Leaflet: information for the user

Rubifen Prolong 10 mg modified-release hard capsules EFG

Rubifen Prolong 20 mg modified-release hard capsules EFG

Rubifen Prolong 30 mg modified-release hard capsules EFG

Rubifen Prolong 40 mg modified-release hard capsules EFG

Rubifen Prolong 60 mg modified-release hard capsules 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 Rubifen Prolong and what it is used for

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

3. How to take Rubifen Prolong

4. Possible side effects

5. Storage of Rubifen Prolong

6. Contents of the pack and additional information

What it is used for

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

• It is used in children and adolescents from 6 to 18 years old, and in adults.
• It is used only after having tried treatments that do not include medications, such as counseling and behavioral therapy, have been insufficient.

Methylphenidate should not be used to treat ADHD in children under 6 years old. Its safety and effectiveness in children under 6 years old are unknown.

How it works

Methylphenidate improves the activity of certain parts of the brain that have low activity. This medication helps to improve attention and concentration, and reduces impulsive behavior.

This medication is used as part of a treatment program, which usually includes:

• psychological therapy
• educational therapy and
• social therapy.

Treatment with methylphenidate should only be initiated and used under the supervision of a specialized doctor in ADHD treatment, such as an expert pediatrician, a child and adolescent psychiatrist, or a psychiatrist. A complete examination by this doctor will be necessary. If you are an adult and have not been treated before, the specialist will perform tests to confirm that you have had ADHD since childhood. Using treatment programs and medications helps to control ADHD.

About ADHD

Children and adolescents with ADHD may find it difficult:

• to sit still
• to concentrate

It's not their fault that they can't 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 doing homework.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and distracted. It can be difficult for them to organize their private and work life.

Not all patients with ADHD need to be treated with medications. For children, the decision to use a medication should be based on a very thorough evaluation of the severity and chronic nature of the child's symptoms.

ADHD does not affect intelligence.

Do not take Rubifen Prolong if you or your child:

• are allergic to methylphenidate or any of the other components of this medication (including those 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 medication called monoamine oxidase inhibitor (MAOI) used for depression, or if you or your child have taken an MAOI in the last 14 days (see section "Other medications and Rubifen Prolong")
• have an eating disorder where 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 the blood vessels, which may cause pain in the arms and legs
• have had any heart problems, such as a history of myocardial infarction, irregular heartbeats, chest pain and discomfort, heart failure, heart disease, or heart problems
• have had a problem with blood vessels in the brain, such as stroke, swelling and weakness 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 disease called "schizophrenia"
  • signs of severe mood disorder, such as:
  • • suicidal thoughts
    • severe depression (feeling sad, useless, 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 disorders. If you are unsure, talk to your doctor or pharmacist before taking methylphenidate, as this medication may worsen these problems.

Warnings and precautions

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

• have liver or kidney problems
• have had seizures or abnormal brain wave tests (EEG)
• have abused or have dependence on alcohol, prescription medications, or drugs
• are women and have started menstruating (see section "Pregnancy, breastfeeding, and fertility" later)
• or in your family have had cases of repeated and difficult-to-control contractions of some part of the body or repeat sounds and words (tics)
• have high blood pressure
• have a heart problem that is not mentioned in the section "Do not take Rubifen Prolong"
• have a mental health problem that is not mentioned in the section "Do not take Rubifen Prolong". Other mental health problems include:
• • mood swings (passing from manic to depressive - called "bipolar disorder")
  • experiencing aggressive or hostile behavior for the first time or that worsens
  • see, hear, or feel things that do not exist (hallucinations)
  • believe things that are not real (delusions)
  • feel strangely suspicious (paranoia)
  • feel agitated, anxious, or tense
  • feel depressed or guilty

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

These checks serve to decide if methylphenidate is the suitable medication for you or your child. Your doctor will discuss these aspects with you:

• any other medication you or your child are taking
• if you or your child have a family history of sudden and unexplained death
• any other medical problem (such as heart problems) you, your child, or your family may have
• how you or your child feel, for example, euphoric or depressed, have strange thoughts, or if you or your child have had these feelings in the past
• if there is a family history of "tics" (difficulty controlling oneself, repeated contractions of any part of the body, or repetition of sounds and words)
• any mental health or behavioral problem you or your child or other family members have or have had in the past. Your doctor will explain if you or your child are at risk of developing mood swings (passing from mania to depression - called "bipolar disorder"). Your doctor will check your mental health history and family history of suicide, bipolar disorder, or depression

It is essential to provide as much information as possible. This information will help your doctor decide if methylphenidate is the suitable medication for you or your child. It is possible that your doctor will think that you or your child need other medical tests before starting to take this medication.

Drug analysis

This medication may give positive results in drug tests.

Effects in case of misuse as a doping agent

The use of methylphenidate may induce positive results in doping tests.

