Simkinet Mr

Leaflet attached to the packaging: information for the user

Symkinet MR, 10 mg, modified-release capsules, hard

Symkinet MR, 20 mg, modified-release capsules, hard

Symkinet MR, 30 mg, modified-release capsules, hard

Symkinet MR, 40 mg, modified-release capsules, hard

Methylphenidate hydrochloride

Read the leaflet carefully before using the medicine by the patient or child, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Symkinet MR and what is it used for
• 2. Important information before using Symkinet MR
• 3. How to use Symkinet MR
• 4. Possible side effects
• 5. How to store Symkinet MR
• 6. Contents of the packaging and other information

1. What is Symkinet MR and what is it used for

What is Symkinet MR used for

Symkinet MR is used to treat Attention Deficit Hyperactivity Disorder (ADHD).

• It is used in children and adolescents from 6 to 18 years of age and in adult patients.
• It is used only if previous attempts at treatment without medication, such as psychological counseling and behavioral therapy, have been insufficient. Symkinet MR is not used to treat ADHD in children under 6 years of age. It is not known whether the medicine is safe and provides therapeutic benefits in children under 6 years of age.

How Symkinet MR works

Symkinet MR improves the function of certain parts of the brain that are underactive. The medicine may help improve attention, concentration, and reduce impulsive behavior.

Symkinet MR is used as part of a treatment program that usually includes therapies:

• psychological;
• educational;
• environmental.

Treatment with Symkinet MR should only be initiated and continued by a doctor specializing in the treatment of ADHD, such as a pediatric specialist, child and adolescent psychiatrist, or psychiatrist.

A thorough examination by such a doctor is necessary. If the patient is an adult and has not been treated before, the doctor will conduct examinations to confirm that ADHD has been present since childhood. The use of therapeutic programs and medications helps control ADHD.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still without moving;
• concentrating.

This behavior is not their fault, as they have no control over it.

Many children and young people experience such disorders. However, people with ADHD may have problems in their daily lives due to this. Children and adolescents with ADHD may have difficulty learning and doing homework.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and inattentive. They may have difficulty organizing their private and professional lives.

Not all patients with ADHD require pharmacological treatment. The decision to start treatment in children must be made based on a thorough interview determining the severity and chronic nature of the symptoms in the child.

ADHD does not affect intelligence.

2. Important information before using Symkinet MR

When not to use Symkinet MR

• if the patient is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6). If the patient suspects an allergy, they should consult a doctor;
• if the patient has thyroid function disorders;
• if the patient has increased eye pressure (glaucoma);
• if the patient has a pheochromocytoma (a tumor of the adrenal gland);
• if the patient is currently taking antidepressant medicines (called monoamine oxidase inhibitors) or if these medicines have been taken in the last 14 days (see "Symkinet MR and other medicines");
• if the patient has eating disorders; lack of appetite or need to eat (e.g., anorexia nervosa);
• if the patient has very high blood pressure or narrowing of blood vessels that can cause pain in the arms and legs;
• if the patient has had heart problems, such as: heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease, or congenital heart defects;
• if the patient has had cerebrovascular diseases, such as: stroke, localized dilation of a blood vessel and weakening of its wall (aneurysm), narrowing or blockage of blood vessels, inflammation of blood vessels;
• if the patient has mental health disorders, such as:
• psychopathic disorders or borderline personality;
• abnormal thoughts or visions, or a disease called schizophrenia;
• symptoms of severe mood disorders, such as:
• suicidal thoughts;
• severe depression (when the patient is very sad, feels worthless, and has no hope for the future);
• mania (when the patient is extremely excited, overactive, and uncontrolled in their actions);
• mood swings from depression to mania.

Symkinet MR should not be used if any of the above situations apply to the patient.

In case of doubts, before using Symkinet MR, the patient should consult a doctor or pharmacist, as Symkinet MR may exacerbate these conditions.

