Package Insert: Information for the Patient

Rubifen 5 mg Tablets

Methylphenidate Hydrochloride

Read this package insert carefully before you or your child start taking this medication, as it contains important information for you or your child.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you or your child 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 or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

What it is used for

Rubifenis usedto treat “attention deficit hyperactivity disorder” (ADHD).

• It is used in children and adolescents aged 6 to 18 years.
• It is used only after having tried treatments that do not include medication, such as behavioral therapy and counseling.

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

How it works

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

The medication is administered as part of an integrated treatment program, which usually includes:

• psychological therapy
• educational therapy and
• social therapy.

Only doctors with experience in children's or adolescents' behavioral problems can prescribe it. Although ADHD has no cure, it can be controlled using integrated 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 to do them. However, patients with ADHD may experience 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.

ADHD does not affect the child's or adolescent's intelligence.

Do not take Rubifen if you or your child:

• Are allergic to methylphenidate or any of the other components of this medication (listed in section 6)
• Have a thyroid problem
• Have high eye pressure (glaucoma)
• Have a tumor of 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 and discomfort, heart failure, heart disease, or a congenital heart problem
• Have had a problem with the blood vessels in the brain, such as a stroke, dilation or weakness of a blood vessel (aneurysm), narrowing or blockage of the blood vessels, or inflammation of the blood vessels (vasculitis)
• Are taking or have taken in the last 14 days an antidepressant (known as a monoamine oxidase inhibitor). See "Other medications and Rubifen"
• 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 Rubifen if you or your child:

• Have liver or kidney problems
• Have difficulty swallowing or swallowing whole tablets
• Have a narrowing or blockage in the digestive system
• Have had seizures or any alteration in the electroencephalogram (EEG, a brain study)
• Have abused alcohol, prescription medications, or drugs at any time
• Are a woman and have started menstruating (see below the section "Pregnancy and breastfeeding")
• Have difficulty controlling repetitive movements of some parts of the body or sounds and words
• Have high blood pressure
• Have a heart problem not included in the previous section "Do not take methylphenidate if you or your child"
• Have a mental health problem not included 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 that aggression worsens
  • Seeing, hearing, or feeling things that are not there (hallucinations)
  • Believing things that are not real (delusions)
  • Feeling abnormally suspicious (paranoia)
  • Feeling agitated, anxious, or tense
  • Feeling depressed or guilty
• Puberty onset

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, children and adolescents 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 make before you or your child start taking methylphenidate

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 have a family history of sudden, unexplained death
• Other diseases you or your family (such as heart problems) may be prone to
• How you or your child are feeling, if you have mood swings, have abnormal thoughts, or have had feelings of this type 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)
• Possible behavior or mental health problems you or your child have had at any time. 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). Your doctor 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 all the information you can. 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.

Other medications and Rubifen

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medication, even those purchased without a prescription.

Do not take methylphenidate if you or your child:

• Are taking a medication called "monoamine oxidase inhibitor" (MAOI) used for depression or have taken an MAOI in the last 14 days. The use of an MAOI with methylphenidate may cause a sudden increase in blood pressure.

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:

• Other medications for depression
• Medications for severe mental health problems
• Medications for epilepsy
• Medications used to lower or raise blood pressure
• Some cold and cough remedies that contain medications that may affect blood pressure. It is essential to consult your pharmacist when purchasing any of these medications
• Medications that thin the blood to prevent clotting

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. Methylphenidate should not be taken 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 those used in sports.

Taking Rubifen with food, drinks, and alcohol

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

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 and breastfeeding

The available data do not suggest an increased risk of total 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 sexually active. Your doctor will discuss birth control 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 may pass into breast milk. Your doctor will decide if you or your daughter should breastfeed while using methylphenidate

Driving and operating machinery

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

How much to take

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will usually start treatment with a low dose and gradually increase it as needed.

• 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.

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 if you need a different treatment.

Improper use of Rubifen

If Rubifen 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 have ever 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 Rubifen than they 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 have been taken. You can also contact the Toxicology Information Service, phone 91 562 04 20.

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, and dryness of the nose and mouth.

If you or your child forget to take Rubifen

Do not take a double dose to compensate 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 Rubifen

If you or your child stop taking this medication suddenly, the symptoms of ADHD may reappear or unwanted effects such as depression may occur. 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 Rubifen.

