Rubifen 20 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rubifen 20 mg Tablets

Methylphenidate hydrochloride

Read the entire leaflet carefully before you or your child start taking this medicine, as it contains important information for you or your child.

• 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, because it may harm them.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Rubifen is and what it is used for

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

3. How to take Rubifen

4. Possible side effects

5. How to store Rubifen

6. Contents of the pack and other information

1. What Rubifen is and what it is used for

What it is used for

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

• It is used in children and adolescents aged between 6 and 18 years.
• It is used only after trying non-medication treatments first, such as behavioral therapy and counseling.

Rubifen is not indicated for the treatment of ADHD in children under 6 years of age or in adults. Its safety and benefit in these patients are unknown.

How it works

Rubifen 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 behavior.

The medicine is given 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 managing behavioral problems in children or adolescents. Although ADHD cannot be cured, it can be managed using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty concentrating.

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

Many children and adolescents struggle with these tasks. However, patients with ADHD may experience 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.

ADHD does not affect the intelligence of the child or adolescent.

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

Do not take Rubifen 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 tumor of the adrenal glands (pheochromocytoma)
• Have an eating disorder, lack of appetite, or refusal to eat, such as in "anorexia nerviosa"
• 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 problem
• 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 "Other medicines and Rubifen"
• 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 Rubifen if you or your child:

• Have liver or kidney problems
• Have difficulty swallowing or problems swallowing whole tablets
• Have narrowing or blockage in the digestive tract
• 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 a woman who has started menstruating (see section "Pregnancy and breastfeeding" below)
• Have difficulty controlling repetitive movements of certain body parts or repeated sounds and words
• Have high blood pressure
• Have a heart problem not listed in the previous section "Do not take methylphenidate if you or your child"
• Have a mental health condition not listed in the previous section "Do not take methylphenidate if you or your child". Other mental health problems include:
  • Mood swings (from being manic to being depressed, known as "bipolar disorder")
  • Experiencing aggressive or hostile behavior, or worsening aggression
  • 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
• Are entering puberty.

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.

During treatment, children and adolescents 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.

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

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

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 had such feelings in the past
• Whether there have been cases of tics in your family (difficulty controlling repetitive movements of certain body parts or repeated 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.

Other medicines and Rubifen

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Do not take methylphenidate if you or your child:

• Are taking a medicine called a "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.

If you or your child are taking other medicines, methylphenidate may affect how these medicines work or cause adverse effects. 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
• 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 these 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 Rubifen with food, drinks, and alcohol

Taking methylphenidate with food may help relieve stomach pain, nausea, or vomiting.

Do not drink alcohol while taking this medicine. Alcohol may worsen the adverse effects of this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy and breastfeeding

Available data do not suggest an increased risk of overall congenital malformations, although a small increased risk of heart 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 having sexual intercourse. Your doctor will discuss contraception with you
• Are pregnant or think you might be pregnant. Your doctor will decide whether you should use methylphenidate
• Are breastfeeding or plan to breastfeed. Methylphenidate may pass into human milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while using methylphenidate.

Driving and using machines

You or your child may experience dizziness, difficulty focusing, or blurred vision when taking methylphenidate. If this occurs, it may be dangerous to perform certain activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

3. How to take Rubifen

How much to take

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will usually start treatment with a low dose and gradually increase it according to need.

• The maximum daily dose is 60 milligrams.
• The tablet should be swallowed with a glass of water. It is recommended to take the tablets with meals.

The score line is intended solely for breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into equal doses.

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. They may decide whether a different treatment is needed.

Inappropriate use of Rubifen

If Rubifen is not used appropriately, it may cause abnormal behavior. This could also mean that you or your child may 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 intended only for you or your child. Do not give this medicine to anyone else, even if they have similar symptoms.

If you or your child take more Rubifen 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. You may also contact the Toxicology Information Service at telephone number 91 562 04 20.

Signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle contractions, 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, and dryness of the nose and mouth.

If you or your child forget to take Rubifen

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

If you or your child stop taking Rubifen

If you or your child stop taking this medicine suddenly, ADHD symptoms may return or unwanted effects such as depression may occur. Your doctor may want to gradually reduce the amount of medicine you take each day before stopping completely. Consult your doctor before stopping treatment with Rubifen.

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 Rubifen is safe and beneficial
• at least every 6 months after starting treatment, and even more frequently if needed
• also 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 Rubifen.