Warnings and precautions

Before starting Symkinet MR, the patient should discuss the following with their doctor or pharmacist:

• if the patient has liver or kidney function disorders;
• if the patient has had seizures (epilepsy) or abnormal brain electroencephalogram (EEG) recordings;
• if the patient has ever abused or been dependent on alcohol, prescription drugs, or narcotics;
• if the patient is a woman or girl who has started menstruating (see below "Pregnancy, breastfeeding, and fertility");
• or if a family member of the patient has uncontrollable, repetitive movements or sounds (tics);
• if the patient has high blood pressure;
• if the patient has heart diseases other than those listed above in "When not to use Symkinet MR";
• if the patient has mental health disorders not listed in "When not to use Symkinet MR". Other mental health disorders include:
• mood swings (from mania to depression, known as bipolar affective disorder);
• appearance of aggressive or hostile behavior, or increased aggression;
• seeing, hearing, or feeling things that do not exist (hallucinations);
• believing in things that are not real (delusions);
• excessive suspicion (paranoia);
• feeling excited, restless, or tense;
• feeling depressed or guilty.

Before starting treatment, the patient should inform their doctor or pharmacist if they have any of the above conditions. Methylphenidate may exacerbate these conditions. The doctor will monitor how the medicine affects the patient's condition.

During treatment, unexpected long-lasting erections may occur in boys and men. This can be painful and can occur at any time. If an erection lasts longer than 2 hours, especially if it is painful, the patient should immediately contact their doctor.

Medical interview before using methylphenidate

The medical interview is used to decide whether methylphenidate is a suitable medicine for the patient. The doctor will discuss the following with the patient:

• any other medicines the patient is taking;
• any cases of sudden and unexplained death in the patient's family;
• any other medical problems (e.g., heart disease) the patient has or has had in their family;
• the patient's or child's well-being, e.g., their depression or euphoria, strange thoughts, or if such feelings have occurred in the past;
• any tics (uncontrollable, repetitive movements or sounds) in the patient's family;
• any mental health disorders or behavioral problems the patient has or has had, or that have occurred in their family. The doctor will discuss the risk of mood swings (from mania to depression, known as bipolar affective disorder). The doctor will also gather information about the patient's mental health and determine if there have been any cases of suicide, bipolar affective disorder, or depression in their family.

It is essential to provide the doctor with as much information as possible. Based on this information, the doctor will decide whether methylphenidate is a suitable medicine for the patient. The doctor will also decide if any additional medical examinations are necessary before starting treatment with this medicine.

Drug tests

The medicine may cause a positive result in a drug test.

Consequences of improper use as a doping agent

Using Symkinet MR may result in positive doping test results.

Improper use of Symkinet MR as a doping agent may pose a risk to health.

Symkinet MR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Symkinet MR should not be used if the patient or child:

• takes a medicine called a monoamine oxidase inhibitor (MAOI) used to treat depression or has taken an MAOI in the last 14 days. Taking MAOIs with methylphenidate may cause a sudden increase in blood pressure (see "When not to use Symkinet MR").

If the patient or child is taking other medicines, methylphenidate may affect their action or cause side effects. It may be necessary to reduce the dose or stop concurrent treatment. Before taking methylphenidate, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• medicines used to treat depression;
• medicines used to treat severe mental disorders (e.g., schizophrenia);
• antiepileptic medicines;
• medicines used to lower or increase blood pressure;
• certain cough and cold medicines containing ingredients that affect blood pressure. The patient should ask their pharmacist about this when purchasing such medicines;
• blood-thinning medicines that prevent blood clots.

In case of doubts about whether a medicine the patient is taking is on the above list, they should consult their doctor or pharmacist before using methylphenidate.

Surgery

The patient should inform their doctor about any planned surgery. Methylphenidate should not be taken on the day of surgery if a certain type of anesthetic is used, due to the risk of a sudden increase in blood pressure during the operation.

Symkinet MR with food, drink, and alcohol

The patient should not consume alcohol while taking this medicine. Alcohol may increase the side effects of this medicine. The patient should remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Available data do not indicate an increased risk of congenital anomalies in general, although a slight increase in the risk of congenital heart defects during treatment with the medicine in the first three months of pregnancy cannot be ruled out. The doctor will provide the patient with more information about this risk.

Before using methylphenidate, the patient should inform their doctor or pharmacist if:

• they are sexually active. The doctor will discuss methods of preventing pregnancy.
• they are pregnant or think they may be pregnant. The doctor will decide whether methylphenidate should be used.
• they are breastfeeding or plan to breastfeed. Methylphenidate passes into human milk. Therefore, the doctor will decide whether to continue breastfeeding during treatment with methylphenidate.

Driving and using machines

While taking methylphenidate, the patient may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other central nervous system side effects. If such symptoms occur, performing activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees may be dangerous.

