Atenza 36 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atenza 18 mg prolonged-release tablets EFG

Atenza 27 mg prolonged-release tablets EFG

Atenza 36 mg prolonged-release tablets EFG

Atenza 45 mg prolonged-release tablets

Atenza 54 mg prolonged-release tablets EFG

methylphenidate hydrochloride

Read this entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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 other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Atenza is and what it is used for

2. What you need to know before taking 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 Atenza is and what it is used for

What it is used for

This medicine is used to treat "attention deficit hyperactivity disorder" (ADHD).

• It is used in children aged 6 years and older, and in adults.
• It is used only after trying non-medicine treatments first, such as behavioural therapy and counselling.

This medicine is not indicated for the treatment of ADHD in children under 6 years of age.

How it works

This medicine improves the activity of certain parts of the brain that have low activity. The medicine may help improve attention (level of attention), concentration, and reduce impulsive behaviour.

The medicine is given as part of a comprehensive treatment programme, which usually includes:

• psychological therapy
• educational therapy, and
• social therapy.

It is prescribed only by doctors experienced in managing behavioural problems in children, adolescents, or adults. If you are an adult who has not previously received treatment, the specialist will carry out tests to confirm that you have had ADHD since childhood.

Although ADHD cannot be cured, it can be managed through comprehensive treatment programmes.

About ADHD

Children and adolescents with ADHD have difficulty:

• staying still and
• concentrating.

It is not their fault that they cannot do these things.

Many children and adolescents struggle with these tasks. However, ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulties learning and completing homework. They may have trouble behaving appropriately at home, at school, and in other settings.

ADHD does not affect intelligence.

Adults with ADHD often have difficulty concentrating. They frequently feel restless, impatient, and easily distracted. They may have difficulties organising their private lives and work.

Not all patients with ADHD require treatment with medication.

2. What you need to know before taking Atenza

Do not take Atenza if you:

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)

• have a thyroid problem

• have high eye pressure (glaucoma)

• have a tumor of the adrenal glands (pheochromocytoma)

• have an eating disorder, lack of appetite, or do not wish to eat, as in "anorexia nervosa"

• have very high blood pressure or narrowing of blood vessels, which may cause pain in the arms and legs

• have ever had heart problems – such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or a congenital heart condition

• have ever had a problem with blood vessels in the brain such as stroke, dilation or weakness of part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)

• are taking or have taken within the last 14 days an antidepressant medicine (known as a monoamine oxidase inhibitor), see "Other medicines and Atenza"

• have mental health problems such as:

• a "psychopathic" disorder or "borderline personality disorder"

• abnormal thoughts or hallucinations or a condition known as "schizophrenia"

• signs of a serious mood disorder such as:

  • suicidal thoughts
  • severe depression, feeling very sad, worthless, and hopeless
  • mania, feeling unusually elated, more active than normal, and disinhibited.

Do not take methylphenidate if any of the above apply to you. If you are unsure, inform your doctor or pharmacist before taking methylphenidate. This is because methylphenidate may worsen these conditions.

Warnings and precautions

Talk to your doctor before starting this medicine if you:

• have liver or kidney problems

• have difficulty swallowing or trouble swallowing whole tablets

• have a narrowing or blockage in the digestive tract

• have ever had seizures (fits, convulsions, epilepsy) or any abnormalities on an electroencephalogram (EEG, a test of brain activity)

• have ever abused or been dependent on alcohol, prescription medicines, or drugs

• are a woman who has started menstruating (see section "Pregnancy, breastfeeding, and fertility" below)

• have difficulty controlling repetitive movements of certain body parts or repeating sounds and words

• have high blood pressure

• have a heart condition not listed in the previous section "Do not take"

• if you or your child experience blurred vision or other visual disturbances, contact your doctor. Your doctor may consider stopping treatment with Atenza.

• have a mental health condition not listed in the previous section "Do not take". Other mental health problems include:

• mood swings (from manic to depressed, known as "bipolar disorder")

• aggressive or hostile feelings

• seeing, hearing, or feeling things that are not there (hallucinations)

• believing things that are not real (delusions)

• feeling unusually suspicious (paranoia)

• feeling restless, anxious, or tense

• feeling depressed or guilty.

