RITALIN 10 mg Modified-Release Hard Capsule

Зміст інструкції

1. What is Ritalin Prolonged Release and what is it used for
2. What you need to know before taking or giving Ritalin Prolonged Release to your child
3. How to take Ritalin Prolonged Release
4. Possible side effects
5. How to store Ritalin Prolonged Release
6. Package Contents and Other Information

Ritalin Prolonged Release 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, prolonged-release hard capsules
methylphenidate hydrochloride

Read this leaflet carefully before taking, or giving to your child, this
medicine as 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 only for you or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ritalin Prolonged Release is and what it is used for
• 2. What you need to know before you take or give Ritalin Prolonged Release to your child
• 3. How to take Ritalin Prolonged Release
• 4. Possible side effects
• 5. How to store Ritalin Prolonged Release
• 6. Contents of the pack and other information

1. What is Ritalin Prolonged Release and what is it used for

Ritalin Prolonged Release contains the active ingredient methylphenidate hydrochloride, a substance that stimulates the
central nervous system.

What this medicine is used for
This medicine is used to treat ‘Attention Deficit Hyperactivity Disorder’ (ADHD)

• It is used in children and adolescents between the ages of 6 and 18 years.
• It is used only after trying other treatments that do not require the use of medicines, such as support therapy and behavioural therapy, and which have proven insufficient.

This medicine should not be used for the treatment of ADHD in children under 6 years of age
or in adults not previously treated with this medicine. If treatment was started at a young
age, it may be advisable to continue it into adulthood. Your doctor will advise you on this.
The safety and efficacy of this medicine have not been studied in children under 6 years of age, and
therefore it is not known whether this medicine can be used safely or is effective in this age group.

How this medicine works
This medicine improves the activity of certain areas of the brain that are less active. This medicine can
help to improve attention and concentration and to reduce impulsive behaviour.
The medicine is given as part of a comprehensive treatment program. This treatment program also includes psychological, educational and social therapy, in addition to pharmacological treatment. This medicine is prescribed only by doctors who have experience with behavioural disorders. Although there is no cure for ADHD, it can be managed with the help of a treatment program.

Information about ADHD
For children and adolescents with ADHD it is difficult to sit still and concentrate. It is not their fault
if they cannot do these things. Many children and adolescents struggle to do these things. However, having ADHD, they may have problems in everyday life.
Children and young people with ADHD may have difficulty learning and doing homework. It is
difficult for them to behave well at home, at school or in other places. ADHD has no influence
on intelligence.
Not all patients with ADHD need pharmacological treatment.

Checks during treatment with this medicine
To check if this medicine has an undesirable effect, the doctor will regularly check your
health or that of your child (e.g. blood pressure or heart rate). In children using
this medicine, the doctor will also monitor growth. If used for a prolonged period of time,
blood tests will be carried out to monitor the amount of blood cells (white blood cells, red blood cells and platelets).

2. What you need to know before taking or giving Ritalin Prolonged Release to your child

Do not take Ritalin Prolonged Release

• if you, or your child, are allergic to methylphenidate hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you, or your child, have a thyroid problem
• if you, or your child, have high pressure in the eye (glaucoma)
• if you, or your child, have a tumor of the adrenal gland (pheochromocytoma)
• if you, or your child, have a problem with eating when not hungry or do not want to eat, such as anorexia nervosa
• if you, or your child, have very high blood pressure or narrowing of blood vessels that can cause pain in the arms and legs
• if you, or your child, have had heart problems in the past, such as heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease, or were born with a heart problem
• if you, or your child, have had a problem 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)
• if you, or your child, have mental disorders, such as:
• a “psychopathic” personality problem or “borderline” personality disorder
• abnormal thoughts/delusions or a mental illness characterized by symptoms such as delusional ideas, perception of things that are not there, and gradual change in personality (schizophrenia)
• signs of severe mood disorders such as:
• wanting to commit suicide
• severe depression, when you feel very sad, useless and hopeless
• feeling of unusual excitement, hyperactivity and lack of inhibition (mania)
• if you, or your child, are using medicines for depression called monoamine oxidase inhibitors (MAOIs). Using a monoamine oxidase inhibitor at the same time as methylphenidate can cause a sudden increase in blood pressure.