The misuse of methylphenidate for doping purposes may put your health at risk.

Other medications and Rubifen Prolong

Inform your doctor or pharmacist if you or your child 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)" 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 Rubifen Prolong").

If you or your child are taking other medications, methylphenidate may affect its mechanism of action or cause side effects. Therefore, it may be necessary to change the dose of the medication or discontinue treatment together. 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 (e.g., schizophrenia)
• medications for epilepsy
• medications used to reduce or increase blood pressure
• some cough and cold remedies whose components may affect blood pressure. It is essential to consult with your pharmacist when buying 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, ask your doctor or pharmacist 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 if you are using a certain type of anesthesia, 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 medication, as alcohol may worsen its side effects. Remember that some foods and medications contain alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

The available data do not suggest an increased risk of total congenital anomalies, although a small increase in the risk of cardiac malformations cannot be ruled out during its use in the first three months of pregnancy. Your doctor will give you more information about this risk.

Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• is sexually active. Your doctor will discuss birth control methods with you
• is pregnant or thinks she may be pregnant. Your doctor will decide if you should take methylphenidate
• is breastfeeding or plans to breastfeed. It is possible that methylphenidate may pass into breast milk. Therefore, your doctor will decide if you should breastfeed 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 hazardous to perform tasks that require attention (such as driving, operating machines, riding a bike, or climbing trees) until you are sure that you or your child are not affected.

Rubifen Prolong contains saccharose

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

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

Dose

Generally, your doctor will start treatment with a low dose that will be gradually increased as needed.

Children (6 years and older) and adolescents

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

Adults

• If it is the first time you take methylphenidate, your doctor will start treatment with a dose of 20 mg once a day and, if necessary, increase the dose gradually in small increments weekly.
• If you have received treatment with a methylphenidate formulation with modified release during childhood and have just turned 18, your doctor may maintain 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 doses of this medication or other medications containing methylphenidate may be available.

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

These tests will include:

Administration form

Rubifen Prolong is for oral use.

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

• The capsule can 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 are unable to swallow the Rubifen Prolong capsule, the contents can be poured onto a small amount of soft food, as follows:

• Open the capsule carefully and pour the granules onto a small amount of soft food (e.g. apple sauce).
• The food should not be hot, as this could affect the special properties of the granules.
• Take the entire medication-food mixture immediately.

Do not store any medication-food mixture for future use.

Instructions for opening the blister pack

This medication is available in peelable blister packs with a child-resistant safety closure. Please follow the following instructions to open the blister pack:

1. Do not push the capsule to remove it from the blister pack, as this will cause it to be crushed.
2. Take the blister pack by the printed label and fold it back along the perforated line, fold the blister pack in the opposite direction and repeat several times. Separate along the perforated line to obtain a dose.

1. Toextract the capsule, carefully separate the label starting from the corner indicated with an arrow and pull it back.

Long-term treatment

Methylphenidate should not, and does not need to, be taken for life. If methylphenidate administration lasts more than a year, your doctor should suspend treatment briefly at least once a year. In children, this can occur during school vacations. In this way, it will be seen if the medication is still needed.

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

If you or your child do not improve, inform your doctor. He may decide that you or your child need a different treatment.

Improper use of Rubifen Prolong

If methylphenidate is not used properly, abnormal behavior may appear. It may 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 a dependence on alcohol, prescription medications, or drugs.

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

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

If you or your child have taken more medication than they should, consult your doctor or call an ambulance immediately. Medical treatment may be necessary. You can also contact the Toxicology Information Service, phone 91 562 04 20.

The signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (sometimes 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, muscle swelling, weak and sensitive muscles, muscle pain, dark urine.

If you or your child forget to take Rubifen Prolong

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

If you or your child stop taking Rubifen Prolong

If you or your child stop taking the medication suddenly, it is possible that the ADHD symptoms or unwanted effects such as depression will reappear. Your doctor will recommend that you or your child gradually reduce the amount of medication taken per day before stopping it completely. Consult your doctor before stopping methylphenidate.

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. Your doctor will talk to you about these side effects.

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

Frequent (can affect up to 1 in 10 people)

• Irregular heartbeats (palpitations)
• Changes in personality
• Excessive teeth grinding (bruxism)

Not common (can affect up to 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 or problems breathing
• Mood changes or alterations

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

• Feeling exceptionally excited, more active than normal, or uninhibited (mania)

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

• Myocardial infarction
• Seizures (attacks, epilepsy with convulsions)
• Peeling of the skin or red, purplish patches
• 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 brain blood vessel problems
• Decreased number of blood cells (red blood cells, white blood cells, and platelets) that may make you more prone to infections and cause easier bleeding and bruising
• 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 (cannot be estimated from available data)

• Unwanted thoughts that recur
• Unexplained fainting, chest pain, shortness of breath (may be signs of heart problems)
• Inability to control urination (incontinence)
• Spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• Stuttering

