Package leaflet: Information for the user

Noku 18 mg prolonged-release tablets, 27 mg prolonged-release tablets, 36 mg prolonged-release tablets, 45 mg prolonged-release tablets, 54 mg prolonged-release tablets

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

Contents of this leaflet

What Noku is and what it is used for
What you need to know before taking Noku
How to take Noku
Possible side effects
How to store Noku
Contents of the pack and other information

1. What Noku is and what it is used for

What it is used for
Noku is used in the treatment of "attention deficit hyperactivity disorder" (ADHD).

It is used in children aged 6 years and older, and in adults.
It is used only after non-pharmacological treatments, such as supportive and behavioural therapy, have been tried.

Noku is not indicated for the treatment of ADHD in children under 6 years of age.
How it works
Noku improves the activity of certain parts of the brain that are underactive. The medicine
can help improve attention (attention capacity), concentration, and reduce impulsive behaviour.
The medicine is administered as part of a therapeutic programme, which usually
includes:

psychological
educational and
social interventions.

Noku may only be prescribed by doctors experienced in treating children, adolescents or adults with behavioural problems. If you are an adult who has never been treated before, the specialist will carry out tests to confirm that you have had ADHD since childhood. Although there is no cure for ADHD, it can be managed using treatment programmes.

Information about ADHD
Children and young people with ADHD have difficulties in:

staying still and
concentrating.

It is not their fault if they cannot do these things.
Many children and adolescents struggle with these activities. However, attention deficit hyperactivity disorder (ADHD) can cause problems in daily life. Children and adolescents with ADHD may have learning difficulties and problems completing school tasks.
They may also have difficulty maintaining appropriate behaviour at home, at school or in other settings.
ADHD does not affect intelligence.
Adults with ADHD often find it difficult to concentrate. They often feel restless, impatient and distracted. They may have difficulties organising their private and working lives.
Not all patients with ADHD need to be treated with medicines.

2. What you need to know before taking Noku

Do not take Noku if:

you are allergic to methylphenidate or to any of the other ingredients of this medicine (listed in section 6)
you have thyroid problems
you have increased eye pressure (glaucoma)
you have a tumour of the adrenal gland (phaeochromocytoma)
you have an eating disorder that prevents you from feeling hunger or desire to eat, such as "anorexia nervosa"
you have very high blood pressure or narrowing of the blood vessels, which may cause pain in the arms and legs
you have ever had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or were born with heart problems
you have had a problem with blood vessels in the brain, such as stroke, swelling and weakening of part of the blood vessels (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 (MAOI); see section “Other medicines and Noku”
you have mental health problems, such as:
- a "psychopathic" or "borderline" personality disorder
- abnormal thoughts or hallucinations, or a condition called "schizophrenia"
- signs of a serious mood disorder, such as:
  - suicidal thoughts
  - severe depression, where you feel very sad, useless, and hopeless
  - mania, i.e. feeling unusually excitable, hyperactive, and disinhibited.

Do not take methylphenidate if any of the above conditions apply to you. If you are
unsure, consult your doctor or pharmacist before taking methylphenidate. This is because
methylphenidate may worsen such disorders.
Warnings and precautions
Talk to your doctor before taking Noku if:

you have liver or kidney problems
you have difficulty swallowing or cannot swallow whole tablets
you have narrowing or blockage of the intestine or oesophagus
you have had seizures (epileptic fits, convulsions, epilepsy) or abnormalities in brain scans (EEG)
you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs
you are female and have started menstruating (see section “Pregnancy, breastfeeding and contraception” below)
you have repeated, uncontrollable spasms anywhere in the body or repeat sounds and words
you have high blood pressure
you have a heart condition not listed in the previous section “Do not take”
if you or your child develops blurred vision or other visual disturbances, contact your doctor, who may consider stopping treatment with Noku
you have a mental health condition not listed in the previous section “Do not take”.

Other mental health problems include:

mood swings (from manic to depressed, known as “bipolar disorder”)
feeling aggressive or hostile
seeing, hearing, or sensing things that are not real (hallucinations)
believing things that are not true (delusions)
unusual suspiciousness (paranoia)
feeling restless, anxious, or tense
feeling depressed or guilty.

