RUBICRONO 36 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Rubicrono 36 mg prolonged-release tablets EFG

methylphenidate, hydrochloride

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

• 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 or your child only. Do not give it to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rubicrono and what is it used for
2. What you need to know before you or your child start taking Rubicrono
3. How to take Rubicrono
4. Possible side effects
5. Storing Rubicrono
6. Contents of the pack and other information

1. What is Rubicrono and what is it used for

What it is used for

Rubicrono is used to treat “attention deficit hyperactivity disorder” (ADHD).

• it is used in children from 6 years of age and in adults.
• it is used only after non-medication treatments such as behavioral therapy and counseling have been tried.

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

How it works

Rubicrono improves the activity of certain parts of the brain that are underactive. 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 normally includes:

• psychological therapy
• educational therapy and
• social therapy.

It is only prescribed by doctors who have experience in behavioral problems in children, adolescents, or adults. 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 has no cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• staying still and
• focusing

It's not their fault that they can't 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, at school, and in other places.

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

Not all patients with ADHD need treatment with medication.

ADHD does not affect intelligence.

2. What you need to know before you or your child start taking Rubicrono

Do not takeRubicronoif you or your child:

• 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, loss of appetite, 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 arm and leg pain
• have had heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a congenital heart problem
• have had a problem with the blood vessels in the brain such as a stroke, dilation or weakness of part of a blood vessel (aneurysm), narrowing or blockage of the blood vessels, or inflammation of the blood vessels (vasculitis)
• are taking or have taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see “Taking Rubicrono with other medications”
• have mental health problems such as:
• • a “psychopathic” or “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, worthless, and desperate
  • mania, feeling exceptionally excited, more active than usual, and uninhibited.

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

Warnings and precautions

Talk to your doctor before starting to take Rubicrono if you or your child:

• have liver or kidney problems
• have difficulty swallowing whole tablets
• have had seizures (attacks, convulsions, epilepsy) or any alteration in electroencephalogram (EEG, a brain study)
• have ever abused or been dependent on alcohol, prescription medications, or drugs
• are female and have started your period (see below the section on “Pregnancy, breastfeeding, and contraception”)
• have difficulty controlling repetitive movements or sounds and words
• 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 changes (from being manic to being depressed, known as “bipolar disorder”)
• feeling aggressive or hostile
• 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

Tell your doctor or pharmacist if you or your child have 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 or your child.

During treatment, male patients may unexpectedly experience prolonged erections. The 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 that your doctor will perform before you or your child start treatment withRubicrono

To decide if methylphenidate is the right medication for you or your child, your doctor will discuss with you:

• the medications you or your child are taking
• if you or your child have a family history of sudden unexplained death
• other diseases that you or your family (such as heart problems) may have
• how you or your child are feeling, if you or your child have mood swings, have had unusual thoughts or have had such feelings in the past
• if there have been cases of tics in your family (difficulty controlling repetitive movements or sounds and words)
• possible behavioral or mental health problems that you or your child or other family members have had.
• Your doctor will explain specifically if you or your child are at risk of experiencing mood changes (from being manic to being depressed, known as bipolar disorder). He/Your doctor will check your or your child's 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 or your child. Your doctor may decide that you or your child need other medical tests before starting to take this medication. For adults who start taking Rubicrono, your doctor may refer you to a cardiologist.

Other medications and Rubicrono

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

Do not takemethylphenidate if you or your child:

• are taking a medication called a “monoamine oxidase inhibitor” (MAOI) used for depression or have taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate can cause a sudden increase in blood pressure (see “Do not take Rubicrono”).

Tell your doctor or pharmacist if you or your child are taking any of the following medications for depression or anxiety:

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

Taking methylphenidate with these types of medications can cause a potentially life-threatening increase in “serotonin” in the brain (serotonin syndrome), which can cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If you or your child experience these side effects, seek medical attention immediately.

If you or your child are taking other medications, methylphenidate may affect how they work or cause side effects. If you or your child 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 increase blood pressure
• certain cough and cold remedies that contain medications that can 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 are unsure whether any of the medications you or your child are taking are included in the list above, consult your doctor or pharmacist for advice before taking methylphenidate.

Before an operation

Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on the day of the operation with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Drug tests

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

Taking Rubicronowith alcohol

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

Pregnancy, breastfeeding, and contraception

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

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

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

Driving and using machines

Dizziness, drowsiness, and visual disturbances may occur during treatment with methylphenidate. If these side effects occur, it may be dangerous to perform certain activities (such as driving, operating machinery, riding a bicycle, or climbing trees) until you are sure that you or your child are not affected.

Rubicrono contains lactose

This medication contains lactose (a type of sugar). If your doctor has told you that you or your child have an intolerance to certain sugars, consult your doctor before taking this medication.

3. How to take Rubicrono

How much to take

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

• Your doctor will usually start treatment with a low dose and increase the daily dose by 18 mg no sooner than once a week if necessary. The goal should be the lowest effective dose for you or your child. Your doctor will decide the maximum daily dose for you or your child.
• Rubicrono is for oral use. You or your child should take the tablet 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.

Use in children from 6 years of age

The recommended initial dose of Rubicrono 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 Rubicrono before:

• adult patients may need a higher daily dose, but the doctor will try to give the lowest effective dose.

• For adults who have nottaken Rubicrono before:

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

If you or your child do not feel better after 1 month of treatment

Tell your doctor. Your doctor may decide if you or your child need a different treatment.