If any of these conditions apply to you or your child, do not take methylphenidate. If you are not sure, ask your doctor or pharmacist before taking methylphenidate. This is because methylphenidate can
worsen these conditions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ritalin Prolonged Release if you or your child:

• have liver or kidney problems
• have had seizures (epilepsy) or if any electroencephalogram tests have been abnormal (electroencephalogram, EEG)
• have ever had episodes of abuse or have been addicted to alcohol, prescription drugs or common drugs
• are a girl and have started having periods (see “Pregnancy, breastfeeding and fertility”)
• have repetitive and difficult-to-control contractions of any part of the body or repeat sounds and words
• have high blood pressure
• have heart problems not mentioned in the previous section “Do not take Ritalin Prolonged Release”
• have a mental health problem not mentioned in the previous section “Do not take Ritalin Prolonged Release”. Other mental health problems include:
• (having) mood swings (from manic to depressed - this is called “bipolar disorder”)
• starting to become aggressive or hostile, or a worsening of your aggression
• seeing, hearing or perceiving 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.

Methylphenidate can worsen these conditions. The doctor will want to check how the medicine is working on
you or your child.
During treatment, males and adolescents may experience unexpectedly prolonged erections.
These can be painful and occur at any time. It is important to contact your doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Checks your doctor will perform before starting treatment with this medicine:
These checks are to decide if methylphenidate is the right medicine for you or your child. The
doctor will ask you, or your child, about:

• any other medicines that you, or your child, are taking
• any cases of sudden unexplained death in the family
• any other medical problems (e.g. heart problems) that affect you, your child or other family members
• how you, or your child feel, for example if you feel well or unwell, if you have strange thoughts or if you have ever had any of these feelings in the past
• any family history of “tics” (repetitive and difficult-to-control contractions of any part of the body or repetition of sounds and words)
• any mental or behavioral health problems that you, your child or other family members have had. The doctor will check if you, or your child, are at risk of having mood swings (from manic to depressed, so-called “bipolar disorder”). They will check the history of mental health, yours or your child's, and if your family has a history of suicide, manic-depressive (bipolar) disorder or depression.

It is important that you, or your child, provide as much information as possible. This will help the doctor to
decide if methylphenidate is the right medicine for you or your child. The doctor may decide that
further medical examinations are necessary before starting treatment with this medicine.

Other medicines and Ritalin Prolonged Release
Tell your doctor or pharmacist if you, or your child, are taking, have recently taken or might
take any other medicines.
If you, or your child, are taking other medicines, methylphenidate may affect their effectiveness or
cause unwanted effects. It may be necessary to adjust the dose or stop taking methylphenidate or these other medicines. If you, or your child, are using any of the following
medicines, consult your doctor or pharmacist before taking methylphenidate:

• other medicines for depression
• medicines for serious mental health problems
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies containing substances that can affect blood pressure. It is important to check with the pharmacist when purchasing one of these products
• medicines that thin the blood to prevent blood clots

If you have any doubts about whether any of the medicines that you, or your child, are taking are included
among those listed above, ask your doctor or pharmacist for advice before taking methylphenidate.

In case of surgery
Tell your doctor if you, or your child, are going to have surgery. You should not take
methylphenidate on the day of surgery if certain types of anesthetics are used. This is because there is
a possibility of a sudden increase in blood pressure during surgery.

Tests for drug abuse
In laboratory tests for amphetamines, methylphenidate can give a false positive result,
especially in immunological screening tests.

Ritalin Prolonged Release with food, drinks and alcohol
You, or your child, should not drink alcohol when taking this medicine. Alcohol can worsen the
side effects of this medicine. Remember that some foods and some medicines contain alcohol.

Pregnancy, breastfeeding and fertility
Available data do not indicate an increased overall risk of birth defects, while a small increase in the risk of heart malformations following use during the first
three months of pregnancy cannot be excluded. Your doctor can provide you with more information about this risk. No effects on fertility have been observed in animals.
No effects on fertility have been observed in animals.
Tell your doctor or pharmacist before taking methylphenidate if you, or your daughter:

• are sexually active. The doctor will talk to you, or your daughter, about methods of contraception.
• are pregnant, suspect you may be pregnant, or are planning to become pregnant. The doctor will assess whether you should take methylphenidate.
• are breastfeeding or plan to do so. Methylphenidate may pass into breast milk. Therefore, the doctor will decide whether to assess whether you should breastfeed while taking methylphenidate.

