Rubicrono 54 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Rubicrono 54 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, 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 or your child only, and you should not give it to others, even if they have the same symptoms as you or your child, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Rubicrono is and what it is 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. How to store Rubicrono
6. Contents of the pack and other information

1. What Rubicrono is and what it is used for

What it is used for

Rubicrono 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-medication treatments first, such as behavioral therapy and counseling.

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 brain regions that have low activity. The medicine may help improve attention (level of attention), concentration, and reduce impulsive behavior.

The medicine is administered as part of a comprehensive treatment program, which usually includes:

• psychological therapy
• educational therapy and
• social therapy.

It is prescribed only by doctors experienced in behavioral disorders in children, adolescents, or adults. If you are an adult who has not previously received treatment, the specialist will perform tests to confirm that you have had ADHD since childhood. Although ADHD cannot be cured, it can be managed through 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 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.

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

Not all ADHD patients require medication treatment.

ADHD does not affect intelligence.

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

Do not take Rubicrono if you or your child:

• are allergic to methylphenidate or to any of the other ingredients of this medicine (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumour of the adrenal glands (pheochromocytoma)
• have an eating disorder, lack of appetite, or do not want 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 defect
• 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 any antidepressant medicine (known as a monoamine oxidase inhibitor), see "Taking Rubicrono with other medicines"
• have mental health problems such as:
  • a "psychopathic" disorder or "borderline personality disorder"
  • abnormal thoughts or hallucinations or a condition called "schizophrenia"
  • signs of a severe 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 you or your child have any of the above conditions. If you are unsure, inform your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these conditions.

Warnings and precautions

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

• have liver or kidney problems
• have difficulty swallowing whole tablets
• have ever had seizures (fits, convulsions, epilepsy) or any abnormalities on electroencephalogram (EEG, a test of brain activity)
• have ever abused or been dependent on alcohol, prescription medicines, or drugs
• are female and have started menstruation (see section "Pregnancy, breastfeeding and contraception" below)
• have difficulty controlling repetitive movements of parts of the body or repeating sounds and words
• have high blood pressure
• have a heart condition not included in the previous "Do not take" section
• have a mental health condition not included in the previous "Do not take" section.

Other mental health problems include:

• mood changes (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 unusually suspicious (paranoia)
• feeling restless, anxious, or tense
• feeling depressed or guilty

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

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

During treatment, male patients may experience unexpected prolonged erections. These erections may be painful and can occur at any time. It is important to contact your doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Checks your doctor will make before you or your child start treatment with Rubicrono

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

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

It is important that you provide as much information as possible. This will help your doctor decide whether methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need further medical tests before starting this medicine. For adults starting Rubicrono, your doctor may refer you to a cardiologist.

Other medicines and Rubicrono

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

Do not take methylphenidate if you or your child:

• 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 Rubicrono").

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

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

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 restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If you or your child experience these side effects, see your doctor immediately.

If you or your child are taking other medicines, methylphenidate may affect how these medicines work or cause side effects. If you or your child 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 such medicines
• medicines that thin the blood to prevent clots.

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

Before surgery

Inform your doctor if you or your child are due to have surgery. Methylphenidate should not be taken on the day of surgery when certain types of anaesthetics are used, as it may cause a sudden increase in blood pressure during the procedure.

Drug testing

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

Taking Rubicrono with 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 contraception

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 you with 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 whether you should use 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

Dizziness, drowsiness, and visual disturbances may occur during treatment with methylphenidate. If these side effects occur, it may be dangerous to perform certain demanding 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 medicine contains lactose (a type of sugar). If your doctor has informed you or your child that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Rubicrono

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, not more frequently than once a week if necessary. The goal should be the lowest dose that is effective 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 daily in the morning with a glass of water.

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

Use in children aged 6 years and older

The recommended starting dose of Rubicrono 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 Rubicrono:

• if you previously took Rubicrono 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 prescribe the lowest effective dose.

• For adults who have not previously taken Rubicrono:

• the recommended starting 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

Inform your doctor. Your doctor may decide whether a different treatment is needed.

