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 the patient or child uses the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 taking Symkinet MR
• 3. How to take Symkinet MR
• 4. Possible side effects
• 5. How to store Symkinet MR
• 6. Contents of the pack 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 adults.
• It is used only if other treatments, such as psychological counseling and behavioral therapy, have been tried first and have not worked. Symkinet MR should not be used to treat ADHD in children under 6 years of age. It is not known whether the medicine is safe or effective 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.

• psychological;
• educational;
• environmental.

Treatment with Symkinet MR should only be started and continued by a doctor who specializes in ADHD, such as a pediatrician, child and adolescent psychiatrist, or psychiatrist.

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and remaining inactive;
• focusing their attention.

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 assessment of the severity and chronic nature of the symptoms.

ADHD does not affect intelligence.

2. Important information before taking Symkinet MR

When not to take 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 that they are allergic, they should consult a doctor;
• if the patient has thyroid problems;
• if the patient has increased eye pressure (glaucoma);
• if the patient has a tumor of the adrenal gland (pheochromocytoma);
• if the patient is currently taking antidepressant medicines (called monoamine oxidase inhibitors) or has taken them in the last 14 days (see "Symkinet MR and other medicines");
• if the patient has eating disorders; loss of appetite or need to eat (e.g., anorexia nervosa);
• if the patient has very high blood pressure or narrowing of the blood vessels, which 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 problems, such as: stroke, local 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 problems, such as:
• psychopathic disorders or borderline personality;
• unusual 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, overly active, and uncontrollable in their actions);
• mood swings from depression to mania.

Do not take methylphenidate if any of the above situations apply to the patient.

Warnings and precautions

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

• if the patient has liver or kidney problems;
• if the patient has had seizures (epilepsy) or abnormal brain electrical activity (EEG);
• if the patient has ever abused or been dependent on alcohol, prescription drugs, or street drugs;
• if the patient is a woman or girl who has started menstruating (see "Pregnancy, breastfeeding, and fertility" below);
• or if a family member of the patient has uncontrollable, repetitive movements of a body part or repeats words and sounds (tics);
• if the patient has high blood pressure;
• if the patient has heart problems other than those listed above in "When not to take Symkinet MR";
• if the patient has mental health problems not listed in "When not to take Symkinet MR". Other mental health problems 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 suspiciousness (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.

Medical history before taking methylphenidate

The medical history is used to decide whether methylphenidate is a suitable medicine for 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 problems) the patient or their family members have had;
• the patient's or child's well-being, e.g., their depression or euphoria, strange thoughts or if they have had such feelings in the past;
• any tics (uncontrollable, repetitive movements of a body part or repetition of words and sounds) in the patient's family;
• any mental health problems or behavioral problems the patient or their family members have had.

It is essential to provide the doctor with as much information as possible.

Drug tests

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

Consequences of improper use as a doping agent

Taking Symkinet MR may result in positive doping test results.

Symkinet MR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or plan to take.

• if the patient is taking a medicine called a monoamine oxidase inhibitor (MAOI) used to treat depression or has taken an MAOI in the last 14 days.

If the patient is taking other medicines, methylphenidate may affect their action or cause side effects.

Surgery

The patient should inform their doctor about any planned surgery.

Symkinet MR with food, drink, and alcohol

The patient should not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

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

• if the patient is sexually active. The doctor will discuss methods of preventing pregnancy.
• if the patient is pregnant or thinks they may be pregnant. The doctor will decide whether methylphenidate should be taken.
• if the patient is breastfeeding or plans to breastfeed. Methylphenidate passes into human milk.

Driving and using machines

While taking methylphenidate, the patient may experience dizziness, drowsiness, difficulty focusing their eyes, blurred vision, hallucinations, or other central nervous system side effects.

Symkinet MR contains sucrose

Symkinet MR contains sucrose (a type of sugar).

3. How to take Symkinet MR

This medicine should always be taken exactly as the doctor has instructed.

Dosage

The doctor will usually start treatment with a low dose and gradually increase it if necessary.

