Patient Information Leaflet: Information for the User

Tuzulby 20 mg prolonged-release chewable tablets, 30 mg prolonged-release chewable tablets, 40 mg prolonged-release chewable tablets

methylphenidate hydrochloride
Please read all of this leaflet carefully before you take 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 other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

The last section is a special section that children or adolescents are encouraged to read.
1. What Tuzulby is and what it is used for
2. What you need to know before taking Tuzulby
3. How to take Tuzulby
4. Possible side effects
5. How to store Tuzulby
6. Contents of the pack and other information

1. What Tuzulby is and what it is used for

Tuzulby contains the active substance methylphenidate hydrochloride. It belongs to a group of medicines that act on brain activity.
Tuzulby is intended for the treatment of children and adolescents aged 6 years to less than 18 years who have attention deficit hyperactivity disorder (ADHD).
It is used in combination with comprehensive treatment programmes (such as psychological, educational, and social interventions) when these programmes alone are not sufficient to control ADHD symptoms.
The diagnosis must be made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders and must be based on a complete history and assessment of the child/adolescent.
Treatment with Tuzulby is not indicated for all children with ADHD, and the decision to use the medicine must be based on the severity and persistence of symptoms, taking into account the age of the child/adolescent.
Tuzulby works by improving the functioning of certain parts of the brain. Although the exact mechanism of action of the active substance in Tuzulby is not yet fully understood, it is believed to increase levels of dopamine, a neurotransmitter that regulates mood and attention. This occurs by blocking proteins in the brain that reabsorb or transport dopamine back into the nerves. This helps improve attention and concentration and may help control impulsive behaviours.

2. What you need to know before taking Tuzulby

Do not take Tuzulby if you or the child

are allergic to methylphenidate or to any of the other ingredients of this medicine listed in section 6
have an overactive thyroid (hyperthyroidism) or unusually high blood levels of thyroid hormones (thyrotoxicosis)
are currently taking monoamine oxidase inhibitors (MAOIs) (a medicine for depression) or have taken them within the last 14 days – see 'Other medicines and Tuzulby'
have glaucoma (increased pressure in the eye)
have phaeochromocytoma (a tumour of the adrenal gland)
have very high blood pressure or arterial occlusive disease (narrowing of blood vessels)
have heart problems (such as heart attack, severely abnormal or irregular heartbeat [arrhythmia], or conditions caused by ion channels controlling electrical activity [channelopathies], chest pain and discomfort [angina], heart failure, heart disease, damage to the heart muscle [cardiomyopathy])
have or have had problems with blood vessels in the brain (such as stroke, aneurysm [swelling and weakening of a part of a blood vessel], narrowed or blocked blood vessels, or vasculitis [inflammation of blood vessels])
have or have had mental health problems such as:
severe depression, suicidal thoughts
eating disorders, such as anorexia nervosa or other anorexic disorders
psychosis (a serious mental disorder in which a person loses the ability to recognize reality or relate to others), psychopathic or borderline personality disorder
severe mood disorder, mania
severe and episodic bipolar disorder, currently or previously diagnosed, not adequately controlled.

Methylphenidate must not be taken if you or the child fall into any of the situations listed above. If in doubt, consult your doctor or pharmacist before taking methylphenidate.

Warnings and precautions

Before starting treatment with Tuzulby, talk to your doctor about:

