TUZULBY 20 mg Extended-Release Chewable Tablets

Зміст інструкції

1. Tuzulby 20 mg chewable prolonged-release tablets, 30 mg chewable prolonged-release tablets, 40 mg chewable prolonged-release tablets
   1. What is Tuzulby and what is it 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

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

methylphenidate hydrochloride

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 invited to read.
• 1. What Tuzulby is and what it is used for
• 2. What you need to know before you take 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 is Tuzulby and what is it used for

Tuzulby contains the active ingredient 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 and under 18
years with attention deficit hyperactivity disorder (ADHD).
It is used in combination with comprehensive treatment programs (such as psychological,
educational and social therapy) when such programs alone are not sufficient to control the symptoms
of ADHD. The diagnosis must be made according to the criteria of the Manual of Mental Disorders and must
be based on a complete medical history and an assessment of the child/adolescent.
Treatment with Tuzulby is not indicated in all children with ADHD and the decision to use the
medicine must be based on the severity and persistence of the symptoms in consideration of the age of the
child/adolescent.
Tuzulby works by improving the functioning of certain parts of the brain. Although the mechanism of action of the active ingredient contained in Tuzulby is not yet
fully understood, it is believed to increase levels
of dopamine, a hormone that regulates mood and attention. This happens by blocking proteins in the
brain that reabsorb or return dopamine to the nerves. This helps to improve attention and
concentration and can help control impulsive behaviors.

2. What you need to know before taking Tuzulby

Do not take Tuzulby if you or the child

• is allergic to methylphenidate or any of the other ingredients of this medicine listed in section 6
• has an overactive thyroid (hyperthyroidism) or unusually high levels of thyroid hormones in the blood (thyrotoxicosis)
• is currently taking monoamine oxidase inhibitors (MAOIs) (a medicine for depression) or has taken them in the last 14 days - see 'Other medicines and Tuzulby'
• has glaucoma (high pressure in the eye)
• has a pheochromocytoma (a tumor of the adrenal gland)
• has very high blood pressure or occlusive arterial disease (narrowing of blood vessels)
• has heart problems (such as a heart attack, a severely abnormal or irregular heartbeat [arrhythmia] or disorders caused by channels that control electrical activity [channelopathies], chest pain and discomfort [angina], heart failure, heart disease, damage to the heart muscle [cardiomyopathy])
• has or has 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])
• has or has had mental health problems such as:
• severe depression, suicidal thoughts
• eating disorder, 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 sufficiently controlled.

Methylphenidate must not be taken if you or the child falls into one of the situations listed above. If you have any doubts, consult your doctor or pharmacist before taking methylphenidate.

Warnings and precautions
Before starting to take Tuzulby, talk to your doctor about:

• Prolonged use in children and adolescents: re-evaluation of the long-term benefit of the medicine to assess the patient's behavior.
• 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, the doctor will perform a careful evaluation, including tests and a review of your and your family’s medical history, to check for heart disease or serious arrhythmia problems. During treatment, the doctor will also 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, especially in those with serious heart problems or structural heart abnormalities. Stimulant medicines are not recommended in children or adolescents with known serious heart disease, as they may increase the risk of sudden death.
• If you experience symptoms of heart disease during treatment with Tuzulby, such as palpitations, chest pain during exercise, fainting or shortness of breath, tell your doctor immediately.
• Cerebrovascular disorders; signs and symptoms should be evaluated after starting treatment with methylphenidate.
• Psychiatric disorders; must be monitored with each dose adjustment.
• Worsening of psychotic or manic symptoms.
• Onset of new psychotic or manic symptoms.
• Aggressive or hostile behavior.
• Suicidal tendency.
• Tics.
• Anxiety, agitation or tension.
• Forms of bipolar disorder.
• Effects on growth.
• Convulsions.
• Abuse, misuse and diversion.
• Withdrawal.