Long-term treatment

Rubifen does not need to be taken indefinitely. If you or your child take Rubifen 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.

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 experiences 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 (affects less than 1 in 10 people)

• Irregular heartbeat (palpitations)
• Changes or disturbances in mood or changes in personality

Uncommon (affects less than 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 (affects less than 1 in 1,000 people)

• Feeling exceptionally elated, more active than normal, and disinhibited (mania)

Very rare (affects less than 1 in 10,000 people)

• Heart attack
• Seizures (fits, convulsions, epilepsy)
• Skin peeling or purplish red spots
• Uncontrollable muscle spasms affecting the eyes, head, neck, body, and nervous system as a result of reduced blood flow to the brain
• Paralysis or problems with movement and vision, difficulty speaking (may be signs of blood vessel problems in the brain)
• Decrease in blood cell counts (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 methylphenidato or by other medicines taken in combination with methylphenidate

Other adverse effects (frequency unknown)

• Unwanted thoughts that keep recurring
• Unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)

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 frequent (affects more than 1 in 10 people)

• Headache
• Feeling nervous
• Difficulty sleeping

Frequent (affects less than 1 in 10 people)

• Joint pain
• Dry mouth
• Elevated temperature (fever)
• Unusual hair loss or reduced hair thickness (thinner hair)
• Drowsiness or unusual drowsiness
• Loss of appetite or reduced appetite
• Itching, rash, or increased itching of red rashes (urticaria)
• Cough, sore throat, and irritation of the throat or nose
• High blood pressure, rapid heartbeat (tachycardia)
• Dizziness, uncontrolled movements, unusual activity
• Aggressiveness, agitation, anxiety, depression, irritability, and abnormal behavior
• Abdominal pain, diarrhea, nausea, stomach discomfort, and vomiting
• Excessive teeth grinding (bruxism)

Uncommon (affects less than 1 in 100 people)

• Constipation
• Chest discomfort
• Blood in urine
• Restlessness or tremor
• Double vision or blurred vision
• Muscle pain, muscle twitching
• Shortness of breath or chest pain
• Increased liver test results (seen in blood tests)
• Anger outbursts (irritability), restlessness or tearfulness, excessive awareness of surroundings, trouble sleeping
• Dry eyes

Rare (affects less than 1 in 1,000 people)

• Changes or disturbances in sexual desire
• Feeling disoriented
• Dilated pupils, vision problems
• Breast swelling in men
• Excessive sweating, skin flushing, increased redness of skin rashes
• Obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, pinch the skin, having repetitive unwanted thoughts, feelings, images, or impulses [obsessive thoughts], performing repetitive behaviors or mental rituals [compulsions])

Very rare (affects less than 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
• Suicidal ideation (including completed suicide), abnormal thinking, absence of feelings or emotions
• Numbness, tingling, and color changes in fingers and toes when exposed to cold (from white to blue, then red) ("Raynaud's phenomenon")

Other adverse effects (frequency unknown)

• Migraine
• Very high fever
• Slow, fast, or irregular heartbeats (palpitations)
• Major epileptic seizure ("grand mal convulsions")
• Believing things that are not true, confusion
• Severe stomach pain with nausea and vomiting
• Problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• Erectile dysfunction
• Excessive and uncontrolled speech
• Prolonged erections, sometimes painful, or increased number of erections
• Inability to control urination (incontinence)
• Spasm of jaw muscles making it difficult to open the mouth (trismus)
• Stuttering
• Nosebleeds
• Increased eye pressure
• Eye diseases that may cause vision loss due to damage to the optic nerve (glaucoma)

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 gain or height increase.
• 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 temporarily interrupted.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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

Keep this medicine out of sight and reach of children.

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

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicine containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rubifen 20 mg

The active substance is methylphenidate hydrochloride.

Each Rubifen 20 mg tablet contains 20 mg of methylphenidate hydrochloride.

The other components are dibasic calcium phosphate dihydrate, microcrystalline cellulose (E460i), maize starch, and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Rubifen 20 mg tablets are scored, white, round, and flat, marked “RU 20” on one side.

Each pack contains 20, 30, 40, 50 or 100 tablets. Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Rubió, S.A.

C/ Industria, 29. Pol. Ind. Comte de Sert.

08755 Castellbisbal (Barcelona) - Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Methylpheni TAD 20 mg Tabletten

Spain: Rubifen 20 mg Comprimidos

Portugal: Rubifen 20 mg Comprimidos

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

Other sources of information

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/)