Rubifen Prolong 10 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rubifen Prolong 10 mg prolonged-release hard capsules EFG

Rubifen Prolong 20 mg prolonged-release hard capsules EFG

Rubifen Prolong 30 mg prolonged-release hard capsules EFG

Rubifen Prolong 40 mg prolonged-release hard capsules EFG

Rubifen Prolong 60 mg prolonged-release hard capsules 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 must not be given to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Rubifen Prolong is and what it is used for

What it is used for

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

• It is used in children and adolescents aged 6 to 18 years, and in adults.
• It is used only after non-medicinal treatments, such as counselling and behavioural therapy, have proven insufficient.

Methylphenidate must not be used to treat ADHD in children under 6 years of age. It is unknown whether it is safe or beneficial in children under 6 years of age.

How it works

Methylphenidate improves the activity of certain parts of the brain that show low activity. This medicine helps improve attention and concentration, and reduces impulsive behaviour.

This medicine is used as part of a treatment programme, which usually includes:

• psychological therapy
• educational therapy, and
• social therapy.

Treatment with methylphenidate should only be initiated and used under the supervision of a doctor specialised in the treatment of ADHD, such as an expert paediatrician, a child and adolescent psychiatrist, or a psychiatrist. A thorough evaluation by this specialist is required. If you are an adult who has not been previously treated, the specialist will carry out assessments to confirm that you have had ADHD since childhood. Using a comprehensive treatment programme, including medication, helps manage ADHD effectively.

About ADHD

Children and adolescents with ADHD may find it difficult to:

• stay seated
• concentrate.

It is not their fault that they cannot do these things.

Many children and adolescents try hard to do these things. However, ADHD can be problematic in daily life. Children and adolescents with ADHD may have difficulties learning and completing homework.

Adults with ADHD often have trouble concentrating. They frequently feel restless, impatient, and easily distracted. They may find it difficult to organise their private lives and work.

Not all patients with ADHD require treatment with medication. In children, the decision to use medication should be based on a very thorough assessment of the severity and chronic nature of the child's symptoms.

ADHD does not affect intelligence.

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

Do not take Rubifen Prolong if you or your child:

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor of the adrenal glands (pheochromocytoma)
• are taking a medicine called monoamine oxidase inhibitor (MAOI) used for depression, or if you or your child have taken an MAOI within the last 14 days (see section "Other medicines and Rubifen Prolong")
• suffer from an eating disorder in which you or your child do not feel hungry or do not want to eat (such as 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 history of heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or other heart problems
• have had a problem with blood vessels in the brain such as stroke, swelling and weakening of part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• have mental health problems such as
  • a "psychopathic personality" or "borderline personality disorder"
  • have abnormal thoughts or hallucinations, or a condition called "schizophrenia"
  • signs of serious mood problems, such as:
    • suicidal thoughts
    • severe depression (feeling sad, worthless, and hopeless)
    • mania (unusual feeling of excitement, hyperactivity, or disinhibition)
    • mood swings from depression to mania

Do not take methylphenidate if you or your child have any of the above conditions. If you are unsure, speak with your doctor or pharmacist before taking methylphenidate, as this medicine may worsen these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before starting Rubifen Prolong if you or your child:

• have liver or kidney problems
• have had seizures (fits, convulsions, epilepsy) or abnormal brain scans (EEG)
• have abused or are dependent on alcohol, prescription medicines, or drugs
• are women who have started menstruating (see section "Pregnancy, breastfeeding and fertility" below)
• have or have had in the family repeated, difficult-to-control body movements or repeated sounds and words (tics)
• have high blood pressure
• have a heart condition not mentioned in the section "Do not take Rubifen Prolong"
• have a mental health condition not mentioned in the section "Do not take Rubifen Prolong". Other mental health problems include:
  • mood changes (switching from manic to depressive states – called "bipolar disorder")
  • new or worsening aggressive or hostile behavior
  • seeing, hearing, or feeling things that are not real (hallucinations)
  • believing things that are not true (delusions)
  • feeling unusually suspicious (paranoia)
  • feeling restless, anxious, or tense
  • feeling depressed or guilty

Before starting treatment, inform your doctor or pharmacist if you or your child have any of the disorders or symptoms listed above, as this medicine may worsen these problems. Your doctor will want to monitor the effects of the medicine on you or your child.

During treatment, children and adolescents may unexpectedly experience 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 longer than 2 hours, especially if it is painful.

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

Checks your doctor will carry out before you or your child start treatment with methylphenidate

These checks help determine whether methylphenidate is the right medicine for you or your child. Your doctor will discuss the following with you:

• any other medicines you or your child are taking
• family history of unexplained sudden death
• any other medical conditions (such as heart problems) that you, your child, or your family may have
• how you or your child feel emotionally, for example, overly excited or down, having unusual thoughts, or whether you or your child have had such feelings in the past
• family history of "tics" (difficulty controlling oneself, repeated contractions of any body part, or repeating sounds and words)
• any history of mental health or behavioral problems in you, your child, or other family members. Your doctor will explain whether you or your child may be at risk of mood changes (switching from mania to depression – called "bipolar disorder"). Your doctor will review your personal and family history of mental health, suicide, bipolar disorder, or depression.

