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 leaflet carefully before taking this medicine, either for yourself or for a child,
as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Symkinet MR is and what it is used for
2. What you need to know 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 proved 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 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.
It is used as part of a treatment programme that usually includes:

• psychological;
• educational;
• social therapies.

Treatment with Symkinet MR must be initiated and continued only by a doctor specialised in the treatment of ADHD, such as a paediatrician, child and adolescent psychiatrist, or psychiatrist. A thorough assessment by such a doctor is required. If the patient is an adult who has not previously been treated, the doctor will carry out an evaluation to confirm that ADHD has been present since childhood. Therapeutic programmes and medication can help control ADHD.

About ADHD
Children and adolescents with ADHD have difficulties:

• sitting still;
• concentrating.

This behaviour is not their fault, as they cannot control it.
Many children and young people experience such problems. However, people with ADHD may have difficulties in everyday life. Children and adolescents with ADHD may have problems with learning and completing homework.
Adults with ADHD often have difficulties concentrating. They may often feel restless, impatient, and inattentive. They may have difficulties organising 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 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 peripheral vascular constriction that may cause pain in 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 vessel dilation and weakened vessel wall (aneurysm), narrowing or blockage of blood vessels, vasculitis;
• 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.
In case of 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) findings;
• has ever abused or been dependent on alcohol, prescription medicines, or 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 vocal tics (motor or vocal tics);
• has high blood pressure;
• has heart diseases other than those listed above under "When not to use Symkinet MR";
• has psychiatric disorders not listed under "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);
• false beliefs (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. 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 painful, contact a doctor immediately.
Medical history before using methylphenidate
The medical history helps determine whether methylphenidate is suitable for the patient. The doctor will discuss with the patient:

• any other medicines the patient is taking;
• any family history of sudden or unexplained death;
• any other medical problems (e.g. heart disease) in the patient or their family;
• the patient’s or child’s emotional state, such as depression or euphoria, unusual thoughts, or whether such feelings occurred in the past;
• presence of tics (uncontrollable, repetitive movements or sounds) in the patient’s family;
• any psychiatric or behavioural disorders in the patient or 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 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 needed before starting treatment.
Drug screening tests
This medicine may cause a positive result in drug screening tests.
Misuse as a performance-enhancing drug
Use of Symkinet MR may result in positive anti-doping test results.
Improper use of Symkinet MR as a performance-enhancing drug 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 called 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. Dose reduction or discontinuation of concomitant treatment may be necessary. 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;
• some 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 surgery. 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, breastfeeding, suspects she may be pregnant, or plans 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 three months 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 contraception methods.
• 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 intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Symkinet MR

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
Dosage
Your 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 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 who are taking Symkinet MR for the first time, the doctor will start treatment with a daily dose of 20 mg and, if necessary, gradually increase the dose weekly.
• If a patient has previously been treated with a modified-release methylphenidate medicine as a child or adolescent and has recently turned 18 years old, the doctor may continue with 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.
Smaller doses of this medicine or other medicines containing methylphenidate are also available.
Procedures your doctor will carry out before and during treatment (for adult or child patients)
Your doctor will perform certain assessments:

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

Instructions for administration
Symkinet MR is intended 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 mixed with 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. The capsule contents must not be stored for later use.

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

1. Do not push the capsule through the blister, as this may damage the capsule.
2. Hold the blister with the printed foil on top. 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, carefully peel back the protective foil starting from the corner indicated by the arrow, and then fully remove it.

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 has not improved after 1 month of treatment
If the patient's condition has not improved 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 behaviors and may also cause the patient to become dependent 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 seem similar.
Taking more than the recommended dose of Symkinet MR
If a patient takes more than the prescribed dose, contact a doctor immediately or call emergency services. Inform them of the amount of medicine taken. Medical treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling overstimulated, tremors, increased involuntary movements, muscle twitching, seizures (possibly followed by 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 mucosa and oral cavity, muscle swelling, weakness, tenderness, and muscle pain, and dark-colored 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 treatment with 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 discontinuing 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Your doctor will inform you about these adverse effects.
Some adverse effects may be serious. If any of the following adverse 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 of excessive excitement, hyperactivity and lack of inhibition (mania).

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

• Heart attack;
• Seizures (epileptic fits, epilepsy with convulsions);
• Skin peeling or purple-red spots on the skin;
• 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 problems affecting blood vessels in the brain);
• Decrease in blood cell count (red blood cells, white blood cells and platelets), which may lead to increased susceptibility to infections, as well as predispose to 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 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.

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

• Decreased appetite;
• Headache;
• Nervousness;
• Insomnia;
• Nausea;
• Dryness of the mouth.

Common (may affect up to 1 in 10 patients)

• Joint pain;
• High body temperature (fever);
• Excessive hair loss or thinning;
• Feeling unusually sleepy;
• Loss of appetite;
• Weight loss in adult patients;
• Panic attacks;
• Decreased libido;
• Toothache;
• Itching, rash or raised, red, itchy rash (hives);
• 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;
• Tremors 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 stomach and small intestine mucosa;
• Presence of blood in urine;
• Double vision or blurred vision;
• Muscle pain, muscle cramps, muscle stiffness;
• Elevated liver function test results (in blood tests);
• Anger, tearfulness, heightened awareness of surroundings, 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;
• Inflammation or arterial blockage in the brain;
• Liver dysfunction, including liver failure and coma;
• Changes in laboratory test results – including liver function and blood tests;
• Suicide attempts (including completed suicides), disturbances in thinking, lack of feelings or emotions, repetitive behaviours, obsessive focus on one thing;
• 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 available data)

• Migraine;
• Very high fever;
• Slow, fast or irregular heartbeat;
• Major convulsive seizure ("grand mal" seizures);
• Belief in things that are not true, confusion;
• Severe abdominal pain, often with nausea and vomiting;
• Problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral vessel occlusion);
• 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, this medicine may in some children slow down growth. This affects fewer than 1 in 10 children.

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to 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 are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 are:
  Capsule contents: methacrylic acid–ammonium methacrylate copolymer (type B), methacrylic acid–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, size “2”, consisting of an opaque dark yellow cap and an opaque white body, printed with a red “RUB” on the cap and a red “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, size “2”, opaque white, printed with a red “RUB” on the cap and a red “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, size “2”, opaque ivory-coloured, printed with a red “RUB” on the cap and a red “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, size “1”, opaque dark yellow, printed with a red “RUB” on the cap and a red “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 carton.

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 European Economic Area (EEA) 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