Atenza

Leaflet accompanying the packaging: information for the user

Atenza, 18 mg, prolonged-release tablets

Atenza, 27 mg, prolonged-release tablets

Atenza, 36 mg, prolonged-release tablets

Atenza, 45 mg, prolonged-release tablets

Atenza, 54 mg, prolonged-release tablets

Methylphenidate hydrochloride

You should carefully read the contents of the leaflet before the patient or child takes the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the person it is intended for. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Atenza is and what it is used for
• 2. Important information before taking Atenza
• 3. How to take Atenza
• 4. Possible side effects
• 5. How to store Atenza
• 6. Contents of the packaging and other information

1. What Atenza is and what it is used for

What Atenza is used for

Atenza is used to treat attention deficit hyperactivity disorder (ADHD).

• It is used in children and adolescents from 6 years of age and older, as well as in adults.
• It is used only after previous attempts at treatment without medication, such as psychological counseling and behavioral training (behavioral therapy).

Atenza is not intended for use in the treatment of ADHD in children under 6 years of age.

How Atenza works

Atenza improves the function of certain parts of the brain that are underactive. The medicine may help improve attention, concentration, and reduce impulsive behavior.

Atenza is used as part of a treatment program that usually includes therapy:

• psychological
• educational
• environmental. The medicine is prescribed only by a doctor with experience in the field of behavioral disorders in children and adolescents or adults. In adults who have not been treated before, a specialist will conduct tests to confirm that the patient has had ADHD since childhood. Although there is no cure for ADHD, it can be managed with therapeutic programs.

Information about ADHD

Children and adolescents with ADHD have difficulty:

• sitting still for a long time
• concentrating.

This behavior is not their fault, as they have no control over it.

Many children and adolescents experience such disorders. However, ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving at home, school, and other places.

ADHD does not affect intelligence.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and inattentive. They may have trouble organizing their private and professional lives.

Not all patients with ADHD require pharmacological treatment.

2. Important information before taking Atenza

When not to take Atenza

• if the patient is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has thyroid disorders
• if the patient has increased eye pressure (glaucoma)
• if the patient has a pheochromocytoma (a tumor of the adrenal gland)
• if the patient has eating disorders - lack of appetite or no need to eat - so-called anorexia nervosa
• if the patient has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• if the patient has ever had heart problems, such as: heart attack, irregular heartbeat, chest pain, or heart failure
• if the patient has had cerebral vascular diseases, such as: stroke, aneurysm (local expansion and weakening of the blood vessel wall), narrowing, or blockage of blood vessels
• if the patient is currently taking antidepressant medicines (called monoamine oxidase inhibitors) or if these medicines have been taken in the last 14 days - see "Atenza and other medicines"
• if the patient has mental disorders, such as:
• psychopathic or emotionally unstable personality (borderline type)
• abnormal thoughts or visions or a disease called schizophrenia
• severe mood disorders with symptoms such as: thoughts or suicidal tendencies, severe depression, when the patient is very sad, feels worthless, and has no hope for the future, mania, when the patient is extremely excited, overly active, and uncontrolled in their actions. Methylphenidate should not be taken if any of these situations apply to the patient. In case of doubt, before taking methylphenidate, the patient should consult a doctor or pharmacist, as methylphenidate may exacerbate these conditions.

Warnings and precautions

Before starting treatment with Atenza, the patient should discuss with their doctor if they:

• have liver or kidney function disorders
• have difficulty swallowing or swallowing whole tablets
• have narrowing or obstruction of the intestines or esophagus
• have had seizures (seizures, epilepsy) or abnormal brain electroencephalogram (EEG)
• have ever abused or been dependent on alcohol, prescription drugs, or narcotics
• are a woman or girl who has started menstruating (see below "Pregnancy, breastfeeding, and contraception")
• have uncontrollable, repetitive movements or sounds (tics)
• have high blood pressure
• have heart diseases other than those listed above in "When not to take Atenza"
• have other mental disorders than those listed above in "When not to take Atenza".

Other mental disorders include:

• mood swings (from mania to depression, known as "bipolar affective disorder")
• feeling aggressive or hostile
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing in things that are not true (delusions)
• excessive suspiciousness (paranoia)
• feeling excited, anxious, and tense
• feeling depressed or guilty.

Before starting treatment, the patient should inform their doctor or pharmacist if any of these symptoms or diseases apply to them, as methylphenidate may exacerbate these conditions.

The doctor will want to monitor how the medicine affects the patient.

During treatment in boys and young men, unexpected, prolonged erections may occur. This can be painful and occur at any time. If an erection lasts longer than 2 hours, the patient should immediately contact their doctor, especially if it is painful.