Driving and operating machinery
While taking methylphenidate, you, or your child, may feel dizzy or have difficulty
falling asleep or focusing or have blurred vision. If this happens, it may be
dangerous to perform activities such as driving, operating machinery, riding a horse or bicycle or
climbing trees.

Doping
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Ritalin Prolonged Release contains sucrose
If your doctor has diagnosed you, or your child, with an intolerance to certain sugars, contact your doctor
before taking this medicine.

3. How to take Ritalin Prolonged Release

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The capsules contain two different types of granules. Half of the granules release the active ingredient (methylphenidate)
immediately after taking it, while the other half releases the methylphenidate after 4 hours. This special
formulation is designed to provide effective treatment throughout the school day (not the entire
day) without the need for an additional dose at lunchtime.

• The doctor will generally start treatment at a low dose and increase it gradually as needed.
• The maximum daily dose in children/adolescents is 60 mg.
• The maximum daily dose in adults is 80 mg.
• If you have already been treated during childhood with this medicine for ADHD and have recently turned 18, the doctor may continue to prescribe the same dose. If you were already treated with Ritalin tablets during childhood, the doctor will prescribe you the equivalent dose of Ritalin Prolonged Release.
• This medicine is taken once a day, usually in the morning. To prevent sleep disturbances, do not take the medicine too late in the day.
• This medicine can be taken with or without food.
• The capsule must be swallowed whole with a sip of water.
• Do not crush, chew, or divide the capsule or its contents.

If you, or your child, are unable to swallow this medicine, you can sprinkle the contents on
a small amount of food as follows:

• Carefully open the capsule and sprinkle the microspheres on a small amount of a soft food (e.g. applesauce).
• The food should not be hot because heat could affect the special properties of the microspheres.
• This mixture of medicine and food should be taken immediately.

Never save the mixture of medicine and food for later use.

If you, or your child, do not feel better after 1 month of treatment
If you, or your child, do not feel better, talk to your doctor. The doctor may assess the need
for different treatment.

If you, or your child, do not use this medicine correctly
If this medicine is not used correctly, it can cause abnormal behavior. It can also
mean that you, or your child, begin to develop a dependence on the medicine. Tell your doctor if you,
or your child, have ever abused or been dependent on alcohol, prescription medications, or street drugs.
This medicine has been prescribed only for you, or your child. Do not give this medicine to others
even if their symptoms seem similar to yours.

If you, or your child, takes more Ritalin Prolonged Release than you should
If you, or your child, takes an excessive dose of medicine, contact your doctor or call an
ambulance directly. Tell them how much medicine was taken.
Signs of overdose may include: vomiting, restlessness (agitation), tremors, increased
uncontrolled movements, muscle contractions, seizures (which may be followed by coma),
feeling of euphoria, confusion, seeing, hearing, or perceiving things that are not real (hallucinations),
sweating, hot flashes (redness), headache, high fever, changes in heartbeat
(slow, fast, or irregular), high blood pressure, dilated pupils, dry nose and dry mouth, and reddish-brown discoloration of the urine, which may be signs of abnormal muscle breakdown
(rhabdomyolysis).

If you, or your child, forgets to take Ritalin Prolonged Release
Do not take a double dose to make up for a missed dose. If you, or your child, forget
a dose, wait until the time of the next dose.

If you, or your child, stops taking Ritalin Prolonged Release
If you, or your child, suddenly stops taking this medicine, the symptoms of ADHD may
reappear or side effects such as depression may occur. The doctor may consider gradually reducing the amount of medicine taken each day, before
stopping treatment definitively. Tell your doctor before you, or your child, stop
treatment.

What the doctor will do during treatment

The doctor will perform some checks:

• Before starting treatment - to ensure that this medicine is safe and beneficial for you or your child
• After starting treatment - at least every 6 months, but if possible more often. These will also be performed when the dose is changed. These examinations include:
• checking appetite
• measuring height and weight in children
• measuring weight in adults
• measuring blood pressure and heart rate
• checking for any problems regarding mood, state of mind, or any other unusual feelings you or your child may have, or any worsening during the period of taking this medicine.

