Patient Information Leaflet: Product Information

Rubicrono 54 mg prolonged-release tablets EFG

methylphenidate hydrochloride

Read this leaflet carefully before you or your child start taking this medicine, as 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 should not be given 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Rubicrono 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. Storage of Rubicrono

6. Contents of the pack and additional information

What it is used for

Rubicronois 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.

Rubicronois not indicated for ADHD treatment in children under 6 years.

How it works

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

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

• psychological therapy
• educational therapy and
• social therapy.

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

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.

ADHD does not affect intelligence.

Do not takeRubicronoif you or your child:

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have a feeding 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, heart failure, heart disease, or a congenital heart problem
• have had any problems 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 “Taking Rubicrono with other medicines”
• 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 or your child experience any of the above. If you are unsure, inform your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these problems.

Warnings and precautions

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

• have liver or kidney problems
• have trouble swallowing the whole tablets
• have had seizures or any alteration in electroencephalogram (EEG, a brain study)
• have abused alcohol, prescription medications, or drugs
• are a woman and have started menstruating (see below the section on “Pregnancy, breastfeeding, and contraception”)
• have difficulty controlling, 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 or your child experience 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 experience, unexpectedly, 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 or your child start treatment with Rubicrono

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 family have a history of sudden, unexplained death
• other health conditions you or your family may have (such as heart problems)
• how you or your child are feeling, 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 behavior or mental health problems you or your child have had in the past or that other family members have had.
• Your doctor will explain specifically if you or your child are at risk of developing mood swings (from being manic to being depressed, known as bipolar disorder). They 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 as much information as possible. 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 this medication.Your doctor may refer adult patients starting Rubicrono to a cardiologist.

Other medicines and Rubicrono

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

Do not take methylphenidate if you or your child:

• are taking a medication called “monoamine oxidase inhibitor” (MAOI) that is used for depression or have taken an MAOI in the last 14 days. Taking 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 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 may cause 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 or your child experience these adverse effects, see your doctor immediately.

If you or your child are taking other medications, methylphenidate may affect the mechanism of action of these medications or cause adverse 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 raise blood pressure
• some 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 blood clots.

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

Before surgery

Inform your doctor if you or your child are undergoing surgery. Do not take methylphenidate on the day of surgery with certain types of anesthetics, as 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 tests used in sports.

Taking Rubicrono 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 contraception

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 congenital anomalies, although a small increased risk of cardiac malformations cannot be ruled out during the first three months of pregnancy. 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 contraceptive options
• are pregnant or think they may be pregnant. Your doctor will decide if you should use methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate passes into breast milk. Your doctor will decide if you or your daughter should breastfeed while using methylphenidate.

Driving and operating machinery

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

Rubicrono contains lactose

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

How much to take

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, 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 more 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 taken orally. 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 aged 6 and above

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:

• If you have taken Rubicrono 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 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 improve after 1 month of treatment

Inform 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, you or your child will be tested at least every 6 months and more often if necessary. Testing will also be done when the dose is changed
• These tests will include:

• Appetite control
• Height and weight measurement
• Blood pressure and heart rate measurement
• Mental state evaluation, including any rare feelings. 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 you or your child to demonstrate if you still need the medication.

Abuse of Rubicrono

If Rubicrono is not used properly, it may cause abnormal behavior. This can also mean that you or your child start to depend on the medication. Inform your doctor if you or your child have 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 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 tell them how many tablets were taken. Medical treatment may be necessary.

You can also contact the Toxicology Information Service, Teléfono 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, dryness of the nose and mouth, muscle swelling, weak and sensitive muscles, muscle pain, dark urine.

If you or your child forget to take Rubicrono

Do not take a double dose to make up for the missed 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 stop taking this medication suddenly, you may experience a recurrence of ADHD symptoms or unwanted effects such as depression. Your doctor may want to gradually reduce the amount of medication taken each day before stopping it completely. Consult your doctor before stopping treatment with Rubicrono.

If you have any other questions about using 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.A doctor or pharmacist will inform you about these side effects.

Some side effects can be serious. If you or your child 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 personality changes.

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

• Thoughts or suicidal feelings
• Seeing, feeling, or hearing things that are not real, which 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, or difficulty 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
• Seizures (attacks, 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 due 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 easy bruising and bleeding
• Sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain 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 or your child 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 thinning of hair (hair becomes finer)
• 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 tingling, itching, or numbness 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 problems or double vision
• Swelling of the chest in men
• Redness of the skin, 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 seizures (convulsions)
• 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)
• Spasm of the jaw muscles 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 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 treatment with methylphenidate may be interrupted for a short period of time.

Reporting side effects

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

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

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Expiration after opening the packaging:

54 mg tablets: 6 months

Medicines should not bethrown into the drains or trash.Dispose of the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment..

Composition ofRubicrono

The active ingredient ismethylphenidate hydrochloride

• Rubicronocontains 54 milligrams of methylphenidate hydrochloride, corresponding to 46.7 mg of methylphenidate.

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

Coating:

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

Printing ink:

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

Appearance of the product and contents of the package

54 milligram tablet: biconvex tablet, capsule-shaped, brownish-red, 6.8 mm x 12 mm, with “2395” printed in black on one face

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Rubió, S.A.

Industrial Street 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal

Barcelona, Spain

Responsible 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:

GermanyKinecteen 54mg Retardtabletten

NetherlandsKinecteen tablets with prolonged release

SpainRubicrono 54 mg prolonged-release tablets EFG

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

Last review date of this leaflet: November 2023

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