Leaflet: information for the user

Atenza 18 mg prolonged-release EFG tablets

Atenza 27 mg prolonged-release EFG tablets

Atenza 36 mg prolonged-release EFG tablets

Atenza 45 mg prolonged-release tablets

Atenza 54 mg prolonged-release EFG tablets

methylphenidate hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhavethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,eveniftheyare not listed in this leaflet. See section 4.

1.What is Atenza and what it is used for

2.What you need to knowbeforestarting totake Atenza

3.How to take Atenza

4.Possible side effects

5Storage of Atenza

6.Contents of the pack and additional information

What it is used for

This medicationis used to treat “attention deficit hyperactivity disorder” (ADHD).

• It is used in children aged 6 years and above and in adults.
• It is used only after having tried treatments that do not include medications, such as behavioral therapy and counseling.

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

How it works

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

The medication is administered as part of a comprehensive treatment program, which typically includes:

• psychological therapy
• educational therapy and
• social therapy.

Only doctors with experience in behavioral problems in children, adolescents, or adults prescribe this medication. If you are an adult and have not received treatment before, the specialist will perform tests to confirm that you have had ADHD since childhood.

Although ADHD is not curable, it can be controlled using comprehensive treatment programs.

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 to do them. However, ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, school, and other places.

ADHD does not affect intelligence.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and distracted. They may have difficulty organizing their personal and work life.

Not all patients with ADHD need medication treatment.

Do not take Atenza if you:

• are allergic to methylphenidate or any of the other components of this medication (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have an eating disorder, are not hungry, or do not want to eat, such as in "anorexia nervosa"
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had any heart problems - such as a heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease, or a congenital heart problem
• have had a problem with blood vessels in the brain, such as a stroke, dilation or weakness of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• are taking or have taken in the last 14 days any antidepressant (known as monoamine oxidase inhibitor), see "Other medications and Atenza"
• have mental health problems such as:

• a "psychopathic" disorder or a "borderline personality disorder"
• abnormal thoughts or visions or a disease called "schizophrenia"
• signs of a severe mood disorder such as:
• • suicidal thoughts
  • severe depression, feeling very sad, despised, and desperate
  • mania, feeling exceptionally excited, more active than normal, and uninhibited

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

Warnings and precautions

Consult your doctor before starting to take this medication if you:

• have liver or kidney problems
• have trouble swallowing or swallowing whole tablets
• have a narrowing or blockage in the digestive system
• have had seizures or any alteration in the electroencephalogram (EEG, a brain study)
• have a history of alcohol abuse or dependence on prescription medications or drugs
• are a woman and have started menstruating (see below the section "Pregnancy, breastfeeding, and fertility")
• have difficulty controlling movements, repetitive movements of some parts of the body, or sounds and words repeated
• have high blood pressure
• have a heart problem not included in the previous section "Do not take"
• have a mental health problem not included in the previous section "Do not take". Other mental health problems include:

• mood swings (from being manic to being 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 strangely suspicious (paranoia)
• feeling agitated, anxious, or tense
• feeling depressed or guilty

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

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

Checks your doctor will do before you start treatment with Atenza

To decide if methylphenidate is the right medication for you. Your doctor will talk to you about:

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

It is essential to provide all the information you can. This will help your doctor decide if methylphenidate is the right medication for you. Your doctor may decide that you or your child need other medical tests before starting this medication. For adults starting this medication, your doctor may refer you to a cardiologist.

Other medications and Atenza

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Do not take methylphenidate if you:

• are taking a medication called "monoamine oxidase inhibitor" (MAOI) used for depression or have taken an MAOI in the last 14 days. The use of 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 medications for depression or anxiety:

• tricyclic antidepressant
• selective serotonin reuptake inhibitor (SSRI)
• serotonin and norepinephrine reuptake inhibitor (SNRI)

Taking methylphenidate with these types of medications may produce a potentially fatal increase in "serotonin" in the brain (serotonin syndrome), which can cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeats. If you present these adverse effects, see your doctor immediately.