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

Drug testing

This medicine may give positive results in drug tests.

Effects in case of misuse as a doping agent

The use of methylphenidate may lead to positive results in doping tests.

Misuse of methylphenidate for doping purposes may pose serious health risks.

Other medicines and Rubifen Prolong

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

Do not take methylphenidate if you or your child:

• are taking a medicine called "monoamine oxidase inhibitor (MAOI)" used to treat depression, or have taken an MAOI within the last 14 days. Taking an MAOI together with methylphenidate may cause a sudden increase in blood pressure (see "Do not take Rubifen Prolong").

If you or your child are taking other medicines, methylphenidate may affect how they work or cause side effects. Therefore, it may be necessary to adjust the dose of the medicine or stop treatment. If you or your child are taking any of the following medicines, consult your doctor or pharmacist before taking methylphenidate:

• other medicines for depression
• medicines for serious mental health conditions (e.g., schizophrenia)
• medicines for epilepsy
• medicines used to lower or raise blood pressure
• some cough and cold remedies whose ingredients may affect blood pressure. It is important to consult your pharmacist when purchasing such medicines
• medicines that thin the blood to prevent blood clots

If you are unsure whether any of the medicines you or your child are taking are included in the list above, ask your doctor or pharmacist 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 if certain types of anesthesia are used, as there is a risk of a sudden increase in blood pressure during the procedure.

Taking Rubifen Prolong with food, drinks, and alcohol

Do not drink alcohol while taking this medicine, as alcohol may worsen its side effects. Remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this 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 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 contraceptive methods with you
• are pregnant or think you may be pregnant. Your doctor will decide whether you should take methylphenidate
• are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, your doctor will decide whether breastfeeding should continue while taking 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 potentially hazardous activities (such as driving, operating machinery, riding a bicycle, or climbing trees) until you are certain that you or your child are not affected.

Rubifen Prolong contains sucrose

Rubifen Prolong contains sucrose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Rubifen Prolong

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dosage

Generally, your doctor will start treatment with a low dose and gradually increase it as needed.

Children (from 6 years of age) and adolescents

The recommended starting dose is 20 mg once daily. According to the doctor's judgment, treatment with methylphenidate may also be initiated with a dose of 10 mg. The maximum daily dose is 60 mg. Rubifen Prolong is taken once daily in the morning in patients under 18 years of age.

Adults

• If you are taking methylphenidate for the first time, your doctor will start treatment with a dose of 20 mg once daily and, if necessary, gradually increase the dose in small weekly increments.
• If you received treatment with a modified-release formulation of methylphenidate during childhood and have just turned 18 years old, your doctor may continue treatment at the same dose. If during childhood you were treated with an immediate-release formulation, your doctor will prescribe the equivalent dose of Rubifen Prolong.

The maximum daily dose is 80 mg.

For lower doses or smaller increments, different strengths of this medicine or other medicines containing methylphenidate may be available.

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 methylphenidate is safe and beneficial (detailed in the section "Monitoring your doctor will perform before you or your child start treatment with methylphenidate").
• after you or your child have started treatment: these tests will be performed at least every 6 months, but possibly more frequently. They will also be performed when the dose is changed.

These tests will include:

• checking appetite
• measuring height and weight, in children
• measuring weight, in adults
• measuring blood pressure and heart rate
• checking for mood problems or other unusual feelings, or whether these have worsened since starting Rubifen Prolong

Instructions for use

Rubifen Prolong is for oral use.

Take methylphenidate once daily in the morning. Methylphenidate should not be taken too late in the day, as it may cause sleep disturbances.

• The capsule may be taken with or without food.
• The capsule must be swallowed whole with a glass of water.
• Do not crush, chew, or divide the capsule or its contents.

If you or your child cannot swallow the Rubifen Prolong capsule, you may mix the contents with a small amount of food, as follows:

• Carefully open the capsule and pour the granules onto a small amount of soft food (e.g., applesauce).
• The food should not be hot, as this could affect the special properties of the granules.
• Take the entire mixture of medicine and food immediately.

Do not store any medicine/food mixture for future use.

Instructions for opening the blister pack

This medicine is available in peelable blister packs with a child-resistant safety seal. Please follow the instructions below to open the blister:

1. Do not push the capsule out of the blister, as this will crush it.
2. Hold the blister with the printed foil side up and fold backwards along the perforated line; bend the blister in the opposite direction and repeat several times. Separate at the perforated area to obtain one dose.