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

During treatment, children and adolescents may unexpectedly experience prolonged erections. These erections can be painful and occur at any time. It is important to contact your doctor immediately if an erection lasts longer than 2 hours, especially if it is painful.

Checks your doctor will make before you start treatment with Atenza

To determine whether methylphenidate is the right medicine for you, your doctor will discuss with you:

• the medicines you are taking
• if there is a family history of unexplained sudden death
• other illnesses you or your family may have (such as heart problems)
• how you are feeling, if you have mood swings, strange thoughts, or have had such feelings in the past
• if there have been cases of "tics" in your family (difficulty controlling repetitive movements of certain body parts or repeating sounds and words)
• any possible behavioral or mental health problems you or other family members may have had. Your doctor will specifically explain whether you are at risk of mood changes (from manic to depressed, known as "bipolar disorder"). They will review your mental health history and check whether any family members have a history of suicide, bipolar disorder, or depression.

It is important to 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 you or your child need further medical tests before starting this medicine. For adults starting this medicine, your doctor may refer you to a cardiologist.

Other medicines and Atenza

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Do not take methylphenidate if you:

• are taking a medicine called "monoamine oxidase inhibitor" (MAOI) used for depression or have taken an MAOI within the last 14 days. Using an MAOI with methylphenidate may cause a sudden increase in blood pressure (see "Do not take Atenza").

Inform your doctor or pharmacist if you are taking any of the following medicines for depression or anxiety:

• tricyclic antidepressants
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin-norepinephrine reuptake inhibitors (SNRIs).

Taking methylphenidate with these types of medicines may cause a potentially life-threatening increase in "serotonin" in the brain (serotonin syndrome), which may lead to confusion or agitation, sweating, chills, muscle spasms, or rapid heartbeat. If you experience these side effects, seek medical help immediately.

If you are taking other medicines, methylphenidate may affect how they work or cause side effects. If you are taking any of the following medicines, consult your doctor or pharmacist before taking methylphenidate:

• medicines for serious mental health conditions
• medicines for Parkinson's disease (such as levodopa)
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies containing medicines that may affect blood pressure. It is important to consult your pharmacist when purchasing any of these medicines
• medicines that thin the blood to prevent clots.

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

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Before surgery

Inform your doctor if you are due to have surgery. Methylphenidate should not be taken on the day of surgery when certain types of anesthetics are used. This is because a sudden increase in blood pressure may occur during the procedure.

Drug testing

This medicine may give a positive result in drug tests, including those used in sports.

Atenza and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Available data do not suggest an increased risk of overall congenital malformations, although a small increased risk of cardiac malformations during use in the first three months of pregnancy cannot be ruled out. Your doctor will provide further information about this risk. Consult your doctor or pharmacist before using methylphenidate if you:

• are sexually active. Your doctor will discuss contraception with you
• are pregnant or think you may be pregnant. Your doctor will decide whether you should take methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate passes into breast milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while using methylphenidate.

Driving and using machines

You or your child may experience dizziness, difficulty focusing, or blurred vision when taking methylphenidate. If this occurs, it may be dangerous to carry out certain activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

This medicine may affect your ability to drive. Do not drive while taking this medicine until you know how it affects you. It may be an offense to drive if your ability to do so safely is impaired.

Atenza contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Atenza contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Atenza

How much to take

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will usually start treatment with a low dose and may increase the daily dose by 18 mg no more frequently than once a week, if necessary.

The goal should be the lowest dose that is effective for you. Your doctor will decide the maximum daily dose for you or your child.

You should take this medicine once daily in the morning with a glass of water.

The tablet should be swallowed whole and not chewed, broken, or crushed. The tablet may be taken with or without food.

The tablet does not completely dissolve after the drug has been released, and sometimes the tablet shell may appear in the stools. This is normal.

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 switching from another stimulant to methylphenidate.
• The maximum daily dose is 54 mg.