If you are taking other medications, methylphenidate may affect the mechanism of action of these medications or cause adverse effects. If you are taking any of the following medications, consult your doctor or pharmacist before taking methylphenidate:

• medications for severe mental health problems
• medications for Parkinson's disease (such as levodopa)
• medications for epilepsy
• medications used to lower or raise blood pressure
• some cough and cold remedies that contain medications that may affect blood pressure. It is essential to consult your pharmacist when purchasing any of these medications
• medications that thin the blood to prevent clotting

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

Inform your doctor or pharmacist if you are using or have used recently any other medications, even those purchased without a prescription.

Before surgery

Inform your doctor if you are undergoing surgery. Do not take methylphenidate on the day of surgery with certain types of anesthetics. This is because it may cause a sudden increase in blood pressure during the procedure.

Drug analysis

This medication may give a positive result in drug tests, even in those used in sports.

Atenza with alcohol

Do not drink alcohol while taking this medication. Alcohol may worsen the adverse effects of this medication. Remember that some foods and medications contain alcohol.

Pregnancy, breastfeeding, and fertility

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

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

• are having sex. Your doctor will talk to you about contraceptives
• are pregnant or think you may be pregnant. Your doctor will decide if you should take methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate passes into breast milk. Therefore, your doctor will decide if you or your baby 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 hazardous to perform certain activities such as driving, operating machines, riding a bike or horse, or climbing trees.

This medication may affect your ability to drive. Do not drive while taking this medication 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

Atenza contains sodium

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

How much to take

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be taken exactly as directed by your doctor.Consult your doctor or pharmacist again if you are unsure.

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

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

You should take this medication once a day in the morning with a glass of water.

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

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

Use in children aged 6 and above

• The initial recommended dose of Atenza is 18 mg once a day 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

For adults who have taken Atenza before:

• If you have taken Atenza as a child or adolescent, the same daily dose (mg/day) may be used; your doctor will check regularly if any adjustment is needed.
• Adult patients may need a higher daily dose, but your doctor will try to give you the lowest effective dose.

For adults who have not taken Atenza before:

• The initial recommended 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 if you need a different treatment.

Abuse of Atenza

Abuse of this medication may cause abnormal behavior. This may also mean that you start to depend on the medication. Inform your doctor if you have ever been dependent on alcohol, prescription medications, or drugs.

This medication is only for you. Do not give this medication to anyone else, even if they have similar symptoms.

If you take more Atenza than you should

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

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

The signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which may be followed by coma), feeling extremely happy, 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 compensate for the missed dose. If you or your child forget a dose, wait to take the next dose at the scheduled time.

If you interrupt treatment with Atenza

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

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

Your doctor will perform some tests

• before you start treatment to ensure that this medication is safe and beneficial
• once treatment has started, at least every 6 months and more often. These tests will also be done when the dose is changed
• these tests will include:

• appetite control
• measurement of height and weight
• measurement of blood pressure and heart rate
• evaluation of any rare mood, mental state, or feeling problems. Or if this has worsened while taking this medication.

Long-term treatment

This medication does not need to be taken indefinitely. If you take this medication for more than a year, your doctor should stop treatment for a short period, such as during school holidays. This allows you to demonstrate if you still need the medication.

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

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

Some side effects can be serious. If you have any of the side effects listed below, seek immediate medical attention:

Frequent (may affect up to 1 in 10 people)

• Irregular heartbeats (palpitations)
• Changes or alterations in mood or changes in personality.

Less frequent (may affect up to 1 in 100 people)

• Thoughts or suicidal feelings
• Seeing, feeling, or hearing things that are not real, are symptoms of psychosis
• Uncontrolled speech and body movements (Tourette's syndrome)
• Allergic signs such as hives, itching, or urticaria 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 exceptionally excited, more active than normal, and uninhibited (mania).

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

• Myocardial infarction
• Sudden death
• Suicidal intent
• Crisis (seizures, convulsions, epilepsy)
• Peeling of the skin or purpuric patches
• Inflammation or blockage of the arteries in the brain
• Temporal paralysis or movement and vision problems, speech difficulties (these signs may be related to problems with blood vessels in the brain)
• Uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system
• Decreased number of blood cells (red blood cells, white blood cells, and platelets) that may increase the risk of infections and cause easier bleeding and bruising
• Sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely clear that this side effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Unknown (frequency cannot be estimated from available data)

• Unwanted thoughts that recur
• Unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)
• Prolonged erections, sometimes painful, or increased number of erections.