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

Your doctor will perform some tests

• before you or your child start treatment to ensure that Rubifen is safe and beneficial
• once treatment has started, they will be performed at least every 6 months and more often
• also when the dose is changed
• these tests will include:
• • appetite control
  • height and weight measurement
  • blood pressure and heart rate measurement
  • evaluation of mood-related problems, mental state, or any other infrequent feelings. Or if this has 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 a year, your doctor should stop treatment for a short period, such as during school holidays. This allows them to demonstrate if they still need the medication.

If you have any other questions about the use of 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.

Some side effects can be serious. If you or your child have any of the side effects listed below, seek immediate medical attention:

Frequent (affects less than 1 in 10 people)

• Irregular heartbeats (palpitations)
• Changes or alterations in mood or personality

Less frequent (affects less than 1 in 100 people)

• Thoughts or feelings of suicide
• 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, difficulty breathing

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

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

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

• Myocardial infarction
• Seizures (attacks, convulsions, epilepsy)
• Peeling of the skin or purpuric rash
• Uncontrolled muscle spasms, affecting the eyes, head, neck, body, and nervous system due to lack of blood flow to the brain
• Paralysis or difficulty with movement and vision, difficulty speaking (may be signs of cerebral vascular problems)
• 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

Other side effects (unknown frequency)

• Unwanted thoughts that recur
• Unexplained fainting, chest pain, shortness of breath (may be signs of cardiac problems)

If you or your child have any of the side effects listed above, seek immediate medical attention.

The following side effects are listed below. If they become serious, please inform your doctor or pharmacist:

Frequent (affects more than 1 in 10 people)

• Headache
• Nervousness
• Difficulty sleeping

Less frequent (affects less than 1 in 10 people)

• Joint pain
• Dry mouth
• High temperature (fever)
• Excessive hair loss or thinning of hair
• Excessive drowsiness or drowsiness
• Loss of appetite or decreased appetite
• Itching, hives, or increased itching of hives (urticaria)
• Cough, sore throat, and irritation of the throat or nose
• High blood pressure, rapid heartbeat (tachycardia)
• Dizziness, uncontrolled movements, excessive activity
• Aggression, agitation, anxiety, depression, irritability, and abnormal behavior
• Abdominal pain, diarrhea, nausea, stomach upset, and vomiting
• Excessive grinding of teeth (bruxism)

Less frequent (affects less than 1 in 100 people)

• Constipation
• Chest discomfort
• Blood in the urine
• Restlessness or tremor
• Dual vision or blurred vision
• Muscle pain, muscle spasms
• Shortness of breath or chest pain
• Increased liver enzyme results (seen in blood tests)
• Irritability (anger), restlessness, or tearfulness, excessive awareness of the environment, difficulty sleeping

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

• Changes or alterations in sexual desire
• Feeling disoriented
• Dilated pupils, vision problems
• Swelling of the chest in men
• Excessive sweating, skin redness, increased redness of hives on the skin

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

• Myocardial infarction
• Sudden death
• Muscle cramps
• Small red spots on the skin
• Cerebral vascular problems, including inflammation or blockage of cerebral arteries
• Abnormal liver function, including liver failure and coma
• Changes in test results, including liver and blood tests
• Intentional suicide (including completed suicide), abnormal thinking, absence of feelings or emotions, repetitive behavior, obsession with something
• Numbness or tingling in the fingers and toes, change in color with cold (white to blue then red) ("Raynaud's phenomenon")

Other side effects (unknown frequency)

• Migraine
• Very high fever
• Slow, rapid, or irregular heartbeats
• Major seizures (grand mal seizures)
• Believing things that are not true, confusion
• Severe stomach pain with nausea and vomiting
• Cerebral vascular problems, including 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)
• Mandibular muscle spasms that make it difficult to open the mouth (trismus)
• Stuttering
• Nasal bleeding

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 increase.
• Your doctor will carefully check your or your child's height and weight, as well as diet.
• If you or your child do not grow as expected, 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD:. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30?°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging of the medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help protect the environment.

Composition ofRubifen 5 mg

The active ingredient is methylphenidate hydrochloride.

Each Rubifen 5 mg tablet contains 5 mg of methylphenidate hydrochloride.

The other components are calcium dihydroxide phosphate, microcrystalline cellulose (E460i), cornstarch, and magnesium stearate (E470b).

Appearance of the product and contents of thepackaging

Rubifen 5 mg tablets are white, round, and flat, marked “RU” on one side and “5” on the other.

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

Holder of the marketing authorization and responsible 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 with the following names:

Germany:Methylpheni TAD 5 mg Tablets

Spain:Rubifen 5 mg Tablets

Portugal:Rubifen 5 mg Tablets

Last review date of this leaflet:April 2024

Other sources of information

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