Atenza

Package Leaflet: 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

Read the package leaflet carefully before the patient or child takes this medicine, as it contains important information.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Atenza and what is it used for

What is Atenza used for

Atenza is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 years and older, as well as in adults.

• It is used when patients have tried other treatments for ADHD, such as psychological therapy or behavioral therapy, and they have not worked.
• Atenza is part of a treatment program that usually includes psychological, educational, and social measures.

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

How Atenza works

Atenza improves the function of certain parts of the brain that are underactive. It helps improve attention, concentration, and reduces impulsive behavior.

Atenza is prescribed only by a doctor with experience in treating 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 controlled with therapeutic programs.

Information about ADHD

Children and adolescents with ADHD have difficulty:

• sitting still for a long time
• focusing.

This behavior is not their fault, as they have no control over it. Many children and adolescents experience these 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 may feel restless, impatient, and inattentive. They may have trouble organizing their personal and professional life.

Not all patients with ADHD require pharmacological treatment.

2. Before you take Atenza

When not to take Atenza

• if you are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• if you have thyroid problems
• if you have increased eye pressure (glaucoma)
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have eating disorders - lack of appetite or no need to eat - so-called anorexia nervosa
• if you have very high blood pressure or narrowing of blood vessels, which can cause pain in the arms and legs
• if you have had heart problems, such as heart attack, irregular heartbeat, chest pain, or heart failure
• if you have had cerebral blood vessel problems, such as stroke, aneurysm, narrowing, or blockage of blood vessels
• if you are currently taking antidepressant medicines (called monoamine oxidase inhibitors) or if you have taken them in the last 14 days - see "Atenza and other medicines" below
• if you have mental health problems, such as:
• psychopathic or emotionally unstable personality (borderline type)
• abnormal thoughts or visions or schizophrenia
• severe mood swings (from mania to depression, known as "bipolar affective disorder")

Warnings and precautions

Before starting treatment with Atenza, you should discuss the following with your doctor:

• if you have liver or kidney problems
• if you have difficulty swallowing or swallowing whole tablets
• if you have narrowing or blockage of the intestines or esophagus
• if you have had seizures (epilepsy) or abnormal brain wave patterns (EEG)
• if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs
• if you are a woman or girl who has started menstruating (see "Pregnancy, breastfeeding, and contraception" below)
• if you have uncontrollable, repetitive movements or sounds (tics)
• if you have high blood pressure
• if you have heart problems other than those mentioned above in "When not to take Atenza"
• if you have other mental health problems than those mentioned above in "When not to take Atenza"

Other mental health problems 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 things that are not true (delusions)
• excessive suspicion (paranoia)
• feeling anxious, tense, or uneasy
• feeling depressed or guilty.

Before starting treatment, you should tell your doctor or pharmacist if any of these symptoms or conditions apply to you, as methylphenidate may worsen them. Your doctor will want to monitor how the medicine affects you.

Atenza and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

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

Tell your doctor or pharmacist if you are taking any of the following 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, agitation, sweating, shaking, muscle contractions, or rapid heartbeat. If you experience these side effects, you should contact your doctor immediately.

If you are taking other medicines, methylphenidate may affect their action or cause side effects. Before taking methylphenidate, tell your doctor or pharmacist if you 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 to prevent blood clots.

If you are unsure whether any of the medicines you are taking are on the above list, you should consult your doctor or pharmacist before taking methylphenidate.

Before surgery

Tell your doctor that you are taking Atenza before any surgery. You should not take Atenza on the day of the operation if a certain type of anesthetic is used, due to the risk of sudden high blood pressure during surgery.

Drug tests

This medicine may cause a positive result in drug tests, including tests for athletes.

Atenza and alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase the side effects of this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding, and contraception

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.

• if you are sexually active. Your doctor will discuss contraception methods with you.
• if you are pregnant or think you may be pregnant. Your doctor will decide whether Atenza should be used.
• if you are breastfeeding or plan to breastfeed. Methylphenidate passes into human milk. Your doctor will decide whether to continue breastfeeding during treatment with methylphenidate.

Driving and using machines

While taking methylphenidate, you may experience dizziness, blurred vision, or difficulty concentrating. If this happens, it may be dangerous to perform activities such as driving a vehicle, operating machinery, riding a bicycle, 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. Driving while your ability to drive is impaired may be an offense.

Atenza contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Atenza contains sodium

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

3. How to take Atenza

What dose to take

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

• Your doctor will usually start treatment with a low dose and may gradually increase the daily dose by 18 mg, no more than once a week. The aim is to find the lowest dose that works for you. Your doctor will decide what the maximum daily dose is for you.
• Take Atenza once a day, in the morning, with a glass of water. Swallow the tablet whole. Do not chew, divide, or crush the tablet. You can take the tablet with or without food. The tablet may not dissolve completely after the active substance is released, and you may sometimes notice the tablet shell in your stool. This is normal.

Use in children aged 6 years and older

• The recommended starting 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 medicine to methylphenidate.
• The maximum daily dose is 54 mg.

Use in adults

Adults who have previously taken Atenza:

• if you took Atenza as a child or adolescent, you can take the same daily dose (mg/day); your doctor will regularly check if a dose adjustment is needed.
• adult patients may require a higher daily dose, but your doctor will aim to use the lowest effective dose.

Adults who have not previously taken Atenza:

• The recommended starting dose is 18 mg once daily.
• The maximum daily dose in adults is 72 mg.

If you do not feel better after one month of treatment

If you do not feel better after one month of treatment, tell your doctor, who may decide to use a different treatment.