During treatment, prolonged unexpected erections may occur in boys and adolescents. It 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. Tell your doctor or pharmacist if any of the above conditions apply to you before starting treatment. This is because methylphenidate can worsen these problems. The doctor will want to monitor the effect of the medicine on you. If Tuzulby is not used correctly, it may cause abnormal behavior. It can also cause the onset of a dependence on the medicine. Tell your doctor if you have ever abused or been addicted to alcohol, prescription drugs or illegal drugs.

Checks your doctor will perform before starting therapy with methylphenidate
These checks are to establish whether methylphenidate is the right medicine for you. The doctor will ask you about the following:

• any other medicines you are taking
• if there is a 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 if you feel euphoric or depressed, if you have strange thoughts or if you have had these feelings in the past
• if there is a family history of "tics" (repetitive and difficult-to-control contractions of any part of the body or repeated sounds and words)
• any mental or behavioral health problems that you or other family members have had. The doctor will tell you if you are at risk of mood swings (from manic to depressive, the so-called "bipolar disorder"). Your medical history regarding mental health will be checked and if there are cases of suicide, bipolar disorder or depression in your family. It is important that you provide as much information as possible. This will help the doctor decide if methylphenidate is the right medicine for you. The doctor may decide that further tests are needed before starting therapy with this medicine.

Use in adults and the elderly
Methylphenidate is not indicated for use in adults with ADHD.
Methylphenidate should 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 should not be used in children under 6 years of age. Safety and efficacy have not been established in these age groups.

Other medicines and Tuzulby
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Methylphenidate can affect the effectiveness of other medicines or can cause unwanted effects if used in combination with certain medicines. It may therefore be necessary to change the dosage of the 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 problems (e.g. against schizophrenia)
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies containing medicines that can affect blood pressure. It is important to consult the pharmacist when purchasing one of these products
• medicines that thin the blood to prevent blood clots
• alcohol
• medicines that act as central alpha-2 agonists (e.g. clonidine) If you have any doubt that any of the medicines you are taking are on the list above, ask your doctor or pharmacist for clarification before taking methylphenidate.

Surgery
Tell your doctor if you are going to have surgery. You should not take methylphenidate on the day of surgery if a halogenated anesthetic (a certain type of anesthetic) is 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 tests for drug use. These include tests used in sports.

Taking Tuzulby with food, drinks and alcohol
Do not drink alcohol while taking this medicine. Alcohol can worsen the side effects of this medicine.

Pregnancy, breastfeeding
Methylphenidate should not be used during pregnancy unless your doctor believes that the benefits of taking this medicine outweigh the risks to the fetus.
Do not breastfeed while taking Tuzulby unless your doctor tells you that you can. If you are breastfeeding, suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
If you take methylphenidate, you may feel dizzy, have difficulty concentrating or blurred vision. If you experience these side effects, it can be dangerous to perform activities such as driving, using machinery, cycling or horseback riding 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 extended-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 disease in which phenylalanine accumulates because the body cannot eliminate it correctly.

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 told you. If you have any doubts,
consult your doctor or pharmacist.
Treatment must be carried out under the supervision of a specialist in childhood behavioral disorders.

• Usually the doctor will start treatment with a low dose (20 mg) and will 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 (prolonged-release methylphenidate).
• Tuzulby should be taken once a day. Tuzulby can be taken with or without food. Tuzulby is a prolonged-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 can help relieve stomach pain, nausea and vomiting.
• Tuzulby 20 mg and 30 mg chewable tablets are scored (divided in two) and can be split. Tuzulby 20 mg and 30 mg can be divided into equal doses.

Do not ingest the desiccant container contained in the bottle.

Prolonged treatment
If you take Tuzulby for more than a year, your doctor will need to stop treatment for a short
period to check if the medicine is still needed. This activity can be planned
during school holidays. The improvements observed during the taking of the medicine
may persist even after stopping therapy.