Symkinet MR contains sucrose

Symkinet MR contains sucrose (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Symkinet MR

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

The doctor usually starts treatment with a low dose and increases it gradually if necessary.

Children (6 years and older) and adolescents

The recommended initial dose is 20 mg, once daily. The doctor may also decide to start treatment with a dose of 10 mg. The maximum daily dose is 60 mg. In patients under 18 years of age, Symkinet MR should be taken once daily, in the morning.

Adult patients

• In adult patients taking Symkinet MR for the first time, the doctor will start treatment with a daily dose of 20 mg and, if necessary, will gradually increase it every week.
• If the patient has taken methylphenidate in a modified-release form as a child or adolescent and has recently turned 18, the doctor may use the same daily dose. If the patient was treated with an immediate-release medicine as a child or adolescent, the doctor will use an appropriate dose of Symkinet MR.

The maximum daily dose is 80 mg.

Lower doses of this medicine or other methylphenidate-containing medicines are available.

Tasks to be performed by the doctor before and during treatment of the patient (adult or child)

The doctor will perform certain examinations:

• before starting treatment - to ensure that the use of Symkinet MR is safe and beneficial for the patient (listed in "Medical interview before using methylphenidate");
• after starting treatment - at least every 6 months, but possibly more often, as well as with every dose change. The examinations will include:
• checking appetite;
• measuring the child's growth and weight;
• measuring the adult patient's weight;
• measuring blood pressure and heart rate;
• assessing mood disorders, mental state, or any other abnormalities and whether they have worsened while taking Symkinet MR.

Method of administration

Symkinet MR is intended for oral use.

Symkinet MR should be taken once daily, in the morning. The medicine should not be taken too late, as it may cause sleep disturbances.

• The capsules can be taken with or without food.
• The capsules should be swallowed whole, with a glass of water.
• The capsules or their contents should not be crushed, chewed, or divided.

If the patient or child is unable to swallow the Symkinet MR capsule, the contents of the capsule can be sprinkled on a small amount of food, as follows:

• The capsule should be carefully opened and its contents sprinkled on a small amount of food (e.g., apple sauce).
• The food should not be hot, as it may affect the special properties of the pellets.
• The medicine mixed with food should be taken immediately. The medicine sprinkled from the capsule should not be stored for later use.

Instructions for opening the blister pack

The medicine is available in tear-off blister packs that protect against access by children. The instructions for opening the blister pack are as follows:

• 1. The capsule should not be pushed out of the blister pack, as this may damage the capsule.
• 2. The blister pack should be held with the printed foil on top and bent backwards along the perforated line, then bent in the opposite direction, and this action should be repeated several times. Then, the blister pack should be torn along the perforation to separate a single dose.

• 3. To remove the capsule, the protective foil should be carefully peeled off, starting from the corner indicated by the arrow, and then removed.

Long-term treatment

There is no need to use Symkinet MR indefinitely. If the patient has been taking Symkinet MR for more than a year, the doctor should interrupt treatment for a short period every year. In children, this may occur during school holidays. This will allow the doctor to assess whether continued treatment with the medicine is necessary.

If the patient's condition does not improve after 1 month of treatment

If the patient's condition does not improve after 1 month of treatment, they should inform their doctor. The doctor may decide to change the treatment.

Improper use of Symkinet MR

Improper use of Symkinet MR may lead to abnormal behavior. It may also cause dependence on the medicine. If the patient has ever abused or been dependent on alcohol, prescription drugs, or narcotics, they should inform their doctor. This medicine is intended only for the person it has been prescribed for. It should not be given to others, even if the symptoms of their illness are similar.

Using a higher dose of Symkinet MR than recommended

If the patient takes too much of the medicine, they should immediately contact their doctor or call emergency services. They should say what amount of the medicine was taken. Treatment may be necessary.

Symptoms of overdose may include: vomiting, excitement, tremors, increased involuntary movements, muscle twitching, seizures (which may be followed by coma), euphoria, disorientation, seeing, feeling, or hearing things that do not exist (hallucinations), sweating, flushing, headache, high fever, changes in heart rhythm (slow, fast, irregular), high blood pressure, dilated pupils, dryness of the oral mucosa, muscle weakness, tenderness, and pain.

