Rubicrono 27 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rubicrono 27 mg prolonged-release tablets EFG

methylphenidate hydrochloride

Read the 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, consult 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 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 Rubicrono is and what it is used for
2. What you need to know before you or your child take 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 non-medicinal treatments, such as behavioural therapy and counselling, 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 have low activity. The medicine may help improve attention (level of attention), concentration, and reduce impulsive behaviour.

The medicine is administered 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 assessments 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.

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

Not all patients with ADHD 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 components 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 want to eat, such 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 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 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 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 menstruating (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 problem not listed in the previous "Do not take" section
• have a mental health condition not listed in the previous "Do not take" section.

Other mental health problems include:

• mood swings (from being 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 true (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 unexpectedly develop prolonged erections. These erections may be painful and can occur at any time. It is important to contact a doctor immediately if an erection lasts longer than 2 hours, especially if it is painful.

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

To determine 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 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, whether you have mood swings, strange thoughts, or have previously had such feelings
• whether there is a family history of tics (difficulty controlling repetitive movements of parts of the body or repeating sounds and words)
• any possible behavioral 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 mania to depression, known as bipolar disorder). Your doctor will review your or your child's 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 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

Inform 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 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 cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If you or your child experience these side effects, seek medical help 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 scheduled for surgery. Methylphenidate should not be taken on the day of surgery when certain types of anesthetics are used, as this 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 or 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 could not be ruled out. Your doctor will provide further information about this risk. Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• 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 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 certain 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 your doctor before taking this medicine.

3. How to take Rubicrono

How much to take

Follow exactly the instructions for use of this medicine 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 determine 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 from 6 years of age

The recommended initial 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 give the lowest effective dose.

• For adults who have not previously taken Rubicrono:

• 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

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 carry out some 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 state, 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 needed.

Misuse of Rubicrono

If Rubicrono is not used properly, it may lead to abnormal behavior. This may also mean that you or your child begin 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, consult your doctor immediately or go to the nearest hospital emergency department and inform 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 take 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 nose and mouth, muscle swelling, weak and tender muscles, muscle pain, 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 wish 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 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 gets 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 adverse 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 exceptionally elated, more active than normal and disinhibited (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 purpuric red 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 cause bleeding and bruising more easily
• 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 reoccur
• unexplained fainting, chest pain, shortness of breath (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 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 headache
• dry mouth, thirst
• difficulty falling asleep
• elevated temperature (fever)
• decreased sex drive
• abnormal hair loss or reduced thickness (thinner hair)
• muscle tension, muscle cramps
• loss of appetite or decreased appetite
• inability to achieve or maintain an erection
• itching, rash or red, itchy rashes (hives)
• drowsiness or excessive 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, 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 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 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, 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 enlargement in men
• 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 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, absence of feelings or emotions
• feeling cold in arms and legs
• numbness, tingling and colour change in fingers and toes with 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 heartbeats (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 kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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.

Expiry after opening the package:

27 mg tablets: 6 months

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 27 milligrams of methylphenidate hydrochloride, equivalent to 23.3 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:

27 mg: partially hydrolyzed polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine aluminium lake (E132), black iron oxide (E172).

Printing ink:

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

Appearance of the product and contents of the container

27 mg tablet: grey, biconvex, capsule-shaped tablet, 6.7 mm x 12 mm, with "2393" 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 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Kinecteen 27 mg Retardtabletten

Netherlands Kinecteen tabletten met verlengde afgifte

Spain Rubicrono 27 mg prolonged-release tablets EFG

United Kingdom (Northern Ireland) Xaggitin XL 27 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es