Long-term treatment
You do not need to take this medicine forever. If you, or your child, take this medicine
for more than a year, the doctor should interrupt the treatment for a short period at least once
a year. In the case of children, this period may coincide with a school holiday. This will help to
understand whether the medicine is still necessary.
If you have any doubts about 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.

Some side effects can be serious.
If you, or your child, experience any of the side effects listed below, contact a doctor immediately.
Common(may affect up to 1 in 10 people)

• heart rhythm disorder (arrhythmia), increased heart rate (tachycardia), fast heartbeat (palpitations)
• changes or fluctuations in mood or changes in personality

Uncommon(may affect up to 1 in 100 people)

• thinking about suicide or wanting to harm yourself
• perceiving or hearing things that are not real; these are signs of psychosis
• uncontrolled body and language movements (tics or Tourette's syndrome)
• 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 difficulty breathing

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

• feeling unusually excited, hyperactive and lacking inhibitions (mania)

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

• heart attack
• seizures (epilepsy)
• skin peeling or red-purple spots
• uncontrollable muscle spasms affecting the eyes, head, neck, body and nervous system - this is due to a temporary lack of blood flow to the brain
• paralysis or problems with movements and vision, difficulty speaking (these can be signs of problems with blood vessels in the brain)
• decreased number of blood cells (white blood cells and platelets), which can make infections more likely and make bleeding and bruising easier
• sudden increase in body temperature, very high blood pressure and severe convulsions (Neuroleptic Malignant Syndrome, NMS). It is not clear whether these side effects are caused by methylphenidate or other medicines that may be taken in combination with methylphenidate.

Other side effects(frequency cannot be estimated based on available data)

• unwanted thoughts that keep coming back
• fainting for no reason, chest pain, shortness of breath (these can be signs of heart problems)

If you, or your child, experience any of the side effects listed above, contact a doctor immediately.

Other side effects
If these side effects become severe, tell your doctor or pharmacist:
Very common(may affect more than 1 in 10 people)

• headache
• decreased appetite
• nervousness
• insomnia
• feeling unwell (nausea)
• dry mouth

Common(may affect up to 1 in 10 people)

• joint pain (e.g. knee, ankle or shoulder)
• high temperature (fever)
• common cold (nasopharyngitis)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy
• fatigue
• thirst
• excessive sweating
• itching, rash or raised, red, itchy bumps on the skin (hives)
• cough, sore throat or irritation of the nose and throat, shortness of breath
• high blood pressure, cold hands and feet (peripheral coldness)
• dizziness, uncontrolled movements (dyskinesia), trembling or shaking, being unusually active
• feeling aggressive, agitated, depressed, irritable, anxious or restless
• abnormal behaviour, decreased sexual drive, sleep problems, panic attacks, feeling stressed
• toothache
• fatigue
• stomach pain, diarrhoea, stomach upset, indigestion with a feeling of fullness or stomach pain, belching, nausea, vomiting and heartburn (dyspepsia) and vomiting. These effects

undesirable effects occur at the beginning of treatment and can be reduced by taking the medicine with food

• weight loss
• excessive nervousness
• excessive teeth grinding (bruxism)

Uncommon(may affect up to 1 in 100 people)

• constipation
• blood in the urine
• double or blurred vision
• muscle pain, muscle contraction, muscle stiffness
• chest pain
• increased values in liver function tests (found during a blood test)
• anger, wanting to cry, tension, excessive awareness of the surrounding environment (hypervigilance)
• inability to stay or stand still (akathisia)
• inflammation of the stomach and intestines (gastroenteritis)
• numbness, drowsiness (sedation).

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

• changes in sexual drive
• feeling disoriented
• dilated pupils (mydriasis), vision disturbances
• breast enlargement in men
• redness of the skin, raised red skin rashes
• feeling of tightness and pain in the chest (angina pectoris).