Missing a dose of Symkinet MR

The patient should not take a double dose to make up for a missed dose. If a dose is missed, the next dose should be taken at the usual time.

Stopping Symkinet MR treatment

Suddenly stopping treatment with this medicine may lead to a recurrence of ADHD symptoms or the appearance of unexpected symptoms, such as depression. Before completely stopping the medicine, the doctor will gradually reduce the daily dose. The patient should consult their doctor before stopping Symkinet MR treatment.

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Symkinet MR can cause side effects, although not everybody gets them.

The doctor will inform the patient about these side effects.

Some side effects can be serious. If the patient experiences any of the following side effects, they should immediately consult their doctor:

Common (may affect up to 1 in 10 people)

• irregular heartbeat (arrhythmia);
• changes in personality;
• excessive teeth grinding (bruxism).

Uncommon (may affect up to 1 in 100 people)

• suicidal thoughts or tendencies;
• seeing, feeling, or hearing things that do not exist - these are symptoms of psychosis;
• uncontrolled speech and movements (Tourette's syndrome);
• allergic reactions, such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, difficulty breathing, wheezing, or shortness of breath;
• mood swings.

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

• feeling overly excited, active, and uncontrolled (mania).

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

• heart attack;
• seizures (convulsions, epilepsy);
• skin peeling or purple-red spots on the skin;
• involuntary muscle contractions, affecting the eyes, head, neck, or the rest of the body, and neurological symptoms related to transient cerebral ischemia;
• paralysis or problems with movement and vision, difficulties with speech (these may be symptoms of cerebrovascular problems);
• reduced blood cell count (red blood cells, white blood cells, and platelets), which can lead to increased susceptibility to infections, as well as bleeding and bruising;
• sudden high body temperature, very high blood pressure, and severe convulsions (malignant neuroleptic syndrome). It is not certain whether this side effect is caused by methylphenidate or other medicines that may be used in combination with methylphenidate.

Frequency not known (frequency cannot be estimated from the available data)

• recurring unwanted thoughts;
• loss of consciousness for an unknown reason, chest pain, shortness of breath (these may be symptoms of heart disease);
• inability to control urination (urinary incontinence);
• muscle contraction in the jaw that makes it difficult to open the mouth (trismus);
• stuttering.

The patient should inform their doctor or pharmacist if any of the following side effects worsen:

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

• reduced appetite;
• headache;
• nervousness;
• insomnia;
• nausea;
• dry mouth.

Common (may affect up to 1 in 10 people)

• joint pain;
• high temperature (fever);
• excessive hair loss or thinning;
• feeling unusually drowsy;
• loss of appetite;
• weight loss in adult patients;
• panic attacks;
• reduced sexual desire;
• toothache;
• itching, rash, or hives on the skin;
• excessive sweating;
• cough, sore throat, or nasal and throat irritation, as well as shortness of breath, chest pain;
• changes in blood pressure (usually high blood pressure);
• rapid heart rate (tachycardia);
• cold hands and feet;
• tremors and shaking, dizziness, involuntary movements, feeling of inner restlessness;
• increased activity;
• aggression, excitement, restlessness, emotional instability, anxiety, depression, stress, irritation, abnormal behavior, sleep problems, fatigue;
• abdominal pain, diarrhea, discomfort in the abdomen, nausea, thirst, vomiting. These symptoms 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;
• discomfort in the chest;
• inflammation of the lining of the stomach and small intestine;
• blood in the urine;
• double vision or blurred vision;
• muscle pain, muscle spasms, muscle stiffness;
• elevated liver function test results (in blood tests);
• anger, tearfulness, excessive awareness of the surroundings, tension.

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

• changes in sexual desire;
• feeling disoriented;
• dilated pupils, difficulty seeing;
• breast enlargement in men;
• redness of the skin, red, raised rash on the skin.

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

• heart attack;
• sudden death;
• muscle spasms;
• small, red spots on the skin;
• inflammation or blockage of blood vessels in the brain;
• abnormal liver function, including liver failure and coma;
• changes in laboratory test results, including liver function and blood tests;
• suicide attempts (including successful attempts), thought disorders, lack of feelings or emotions, repetitive behaviors, obsessive focus on one thing;
• numbness of fingers and toes, feeling cold, tingling, and change in skin color from pale to blue, and then to red, in response to cold (Raynaud's phenomenon).