Before starting treatment, inform your doctor or pharmacist if any of the above conditions apply to you.
This is because methylphenidate may worsen these problems. Your doctor will want to
monitor the effects of the medicine on you.
During treatment, boys and adolescents may experience prolonged, unexpected erections.
This may be painful and can 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 carry out before you start taking Noku
These checks are to determine whether methylphenidate is the right medicine for you. Your doctor will discuss with you:

any other medicines you are taking
any cases of unexplained sudden death in your family
any other medical conditions (such as heart problems) that you or your family may have
how you feel, whether you feel happy or depressed, if you have strange thoughts, or have experienced any of these feelings in the past
any family history of “tics” (repetitive, uncontrollable muscle contractions anywhere in the body or repetition of sounds and words)
any history of mental or behavioural health problems in you or other family members. Your doctor will assess whether you are at risk of mood swings (from mania to depression, 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 allow your doctor
to determine whether methylphenidate is suitable for you. Your doctor may decide that further clinical tests are needed before starting this medicine. For adult patients who are new to taking Noku, the prescribing doctor may refer you to a cardiologist.
Other medicines and Noku
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take methylphenidate if:

you are taking a medicine called a “monoamine oxidase inhibitor” (MAOI), used for depression, or have taken an MAOI within the last 14 days. Taking an MAOI with methylphenidate may cause a sudden increase in blood pressure (see section “Do not take Noku”). Inform your doctor or pharmacist if you are taking any of the following medicines for depression or anxiety:
- tricyclic antidepressants
- selective serotonin reuptake inhibitors (SSRIs)
- serotonin and noradrenaline reuptake inhibitors (SNRIs).

Taking methylphenidate together with these medicines may cause a potentially life-threatening increase in serotonin levels in the brain (serotonin syndrome), which may present with symptoms such as: confusion or restlessness, sweating, shivering, muscle spasms, or rapid heartbeat. If you experience any of these side effects, seek medical advice immediately.
If you are taking other medicines, methylphenidate may affect their effectiveness or cause side effects. If you are taking any of the following medicines, consult your doctor or pharmacist before taking methylphenidate:

medicines for severe mental health conditions
medicines for Parkinson’s disease (such as levodopa)
medicines for epilepsy
medicines used to lower or raise blood pressure
some cough and cold remedies containing ingredients that may affect blood pressure. It is important to seek advice from your pharmacist when purchasing these products
medicines that thin the blood to prevent clotting.

If you are unsure whether any of your medicines are included in the list above,
consult your doctor or pharmacist before taking methylphenidate.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine,
including those without a prescription.
Surgery
Inform your doctor if you are scheduled for surgery. Methylphenidate should not be taken
on the day of surgery if a certain type of anaesthetic is to be used. This is because there is a risk of a sudden increase in blood pressure during the procedure.
Drug testing
This medicine may give a positive result in drug tests for illicit substances. This includes tests performed in sports.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Noku and alcohol
Do not drink alcohol when taking this medicine. Alcohol may worsen the side effects of this medicine. Please note that some foods and medicines contain alcohol.
Pregnancy, breastfeeding and contraception
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Available data do not indicate an increased risk of overall birth defects, but a small increase in the risk of heart malformations cannot be ruled out following use during the first three months of pregnancy. Your doctor can provide further information on this risk. Before using methylphenidate, inform your doctor or pharmacist if you:

are sexually active. Your doctor will discuss contraceptive measures with you
are pregnant or suspect you may be pregnant. Your doctor will decide whether you should take methylphenidate
are breastfeeding or intend to breastfeed. Methylphenidate may be excreted in breast milk. Therefore, your doctor will decide whether you can breastfeed while taking methylphenidate.

Driving and using machines
While taking methylphenidate, you may feel dizzy, have difficulty concentrating, or experience blurred vision. If this happens, it may be dangerous to perform activities such as driving, operating machinery, cycling, horse riding, or climbing trees.
This medicine may affect your ability to drive.
Do not drive while taking this medicine until you know how it affects you.
It may be an offence to drive if your ability to drive safely is impaired.
Noku contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Noku contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Noku

Dosage
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will usually start treatment with a low dose and, if necessary, may increase the daily dose by 18 mg no sooner than one week later. The goal should be the lowest dose that is effective for you. Your doctor will determine the maximum daily dose for you or your child.
You should take Noku once daily in the morning, with a glass of water. The tablet must be swallowed whole and must not be chewed, broken, or crushed. The tablet may be taken with or without food. After the entire drug has been released, the tablet does not completely dissolve and sometimes the tablet coating may appear in the stool. This is normal.

Use in children aged 6 years and older

The recommended initial dose of Noku is 18 mg once daily in children who are not already taking methylphenidate or who are switching from another stimulant to methylphenidate.
The maximum daily dose is 54 mg.

Use in adults
For adults who have previously taken Noku:

If you have previously taken Noku during childhood or adolescence, the same daily dose (mg/day) may be used; your doctor will regularly check whether dose adjustment is needed.
Adult patients may require a higher daily dosage, but your doctor will determine the lowest effective dose.
For adults who have not previously taken Noku:
The recommended starting dose is 18 mg per day.
The maximum daily dose in adults is 72 mg.