Children (6 years and older) and adolescents

The recommended starting dose is 20 mg, once a day. The doctor may also decide to start treatment with a dose of 10 mg.

Adults

• For patients taking Symkinet MR for the first time, the doctor will start treatment with a daily dose of 20 mg and may increase it gradually, weekly if necessary.
• 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.

The maximum daily dose is 80 mg.

Tasks for the doctor to perform before and during treatment of the patient (adult or child)

The doctor will perform certain tests:

• before starting treatment - to ensure that Symkinet MR is safe and beneficial for the patient (listed in "Medical history before taking methylphenidate");
• after starting treatment - at least every 6 months, but possibly more often, as well as with every dose change.

Method of administration

Symkinet MR is for oral use only.

• 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 cannot swallow the Symkinet MR capsule, the contents of the capsule can be sprinkled on a small amount of food, as follows:

• Open the capsule carefully and sprinkle its contents 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 should be taken immediately after mixing it with food.

Instructions for opening the blister pack

The medicine is available in child-resistant blister packs.

• 1. Do not push the capsule out of the blister pack, as this may damage the capsule.
• 2. Hold the blister pack with the printed foil facing upwards and bend it backwards along the perforated line, then bend it in the opposite direction, repeat this action several times.

• 3. To remove the capsule, carefully peel off the protective foil, starting from the corner indicated by the arrow, and then pull it off.

Long-term treatment

There is no need to take Symkinet MR indefinitely.

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.

Incorrect use of Symkinet MR

Incorrect use of Symkinet MR may lead to unusual behavior.

Take more than the prescribed dose of Symkinet MR

If the patient takes too much of the medicine, they should immediately contact their doctor or call an emergency number.

Miss a dose of Symkinet MR

Do not take a double dose to make up for a forgotten dose.

Stop taking Symkinet MR

Suddenly stopping treatment with this medicine may lead to a return of ADHD symptoms or the appearance of unexpected symptoms, such as depression.

4. Possible side effects

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

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

Common (may affect up to 1 in 10 people)

• abnormal heart rhythm (arrhythmia);
• changes in personality;
• excessive teeth grinding (bruxism).

Uncommon (may affect up to 1 in 100 people)

• suicidal thoughts or attempts;
• seeing, hearing, or feeling 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 or wheezing;
• mood swings.

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

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

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

• heart attack;
• seizures (convulsions, epilepsy);
• peeling of the skin 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 temporary cerebral ischemia;
• paralysis or problems with movement and vision, difficulty with speech (these may be symptoms of cerebrovascular problems);
• reduced number of blood cells (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 taken 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 (incontinence);
• muscle spasm in the jaw, making it difficult to open the mouth (trismus);
• stuttering.

Tell the doctor or pharmacist if any of the following side effects get worse:

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 sleepy;
• loss of appetite;
• weight loss in adults;
• panic attacks;
• reduced sexual desire;
• toothache;
• itching, rash, or hives on the skin;
• excessive sweating;
• cough, sore throat, or nose, and irritation of the throat;
• changes in blood pressure (usually high blood pressure);
• rapid heartbeat (tachycardia);
• cold hands and feet;
• shaking and trembling, dizziness, involuntary movements;
• increased activity;
• aggression, excitement, restlessness, emotional instability, anxiety, depression, stress, irritability, abnormal behavior, sleep problems, fatigue;
• stomach 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;
• increased liver enzyme levels (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 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 color change of the skin 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 stomach pain, often with nausea and vomiting;
• problems with blood vessels in the brain (stroke, inflammation of cerebral vessels, or blockage of cerebral vessels);
• 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.

• The child may not gain weight or grow at the expected 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 stopped for a short period.

Reporting side effects

If side effects occur, they should be reported to the doctor or pharmacist.

5. How to store Symkinet MR

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

Do not use this medicine after the expiry date stated on the carton and blister pack.

The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What Symkinet MR contains

• The active substance is methylphenidate hydrochloride.
• The other ingredients are:

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.

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

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

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

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

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

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

The medicine is available in child-resistant blister packs (Aclar/PVC/Aluminum/PET) 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 pack 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