Frequency not known (frequency cannot be estimated from the available data)

• migraine;
• very high fever;
• slow, fast, or irregular heartbeat;
• grand mal seizure;
• believing in things that are not true, confusion;
• severe abdominal pain, often with nausea and vomiting;
• problems with blood vessels in the brain (stroke, inflammation of blood vessels in the brain, or blockage of blood vessels in the brain);
• erectile dysfunction;
• prolonged erections, sometimes painful, or increased frequency of erections;
• excessive, uncontrolled speech;
• nosebleeds.

Effect on growth and weight

In the case of long-term use of methylphenidate (more than one year), the medicine may slow down growth in some children. This affects less than 1 in 10 children.

• The child may not gain weight or grow at a normal rate.
• The doctor will carefully monitor the child's growth and weight, as well as their food intake.
• If the patient is not growing as expected, their treatment with methylphenidate may be interrupted for a short period.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Symkinet MR

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiration date stated on the packaging and blister pack after: EXP.

The expiration date refers to the last day of the specified month.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Symkinet MR contains

• The active substance of the medicine is methylphenidate hydrochloride. Symkinet MR, 10 mg, modified-release capsules, hard contain 10 mg of methylphenidate hydrochloride, which corresponds to 8.65 mg of methylphenidate. Symkinet MR, 20 mg, modified-release capsules, hard contain 20 mg of methylphenidate hydrochloride, which corresponds to 17.3 mg of methylphenidate. Symkinet MR, 30 mg, modified-release capsules, hard contain 30 mg of methylphenidate hydrochloride, which corresponds to 25.95 mg of methylphenidate. Symkinet MR, 40 mg, modified-release capsules, hard contain 40 mg of methylphenidate hydrochloride, which corresponds to 34.6 mg of methylphenidate.
• The other ingredients are: Capsule contents: ammonio methacrylate copolymer (type B), methacrylic acid, and methyl methacrylate copolymer (1:1), povidone K30, sucrose, pellets, talc, triethyl citrate. Capsule shell: gelatin, titanium dioxide (E 171). Additionally, Symkinet MR, 10 mg, 30 mg, 40 mg contain: yellow iron oxide (E 172). Ink: potassium hydroxide, propylene glycol, red iron oxide (E 172), shellac, concentrated ammonia.

What Symkinet MR looks like and contents of the pack

Symkinet MR, 10 mg, modified-release capsules, hard

Hard gelatin capsules, size "2", consisting of a dark yellow, opaque cap and a white, opaque body, with a red print "RUB" on the cap and a red print "M10" on the body, containing white and off-white pellets. Capsule length: 18 mm.

Symkinet MR, 20 mg, modified-release capsules, hard

Hard gelatin capsules, size "2", opaque, white, with a red print "RUB" on the cap and a red print "M20" on the body, containing white and off-white pellets. Capsule length: 18 mm.

Symkinet MR, 30 mg, modified-release capsules, hard

Hard gelatin capsules, size "2", opaque, ivory, with a red print "RUB" on the cap and a red print "M30" on the body, containing white and off-white pellets. Capsule length: 18 mm.

Symkinet MR, 40 mg, modified-release capsules, hard

Hard gelatin capsules, size "1", opaque, dark yellow, with a red print "RUB" on the cap and a red print "M40" on the body, containing white and off-white pellets. Capsule length: 20 mm.

The medicine is available in blister packs (Aclar/PVC/Aluminum/PET) that protect against access by children, placed in a cardboard box.

Package sizes:

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

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

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

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.

ul. Koszykowa 65

00-667 Warsaw

tel.: +48 22 822 93 06

e-mail: biuro@farmakinternational.pl

Manufacturer

Laboratorios Rubio, S.A.

Calle Industria, 29. Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

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

Germany:

Methylphenidat Rubio 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Methylphenidat Rubio 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Methylphenidat Rubio 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Methylphenidat Rubio 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Poland:

Symkinet MR

Portugal:

Rubifen Retard

Spain:

Rubifen Prolong 10 mg cápsulas duras de liberación modificada EFG

Rubifen Prolong 20 mg cápsulas duras de liberación modificada EFG

Rubifen Prolong 30 mg cápsulas duras de liberación modificada EFG

Rubifen Prolong 40 mg cápsulas duras de liberación modificada EFG

Date of last revision of the leaflet:April 2025