Long-term use in children and adolescents: Re-evaluation of the long-term benefit of the medicine to assess the patient's behaviour.
Cardiovascular diseases: Conditions affecting the heart and blood circulation, including any family history of sudden or unexplained death or serious heart rhythm problems. Before starting treatment with Tuzulby, your doctor will perform a careful assessment, including examinations and a review of your and your family's medical history, to check for heart disease or serious arrhythmias. During treatment, your doctor will regularly monitor blood pressure and heart rate, especially when the dose is changed, and at least every 6 months.
Cases of sudden death have been reported in children taking stimulants at normal doses, particularly in those with serious heart problems or structural heart abnormalities. Stimulant medicines are not recommended in children or adolescents with known serious heart conditions, as they may increase the risk of sudden death.
If symptoms of heart disease such as palpitations, chest pain during physical exercise, fainting, or shortness of breath occur during treatment with Tuzulby, inform your doctor immediately.
Cerebrovascular disorders: Neurological signs and symptoms should be evaluated after starting treatment with methylphenidate.
Psychiatric disorders: These should be monitored with every dose adjustment.
Worsening of psychotic or manic symptoms.
Onset of new psychotic or manic symptoms.
Aggressive or hostile behaviour.
Suicidal tendencies.
Tics.
Anxiety, agitation or tension.
Forms of bipolar disorder.
Effects on growth.
Seizures.
Abuse, misuse and diversion.
Withdrawal.

During treatment, unexpected prolonged erections may occur in boys and adolescents. This may be painful and can happen at any time. It is important to contact your doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Inform your doctor or pharmacist if any of the conditions listed above apply to you before starting treatment. This is because methylphenidate may worsen these problems. Your doctor will want to monitor the effect of the medicine on you.

If Tuzulby is not used correctly, it could cause abnormal behaviours. It may also lead to the development of dependence on the medicine. Inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines or drugs.

Checks your doctor will perform before starting methylphenidate therapy

These checks are intended to determine whether methylphenidate is the right medicine for you. Your doctor will ask you about the following:

any other medicines you are taking
any family history of sudden unexplained death
any other medical problems (such as heart problems) that you or your family may have
how you feel, for example, whether you feel euphoric or depressed, have strange thoughts, or have experienced any of these feelings in the past
any family history of "tics" (repeated, difficult-to-control contractions of any part of the body or repeated sounds and words)
any mental health or behavioural problems you or other family members have had. Your doctor will assess your risk of mood swings (from manic to depressive states, so-called "bipolar disorder"). Your medical history regarding mental health will be reviewed, as well as any family 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 decide that further tests are needed before starting treatment with this medicine.

Use in adults and elderly

Methylphenidate is not indicated for use in adults with ADHD.

Methylphenidate must not be used in the elderly.

Safety and efficacy have not been established in these age groups.

Use in children under 6 years of age

Methylphenidate must not be used in children under 6 years of age. Safety and efficacy have not been established in this age group.

Other medicines and Tuzulby

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

Methylphenidate may affect the effectiveness of other medicines or may cause adverse effects when used in combination with certain medicines. It may therefore be necessary to adjust the dose of your medicine or stop taking it altogether if you are taking other medicines. Consult your doctor or pharmacist before taking methylphenidate if you are already taking:

medicines for depression
medicines for serious mental health conditions (e.g. for schizophrenia)
medicines for epilepsy
medicines used to lower or raise blood pressure
some cough and cold remedies containing medicines that may affect blood pressure. It is important to consult your pharmacist when purchasing any of these products
medicines that thin the blood to prevent clotting
alcohol
medicines that act as central alpha-2 agonists (e.g. clonidine)

If you have any doubts whether any of the medicines you are taking are included in the list above, consult your doctor or pharmacist for clarification before taking methylphenidate.

Surgery

Inform your doctor if you are scheduled for surgery. You must not take methylphenidate on the day of surgery if a halogenated anaesthetic (a certain type of anaesthetic) is to be used. This is because there is a risk of a sudden increase in blood pressure and heart rate during surgery.

Drug testing

This medicine may give positive results in drug tests for substance abuse. This includes tests used in sports.

Taking Tuzulby with food, drinks and alcohol

Do not drink alcohol while taking this medicine. Alcohol may worsen the side effects of this medicine.

Pregnancy and breastfeeding

Methylphenidate must not be used during pregnancy unless your doctor considers that the benefits of taking this medicine outweigh the risks to the foetus.

Do not breastfeed while taking Tuzulby unless your doctor tells you that you may do so.

If you are breastfeeding, suspect you are pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

While taking methylphenidate, you may experience dizziness, difficulty concentrating or blurred vision. If you experience these side effects, it may be dangerous to perform activities such as driving, operating machinery, riding a bicycle or a horse, or climbing trees.