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

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of the arteries in the brain
• abnormalities in liver function, including liver failure and coma
• changes in test results (including liver function tests and blood tests)
• attempted suicide, abnormal thinking, lack of feelings or emotions, doing things repeatedly, being obsessed with something
• numbness, tingling and colour changes (from white to blue, then red) in the fingers and toes when they are cold (Raynaud's phenomenon)
• anaemia

Other side effects(frequency cannot be estimated based on available data)

• migraine
• very high fever
• slow, fast or extra heartbeats
• a major convulsion ('grand mal')
• believing things that are not true, confusion
• talking excessively and uncontrollably (logorrhea)
• severe stomach pain, often with nausea and vomiting
• problems with blood vessels in the brain (stroke, inflammation of the arteries in the brain, blockage of the cerebral artery)
• impotence
• prolonged, sometimes painful, erections or increased number of erections
• dependence
• delusions
• inability to control urination (incontinence)
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• stammering
• nosebleeds

Effects on growth
When used for more than one year, methylphenidate may cause some children to have a delay in growth.
This phenomenon occurs in less than 1 in 10 children.

• It may occur that weight and height do not increase.
• The doctor will carefully monitor your child's height and weight and whether they are eating properly.
• If your child is not growing as expected, treatment with methylphenidate may be interrupted for a short period.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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.

5. How to store Ritalin Prolonged Release

Make sure to store the medicine in a safe place, so that no one else can take it,
especially younger siblings.
Do not store at a temperature above 30°C.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date that is reported on the bottle or on the box after Exp. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is damaged or has been tampered with.
Do not dispose of any medicine down the drain or in household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ritalin Prolonged Release contains
The active ingredient is methylphenidate hydrochloride.

• Ritalin Prolonged Release 10 mg contains 10 mg of methylphenidate hydrochloride.
• Ritalin Prolonged Release 20 mg contains 20 mg of methylphenidate hydrochloride.
• Ritalin Prolonged Release 30 mg contains 30 mg of methylphenidate hydrochloride.
• Ritalin Prolonged Release 40 mg contains 40 mg of methylphenidate hydrochloride.
• Ritalin Prolonged Release 60 mg contains 60 mg of methylphenidate hydrochloride.

The other components are:
Capsule content:
Type B ammonium methacrylate copolymer
Macrogol 6000
Sugar granules (corn starch and sucrose)
Methacrylic acid-methyl methacrylate copolymer (1:1)
Talc
Triethyl citrate
Capsule shell:
Gelatin
Titanium dioxide (E 171)
Black iron oxide and red iron oxide (E 172) (10, 40 and 60 mg)
Yellow iron oxide (10, 30, 40 and 60 mg)
Printing ink:
Glycerol (E 904)
Red iron oxide (E 172)
Yellow iron oxide (E 172)
Titanium dioxide (E 171)
Potassium hydroxide (E 525)
Ammonia (E 527)
Propylene glycol (E 1520)

Description of the appearance of Ritalin Prolonged Release and package contents
Ritalin Prolonged Release modified-release hard capsules are available in five different dosages: 10 mg,
20 mg, 30 mg, 40 mg and 60 mg.
Ritalin Prolonged Release 10 mg is a hard gelatin capsule with an opaque light brown cap and
an opaque white body, imprinted with “NVR” on the cap and “R10” on the body.
The capsule contains microspheres ranging in color from white to off-white.
Ritalin Prolonged Release 20 mg is a hard gelatin capsule, opaque and white in color, imprinted
“NVR” on the cap and “R20” on the body. The capsule contains microspheres ranging in color from
white to off-white.
Ritalin Prolonged Release 30 mg is a hard gelatin capsule, opaque and yellow in color, imprinted
“NVR” on the cap and “R30” on the body. The capsule contains microspheres ranging in color from
white to off-white.
Ritalin Prolonged Release 40 mg is a hard gelatin capsule, opaque and light brown in color, with
imprinted “NVR” on the cap and “R40” on the body. The capsule contains microspheres ranging in color from
white to off-white.
Ritalin Prolonged Release 60 mg is a hard gelatin capsule with an opaque light brown cap and
an opaque yellow body, imprinted with “NVR” on the cap and “R60” on the body.
The capsule contains microspheres ranging in color from white to off-white.
The medicine is available in bottles of 30 and 100 capsules.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Italy: Ritalin Prolonged Release 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, modified-release hard
capsules
Poland: Cognimentin LA 10 mg, 20 mg, 30 mg, 40 mg i 60 mg, kapsułki twarde o
zmodyfikowanym uwalnianiu
Netherlands: Ritalin LA 10 mg, 20 mg, 30 mg, 40 mg en 60 mg, harde capsules met
gereguleerde afgifte