Medical history before starting Atenza

The medical history is intended to decide whether methylphenidate is a suitable medicine for the patient. The doctor will discuss with the patient:

• all other medicines taken by the patient
• any cases of sudden, unexplained death in the family
• any other diseases (such as heart disease) that the patient or their family members have
• the patient's well-being, e.g., whether they have mood swings, unusual thoughts, or have had such feelings in the past
• the occurrence of tics (uncontrollable, repetitive movements or sounds) in the patient's family
• any mental health or behavioral disorders that have occurred in the patient or their family members. The doctor will assess the risk of mood swings (from mania to depression, known as "bipolar affective disorder"). This will involve conducting a psychological interview, including questions about suicidal attempts in the family, the occurrence of bipolar affective disorder or depression. It is essential to provide as much information as possible. This will help the doctor decide whether methylphenidate is a suitable medicine for the patient. Before taking the medicine, the doctor may decide to perform other tests. In the case of adult patients who are starting to take Atenza for the first time, the doctor may refer the patient to a heart specialist.

Atenza and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• The patient should not take methylphenidate if they are taking a medicine called a "monoamine oxidase inhibitor" (MAOI), used to treat depression, or if this medicine has been taken in the last 14 days. Taking this medicine with methylphenidate may cause a sudden increase in blood pressure (see "When not to take Atenza").

The patient should tell their doctor or pharmacist if they are taking any of the following antidepressant or anti-anxiety medicines:

• tricyclic antidepressants
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin-norepinephrine reuptake inhibitors (SNRIs). Taking methylphenidate with these medicines may lead to a life-threatening increase in serotonin levels in the brain (serotonin syndrome), which can cause confusion, anxiety, sweating, shivering, muscle contractions, or rapid heartbeat. If the patient experiences these side effects, they should immediately contact their doctor.

If the patient is taking other medicines, methylphenidate may affect their action or cause side effects. Before taking methylphenidate, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• medicines used to treat severe mental disorders
• medicines used to treat Parkinson's disease (such as levodopa)
• antiepileptic medicines
• medicines used to lower or increase blood pressure
• certain cough and cold medicines that contain ingredients that can affect blood pressure. It is essential to consult a pharmacist when buying such medicines.
• blood-thinning medicines that prevent blood clots.

In case of doubt, whether any of the medicines taken by the patient are on the above list, the patient should consult their doctor or pharmacist before taking methylphenidate.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription.

Before surgery

The patient should tell their doctor about any planned surgery. The patient should not take methylphenidate on the day of the operation if a certain type of anesthetic is used, due to the risk of a sudden increase in blood pressure during the operation.

Drug tests

The medicine may cause a positive result in drug tests. This also applies to tests performed on athletes.

Atenza and alcohol

The patient should not drink alcohol while taking this medicine. Alcohol may exacerbate the side effects of this medicine. The patient should remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding, and contraception

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

• The patient is sexually active. The doctor will discuss contraception methods with the patient.
• The patient is pregnant or thinks they may be pregnant. The doctor will decide whether methylphenidate should be taken.
• The patient is breastfeeding or plans to breastfeed. Methylphenidate passes into human milk. Therefore, the doctor will decide whether to continue breastfeeding during treatment with methylphenidate.

Driving and using machines

While taking methylphenidate, the patient may experience dizziness, concentration disorders, and blurred vision. If this happens, it may be dangerous to perform activities such as driving a vehicle, operating machines, riding a bicycle, horse riding, or climbing trees.

This medicine may affect the patient's ability to drive. The patient should not drive while taking this medicine until they know how it affects them. Driving may be an offense if the patient's ability to drive safely is impaired.

Atenza contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.

Atenza contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Atenza

What dose to take

This medicine should always be taken according to the doctor's instructions. In case of doubt, the patient should consult their doctor or pharmacist.

• The doctor usually starts treatment with a small dose and, if necessary, gradually increases the daily dose by 18 mg, no more than once a week. The goal should be the smallest dose that is effective for the patient. The doctor will decide what the maximum daily dose will be for the patient.
• Atenza should be taken once a day, in the morning, with a glass of water. The tablet should be swallowed whole. The tablets should not be chewed, divided, or crushed. The tablet can be taken with or without food. The tablet may not dissolve completely after the release of the active substance, and therefore, its coating may sometimes be visible in the patient's stool. This is a normal phenomenon.

Use in children aged 6 years and older

• The recommended initial dose of Atenza is 18 mg once daily for children who are not currently taking methylphenidate or for children who are switching from another stimulant to methylphenidate,
• The maximum daily dose is 54 mg.