This medicine contains aspartame

Each 20 mg chewable tablet contains 6.1 mg of aspartame (E 951).

Each 30 mg chewable tablet contains 9.15 mg of aspartame (E 951).

Each 40 mg prolonged-release chewable tablet contains 12.2 mg of aspartame (E 951).

Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per modified-release chewable tablet, i.e. it is essentially "sodium-free".

3. How to take Tuzulby

Take this medicine exactly as your doctor has instructed you. If in doubt,
consult your doctor or pharmacist.
Treatment must be carried out under the supervision of a specialist in paediatric behavioural disorders.

Usually, your doctor will start treatment with a low dose (20 mg) and gradually increase it as needed. The maximum daily dose is 60 mg.
If you are already taking immediate-release methylphenidate, your doctor may prescribe you an equivalent dose of Tuzulby (methylphenidate extended-release).
Tuzulby should be taken once daily. Tuzulby can be taken with or without food. Tuzulby is an extended-release chewable tablet. This means that after taking the tablet, the medicine is released into the body over the course of the day.
The tablets must be chewed.
Taking methylphenidate with food may help reduce stomach pain, nausea, and vomiting.
The 20 mg and 30 mg Tuzulby chewable tablets are scored (divided in two) and can be split. Tuzulby 20 mg and 30 mg may be divided into equal doses.

Do not ingest the desiccant container contained in the bottle.
Long-term treatment
If you take Tuzulby for more than one year, your doctor will temporarily interrupt treatment to assess whether the medicine is still necessary. This interruption may be planned during school holidays. Improvements observed during treatment may persist even after stopping the medicine.
If you take more Tuzulby than you should
Taking too much Tuzulby can cause serious adverse effects on the nervous system. If you take an excessive dose, contact a doctor immediately or call an ambulance. Inform them of the amount of medicine taken.
Signs of overdose may include: vomiting, agitation, tremors, increased involuntary movements, muscle twitches, seizures (which may be followed by coma), feelings of extreme happiness, confusion, seeing, hearing, or sensing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms, fever, red-brown urine which could be possible signs of abnormal muscle breakdown (rhabdomyolysis). If you experience any of these symptoms, contact your doctor immediately.
If you forget to take Tuzulby
Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until the next scheduled dose.
If you stop taking Tuzulby
If you suddenly stop taking this medicine, ADHD symptoms may return or side effects such as depression may occur. Your doctor may decide to gradually reduce the daily dose before stopping treatment completely. Consult your doctor before stopping Tuzulby.
If you have any questions about how to use the product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss these side effects with you.
Some side effects may be serious. If you experience any of the following side effects, consult a doctor immediately:

Common (may affect up to 1 in 10 people)

irregular heartbeat (palpitations, tachycardia, arrhythmia)
changes in mood, mood swings, or changes in personality

Uncommon (may affect up to 1 in 100 people)

thoughts or desire to harm yourself (suicidal thoughts)
suicide
seeing or hearing things that are not real; these are symptoms of psychosis
uncontrolled speech and body movements (Tourette’s syndrome), emotional blunting
signs of allergy such as rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing, itching

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

feeling unusually excited, hyperactive and disinhibited (mania)

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

heart attack, myocardial infarction
seizures (epileptic fits, convulsions, epilepsy)
skin peeling or red-purple patches, erythema multiforme
uncontrollable muscle spasms affecting the eyes, head, neck, body and nervous system, due to a temporary lack of blood flow to the brain
paralysis or movement and vision problems, difficulty speaking; these may be signs of problems affecting the blood vessels in the brain
decrease in blood cell count (red blood cells, white blood cells and platelets), which may increase susceptibility to infections, cause easier bleeding and bruising, and decrease in white blood cells
sudden increase in body temperature, very high blood pressure and severe convulsions ('neuroleptic malignant syndrome'). It is not certain whether this side effect is caused by methylphenidate or by other medicines that may be taken in combination 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
inability to control urination (incontinence)
jaw muscle spasm making it difficult to open the mouth (trismus)
stuttering