If you take more Tuzulby than you should
Taking an excessive amount of Tuzulby can cause serious side effects on the
nervous system. If you take an excessive dose of the medicine, consult a doctor immediately or
call an ambulance. Tell them the amount of medicine you have taken.
Signs of overdose may include: vomiting, agitation, tremors, increased involuntary movements, muscle contractions, seizures (which may be followed by coma), feeling
of extreme happiness, confusion, seeing, hearing or perceiving things that are not real (hallucinations),
sweating, flushing, headache, high fever, changes in heartbeat (slow, fast or
irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms,
fever, reddish-brown urine which may be possible signs of abnormal muscle breakdown (rhabdomyolysis). If you notice any of these symptoms, call your doctor immediately.

If you forget to take Tuzulby
Do not take a double dose to make up for a missed dose. If you forget a dose,
wait for the time of the next dose.

If you stop taking Tuzulby
If you suddenly stop taking this medicine, the symptoms of ADHD may
reappear or side effects such as depression may occur. Your doctor may
decide to gradually reduce the amount of medicine you take each day before stopping it
completely. Consult your doctor before stopping taking Tuzulby.
If you have any doubts about the use of the product, ask 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 talk to you about these side effects.

Some side effects may be serious. If you get any of the side effects listed below, tell your doctor immediately:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• thinking about or wanting to kill yourself (suicidal tendency).
• suicide.
• feeling or hearing things that are not real; these are symptoms of psychosis.
• uncontrolled language and body movements (Tourette's syndrome), emotional blunting.
• 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, 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 seizures, convulsions, epilepsy).
• skin peeling or red-purple patches, erythema multiforme.
• uncontrollable muscle spasms affecting eyes, head, neck, body and nervous system, due to a temporary lack of blood flow to the brain.
• paralysis or problems with movement and vision, difficulty speaking; these may be signs of problems with the blood vessels in the brain.
• decrease in the number of blood cells (red blood cells, white blood cells and platelets) which may increase your susceptibility to infections, cause bleeding and bruising more easily and decrease white blood cells.
• a 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 other medicines that may be taken in combination with methylphenidate.

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

• unwanted thoughts that keep coming back.
• unexplained fainting, chest pain, shortness of breath; these may be signs of heart problems.
• inability to control urination (incontinence).
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus).
• stammering.

If you get any of these side effects, tell your doctor immediately.

Other side effects include the following; if they become severe, tell your doctor or
pharmacist:
Very common (affects more than 1 in 10 people)

• decreased appetite.
• headache.
• feeling nervous (nervousness).
• difficulty sleeping (insomnia).
• nausea.
• dry mouth.

Common (may affect up to 1 in 10 people)

• joint pain (arthralgia).
• high temperature (fever).
• hair loss or thinning of hair.
• unusual drowsiness or dizziness.
• loss of appetite (anorexia).
• panic attacks.
• decreased sexual drive.
• toothache.
• excessive teeth grinding (bruxism).
• nasopharyngitis.
• itching, skin rash or raised, red, itchy bumps on the skin (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, fast heartbeat (tachycardia), cold hands and feet.
• tremors, feeling dizzy, movements that you cannot control, being unusually active
• feeling aggressive, agitated, anxious, depressed, irritable, having abnormal behaviour, problems sleeping, fatigue.
• stomach pain, diarrhoea, nausea, discomfort in the stomach and vomiting. These side effects usually occur at the beginning of treatment and can be reduced by taking the medicine with food.

Uncommon (may affect up to 1 in 100 people)

• constipation.
• chest discomfort.
• blood in the urine (hematuria).
• double vision or blurred vision (diplopia).
• muscle pain, muscle contractions, muscle tension.
• increase in the values of tests for liver function (observed in a blood test).
• anger, feeling restless or crying, excessive awareness of the surroundings, tension.
• sedation, decreased 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 (gynecomastia).
• redness of the skin, 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.
• attempt to commit suicide, abnormal thinking, lack of sensations or emotions, repeatedly repeating an action, being obsessed with something.
• numbness of the fingers of the hands and feet, which turn cold and change colour (from white to blue, then red) (Raynaud's phenomenon).

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

• migraine.
• very high fever.
• slow, fast or irregular heartbeat.
• a severe seizure ('grand mal' convulsions), migraine.
• believing 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, erections that are permanent, sometimes painful, or more frequent.
• blood cell disorders (increase and decrease).
• talking excessively and uncontrollably.
• pancytopenia.