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

Your doctor will perform some tests

• before you or your child start treatment to ensure that Rubicrono is safe and beneficial
• once treatment has started, at least every 6 months and even more often. They will also be performed when the dose is changed
• these tests will include:

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

Long-term treatment

Rubicrono does not need to be taken indefinitely. If you or your child take Rubicrono for more than a year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows demonstration of whether you or your child still need the medication.

Incorrect use ofRubicrono

If Rubicrono is not used correctly, it can cause abnormal behavior. This can also mean that you or your child start to depend on the medication. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medications, or drugs.

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

If you or your child take moreRubicronothan you should

If you or your child take too many tablets, consult your doctor immediately or go to the emergency department of the nearest hospital and tell them how many tablets were taken. Medical treatment may be necessary.

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.

Signs of overdose may include: being sick, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which can be followed by coma), feeling very happy, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeats (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, swelling of the muscles, weak and sensitive muscles, muscle pain, dark urine.

If you or your child forget to takeRubicrono

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

If you or your child stop taking Rubicrono

If you or your child suddenly stop taking this medication, ADHD symptoms 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 stopping treatment with Rubicrono.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Although some people present adverse effects, most people are helped by methylphenidate. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If you or your child have any of the following adverse effects, go to your doctor immediately:

Frequent (may affect up to 1 in 10 people)

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

Infrequent (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)
• allergy signs 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 exceptionally excited, more active than normal, and uninhibited (mania).

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

• heart attack
• sudden death
• suicidal intention
• seizures (attacks, convulsions, epilepsy)
• skin peeling or red purpuric spots
• inflammation or blockage of the arteries in the brain
• temporary paralysis or movement and vision problems, speech difficulties (these signs may be related to problems with blood vessels in the brain)
• uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets) that can cause a higher risk of infections and easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this adverse effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Frequency Not Known (cannot be estimated from available data)

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

If you or your child have any of the above adverse effects, go to your doctor immediately.

Other adverse effects are indicated below, and if they become severe, please inform your doctor or pharmacist:

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

• headache
• feeling of nervousness
• difficulty sleeping.

Frequent (may affect up to 1 in 10 people)

• joint pain
• blurred vision
• tension headache
• dry mouth, thirst
• difficulty staying asleep
• fever
• decreased sexual desire
• hair loss or decreased hair thickness (thinner hair)
• muscle tension, muscle cramps
• loss of appetite or decreased appetite
• inability to have or maintain an erection
• itching, rash, or red eruptions that itch (hives)
• excessive drowsiness or sleepiness, 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 irritation of the throat or nose; upper respiratory tract infection, sinusitis
• high blood pressure, rapid heartbeat (tachycardia)
• dizziness (vertigo), feeling of weakness, uncontrolled movements, abnormal activity
• aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior
• stomach discomfort or indigestion, stomach pain, diarrhea, feeling nauseous, stomach upset, and vomiting.
• excessive sweating
• weight loss

Infrequent (may affect up to 1 in 100 people)

• dry eyes

• constipation
• chest discomfort
• blood in the urine
• apathy
• agitation or tremors
• increased need to urinate
• muscle pain, muscle spasms
• shortness of breath or chest pain
• feeling of heat
• increased liver test results (seen in a blood test)
• anger reaction (angry), restless or tearful, excessive awareness of the environment, sleep problems.

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

• changes in sexual desire
• feeling disoriented or confused
• vision problems or double vision
• breast swelling in men
• redness of the skin, increased redness of skin rashes
• obsessive-compulsive disorder (OCD) (includes irresistible urge to pull out body hair, having unwanted thoughts, feelings, images, or impulses in the mind (obsessive thoughts), performing repeated mental behaviors or 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
• feeling of cold in arms and legs
• fingers and toes numbness, tingling, and color change with cold (from white to blue then red) ("Raynaud's phenomenon").

Frequency Not Known (cannot be estimated from available data)

• migraine
• dilated pupils
• very high fever
• slow, rapid, or irregular heartbeats, palpitations
• major epileptic seizure ("grand mal" convulsions)
• believing things that are not true
• severe stomach pain with feeling of discomfort and vomiting
• problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• inability to control urine elimination (incontinence)
• muscle spasm of the jaw that makes it difficult to open the mouth (trismus)
• stuttering
• nosebleed

Effects on Growth

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 or height gain
• your doctor will carefully check the height and weight of you or your child, as well as nutrition

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rubicrono

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Expiration after opening the package:

36 mg tablets: 6 months

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rubicrono

The active ingredient is methylphenidate hydrochloride

• Rubicrono contains 36 milligrams of methylphenidate hydrochloride, corresponding to 31.1 mg of methylphenidate.

The other components are: lactose monohydrate, hypromellose, colloidal anhydrous silica, magnesium stearate, fumaric acid, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), triethyl citrate, talc

Coating:

36 mg: partially hydrolyzed polyvinyl alcohol, macrogol (3350), talc, and titanium dioxide (E171).

Printing ink:

Lacquer, black iron oxide (E172), and propylene glycol.

Appearance of the Product and Package Contents

36 mg tablet: biconvex tablet, capsule-shaped, white, 6.7 mm x 12 mm, with "2394" printed in black on one side

The medicine is presented in child-resistant closure bottles with a silica gel desiccant inserted in the cap, containing 28, 29, 30, or 100 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Rubió, S.A.

Calle Industria 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal

Barcelona, Spain

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str

Dupnitsa 2600, Bulgaria

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany Kinecteen 36 mg Retardtabletten

Netherlands Kinecteen tabletten met verlengde afgifte

Spain Rubicrono 36 mg prolonged-release tablets EFG

United Kingdom (Northern Ireland) Xaggitin XL 36 mg Prolonged-release Tablets

Date of the last revision of this leaflet: August 2025

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