Use in adults

Adults who have previously taken Atenza:

• If the patient has already taken Atenza as a child or adolescent, they can take the same daily dose (mg/day); the doctor will regularly check if it is necessary to adjust the dose.
• Adult patients may require a higher daily dose, but the doctor will aim to use the smallest dose that is effective.

Adults who have not previously taken Atenza:

• The recommended initial dose is 18 mg per day.
• The maximum daily dose in adults is 72 mg.

If the patient does not feel better after a month of treatment

If the patient does not feel better after a month of treatment, they should tell their doctor, who may decide to use a different treatment.

Incorrect use of Atenza

Incorrect use of Atenza can lead to abnormal behavior. This can also be a sign of dependence on the medicine. The patient should tell their doctor if they have ever abused or been dependent on alcohol, prescription drugs, or narcotics.

The medicine is intended only for the patient it was prescribed for. It should not be given to another person, even if they have similar symptoms.

Taking a higher dose of Atenza than recommended

If the patient has taken too much of the medicine, they should immediately contact their doctor or call the emergency services. They should inform their doctor about the amount of medicine taken.

Overdose symptoms may include: vomiting, excitement, shivering, increased involuntary movements, muscle twitching, seizures (which may be followed by coma), feeling of euphoria, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), increased sweating, hot flashes, headache, high fever, changes in heart rhythm (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the mucous membranes of the nose and mouth.

Missing a dose of Atenza

The patient should not take a double dose to make up for a missed tablet. If the patient forgets to take a tablet, they should wait until it is time for the next scheduled dose.

Stopping treatment with Atenza

If the patient suddenly stops taking the medicine, ADHD symptoms may return or side effects may occur, such as depression. The doctor may recommend gradually reducing the amount of medicine taken each day before it is completely stopped. The patient should discuss this with their doctor before stopping treatment with Atenza.

Tests performed by the doctor during treatment

The doctor will perform several tests

• before starting treatment to ensure that Atenza is safe and beneficial for the patient;
• after starting treatment, at least every 6 months, but possibly more often, as well as when the dose is changed;
• the tests will include:
• checking appetite
• measuring growth and weight
• measuring blood pressure and heart rate
• assessing mood disorders, mental state, or any other abnormalities in the patient, and whether they have worsened while taking Atenza.

Long-term treatment

Treatment with Atenza does not have to be long-term. If Atenza has been taken for more than 1 year, the doctor should stop it for a short time, e.g., during school vacations. This will allow the doctor to assess whether the medicine is still needed.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Atenza can cause side effects, although not everybody gets them.

Although some people experience side effects, most patients find that methylphenidate helps them.

The doctor will discuss these side effects with the patient.

Some side effects can be serious. If the patient experiences any of the following side effects, they should immediately inform their doctor.

Common side effects (may occur in up to 1 in 10 people)

• irregular heartbeat (palpitations)
• mood changes or personality changes.

Uncommon side effects (may occur in up to 1 in 100 people)

• suicidal thoughts or tendencies
• seeing, feeling, or hearing things that are not real - these are symptoms of psychosis
• uncontrolled sounds or movements (Tourette's syndrome)
• allergic reactions, such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, difficulty breathing, wheezing, or shortness of breath.

Rare side effects (may occur in up to 1 in 1,000 people)

• feeling overly excited, overly active, and uncontrolled (mania).

Very rare side effects (may occur in up to 1 in 10,000 people)

• heart attack
• sudden death
• suicide attempts
• seizures (epileptic fits, epilepsy)
• skin peeling or purple-red spots on the skin
• inflammation or blockage of cerebral blood vessels
• transient paralysis or movement disorders, vision, and speech disorders (these may be symptoms of cerebral vascular disorders)
• involuntary muscle contractions, head, neck, body, and neurological symptoms
• reduced blood cell count (red, white, and platelets), which can increase the risk of infections, bleeding, and bruising
• sudden increase in body temperature, very high blood pressure, and severe seizures (malignant neuroleptic syndrome). It is not certain whether this side effect is caused by methylphenidate or other medicines that may be taken at the same time.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• recurring unwanted thoughts
• unexplained fainting, chest pain, shortness of breath (these may be symptoms of heart disease)
• prolonged erections, sometimes painful or increased number of erections.

If the patient experiences any of these side effects, they should immediately contact their doctor.

The patient should inform their doctor or pharmacist if any of the following side effects worsen:

Very common side effects (may occur in more than 1 in 10 people)

• headache
• nervousness
• insomnia.