Use in adults

For adults who have previously taken Atenza:

• If you have previously taken Atenza as a child or adolescent, the same daily dose (mg/day) may be used; your doctor will regularly check whether any adjustments are needed.
• Adult patients may require a higher daily dose, but the doctor will aim to give you the lowest effective dose.

For adults who have not previously taken Atenza:

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

If you do not feel better after 1 month of treatment

If you do not feel better after 1 month of treatment, inform your doctor. They may decide whether a different treatment is needed.

Misuse of Atenza

If this medicine is not used properly, it may cause abnormal behavior. This could also mean that you start to become dependent on the medicine. Inform your doctor if you have ever been dependent on alcohol, prescription medicines, or drugs.

This medicine is for your use only. Do not give this medicine to anyone else, even if they have similar symptoms.

If you take more Atenza than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. Tell them how many tablets have been taken. Medical treatment may be required.

You may also contact the Toxicology Information Service, Telephone 91 5620420, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle twitching, seizures (which may be followed by coma), feelings of extreme happiness, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth.

If you forget to take Atenza

Do not take a double dose to make up for missed doses. If you or your child forget a dose, wait and take the next dose at the usual time.

If you stop taking Atenza

If you stop taking this medicine suddenly, ADHD symptoms or unwanted effects such as depression may return. Your doctor may want to gradually reduce the amount of medicine you take each day before stopping completely. Consult your doctor before stopping treatment with this medicine.

What your doctor will do while you or your child are on treatment

Your doctor will carry out some tests:

• Before you start treatment, to ensure that this medicine is safe and beneficial.

• After treatment has started, at least every 6 months, and even more frequently. Tests will also be performed when the dose is changed.

• These tests will include:

• Monitoring of appetite

• Measurement of height and weight

• Measurement of blood pressure and heart rate

• Assessment for mood-related problems, mental state, or any other unusual feelings, or whether these have worsened while taking this medicine.

Long-term treatment

This medicine does not need to be taken indefinitely. If you take this medicine for more than one year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows assessment of whether you still need the medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Although some people may experience adverse effects, methylphenidate helps most people. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If you experience any of the following, contact your doctor immediately:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• suicidal thoughts or feelings
• seeing, feeling or hearing things that are not real, symptoms of psychosis
• uncontrolled speech and body movements (Tourette’s syndrome)
• signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, difficulty or problems breathing.

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

• feeling unusually elated, more active than normal and disinhibited (mania).

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

• heart attack
• sudden death
• suicidal ideation
• seizures (fits, convulsions, epilepsy)
• peeling of the skin or red purplish spots
• inflammation or blockage of the arteries in the brain
• temporary paralysis or movement and vision problems, speech difficulties (these signs may indicate problems with blood vessels in your brain)
• uncontrolled muscle spasms affecting the eyes, head, neck, body and nervous system
• decrease in the number of blood cells (red blood cells, white blood cells and platelets) which may increase the risk of infections and cause bleeding and bruising more easily
• sudden increase in body temperature, very high blood pressure and severe seizures (“Neuroleptic Malignant Syndrome”). It is not entirely certain whether this adverse effect is caused by methylphenidate or by other medicines taken in combination with methylphenidate.

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

• unwanted thoughts that reoccur
• unexplained fainting, chest pain, shortness of breath (these may be signs of heart problems)
• prolonged erections, sometimes painful, or increased number of erections.

If you experience any of the adverse effects listed above, contact your doctor immediately.

The following additional adverse effects are listed. If they become severe, please inform your doctor or pharmacist:

Very frequent (may affect more than 1 in 10 people)

• headache
• feeling nervous
• difficulty sleeping.

Frequent (may affect up to 1 in 10 people)

• joint pain
• blurred vision
• tension-type headache
• dry mouth, thirst
• difficulty falling asleep
• elevated temperature (fever)
• decreased sex drive
• abnormal hair loss or reduced hair thickness
• muscle tension, muscle cramps
• loss of appetite or reduced appetite
• inability to achieve or maintain an erection
• itching, rash or itchy red rashes (hives)
• drowsiness or unusual drowsiness, feeling tired
• excessive teeth grinding (bruxism)
• feeling of panic
• tingling, itching or numbness of the skin
• increased levels of alanine aminotransferase in blood (liver enzyme)
• cough, sore throat and throat or nasal irritation; upper respiratory tract infection, sinusitis
• high blood pressure, rapid heartbeat (tachycardia)
• dizziness (vertigo), feeling weak, uncontrolled movements, unusual activity
• aggression, agitation, anxiety, depression, irritability, tension, nervousness and abnormal behaviour
• stomach discomfort or indigestion, stomach pain, diarrhoea, feeling nauseous, stomach upset and vomiting
• excessive sweating
• weight loss.