If you experience any of the above-listed side effects, consult a doctor immediately.
Other side effects include the following; if they become severe, inform your doctor or pharmacist:

Very common (affects more than 1 in 10 people)

reduced appetite
headache
feeling nervous (nervousness)
inability to sleep (insomnia)
nausea
dry mouth

Common (may affect up to 1 in 10 people)

joint pain (arthralgia)
high temperature (fever)
unusual hair loss or thinning
unusual drowsiness or dizziness
loss of appetite (anorexia)
panic attacks
reduced sexual desire
toothache
excessive teeth grinding (bruxism)
rhinopharyngitis
itching, rash or raised red itchy skin eruptions (urticaria)
excessive sweating
cough, sore throat or irritation of the nose and throat, shortness of breath or chest pain
changes in blood pressure, usually high blood pressure, rapid heartbeat (tachycardia), cold hands and feet
tremors, dizziness, uncontrollable movements, unusual activity
feeling aggressive, restless, anxious, depressed, irritable, having abnormal behaviour, sleep problems, fatigue
stomach pain, diarrhoea, nausea, stomach discomfort and vomiting. These side effects usually occur at the beginning of treatment and may be reduced by taking the medicine with food

Uncommon (may affect up to 1 in 100 people)

constipation
chest discomfort
blood in the urine (haematuria)
double vision or blurred vision (diplopia)
muscle pain, muscle contractions, muscle tension
increased values in liver function tests (observed in blood tests)
anger, restlessness or crying, excessive awareness of the surrounding environment, tension
sedation, reduced appetite
exfoliative conditions
heart murmur

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

changes in sexual desire
feeling disoriented
dilated pupils, difficulty seeing
angina pectoris
breast enlargement in men (gynaecomastia)
skin redness, raised red skin rash

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 blood vessels in the brain
abnormal liver function, including liver failure and coma
changes in test results, including liver and blood tests
suicide attempt, abnormal thinking, lack of feelings or emotions, repeated performance of an action, being obsessed with something
numbness of fingers and toes, tingling and colour changes (from white to blue, then red) when cold (Raynaud’s phenomenon)

Not known (frequency cannot be estimated from available data)

migraine
very high fever
slow, fast or irregular heartbeat
a severe seizure ('grand mal' convulsion), migraine
believing in things that are not true, confusion, delusional ideas
severe stomach pain, often accompanied by nausea and vomiting
problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
erectile dysfunction, prolonged, sometimes painful erections, or more frequent erections
blood cell disorders (increase and decrease)
excessive and uncontrollable talking
pancytopenia

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

There may be a lack of weight gain or height growth.
Your doctor will carefully monitor height, weight and nutrition.
If growth is not as expected, treatment with methylphenidate may be temporarily suspended.

Reporting of side effects
If you experience any side effects, 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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tuzulby

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed to protect it from moisture.
Do not use this medicine after the expiry date stated on the label and the carton. The expiry date refers to the last day of the month.
Do not dispose of any medicine 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 Tuzulby contains

The active substance is methylphenidate hydrochloride.

Each 20 mg chewable tablet contains 20 mg of methylphenidate hydrochloride.
Each 30 mg chewable tablet contains 30 mg of methylphenidate hydrochloride.
Each 40 mg chewable tablet contains 40 mg of methylphenidate hydrochloride.

The other excipients are sodium polystyrene sulfonate, povidone (E 1201), triacetin (E 1518), polyvinyl acetate, sodium lauryl sulfate, mannitol (E 421), xanthan gum (E 415), crospovidone (E 1202), microcrystalline cellulose (E 460), guar gum (E 412), aspartame (E 951), citric acid, cherry flavour, talc (E 553b), hydrated colloidal silica, magnesium stearate, polyvinyl alcohol, macrogol, polysorbate 80 (E 433).