If you do not feel better after 1 month of treatment
If you do not feel better after 1 month of treatment, inform your doctor. They may decide that a different treatment is necessary.
Misuse of Noku
Misuse of Noku may lead to abnormal behaviour. It may also mean that you become dependent on the medicine. Inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs.
This medicine is prescribed for you only. Do not give this medicine to others, even if their symptoms seem similar.
If you take more Noku than you should
If you take an excessive dose of this medicine, contact a doctor immediately or call an ambulance. Inform them of the amount taken. Medical treatment may be required.
Signs of overdose may include: vomiting, agitation, tremor, increased involuntary movements, muscle spasms, seizures (which may be followed by coma), feelings of extreme happiness, confusion, seeing, sensing, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth.
If you forget to take Noku
Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until the time for your next dose.
If you stop taking Noku
If you suddenly stop treatment with this medicine, ADHD symptoms may return, or you may experience unwanted effects such as depression. Your doctor may gradually reduce the dose each day before stopping treatment completely.
Consult your doctor before stopping treatment with Noku.
Monitoring by your doctor during treatment
Your doctor will carry out certain checks:

before you start treatment – to ensure that Noku is safe and effective.
after you have started treatment – at least every 6 months, but possibly more frequently. Checks will also be performed when the dose is adjusted.
These checks will include:
- monitoring of appetite
- measurement of height and weight
- measurement of blood pressure and heart rate
- monitoring for mood problems, mental status, or any other unusual feelings, or if these symptoms worsen during treatment with Noku.

Long-term treatment
Noku should not be taken indefinitely. If you take Noku for more than one year, your doctor should interrupt treatment for a short period, for example during school holidays. This will help to determine whether the medicine is still needed.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Even though some people may experience side effects, most people find methylphenidate helpful. Your doctor will discuss these side effects with you.
Some side effects may be serious. If you experience any of the following side effects,
seek immediate medical advice:

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)

suicidal thoughts or desire to harm yourself
seeing, hearing or feeling things that do not exist; these are signs 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 parts of the body, shortness of breath, wheezing or difficulty breathing

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

unusual excitement, hyperactivity and lack of inhibition (mania)

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

heart attack
sudden death
suicide attempt
epileptic seizures (convulsive fits, convulsions, epilepsy)
skin peeling or purplish-red spots
inflammation or blockage of the cerebral arteries
temporary paralysis or problems with movement and vision, difficulty speaking (these may be signs of problems with brain blood vessels)
uncontrollable muscle spasms affecting the eyes, head, neck, body and nervous system
decrease in blood cell counts (red blood cells, white blood cells and platelets), which may increase susceptibility to infections and cause bleeding and bruising more easily
sudden increase in body temperature, very high blood pressure and severe convulsions (“Neuroleptic Malignant Syndrome”). It is unclear whether this side effect is caused by methylphenidate or by other medicines that may be taken together with methylphenidate.

Not known (frequency cannot be estimated from available data)

unwanted thoughts that keep recurring
unexplained fainting, 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 these side effects, seek immediate medical advice.
Other side effects include the following; if they become severe, inform your doctor or
pharmacist:

Very common (affects more than 1 in 10 people)

headache
nervousness
inability to sleep.

Common (affects less than 1 in 10 people)

joint pain
blurred vision
tension headache
dry mouth, thirst
difficulty falling asleep
high temperature (fever)
reduced sexual desire
unusual hair loss or thinning
muscle stiffness, muscle cramps
loss or decrease in appetite
inability to achieve or maintain an erection
itching, skin rash or increase in itchy red bumps (hives)
unusual or excessive drowsiness, feeling of tiredness
teeth grinding (bruxism)
feeling of panic
tingling, pins and needles or numbness of the skin
increased alanine aminotransferase (liver enzyme) in blood
cough, sore throat or nasal-pharyngeal irritation; upper respiratory tract infection; sinusitis
high blood pressure, fast heartbeat (tachycardia)
dizziness (vertigo), feeling of weakness, uncontrollable movements, unusually increased activity
aggression, agitation, anxiety, depression, irritability, tension, nervousness, abnormal behaviour
stomach ache or indigestion, stomach pain, diarrhoea, nausea, abdominal discomfort and vomiting
excessive sweating
weight loss.