Misuse of Atenza

Misuse of Atenza can lead to abnormal behavior. It can also be a sign of the start of dependence on the medicine. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Overdose of Atenza

If you take too much of this medicine, contact your doctor or go to the hospital immediately. Tell them how much you have taken. You may need treatment.

Overdose symptoms may include vomiting, feeling unwell, trembling, increased muscle movement, muscle twitching, seizures (which can lead to coma), feeling euphoric, disoriented, or hallucinating, increased sweating, flushing, headache, high fever, changes in heart rhythm (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the mouth and nose.

Missing a dose of Atenza

Do not take a double dose to make up for a forgotten tablet. If you forget to take a tablet, wait until it is time for your next scheduled dose.

Stopping treatment with Atenza

If you suddenly stop taking this medicine, ADHD symptoms may return or you may experience side effects such as depression. Your doctor may advise you to gradually reduce the dose of Atenza before stopping treatment completely. You should talk to your doctor before stopping treatment with Atenza.

Tests performed by your doctor during treatment

Your doctor will perform several tests:

• before starting treatment to ensure that Atenza is safe and suitable for you;
• after starting treatment, at least every 6 months, and possibly more often, as well as when changing the dose;
• the tests will include:
• checking your appetite
• measuring your height and weight
• measuring your blood pressure and heart rate
• assessing your mood, mental state, or any other problems you may have, and whether they have worsened while taking Atenza.

Long-term treatment
It is not necessary to take Atenza for the rest of your life. If you have been taking Atenza for more than a year, your doctor may decide to stop 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 further questions about this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects can be serious. If you experience any of the following side effects, tell your doctor immediately.

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

• abnormal heart rhythm (palpitations)
• mood changes or personality changes.

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

• suicidal thoughts or attempts
• seeing, hearing, or feeling things that are not there (psychosis)
• uncontrolled movements or sounds (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 or wheezing.

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

• feeling extremely excited, overactive, and lacking self-control (mania).

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

• heart attack
• sudden death
• suicide attempts
• seizures (epilepsy)
• skin peeling or purple spots on the skin
• inflammation or blockage of blood vessels in the brain (stroke, vasculitis, or cerebral vasculitis)
• temporary paralysis or movement problems, vision, or speech problems (which can be symptoms of cerebral vasculitis)
• involuntary muscle contractions, head, neck, or body movements, as well as neurological symptoms
• reduced blood cell count (red, white, or platelets), which can increase the risk of infections, bleeding, or bruising
• sudden high fever, 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, or difficulty breathing (which can be symptoms of heart problems)
• prolonged erections, sometimes painful or increased erections.

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

Tell your doctor or pharmacist if any of the following side effects get worse:

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

• headache
• nervousness
• insomnia.

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

• joint pain
• blurred vision
• pressing headache
• dry mouth, thirst
• difficulty falling asleep
• high fever
• decreased sex drive
• unusual hair loss or thinning
• muscle tension, muscle spasms
• loss of appetite or decreased appetite
• difficulty getting or maintaining an erection
• itching, rash, or hives on the skin
• unusual sleepiness, feeling tired
• excessive grinding of teeth (bruxism)
• feeling panicked
• feeling of pins and needles, numbness, or tingling of the skin
• increased levels of the liver enzyme alanine aminotransferase 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, agitation, anxiety, depression, irritability, tension, and behavioral problems
• nausea, stomach pain, diarrhea, nausea, discomfort in the abdominal area, and vomiting
• excessive sweating
• weight loss.

Uncommon side effects (may affect 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
• difficulty breathing or chest pain
• feeling hot
• abnormal liver function test results (in blood tests)
• anger, feeling impatient or tearful, talkativeness, excessive alertness, sleep disturbances.

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

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

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

• muscle spasms
• small red spots on the skin
• liver function problems, including acute liver failure and coma
• changes in test results, including liver function tests and blood tests
• thinking problems, apathy, repetitive behaviors, excessive focus on one thing
• feeling numbness, tingling, or color change (from white to blue, then red) of the fingers and toes 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 heart rate or extra heartbeats
• grand mal seizures
• delusions
• severe stomach pain, often with nausea and vomiting
• blood vessel problems in the brain (stroke, cerebral vasculitis, or cerebral vessel occlusion)
• inability to control urination (urinary incontinence)
• jaw muscle spasm that makes it difficult to open the mouth (trismus)
• stuttering
• nosebleeds.

Effect on physical development

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

• There may be a lack of weight gain or growth.
• Your doctor will closely monitor your child's growth and weight, as well as their eating habits.
• If your child's development is slower than expected, treatment with methylphenidate may be stopped for a short time.

Reporting side effects

If you experience any side effects, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atenza

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Store the bottle tightly closed to protect from moisture.

There are no special storage instructions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atenza 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 ingredients are:
• Tablet core:hypromellose, macrogol, succinic acid, magnesium stearate, sodium chloride, colloidal silica, anhydrous, iron oxide black (E 172).
• Coating:cellulose acetate, macrogol.
• Colorless coating:hypromellose, macrogol, phosphoric acid (to adjust pH).
• Colored coating:lactose, hypromellose, triacetin, titanium dioxide (E 171), iron oxide yellow (E 172) (18 mg tablet), iron oxide red (E 172) (18 mg, 27 mg, and 54 mg tablets), iron oxide black (E 172) (27 mg tablet), indigo carmine (E 132) (45 mg tablet).

What Atenza looks like and contents of the pack

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

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

The bottle and desiccant containers are packaged in a cardboard box.

Available pack 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