Other side effects are, if they become serious, inform your doctor or pharmacist:

Frequent (can affect more than 1 in 10 people)

• Decreased appetite
• Headache
• Nervousness
• Difficulty sleeping
• Nausea
• Dry mouth

Frequent (can affect up to 1 in 10 people)

• Joint pain
• Elevated temperature (fever)
• Unusual hair loss or decreased hair thickness (hair becomes finer)
• Excessive drowsiness or drowsiness
• Weight loss in adults
• Panic attacks
• Decreased libido
• Toothache
• Hives, itching, or red, itchy patches (urticaria)
• Excessive sweating
• Coughs, sore throat, or irritation of the throat and nose, difficulty breathing or chest pain
• Changes in blood pressure (mainly high blood pressure)
• Fast heartbeats (tachycardia)
• Cold hands and feet
• Tremors or shakiness, dizziness, uncontrolled movements, feeling of inner restlessness
• Feeling unusually active
• Feeling aggressive, nervous, restless, anxious, depressed, stressed, irritable, and having abnormal behavior, difficulty sleeping, and fatigue
• Stomach pain, diarrhea, stomach discomfort, indigestion, thirst, and vomiting. These side effects usually occur at the beginning of treatment and may decrease by taking the medication with food.

Not common (can affect up to 1 in 100 people)

• Constipation
• Chest discomfort
• Inflammation of the mucous membranes of the stomach and small intestine
• Blood in the urine
• Dual or blurred vision
• Muscle pain, muscle contractions, muscle tension
• Increased liver enzyme results (seen in blood tests)
• Irritability, restlessness, or crying, excessive awareness of the environment, tension

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

• Changes in libido
• Feeling disoriented
• Dilated pupils, vision problems
• Swelling of the chest in men
• Redness of the skin, increased redness of skin patches

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

• Myocardial infarction
• Sudden death
• Muscle cramps
• Small red spots on the skin
• Blockage or inflammation of the brain blood vessels
• Abnormal liver function, including liver failure and coma
• Changes in test results, including liver and blood tests
• Attempted suicide (including completed suicide), abnormal thoughts, absence of feelings or emotions, doing things repeatedly, becoming obsessed with something
• Sensation of numbness in the fingers of the hands and feet, tingling, and change of color from white to blue, and then to red with cold (Raynaud's phenomenon)

Unknown (frequency cannot be estimated from available data)

• Migraine
• Very high fever
• Slow, rapid, or irregular heartbeats
• Major seizures ("grand mal" convulsions)
• Believing things that are not true, confusion
• Severe stomach pain with discomfort and vomiting
• Brain blood vessel problems (stroke, cerebral arteritis, or cerebral occlusion)
• Erectile dysfunction
• Prolonged or painful erections, or increased number of erections
• Excessive and uncontrolled talking
• Nasal bleeding

Effects on growth

When used for more than a year, methylphenidate may slow down growth in some children. This affects less than 1 in 10 children.

• There may be a lack of weight or height gain.
• Your doctor will closely monitor height and weight, and how you or your child is eating.
• If your child is not growing as expected, the methylphenidate treatment may be suspended for a short 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 medication.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and the medicines that you no longer need. In this way, you will help to protect the environment..

Composition of Rubifen Prolong

• The active ingredient is methylphenidate hydrochloride.

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

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

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

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

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

• The other components are:

Capule content: copolymer of amine methacrylate (type B), copolymer of methacrylic acid and methyl methacrylate (1:1), povidone 30, sugar spheres (containing sucrose and cornstarch), talc, triethyl citrate.

Capule coating:gelatin, titanium dioxide (E171).

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

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

Appearance of the product and contents of the package

Rubifen Prolong 10 mg hard capsules with modified release EFG

Hard opaque gelatin capsule (size 2) with dark yellow cap and white body with the imprint "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 hard capsules with modified release EFG

Hard opaque gelatin capsule (size 2) with white cap and white body with the imprint "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 hard capsules with modified release EFG

Hard opaque gelatin capsule (size 2) with ivory cap and ivory body with the imprint "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 hard capsules with modified release EFG

Hard opaque gelatin capsule (size 1) with dark yellow cap and dark yellow body with the imprint "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 hard capsules with modified release EFG

Hard opaque gelatin capsule (size 0) with dark yellow cap and ivory body with the imprint "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.

Child-resistant safety closures in blisters (Aclar/PVC//Al/PET) in boxes.

Formats:

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 some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Rubió, S.A.

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:

GermanyMethylphenidatNewLine Pharma Hartkapseln mit veränderter Wirkstofffreisetzung

SpainRubifen Prolong cápsulas duras de liberación modificada EFG

PolandSymkinet MR

PortugalMetilfenidato NewLine Pharma

Last review date of this leaflet: March 2023

For more detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)