1. To remove the capsule, carefully peel back the foil starting from the corner indicated by an arrow and pull it back.

Long-term treatment

Methylphenidate should not be taken, nor is it necessary, for life. If methylphenidate treatment lasts longer than one year, your doctor should temporarily discontinue treatment at least once a year. In children, this may occur during school holidays. This allows assessment of whether the medicine is still needed.

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

If you or your child do not feel better, inform your doctor. Your doctor may decide whether you or your child need a different treatment.

Misuse of Rubifen Prolong

If methylphenidate is not used properly, abnormal behavior may occur. It may also mean that you or your child begin to become dependent on the medicine. Inform your doctor if you or your child have abused or are dependent on alcohol, prescription medicines, or drugs.

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

If you or your child take more Rubifen Prolong than you should

If you or your child have taken more medicine than you should, contact your doctor or call an ambulance immediately. Medical treatment may be necessary. You may also contact the Toxicology Information Service at telephone number 91 562 04 20.

Signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, seizures (sometimes followed by coma), extreme feelings of 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, dark urine.

If you or your child forget to take Rubifen Prolong

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

If you or your child stop taking Rubifen Prolong

If you or your child stop taking the medicine suddenly, ADHD symptoms may return or unwanted effects such as depression may occur. Your doctor will advise you to gradually reduce the daily dose before stopping completely. Consult your doctor before stopping methylphenidate.

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 gets them. Your doctor will discuss these adverse effects with you.

Some adverse effects could be serious. If you or your child experience any of the following adverse effects, inform your doctor immediately:

Frequent (may affect up to 1 in 10 people)

• irregular heartbeat (palpitations)
• changes in personality
• excessive teeth grinding (bruxism)

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
• changes or disturbances in mood

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

• feeling unusually excited, more active than normal, or disinhibited (mania)

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

• heart attack
• seizures (fits, epilepsy with convulsions)
• skin peeling or purplish red spots
• uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system due to lack of blood flow to the brain
• paralysis or movement and vision problems, difficulty speaking; may be signs of problems in the brain’s blood vessels
• decreased number of blood cells (red blood cells, white blood cells, and platelets), which may make you more prone to infections and cause easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure, and severe seizures ("neuroleptic malignant syndrome"). It is not fully certain whether this adverse effect is caused by methylphenidate or other medicines taken in combination with methylphenidate

Not known (frequency cannot be estimated from available data)

• unwanted thoughts that reappear
• unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)
• inability to control urination (incontinence)
• jaw muscle spasm making it difficult to open the mouth (trismus)
• stuttering

Other adverse effects—if they become severe, inform your doctor or pharmacist:

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

• decreased appetite
• headache
• feeling nervous
• difficulty sleeping
• nausea
• dry mouth

Frequent (may affect up to 1 in 10 people)

• joint pain
• high temperature (fever)
• abnormal hair loss or decreased hair thickness (thinner hair)
• unusual drowsiness or numbness
• loss of appetite
• weight loss in adults
• panic attacks
• decreased sex drive
• toothache
• itching, rash, or red, itchy skin rashes (urticaria)
• excessive sweating
• cough, sore throat, or throat and nose irritation, difficulty breathing or chest pain
• changes in blood pressure (mainly high blood pressure)
• rapid heartbeat (tachycardia)
• cold hands and feet
• jerks or tremors, dizziness, uncontrollable movements, inner restlessness
• being unusually active
• feeling aggressive, nervous, restless, anxious, depressed, stressed, irritable, having abnormal behavior, trouble sleeping, and fatigue
• stomach pain, diarrhea, stomach discomfort, indigestion, thirst, and vomiting. These adverse effects usually occur at the beginning of treatment and may be reduced by taking the medicine with food.

Uncommon (may affect up to 1 in 100 people)

• constipation
• chest discomfort
• inflammation of the mucous membranes of the stomach and small intestine
• blood in urine
• double or blurred vision
• muscle pain, muscle contractions, muscle tightness
• increased liver test results (seen in blood tests)
• anger, restlessness, or tearfulness, excessive awareness of surroundings, tension
• dry eyes

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

• changes in sex drive
• feeling disoriented
• dilated pupils, vision problems
• breast swelling in men
• skin redness, increased redness of skin rashes
• obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, skin picking, having repetitive unwanted thoughts, feelings, images, or impulses in the mind [obsessive thoughts], performing repetitive behaviors or mental rituals [compulsions])

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

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of arteries in the brain
• abnormal liver function, including liver failure and coma
• changes in test results, including liver and blood tests
• suicide attempt (including completed suicide), abnormal thoughts, absence of feelings or emotions
• sensation of numbness in fingers and toes, tingling, and color change from white to blue, then to red in cold conditions (Raynaud’s phenomenon)

Not known (frequency cannot be estimated from available data)

• migraine
• very high fever
• slow, fast, or irregular heartbeat (palpitations)
• major epileptic seizure (“grand mal” convulsions)
• believing things that are not true, confusion
• severe stomach pain with nausea and vomiting
• problems in the brain’s blood vessels (stroke, cerebral arteritis, or cerebral occlusion)
• erectile dysfunction
• prolonged, sometimes painful erections, or increased number of erections
• excessive and uncontrollable talking
• nosebleeds
• increased eye pressure
• eye diseases that may cause vision loss due to optic nerve damage (glaucoma)

Effects on growth

When used for more than one year, methylphenidate may reduce growth rate in some children. This affects fewer than 1 in 10 children.

