SYMKINET MR

Package leaflet: 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
Methylphenidati hydrochloridum
Please read this entire leaflet carefully before using this medicine for the patient or child, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents

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

What Symkinet MR is used for
Symkinet MR is used in the treatment of attention deficit hyperactivity disorder (ADHD).

• It is used in children and adolescents aged 6 to 18 years, as well as in adult patients.
• It is used only after non-pharmacological treatment attempts, such as psychological counselling and behavioural therapy, have proven insufficient. Symkinet MR is not used in the treatment of 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 less active. The medicine may help improve attention, concentration, and reduce impulsive behaviours.
Symkinet MR is used as part of a treatment programme that usually includes:

• psychological therapy;
• educational interventions;
• environmental support.

Treatment with Symkinet MR must be initiated and continued only by a physician specialized in the treatment of ADHD, such as a paediatric specialist, child and adolescent psychiatrist, or psychiatrist. A thorough evaluation by such a physician is required. If the patient is an adult who has not been previously treated, the physician will conduct assessments to confirm that ADHD has been present since childhood. Therapeutic programmes combined with medication can help manage ADHD effectively.

About ADHD
Children and adolescents with ADHD have difficulties:

• sitting still without moving;
• concentrating.

This behaviour is not their fault, as they have no control over it.
Many children and young people experience such difficulties. However, individuals with ADHD may face problems in daily life. Children and adolescents with ADHD may have difficulties with learning and completing homework.
Adults with ADHD often have trouble concentrating. They often feel restless, impatient, and inattentive. They may have difficulties organizing their personal and professional lives.
Not all patients with ADHD require pharmacological treatment. The decision to start treatment in children must be based on a thorough assessment determining the severity and chronic nature of the child's symptoms.
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 dysfunction;
• if the patient has increased intraocular pressure (glaucoma);
• if the patient has a chromaffin cell tumour of the adrenal gland (pheochromocytoma);
• if the patient is currently taking antidepressant medicines (called monoamine oxidase inhibitors) or has taken such medicines within the last 14 days (see section "Symkinet MR with other medicines");
• if the patient has eating disorders; lack of appetite or desire to eat (e.g. anorexia nervosa);
• if the patient has very high blood pressure or narrowing of blood vessels which may cause pain in the hands and feet;
• if the patient has ever had heart problems such as: heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or congenital heart defects;
• if the patient has had cerebrovascular disorders such as: stroke, localized dilation and weakening of a blood vessel wall (aneurysm), narrowing or blockage of blood vessels, inflammation of blood vessels;
• if the patient has psychiatric disorders such as:
• psychopathic disorders or borderline personality;
• delusions or hallucinations, or schizophrenia;
• symptoms of severe mood disorders such as:
• suicidal thoughts;
• severe depression (when the patient feels very sad, worthless and hopeless about the future);
• mania (when the patient is extremely excited, excessively active and uncontrolled in their behaviour);
• mood swings from depression to mania.

Methylphenidate should not be used if any of the above conditions apply to the patient.
If in doubt, consult a doctor or pharmacist before using methylphenidate, as methylphenidate may worsen these conditions.
Warnings and precautions
Before starting treatment with Symkinet MR, discuss with a doctor or pharmacist if the patient:

• has liver or kidney dysfunction;
• has had seizures (epilepsy) or abnormal electroencephalogram (EEG) results;
• has ever abused or been dependent on alcohol, prescription medicines or illicit drugs;
• is a woman or girl who has started menstruation (see section below "Pregnancy, breastfeeding and fertility");
• or a family member has uncontrollable, repetitive movements or vocalizations (motor or vocal tics);
• has high blood pressure;
• has heart diseases other than those listed above in the section "When not to use Symkinet MR";
• has psychiatric disorders not listed in the section "When not to use Symkinet MR". Other psychiatric disorders include:
• mood swings (from mania to depression, known as bipolar affective disorder);
• emergence of aggressive or hostile behaviour, or increased aggression;
• seeing, hearing or feeling things that are not real (hallucinations);
• belief in unreal things (delusions);
• excessive suspiciousness (paranoia);
• feelings of restlessness, anxiety or tension;
• feelings of depression or guilt.