If you have any of the side effects listed above, seek immediate medical attention.

The following side effects are listed below, and if they become serious, please inform your doctor or pharmacist:

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

• Headache
• Nervousness
• Difficulty sleeping.

Frequent (may affect up to 1 in 10 people)

• Joint pain
• Blurred vision
• Headache due to muscle tension
• Dry mouth, thirst
• Difficulty falling asleep
• Elevated body temperature (fever)
• Decreased libido
• Excessive hair loss or decreased hair thickness
• Muscle tension, muscle cramps
• Loss of appetite or decreased appetite
• Inability to achieve or maintain an erection
• Itching, rash, or red, itchy patches (hives)
• Excessive drowsiness or drowsiness, feeling tired
• Excessive tooth grinding (bruxism)
• Feeling of panic
• Sensation of numbness, itching, or tingling of the skin
• Increased levels of alanine aminotransferase in the blood (liver enzyme)
• Cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection, sinusitis
• High blood pressure, rapid heartbeat (tachycardia)
• Dizziness (vertigo), feeling weak, uncontrolled movements, excessive activity
• Aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior
• Stomach discomfort or indigestion, stomach pain, diarrhea, feeling dizzy, stomach discomfort, and vomiting
• Excessive sweating
• Weight loss.

Less frequent (may affect up to 1 in 100 people)

• Dry eyes
• Constipation
• Chest discomfort
• Blood in the urine
• Apathy
• Agitation or tremor
• Increased need to urinate
• Muscle pain, muscle spasms
• Shortness of breath or chest pain
• Sensation of heat
• Increased liver enzyme results (seen in a blood test)
• Anger reaction (angry), restless, or tearful, excessive awareness of the environment, difficulty sleeping.

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

• Changes in sexual desire
• Feeling disoriented or confused
• Eye or vision problems
• Swelling of the chest in men
• Excessive sweating, skin redness, increased redness of skin rashes.

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

• Muscle cramps
• Small red patches on the skin
• Abnormal liver function, including sudden liver failure and coma
• Changes in test results, including liver and blood tests
• Abnormal thinking, absence of feelings or emotions, doing things repeatedly, obsession with something
• Fingers and toes numb, tingling, and color change with cold (white to blue then red) ("Raynaud's phenomenon").

Unknown (frequency cannot be estimated from available data)

• Migraine
• Dilated pupils
• Very high fever
• Slow, rapid, or irregular heartbeats
• Major epilepsy seizure ("grand mal seizure")
• Believing things that are not true
• Severe stomach pain with discomfort and vomiting
• Problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• Inability to control urination (incontinence)
• Jaw muscle spasm that makes it difficult to open the mouth (trismus)
• Stuttering
• Nasal bleeding.

Growth effects

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

• May prevent weight gain or height gain
• Your doctor will carefully check your height and weight, as well as your diet
• If you or your child do not grow as expected, the methylphenidate treatment may be interrupted for a short period of time.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label after CAD. The expiration date is the last day of the month indicated.

Keep the bottle perfectly closed to protect it from moisture.

This medication does not require any special storage temperature.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the Sigre point of your usual pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of Atenza

The active ingredient 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, anhydrous colloidal silica, iron oxide black (E172).
• Coating: cellulose acetate, macrogol.
• Transparent coating: hypromellose, macrogol, phosphoric acid (for pH adjustment)
• Colored coating: lactose, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172) (18 mg), iron oxide red (E172) (18 mg, 27 mg, 54 mg), iron oxide black (E172) (27 mg), indigo carmine (E132) (45 mg).

Appearance of the product and packaging contents

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

27 mg: coated tablets, round, biconvex, gray, approximately 9 mm in diameter, with a small hole on one face of the tablet.

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

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

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

This medicine is available in a plastic bottle that contains 2 desiccant bags, with a child-resistant plastic closure. The desiccant bags are used to keep the tablets dry and should not be eaten.

The packaging sizes are: 30 tablets, 60 tablets (2x30) and 90 tablets (3x30).

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain.

Responsible 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 with the following names:

Sweden: Phenichem 18 mg; 27 mg; 36 mg; 45 mg; 54 mg depot tablet

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

Atenza 45 mg prolonged-release tablets

Poland: Atenza

Last review date of this prospectus: May 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)