• Lack of weight or height gain may occur.
• Your doctor will carefully monitor height, weight, and your or your child’s nutritional status.
• If your child is not growing as expected, treatment with methylphenidate may be temporarily suspended.

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 Rubifen Prolong

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Pack contents and other information

Composition of Rubifen Prolong

• The active substance is methylphenidate hydrochloride.

Rubifen Prolong 10 mg modified-release hard capsules EFG contains 10 mg of methylphenidate hydrochloride (equivalent to 8.65 mg of methylphenidate).

Rubifen Prolong 20 mg modified-release hard capsules EFG contains 20 mg of methylphenidate hydrochloride (equivalent to 17.3 mg of methylphenidate).

Rubifen Prolong 30 mg modified-release hard capsules EFG contains 30 mg of methylphenidate hydrochloride (equivalent to 25.95 mg of methylphenidate).

Rubifen Prolong 40 mg modified-release hard capsules EFG contains 40 mg of methylphenidate hydrochloride (equivalent to 34.6 mg of methylphenidate).

Rubifen Prolong 60 mg modified-release hard capsules EFG contains 60 mg of methylphenidate hydrochloride (equivalent to 51.9 mg of methylphenidate).

• The other components are:

Capsule contents: ammonium methacrylate copolymer (type B), methacrylic acid and methyl methacrylate copolymer (1:1), povidone 30, sugar spheres (containing sucrose and maize starch), talc, triethyl citrate.

Capsule shell: gelatin, titanium dioxide (E171).

Additionally, in Rubifen Prolong 10 mg modified-release hard capsules, Rubifen Prolong 30 mg modified-release hard capsules, Rubifen Prolong 40 mg modified-release hard capsules, and Rubifen Prolong 60 mg modified-release hard capsules: yellow iron oxide (E172).

Printing ink: potassium hydroxide, propylene glycol, red iron oxide (E172), shellac, concentrated ammonia solution.

Appearance of the product and pack contents

Rubifen Prolong 10 mg modified-release hard capsules EFG

Opaque hard gelatin capsule (size 2) with dark yellow cap and white body, printed with "RUB" in red ink on the cap and "M10" in red ink on the body, containing white and off-white pellets. Capsule length: 18 mm.

Rubifen Prolong 20 mg modified-release hard capsules EFG

Opaque hard gelatin capsule (size 2) with white cap and white body, printed with "RUB" in red ink on the cap and "M20" in red ink on the body, containing white and off-white pellets. Capsule length: 18 mm.

Rubifen Prolong 30 mg modified-release hard capsules EFG

Opaque hard gelatin capsule (size 2) with ivory cap and ivory body, printed with "RUB" in red ink on the cap and "M30" in red ink on the body, containing white and off-white pellets. Capsule length: 18 mm.

Rubifen Prolong 40 mg modified-release hard capsules EFG

Opaque hard gelatin capsule (size 1) with dark yellow cap and dark yellow body, printed with "RUB" in red ink on the cap and "M40" in red ink on the body, containing white and off-white pellets. Capsule length: 20 mm.

Rubifen Prolong 60 mg modified-release hard capsules EFG

Opaque hard gelatin capsule (size 0) with dark yellow cap and ivory body, printed with "RUB" in red ink on the cap and "M60" in red ink on the body, containing white and off-white pellets. Capsule length: 22 mm.

Blister packs with child-resistant safety closure (Aclar/PVC//Al/PET) in cartons.

Pack sizes:

10 mg: 28, 30, 50, 56, 60, 100 capsules.

20 mg: 28, 30, 50, 56, 60, 84, 100 capsules.

30 mg: 28, 30, 50, 54, 56, 60, 100 capsules.

40 mg: 28, 30, 50, 54, 56, 60, 100 capsules.

60 mg: 28, 30, 40, 50, 56, 60, 100 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Rubió, S.A.

Industria, 29. Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Methylphenidat Rubio Hartkapseln mit veränderter Wirkstofffreisetzung

Spain Rubifen Prolong cápsulas duras de liberación modificada EFG

Poland Symkinet MR

Portugal Rubifen Retard

Date of latest review of this package leaflet: September 2025

Detailed 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)