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

Your doctor will perform certain tests

• before you or your child start treatment to ensure that Rubicrono is safe and beneficial

• once treatment has started, these tests will be performed at least every 6 months, and even more frequently. They 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 of mood-related problems, mental status, or any other unusual feelings, or whether these have 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 one year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows assessment of whether continued medication is still necessary.

Misuse of Rubicrono

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

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

If you or your child take more Rubicrono than you should

If you or your child take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department and 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 heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle swelling, weak and tender muscles, muscle pain, and dark urine.

If you or your child forget to take Rubicrono

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

If you or your child stop taking Rubicrono

If you or your child 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 taken each day before stopping completely. Consult your doctor before stopping treatment with Rubicrono.

If you have any further questions about using 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 may be serious. If you or your child experience any of the following effects, 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)
• skin peeling or purplish-red skin spots
• inflammation or blockage of arteries in the brain
• temporary paralysis or movement and vision problems, speech difficulties (these signs may indicate problems with blood vessels in the 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 make bleeding and bruising more likely
• sudden increase in body temperature, very high blood pressure, and severe convulsions ("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.

Frequency not known (cannot be estimated from available data)

• unwanted thoughts that reappear
• 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 or your child experience any of the adverse effects listed above, contact your doctor immediately.

The following other adverse effects are also reported. If they become severe, please inform your doctor or pharmacist:

Very common (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 (thinner hair)
• muscle tension, muscle cramps
• loss of appetite or decreased appetite
• inability to achieve or maintain an erection
• itching, rash, or itchy red eruptions (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 (a liver enzyme)
• cough, sore throat, throat or nasal irritation; upper respiratory tract infection, sinusitis
• high blood pressure, rapid heartbeat (tachycardia)
• dizziness (vertigo), feeling weak, 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

Uncommon (may affect up to 1 in 100 people)

• dry eyes
• constipation
• chest discomfort
• blood in urine
• apathy
• restlessness or tremor
• increased need to urinate
• muscle pain, muscle twitches
• 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, difficulty sleeping.

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

• changes in sex drive
• feeling disoriented or confused
• vision problems or double vision
• breast swelling in males
• skin redness, increased redness of skin rashes
• obsessive-compulsive disorder (OCD) (including irresistible urge to pull out body hair, skin picking, repeated unwanted thoughts, feelings, images, or impulses in the mind (obsessive thoughts), performing repeated behaviors 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, absence of feelings or emotions
• feeling cold in arms and legs
• numbness, tingling, and color changes in fingers and toes when exposed to cold (from white to blue then red) ("Raynaud's phenomenon").

Frequency not known (cannot be estimated from available data)

• migraine
• dilated pupils
• increased eye pressure
• eye diseases that may cause vision loss due to optic nerve damage (glaucoma)
• very high fever
• slow, fast, or irregular heartbeat (palpitations)
• major epileptic seizure ("grand mal" convulsions)
• 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)
• jaw muscle spasm making it difficult to open the mouth (trismus)
• stuttering
• nosebleeds

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 or height gain
• your doctor will carefully monitor your or your child's height, weight, and 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rubicrono

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

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

This medicine does not require any special storage conditions.

Shelf-life after opening the container:

54 mg tablets: 6 months

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rubicrono

The active substance is methylphenidate hydrochloride.

• Rubicrono contains 54 milligrams of methylphenidate hydrochloride, equivalent to 46.7 mg of methylphenidate.

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

Coating:

54 mg: partially hydrolysed polyvinyl alcohol, polyethylene glycol (3350), talc, titanium dioxide (E171) and red iron oxide (E172).

Printing ink:

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

Nature of the product and pack contents

54 mg tablet: biconvex, capsule-shaped, reddish-brown tablet, 6.8 mm x 12 mm, with "2395" printed in black on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Germany Kinecteen 54 mg Retardtabletten

Netherlands Kinecteen tablets with prolonged release

Spain Rubicrono 54 mg prolonged-release tablets EFG

United Kingdom (Northern Ireland) Xaggitin XL 54 mg Prolonged-release Tablets

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es