain, muscle contractions
• shortness of breath, chest pain
• increased liver function test values (detected during blood tests)
• anger, feeling of restlessness or sadness, excessive awareness of surroundings, sleep disturbances

Rare (affects less than 1 in 1,000 people)

• changes in sex drive
• feeling of disorientation
• dilated pupils, vision disturbances
• breast enlargement in men
• excessive sweating, skin redness, raised red skin rashes

Very rare (affects less than 1 in 10,000 people)

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of cerebral arteries
• liver function abnormalities including liver failure and coma
• changes in test results – including liver and blood tests
• suicide attempt, thought disturbances, lack of feelings or emotions, repetitive actions, obsessive thoughts
• sensation of numbness in fingers and toes, tingling, and colour change (from white to blue, then red) when cold (‘Raynaud’s phenomenon’)

Other side effects (frequency not known)

• migraine
• very high fever
• slow, fast or extra heartbeats
• a major seizure (‘grand mal’)
• believing things that are not true, confusion
• severe stomach pain, often with nausea and vomiting
• problems with cerebral blood vessels (stroke, cerebral arteritis or cerebral occlusion)
• difficulty in achieving or maintaining erection
• excessive, uncontrollable talking
• inability to hold urine (incontinence)
• jaw muscle spasm making it difficult to open the mouth (trismus)
• stuttering
• nosebleeds

Effects on growth
When used for more than one year, methylphenidate may cause delayed growth in some children. This occurs in fewer than 1 in 10 children.

• It may be observed that weight and height do not increase as expected.
• Your doctor will carefully monitor your weight and height, as well as your appetite.
• If you are not growing as expected, treatment with methylphenidate may be interrupted for a short period.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.
Ensure you store the medicine in a safe place, so that no one else can take it,
especially younger brothers or sisters.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last
day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ritalin contains
The active substance is methylphenidate hydrochloride.
Ritalin tablets contain 10 mg of methylphenidate hydrochloride.
The excipients are: calcium phosphate, lactose monohydrate, wheat starch, gelatin, magnesium stearate, talc.

Description of the appearance of Ritalin and pack contents
Ritalin tablets are available in one strength: 10 mg.
The medicine is available in blisters contained in packs of 20, 30, or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Straße 1
64646 Heppenheim
Germany

Selling Agent
InfectoPharm S.r.l.,
Via Generale Gustavo Fara, 28
20124 Milano

Information for children and adolescents with ADHD
This information has been prepared so that you can learn the main characteristics of your medicine called Ritalin.
If you don't like reading, someone such as your mother, father, or caregiver can read it to you and answer any questions you may have.
They can help you by reading it in small sections at a time.

Why have I been given this medicine?
This medicine can help children and adolescents with ADHD.

• ADHD may:
  o make you overactive
  o make it hard for you to pay attention
  o make you act quickly without thinking about what will happen next (that is, make you impulsive)
• ADHD affects your ability to learn, make friends, and how you feel about yourself. It is not your fault.

While taking this medicine

• In addition to taking this medicine, you will also receive support on how to manage ADHD, such as talking with ADHD specialists.
• This medicine should help you, but it does not cure ADHD.
• You will need to visit your doctor several times a year for check-ups. This is to make sure the medicine is working and that your growth and development are on track.
• If you take the medicine for more than one year, your doctor may temporarily stop treatment to assess whether it is still needed. This will likely occur during a school holiday.
• If you take this medicine more than once a day, you might need to remember to take it at school. Your mother, father, or caregiver will need to check what the school rules are about this.
• Do not drink alcohol. Alcohol can worsen the side effects of this medicine.
• Girls must inform their doctor immediately if they think they might be pregnant. We do not know how this medicine affects unborn babies. If you are sexually active, talk to your doctor about contraception.

Some people must not take this medicine
You must not take this medicine if:

• you have a heart disorder
• you feel very unhappy, depressed, or have a mental illness

Some people should talk to their doctor before starting this medicine
You should talk to your doctor if:

• you have epilepsy (seizures)
• you are pregnant or breastfeeding
• you are taking other medicines – your doctor must know about all 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 need to take your medicine.
• Do not stop taking the medicine without first talking to your doctor.

Possible side effects
Side effects are unwanted effects that may occur when you take a medicine. If any of these happen, talk to a trusted adult immediately, who can then inform the doctor. The main things that may happen to you are:

• Feeling nauseous, vomiting, or having stomach ache. This may only occur when you first start taking the medicine. It is better to take the medicine with food.
• Feeling worried or nervous
• Feeling dizzy or having headaches
• Feeling very depressed or unhappy, or having thoughts of harming yourself
• Having a different mood than usual, or having trouble falling asleep
• Skin rashes, easy bruising, or shortness of breath
• The medicine may also make you feel drowsy. If you feel drowsy, it is important that you do not take part in outdoor sports such as horse riding, cycling, swimming, or climbing trees. You could hurt yourself or others.
• Your heart beats faster than usual.
  If you feel unwell at any time while taking this medicine, talk to a trusted adult immediately.

Other things to remember

• Make sure you keep the medicine in a safe place, so that no one else can take it, especially younger brothers or sisters.
• This medicine is prescribed specifically for you – do not let anyone else take it. This medicine can help you, but it could harm someone else.
• If you forget to take your medicine, do not take two tablets next time – just take one tablet as usual.
• If you take too much medicine, tell your mother, father, or caregiver immediately.
• It is important not to take too much medicine, otherwise you will feel unwell.
• Do not stop taking your medicine until your doctor tells you it is okay to do so.

Who should I ask if there is something I do not understand?
Your mother, father, caregiver, doctor, or nurse can help you.