Before starting treatment, inform the doctor or pharmacist if any of the above conditions apply to the patient. Methylphenidate may worsen these conditions. The doctor will monitor how the medicine affects the patient.
During treatment, boys and men may experience unexpected prolonged erections. This may be painful and can occur at any time. If an erection lasts longer than 2 hours, especially if it is painful, contact a doctor immediately.
Medical history before using methylphenidate
This assessment helps determine whether methylphenidate is appropriate for the patient. The doctor will discuss with the patient:

• any other medicines the patient is taking;
• any family history of sudden unexplained death;
• any other medical problems (e.g. heart disease) in the patient or their family;
• the patient's or child's emotional state, e.g. depression or euphoria, unusual thoughts, or whether such feelings occurred in the past;
• any history of tics (uncontrollable, repetitive movements of body parts or repetition of sounds or words) in the patient's family;
• any psychiatric or behavioural disorders in the patient or their family members. The doctor will discuss the risk of mood swings (from mania to depression – known as bipolar affective disorder). The doctor will also take a psychiatric history and determine whether there have been cases of suicide, bipolar affective disorder or depression in the patient's family.

It is important to provide the doctor with as much information as possible. Based on this, the doctor will decide whether methylphenidate is suitable for the patient. The doctor will also decide whether additional medical tests are necessary before starting treatment with this medicine.
Drug screening tests
This medicine may cause a positive result in drug screening tests.
Consequences of misuse as a doping agent
Use of Symkinet MR may lead to positive results in anti-doping tests.
Improper use of Symkinet MR as a doping agent may pose a health risk.
Symkinet MR with other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken by the patient or child, as well as any medicines the patient plans to take.
Do not use methylphenidate if the patient or child:

• is taking or has taken within the last 14 days a medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression. Concurrent use of MAOIs with methylphenidate may cause a sudden increase in blood pressure (see section "When not to use Symkinet MR").

If the patient or child is taking other medicines, methylphenidate may affect their action or cause adverse effects. It may be necessary to reduce the dose or discontinue concomitant treatment. Before taking methylphenidate, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• medicines used to treat depression;
• medicines used to treat serious psychiatric disorders (e.g. schizophrenia);
• antiepileptic medicines;
• medicines used to lower or raise blood pressure;
• certain cough and cold medicines containing ingredients that affect blood pressure. Ask the pharmacist when purchasing such products;
• anticoagulant medicines that prevent blood clots.

If in doubt whether a medicine taken by the patient is on the above list, consult a doctor or pharmacist before using methylphenidate.
Surgical procedure
Inform the doctor about any planned surgical procedure. Do not take methylphenidate on the day of surgery if certain types of anaesthetic agents are to be used, due to the risk of sudden increase in blood pressure during the operation.
Symkinet MR with food, drink and alcohol
Do not consume alcohol while taking this medicine. Alcohol may worsen the adverse effects of this medicine. Remember that some food products and medicines contain alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Available data do not indicate an increased overall risk of congenital malformations, although a small increased risk of cardiac developmental defects during the first trimester of pregnancy cannot be ruled out. The doctor can provide additional information about this risk.
Before using methylphenidate, inform the doctor or pharmacist if the patient:

• is sexually active. The doctor will discuss methods of contraception.
• is pregnant or suspects she may be pregnant. The doctor will decide whether methylphenidate should be used.
• is breastfeeding or plans to breastfeed. Methylphenidate passes into human milk. Therefore, the doctor will decide whether breastfeeding should continue during treatment with methylphenidate.

Driving and operating machinery
While taking methylphenidate, dizziness, drowsiness, difficulty focusing vision, blurred vision, hallucinations or other adverse effects on the central nervous system may occur. If such symptoms occur, activities such as driving vehicles, operating machinery, cycling, horse riding 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 an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Symkinet MR

This medicine should always be taken exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Dosage
Your doctor will usually start treatment with a low dose and increase it gradually if necessary.
Children (6 years of age and older) and adolescents
The recommended starting dose is 20 mg once daily. Your 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

• For 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 the dose weekly.
• If a patient has previously taken methylphenidate in a modified-release formulation as a child or adolescent and has recently turned 18, the doctor may continue the same daily dose. If the patient was previously treated with an immediate-release formulation as a child or adolescent, the doctor will prescribe an appropriate dose of Symkinet MR.

The maximum daily dose is 80 mg.
Lower doses of this medicine or other medicines containing methylphenidate are available.
Procedures your doctor will perform before and during treatment (for adults or children)
Your doctor will carry out certain examinations:

• Before starting treatment – to ensure that Symkinet MR is safe and beneficial for the patient (as listed under “Medical history before using methylphenidate”);
• After starting treatment – at least once every 6 months, but possibly more frequently, and also with any dose adjustment. Examinations will include:
• Checking appetite;
• Measuring growth and body weight in children;
• Measuring body weight in adult patients;
• Measuring blood pressure and pulse;
• Assessing mood disorders, mental status, or any other abnormalities, and whether they have worsened during treatment with Symkinet MR.

Method of administration
Symkinet MR is for oral use.
Symkinet MR should be taken once daily in the morning. Do not take the medicine too late in the day, as it may cause sleep disturbances.