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

• There may be a lack of weight gain or height growth.
• The doctor will carefully monitor height, weight and diet.
• If growth is not as expected, treatment with methylphenidate may be stopped 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 detailed 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 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 on the packaging. The expiry date
refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tuzulby contains

• The active ingredient 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 contents of the pack
Tuzulby 20 mg prolonged-release chewable tablets are capsule-shaped coated tablets
measuring 6.8 x 14.7 mm, speckled, 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.
Tuzulby 30 mg prolonged-release chewable tablets are capsule-shaped coated tablets
measuring 7.7 x 16.8 mm, speckled, 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.
Tuzulby 40 mg prolonged-release chewable tablets are capsule-shaped coated tablets
measuring 8.5 x 18.5 mm, speckled, off-white in colour, with "NP14" engraved on one side and smooth
on the other side.
Tuzulby is available in a child-resistant closure bottle with a 2 g desiccant canister,
containing 30 prolonged-release chewable tablets.

Marketing Authorisation 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 on this medicinal product, contact the local representative of the Marketing Authorisation Holder

Lietuva
Neuraxpharm Pharmaceuticals, S.L.
Tel: +34 93 602 24 21

България
Neuraxpharm Pharmaceuticals, S.L.
Тел.: +34 93 602 24 21

België/Belgique/Belgien
Neuraxpharm France
Tél/Tel: +32 474 62 24 24

Luxembourg/Luxemburg
Neuraxpharm France
Tél/Tel: +32 474 62 24 24

Česká republika
Neuraxpharm Bohemia s.r.o.
Tel: +420 495 736 145

Magyarország
Neuraxpharm Bohemia s.r.o.
Tel.: +36 (30) 542 2071

Danmark
Neuraxpharm Sweden AB
Tlf: +46 (0)8 30 91 41
(Sverige)

Malta
Neruaxpharm Pharmaceuticals, S.L.
Tel.: +34 93 602 24 21

Nederland
Neuraxpharm Netherlands B.V
Tel.: +31 70 208 5211

Eesti
Neruaxpharm Pharmaceuticals, S.L.
Tel: +34 93 602 24 21

Deutschland
neuraxpharm Arzneimittel GmbH
Tel: +49 2173 1060 0

Norge
Neuraxpharm Sweden AB
Tlf: +46 (0)8 30 91 41
(Sverige)

ΕλλάδαÖsterreich
Neuraxpharm Austria GmbH
Tel.: +43 2236 389836

España
Neuraxpharm Spain, S.L.U.
Tel: +34 93 602 24 21
Neuraxpharm Pharmaceuticals, S.L.
Τηλ: +34 93 602 24 21

Polska
Neuraxpharm Polska Sp. z.o.o.
Tel.: +48 783 423 453

France
Neuraxpharm France
Tél: +33 1.53.62.42.90

Portugal
Neuraxpharm Portugal, Unipessoal Lda
Tel: +351 910 259 536

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

Ireland
Neuraxpharm Ireland Ltd.
Tel: +353 1 428 7777

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

Slovenija
Neruaxpharm Pharmaceuticals, S.L.
Tel: +34 93 602 24 21

Ísland
Neuraxpharm Sweden AB
Sími: +46 (0)8 30 91 41
(Svíþjóð)

Slovenská republika
Neuraxpharm Bohemia s.r.o.
Tel: +421 255 425 562

Italia
Neuraxpharm Italy S.p.A.
Tel: +39 0736 980619

Suomi/Finland
Neuraxpharm Sweden AB
Puh/Tel: +46 (0)8 30 91 41
(Ruotsi/Sverige)

Κύπρος
Neuraxpharm Pharmaceuticals, S.L.
Τηλ: +34 93 602 24 21

Sverige
Neuraxpharm Sweden AB
Tel: +46 (0)8 30 91 41

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

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European Medicines Agency:
https://www.ema.europa.eu .