Uncommon (may affect up to 1 in 100 people)

• dry eye
• constipation
• chest discomfort
• blood in the urine
• apathy
• agitation or tremor
• increased need to urinate
• muscle pain, muscle jerks
• shortness of breath or chest pain
• feeling of warmth
• increased liver test results (seen in blood tests)
• angry outbursts, restlessness or tearfulness, excessive awareness of surroundings, sleep problems.

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

• changes in sex drive
• feeling disoriented or confused
• vision problems or double vision
• breast enlargement in males
• excessive sweating, skin redness, increased redness of skin rashes
• Obsessive-Compulsive Disorder (OCD) (including irresistible urge to pull out hair, skin picking, having repetitive unwanted thoughts, feelings, images or impulses in the mind [obsessive thoughts], performing repetitive behaviours or mental rituals [compulsions])

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

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

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

• migraine
• dilated pupils
• very high fever
• slow, fast or irregular heartbeats, palpitations
• major epileptic seizure (“generalized tonic-clonic seizures”)
• believing things that are not true
• severe stomach pain with nausea and vomiting
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
• inability to control urination (incontinence)
• spasm of jaw muscles making it difficult to open the mouth (trismus)
• stuttering
• nosebleeds
• increased eye pressure
• eye diseases that may cause vision loss due to damage to the optic nerve (glaucoma).

Effects on growth

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

• it may prevent weight gain or increase in height
• your doctor will carefully monitor your or your child’s height and weight, as well as nutrition
• if you or your child do not grow as expected, treatment with methylphenidate may be interrupted for a short period of time.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atenza

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Keep the bottle tightly closed to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atenza

The active substance is methylphenidate hydrochloride.

• Each tablet contains 18 mg, 27 mg, 36 mg, 45 mg, or 54 mg of methylphenidate hydrochloride.

The other components are:

• Tablet core: hypromellose, macrogol, succinic acid, magnesium stearate, sodium chloride, colloidal anhydrous silica, black iron oxide (E172).
• Coating film: cellulose acetate, macrogol.
• Transparent coating: hypromellose, macrogol, phosphoric acid (for pH adjustment).
• Coloured coating: lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172) (18 mg), red iron oxide (E172) (18 mg, 27 mg, 54 mg), black iron oxide (E172) (27 mg), indigo carmine (E132) (45 mg).

Appearance of the product and contents of the pack

18 mg: film-coated tablets, round, biconvex, yellow, approximately 9 mm in diameter, with a small hole on one side of the tablet.

27 mg: film-coated tablets, round, biconvex, grey, approximately 9 mm in diameter, with a small hole on one side of the tablet.

36 mg: film-coated tablets, round, biconvex, white, approximately 10 mm in diameter, with a small hole on one side of the tablet.

45 mg: film-coated tablets, round, biconvex, blue, approximately 10 mm in diameter, with a small hole on one side of the tablet.

54 mg: film-coated tablets, round, biconvex, pink, approximately 10 mm in diameter, with a small hole on one side of the tablet.

This medicine is available in plastic bottles containing 2 desiccant sachets with a child-resistant plastic closure. The desiccant sachets are used to keep the tablets dry and must not be ingested.

Pack sizes: 30 tablets, 60 tablets (2x30), and 90 tablets (3x30).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain.

Manufacturer

Laboratorios Liconsa, S.A.

Avenida de Miralcampo, 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

Spain: Atenza 18 mg; 27 mg; 36 mg; 54 mg prolonged-release tablets EFG

Atenza 45 mg prolonged-release tablets

Poland: Atenza

Date of the most recent review of this summary: November 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)