• Capsules may be taken with or without food.
• Capsules must be swallowed whole with a glass of water.
• Capsules or their contents must not be crushed, chewed, or divided.

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

• Carefully open the capsule and sprinkle the contents onto a small amount of soft food (e.g. applesauce).
• The food must not be hot, as this may affect the special properties of the pellets.
• The medicine mixed with food should be taken immediately. Do not store the medicine removed from the capsule for later use.

Instructions for opening the blister pack
The medicine is supplied in child-resistant peelable blisters. The following instructions explain how to open the blister pack.

1. Do not push the capsule through the blister, as this may damage the capsule.
2. Hold the blister with the printed foil side up. Bend the blister backward along the perforated line, then bend it in the opposite direction. Repeat this action several times. Then tear the blister along the perforation to separate a single dose.

3. To remove the capsule, gently peel back the protective foil starting from the corner indicated by the arrow, and then lift it off.

Long-term treatment
There is no need to take Symkinet MR indefinitely. If a patient has been taking Symkinet MR for more than one year, the doctor should interrupt treatment for a short period once a year. In children, this may occur during school holidays. This allows assessment of whether continued treatment is still 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, inform the doctor. The doctor may decide to change the treatment approach.
Misuse of Symkinet MR
Misuse of Symkinet MR may lead to unusual behaviour and may also cause dependence on the medicine. If the patient has ever abused or been dependent on alcohol, prescription medicines, or drugs, this should be reported to the doctor. This medicine is intended only for the person to whom it was prescribed. Do not give it to others, even if their symptoms appear similar.
Taking more than the recommended dose of Symkinet MR
If a patient takes too much medicine, contact a doctor immediately or call emergency services. Inform them of the amount of medicine taken. Treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling of overstimulation, tremors, increased involuntary movements, muscle twitching, seizures (which may lead to coma), feelings of euphoria, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), sweating, facial flushing, headache, high fever, changes in heart rhythm (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nasal and oral mucous membranes, muscle swelling, weakness, tenderness, and muscle pain, and dark-coloured urine.
Missed dose of Symkinet MR
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the usual time.
Stopping Symkinet MR
Suddenly stopping this medicine may lead to a return 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. Consult your doctor before stopping treatment with Symkinet MR.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The doctor will inform the patient about these side effects.
Some of these side effects may be serious. If any of the following side effects occur,
seek immediate medical attention:

Common (may affect up to 1 in 10 patients)

• Irregular heartbeat (palpitations);
• Changes in personality;
• Excessive teeth grinding (bruxism).

Uncommon (may affect up to 1 in 100 patients)

• Suicidal thoughts or tendencies;
• Seeing, feeling, or hearing things that do not exist – these are symptoms of psychosis;
• Uncontrollable speech and body 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, shortness of breath, wheezing or difficulty breathing;
• Mood swings, changes in mood.

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

• Feeling excessively excited, physically overactive and uncontrollable (mania).

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

• Heart attack;
• Seizures (epileptic fits, convulsive epilepsy);
• Skin peeling or purple-red skin spots;
• Uncontrollable muscle contractions affecting the eyes, head, neck or other parts of the body, and neurological symptoms related to transient cerebral ischaemia;
• Paralysis or problems with movement and vision, difficulties with speech (these may be symptoms of cerebrovascular disorders);
• Decrease in blood cell count (red blood cells, white blood cells and platelets), which may lead to increased susceptibility to infections, as well as increased risk of bleeding and bruising;
• Sudden high body temperature, very high blood pressure and severe convulsions (malignant neuroleptic syndrome). It is not certain whether this adverse effect is caused by methylphenidate or by other medicines that may be used in combination with methylphenidate.

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

• Recurrent unwanted thoughts;
• Loss of consciousness for unknown reasons, chest pain, shortness of breath (these may be symptoms of heart disease);
• Inability to control urination (urinary incontinence);
• Jaw muscle spasm making it difficult to open the mouth (trismus);
• Stuttering.

Inform the doctor or pharmacist if any of the following side effects worsen:
Very common (may affect more than 1 in 10 patients)

• Decreased appetite;
• Headache;
• Nervousness;
• Insomnia;
• Nausea;
• Dry mouth.