Description of the appearance of Tuzulby and the contents of the pack
The Tuzulby 20 mg prolonged-release chewable tablets are capsule-shaped, film-coated tablets measuring 6.8 x 14.7 mm, speckled, white to off-white in colour, with "N2" "N2" engraved on one side and divided into two equal parts on the other side.
The chewable tablet can be divided into equal doses.
The Tuzulby 30 mg prolonged-release chewable tablets are capsule-shaped, film-coated tablets measuring 7.7 x 16.8 mm, speckled, white to off-white in colour, with "N3" "N3" engraved on one side and divided into two equal parts on the other side.
The chewable tablet can be divided into equal doses.
The Tuzulby 40 mg prolonged-release chewable tablets are capsule-shaped, film-coated tablets measuring 8.5 x 18.5 mm, speckled, white to off-white in colour, with "NP14" engraved on one side and smooth on the other side.
Tuzulby is available in a bottle with a child-resistant cap and a container with a 2 g desiccant, containing 30 prolonged-release chewable tablets.

Marketing Authorization Holder
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí - Barcelona
Spain
Tel: +34 93 602 24 21
E-mail: [email protected]

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí - Barcelona
Spain
Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Neuraxpharm France Neuraxpharm Pharmaceuticals, S.L.
Tél/Tel: +32 474 62 24 24 Tel: +34 93 602 24 21

България Luxembourg/Luxemburg
Neuraxpharm Pharmaceuticals, S.L. Neuraxpharm France
Teл.: +34 93 602 24 21 Tél/Tel: +32 474 62 24 24

Česká republika Magyarország
Neuraxpharm Bohemia s.r.o. Neuraxpharm Bohemia s.r.o.
Tel: +420 495 736 145 Tel.: +36 (30) 542 2071

Danmark Malta
Neuraxpharm Sweden AB Neuraxpharm Pharmaceuticals, S.L.
Tlf: +46 (0)8 30 91 41 Tel.: +34 93 602 24 21
(Sverige)

Deutschland Nederland
neuraxpharm Arzneimittel GmbH Neuraxpharm Netherlands B.V
Tel: +49 2173 1060 0 Tel.: +31 70 208 5211

Eesti Norge
Neuraxpharm Pharmaceuticals, S.L. Neuraxpharm Sweden AB
Tel: +34 93 602 24 21 Tlf: +46 (0)8 30 91 41
(Sverige)

Ελλάδα Österreich
Neuraxpharm Pharmaceuticals, S.L. Neuraxpharm Austria GmbH
Τηλ: +34 93 602 24 21 Tel.: +43 2236 389836

España Polska
Neuraxpharm Spain, S.L.U. Neuraxpharm Polska Sp. z.o.o.
Tel: +34 93 602 24 21 Tel.: +48 783 423 453

France Portugal
Neuraxpharm France Neuraxpharm Portugal, Unipessoal Lda
Tél: +33 1.53.62.42.90 Tel: +351 910 259 536

Hrvatska România
Neuraxpharm Pharmaceuticals, S.L. Neuraxpharm Pharmaceuticals, S.L.
Teл.: +34 93 602 24 21 Teл.: +34 93 602 24 21

Ireland Slovenija
Neuraxpharm Ireland Ltd. Neuraxpharm Pharmaceuticals, S.L.
Tel: +353 1 428 7777 Tel: +34 93 602 24 21

Ísland Slovenská republika
Neuraxpharm Sweden AB Neuraxpharm Bohemia s.r.o.
Sími: +46 (0)8 30 91 41 Tel: +421 255 425 562
(Svíþjóð)

Italia Suomi/Finland
Neuraxpharm Italy S.p.A. Neuraxpharm Sweden AB
Tel: +39 0736 980619 Puh/Tel: +46 (0)8 30 91 41
(Ruotsi/Sverige)

Κύπρος Sverige
Neuraxpharm Pharmaceuticals, S.L. Neuraxpharm Sweden AB
Τηλ: +34 93 602 24 21 Tel: +46 (0)8 30 91 41

Latvija
Laboratorios Lesvi, S.L.
Tel: +34 93 602 24 21

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency:
https://www.ema.europa.eu