Common side effects (may occur in up to 1 in 10 people)

• joint pain
• blurred vision
• pressing headache
• dry mouth, thirst
• difficulty falling asleep
• high temperature (fever)
• decreased libido
• unusual hair loss or thinning
• muscle tension, muscle spasms
• loss of appetite or decreased appetite
• difficulty achieving or maintaining an erection
• itching, rash, or raised, red, itchy rash (hives)
• unusual drowsiness, feeling tired
• excessive grinding of teeth (bruxism)
• feeling of panic
• feeling of tingling, numbness, or tingling of the skin
• increased alanine aminotransferase (liver enzyme) in the blood
• cough, sore throat, or irritation of the nose and throat; upper respiratory tract infections, sinusitis
• high blood pressure, rapid heartbeat (tachycardia)
• dizziness, feeling weak, involuntary movements, excessive psychomotor activity
• aggression, excitement, anxiety, depression, irritability, tension, shakiness, and behavioral disorders
• nausea, abdominal pain, diarrhea, nausea, discomfort in the abdominal cavity, and vomiting
• excessive sweating
• weight loss.

Uncommon side effects (may occur in up to 1 in 100 people)

• dry eyes
• constipation
• discomfort in the chest
• blood in the urine
• indifference
• tremors
• need to urinate frequently
• muscle pain, muscle spasms
• shortness of breath or chest pain
• feeling hot
• elevated liver function test results (in blood tests)
• anger, feeling impatient or tearful, logorrhea, excessive alertness, sleep disorders.

Rare side effects (may occur in up to 1 in 1,000 people)

• sexual function disorders
• state of disorientation or confusion
• vision or double vision disorders
• breast enlargement in men
• red, raised, itchy rash.

Very rare side effects (may occur in up to 1 in 10,000 people)

• muscle spasms
• small red spots on the skin
• liver function disorders, including acute liver failure and coma
• changes in test results - including liver function tests and blood tests
• thinking disorders, apathy, repetition of actions, excessive focus on one thing
• feeling of numbness in the fingers of the hands and feet, tingling, and change in skin color (from white to blue, and then red) after cooling (Raynaud's phenomenon).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• migraine
• pupil dilation
• very high fever
• slow or fast heartbeat or extra beats
• grand mal seizures
• delusions
• severe abdominal pain, often with nausea and vomiting
• disorders related to blood vessels in the brain (stroke, cerebral vasculitis, or cerebral vascular occlusion)
• inability to control urination (urinary incontinence)
• muscle spasm of the jaw, making it difficult to open the mouth (jaw lock)
• stuttering
• nosebleeds.

Effect on physical development

Methylphenidate taken for more than a year may cause some children to experience slowed physical development. This occurs in less than 1 in 10 children.

• It is possible that the child may not gain weight or grow at the expected rate.
• The doctor will closely monitor the child's growth and weight, as well as their eating habits.
• If the child's development is slower than expected, treatment with methylphenidate may be stopped for a short time.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa; tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Atenza

The medicine should be stored out of sight and reach of children.

The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

The bottle should be kept tightly closed to protect it from moisture.

There are no special instructions for storing the medicine at a certain temperature.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atenza contains

The active substance of the medicine is methylphenidate hydrochloride.

• Each tablet contains 18 mg, 27 mg, 36 mg, 45 mg, or 54 mg of methylphenidate hydrochloride. The other ingredients are:
• Core:hypromellose, macrogol, succinic acid, magnesium stearate, sodium chloride, colloidal silicon dioxide, anhydrous, black iron oxide (E 172).
• Coating:cellulose acetate, macrogol.
• Colorless coating:hypromellose, macrogol, phosphoric acid (to set pH).
• Colored coating:lactose, hypromellose, triacetin, titanium dioxide (E 171), yellow iron oxide (E 172) (18 mg tablet), red iron oxide (E 172) (18 mg, 27 mg, and 54 mg tablets), black iron oxide (E 172) (27 mg tablet), indigo carmine (E 132) (45 mg tablet).

What Atenza looks like and contents of the pack

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

The medicine is available in a plastic bottle with a plastic child-resistant cap, containing 2 desiccant containers. The desiccant containers, which should not be swallowed, ensure that the tablets remain dry.

The bottle is packaged in a cardboard box.

Package sizes: 30 tablets, 60 tablets (2 x 30), or 90 tablets (3 x 30). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.

Szamocka 8

01-748 Warsaw

e-mail: [email protected]

Manufacturer

LABORATORIOS LICONSA S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden: Phenichem 18 mg, 27 mg, 36 mg, 45 mg, 54 mg depottablett

United Kingdom: Phenichem XL 18 mg, 27 mg, 36 mg, 54 mg prolonged release tablets

Spain: Atenza 18 mg, 27 mg, 36 mg, 45 mg, 54 mg comprimidos de liberación prolongada

Poland: Atenza

Date of last revision of the leaflet:24.05.2024