Common (may affect up to 1 in 10 patients)

• Joint pain;
• High body temperature (fever);
• Excessive hair loss or thinning;
• Unusual drowsiness;
• Loss of appetite;
• Weight loss in adult patients;
• Panic attacks;
• Decreased libido;
• Toothache;
• Itching, rash or raised, red, itchy rash (urticaria);
• Excessive sweating;
• Cough, sore throat or nasal pain, throat irritation, shortness of breath, chest pain;
• Changes in blood pressure (usually high blood pressure);
• Increased heart rate (tachycardia);
• Cold hands and feet;
• Trembling and shaking, dizziness, involuntary movements, inner restlessness;
• Increased activity;
• Aggression, agitation, motor restlessness, emotional instability, anxiety, depression, stress, irritability, abnormal behaviour, difficulty falling asleep, fatigue;
• Abdominal pain, diarrhoea, abdominal discomfort, indigestion, 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 patients)

• Constipation;
• Chest discomfort;
• Inflammation of the mucous membrane of the stomach and small intestine;
• Presence of blood in urine;
• Double vision or blurred vision;
• Muscle pain, muscle cramps, muscle stiffness;
• Elevated liver function test results (in blood tests);
• Irritability, tearfulness, excessive environmental awareness, tension.

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

• Changes in sexual desire;
• Feeling of disorientation;
• Dilated pupils, difficulty seeing;
• Breast swelling in men;
• Skin redness, red raised rash on the skin.

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

• Heart attack;
• Sudden death;
• Muscle spasms;
• Small red spots on the skin;
• Arterial inflammation or embolism in the brain;
• Liver dysfunction, including liver failure and coma;
• Changes in laboratory test results – including liver and blood function tests;
• Suicide attempts (including completed suicides), disturbances in thinking, lack of feelings or emotions, repetitive behaviours, obsessive focus on a single subject;
• Numbness in fingers of hands and feet, feeling of cold, tingling and skin colour change from pale to blue and then to red upon exposure 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;
• Major convulsive seizure ("grand mal" seizure);
• Belief in things that are not true, confusion;
• Severe abdominal pain, often with nausea and vomiting;
• Problems with brain blood vessels (stroke, cerebral arteritis or cerebral vessel blockage);
• Erectile dysfunction;
• Prolonged erections, sometimes painful, or increased frequency of erections;
• Excessive, uncontrollable talking;
• Nosebleeds.

Effect on growth and body weight
When methylphenidate is used for longer than one year, in some children this medicine
may slow down growth. This affects fewer than 1 in 10 children.

• The child may not gain weight or grow at the expected rate.
• The treating doctor will carefully monitor the child's growth, body weight and food intake.
• If the patient is not growing as expected, treatment with methylphenidate may be temporarily interrupted.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Symkinet MR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Symkinet MR contains

• The active substance is methylphenidate hydrochloride.
  Symkinet MR 10 mg, modified-release hard capsules contain 10 mg of methylphenidate hydrochloride, equivalent to 8.65 mg of methylphenidate.
  Symkinet MR 20 mg, modified-release hard capsules contain 20 mg of methylphenidate hydrochloride, equivalent to 17.3 mg of methylphenidate.
  Symkinet MR 30 mg, modified-release hard capsules contain 30 mg of methylphenidate hydrochloride, equivalent to 25.95 mg of methylphenidate.
  Symkinet MR 40 mg, modified-release hard capsules contain 40 mg of methylphenidate hydrochloride, equivalent to 34.6 mg of methylphenidate.

• Other ingredients:
  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, and 40 mg contain: iron oxide yellow (E 172).
  Printing ink: potassium hydroxide, propylene glycol, iron oxide red (E 172), shellac, concentrated ammonium hydroxide.

What Symkinet MR looks like and contents of the pack
Symkinet MR 10 mg, modified-release hard capsules
Hard gelatin capsules of size "2", consisting of an opaque dark yellow cap and an opaque white body, printed with the red marking “RUB” on the cap and the red marking “M10” on the body, containing white and off-white pellets. Capsule length: 18 mm.

Symkinet MR 20 mg, modified-release hard capsules
Hard gelatin capsules of size "2", opaque white, printed with the red marking “RUB” on the cap and the red marking “M20” on the body, containing white and off-white pellets. Capsule length: 18 mm.

Symkinet MR 30 mg, modified-release hard capsules
Hard gelatin capsules of size "2", opaque ivory-coloured, printed with the red marking “RUB” on the cap and the red marking “M30” on the body, containing white and off-white pellets. Capsule length: 18 mm.

Symkinet MR 40 mg, modified-release hard capsules
Hard gelatin capsules of size "1", opaque dark yellow, printed with the red marking “RUB” on the cap and the red marking “M40” on the body, containing white and off-white pellets. Capsule length: 20 mm.

The medicine is available in child-resistant blisters (Aclar/PVC/Aluminium/PET), packed in a cardboard box.

Pack 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]

Manufacturer
Laboratorios Rubio, S.A.
Calle Industria, 29. Pol. Ind. Comte de Sert
08755 Castellbisbal (Barcelona)
Spain

This medicinal product is authorised in the member countries 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