Uncommon (affects less than 1 in 100 people)

dry eyes
constipation
chest discomfort
blood in urine
lethargy
tremor or shaking
increased need to urinate
muscle pain, muscle contractions
shortness of breath or chest pain
feeling of warmth
increased liver function test values (seen in blood tests)
anger, restlessness or tendency to cry, excessive talking, excessive awareness of surroundings, sleep disturbances.

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

problems with sexual desire
disorientation or confusion
visual disturbances or double vision
breast enlargement in men
skin redness, raised red skin rash
Obsessive-Compulsive Disorder (OCD) (including irresistible urge to pull out body hair, skin picking, recurrent and unwanted thoughts, sensations, images or impulses in the mind (obsessive thoughts), performance of repetitive behaviours or mental rituals (compulsions)).

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

muscle cramps
small red spots on the skin
changes in liver function, including sudden liver failure and coma
changes in laboratory test results – including liver and blood tests
abnormal thinking, lack of feelings or emotions
numbness of fingers and toes with tingling and colour change (from white to blue, then to red) when exposed to cold (Raynaud’s phenomenon).

Not known: frequency cannot be estimated from available data

migraine
dilation of the pupils
very high fever
slow, fast or irregular heartbeats (extrasystoles)
major epileptic seizures (“grand mal convulsions”)
believing things that are not true
severe stomach pain, often accompanied by nausea and vomiting
problems with brain blood vessels (stroke, cerebral arteritis or cerebral occlusion)
inability to hold urine (incontinence)
jaw muscle spasm making it difficult to open the mouth (trismus)
stuttering
nosebleeds
increased eye pressure
eye diseases that may cause vision loss due to damage to the optic nerve (glaucoma).

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

you may notice lack of weight gain or growth.
your doctor will closely monitor height, weight and nutritional status.
if you do not grow 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, talk to 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.

5. How to store Noku

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after Exp. The expiry date refers to the last day of that month.
Keep the bottle tightly closed to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Noku contains
The active substance is methylphenidate hydrochloride.

Each tablet contains 18 mg, 27 mg, 36 mg, 45 mg, or 54 mg of methylphenidate hydrochloride. The other components are:
Tablet core: hypromellose, macrogol, succinic acid, magnesium stearate, sodium chloride, anhydrous colloidal silica, black iron oxide (E172).
Film coating: cellulose acetate, macrogol.
Transparent coating: hypromellose, macrogol, phosphoric acid (for pH adjustment).
Coloured coating: lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172) (18 mg), red iron oxide (E172) (18 mg, 27 mg, 54 mg), black iron oxide (E172) (27 mg), indigotine (E132) (45 mg).

Description of the appearance of Noku and contents of the pack

18 mg: film-coated tablets, round, biconvex, yellow in colour, approximately 9 mm in diameter, with a small hole on one side of the tablet.
27 mg: film-coated tablets, round, biconvex, grey in colour, approximately 9 mm in diameter, with a small hole on one side of the tablet.
36 mg: film-coated tablets, round, biconvex, white in colour, approximately 10 mm in diameter, with a small hole on one side of the tablet.
45 mg: film-coated tablets, round, biconvex, blue in colour, approximately 10 mm in diameter, with a small hole on one side of the tablet.
54 mg: film-coated tablets, round, biconvex, pink in colour, approximately 10 mm in diameter, with a small hole on one side of the tablet.

The medicine is available in a plastic bottle containing 2 desiccant packs with a child-resistant plastic cap. The desiccant packs are intended to keep the tablets dry and must not be ingested.
Pack sizes: 30 tablets; 60 tablets (2x30); and 90 tablets (3x30).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Italia s.r.l.
Via San Bovio, 3
20054 Segrate (MI)
Italy

Manufacturer
Laboratorios Liconsa S.A.
Avenida de Miralcampo, 7
19200 Azuqueca de Henares
Guadalajara
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Sweden: Phenichem 18 mg, 27 mg, 36 mg, 45 mg, 54 mg depottabletter
Spain: Atenza 18 mg, 27 mg, 36 mg, 45 mg, 54 mg comprimidos de liberación prolongada
Poland: Atenza
Italy: Noku
France:
Portugal: Atexam 18 mg, 27 mg, 36 mg, 45 mg, 54 mg comprimido de libertação prolongada
Austria: Vocuz 18 mg, 27 mg, 36 mg, 45 mg, 54 mg Retardtablette
Belgium:
Czech Republic: Balipre
Finland: Atexam 18 mg, 27 mg, 36 mg, 45 mg, 54 mg depottabletti
Slovakia: Atenza 18 mg, 27 mg, 36 mg, 45 mg, 54 mg tablety s predĺženým uvoľňovaním
Estonia: Osmetil
Latvia: Osmetil
Lithuania: Osmetil