Simkinet Mr

Package Leaflet: Information for the User

Symkinet MR, 10 mg, prolonged-release hard capsules

Symkinet MR, 20 mg, prolonged-release hard capsules

Symkinet MR, 30 mg, prolonged-release hard capsules

Symkinet MR, 40 mg, prolonged-release hard capsules

Methylphenidate hydrochloride

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for them.

• You should 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 your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Symkinet MR is and what it is used for
• 2. Before your child takes 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 to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6-18 years, and in adults.

• Symkinet MR is used when patients have tried other treatments for ADHD, such as psychological therapy, and they have not worked.
• Symkinet MR is not used to treat ADHD in children under 6 years of age. It is not known if it is safe or effective in this age group.

How Symkinet MR works

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

Symkinet MR is part of a treatment program that usually includes psychological, educational, and social measures.

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

About ADHD

Children and adolescents with ADHD have difficulty:

• sitting still and remaining quiet;
• concentrating.

This behavior is not their fault, as they cannot help it.

Many children and adolescents with ADHD have problems at home and at school. They may have difficulty learning and doing homework.

Adults with ADHD may have difficulty concentrating. They may feel restless, impatient, and easily distracted.

Not all patients with ADHD need to take medicine. The decision to start treatment should be based on a thorough medical and psychological evaluation.

ADHD does not affect intelligence.

2. Before your child takes Symkinet MR

When not to take Symkinet MR

• if your child is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
• if your child has thyroid problems;
• if your child has high blood pressure in the eyes (glaucoma);
• if your child has a tumor of the adrenal gland (pheochromocytoma);
• if your child is taking certain antidepressants (called MAOIs) or has taken them in the last 14 days (see section “Symkinet MR with other medicines”);
• if your child has an eating disorder, such as anorexia nervosa;
• if your child has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs;
• if your child has had heart problems, such as a heart attack, irregular heartbeat, chest pain, heart failure, or congenital heart defects;
• if your child has had problems with blood vessels in the brain, such as a stroke, aneurysm, or vasculitis;
• if your child has mental health problems, such as:
• psychopathic or borderline personality disorder;
• abnormal thoughts or visions, or schizophrenia;
• severe mood swings, such as manic depression;
• suicidal thoughts;
• severe depression (when your child is very sad, feels worthless, and has no hope for the future);
• mania (when your child is extremely excited, overactive, and uncontrollable);
• mood swings from depression to mania.

Do not take methylphenidate if any of the above applies to your child. If in doubt, consult your doctor or pharmacist before taking methylphenidate, as it may make these conditions worse.

Warnings and precautions

Before starting treatment with Symkinet MR, discuss the following with your doctor or pharmacist:

• if your child has liver or kidney problems;
• if your child has had seizures (epilepsy) or an abnormal brain wave test (EEG);
• if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs;
• if your child is a female and has started her periods (see section “Pregnancy, breastfeeding, and fertility”);
• if your child or a family member has had tics (repeated, uncontrollable movements or sounds);
• if your child has high blood pressure;
• if your child has heart problems other than those listed above in the section “When not to take Symkinet MR”;
• if your child has mental health problems not listed above in the section “When not to take Symkinet MR”. Other mental health problems include:
• mood swings (from mania to depression, also known as bipolar disorder);
• aggressive behavior or hostility;
• seeing, hearing, or feeling things that are not there (hallucinations);
• believing things that are not true (delusions);
• being overly suspicious (paranoia);
• feeling anxious or tense;
• feeling depressed or guilty.

Tell your doctor or pharmacist if your child has any of the above conditions. Methylphenidate may make these conditions worse. Your doctor will monitor how the medicine affects your child.

During treatment, boys and men may experience unexpected, long-lasting erections. This can be painful and can occur at any time. If an erection lasts for more than 2 hours, or is painful, your child should see a doctor immediately.

Medical history before taking methylphenidate

The medical history is used to decide if methylphenidate is the right medicine for your child. Your doctor will talk to your child about:

• any other medicines your child is taking;
• any cases of sudden, unexplained death in the family;
• any other medical problems your child has (such as heart problems);
• your child’s mood or feelings, such as depression or euphoria;
• any tics in your child’s family;
• any mental health problems or behavior that have occurred in your child or their family. Your doctor will discuss the risk of mood swings (from mania to depression, also known as bipolar disorder). They will also ask about your child’s mental health and any history of suicide, bipolar disorder, or depression in their family.

It is important to give your doctor as much information as possible. Based on this information, your doctor will decide if methylphenidate is the right medicine for your child. Your doctor may also decide to do other medical tests before starting treatment with this medicine.

Drug tests

This medicine may give a positive result in drug tests.

Effects of misuse as a doping agent

Taking Symkinet MR may give a positive result in doping tests.

Misusing Symkinet MR as a doping agent can be a risk to health.

Symkinet MR with other medicines

Tell your doctor or pharmacist about all the medicines your child is taking or has recently taken, and any medicines they plan to take.

Do not take methylphenidate if your child:

• is taking a medicine called a monoamine oxidase inhibitor (MAOI) for depression or has taken an MAOI in the last 14 days. Taking MAOIs with methylphenidate can cause a sudden increase in blood pressure (see section “When not to take Symkinet MR”).

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

• medicines for depression;
• medicines for severe mental health problems (such as schizophrenia);
• medicines for epilepsy;
• medicines to lower or increase blood pressure;
• certain cough and cold medicines that contain ingredients that can affect blood pressure. Ask your pharmacist about this when buying such medicines;
• blood-thinning medicines to prevent blood clots.

If you are unsure if a medicine is on the above list, consult your doctor or pharmacist before taking methylphenidate.

Surgery

Tell your doctor if your child is going to have an operation. Your child should not take methylphenidate on the day of the operation if a certain type of anesthetic is used, due to the risk of a sudden increase in blood pressure during surgery.

Symkinet MR with food, drink, and alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase the side effects of this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding, and fertility

If your child is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor before taking this medicine.

Available data do not suggest an increased risk of birth defects overall, although there may be a small increased risk of heart defects during the first three months of pregnancy. Your doctor will be able to provide more information on this risk.

Before taking methylphenidate, tell your doctor or pharmacist if your child:

• is sexually active. Your doctor will discuss methods of preventing pregnancy;
• is pregnant or thinks they may be pregnant. Your doctor will decide if methylphenidate should be taken;
• is breastfeeding or plans to breastfeed. Methylphenidate passes into human milk. Your doctor will decide if your child should continue breastfeeding while taking methylphenidate.

Driving and using machines

While taking methylphenidate, your child may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other effects on the central nervous system. If these effects occur, activities such as driving, operating machinery, riding a bike, or horse riding, as well as climbing trees, may be dangerous.

Symkinet MR contains sucrose

Symkinet MR contains sucrose (a type of sugar). If your child has been diagnosed with intolerance to some sugars, they should consult their 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, consult your doctor or pharmacist.

Dosage

Your doctor will usually start treatment with a low dose and gradually increase it as needed.

Children (6 years and older) and adolescents

The recommended starting dose is 20 mg, once a day. 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, Symkinet MR should be taken once a day, in the morning.

Adults

• In adults who have not taken Symkinet MR before, the doctor will start treatment with a daily dose of 20 mg, and may increase it gradually, if necessary, at weekly intervals.
• If your child 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 your child was treated with an immediate-release form of methylphenidate 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 for the doctor to perform before and during treatment

The doctor will perform certain tests:

• before starting treatment - to ensure that Symkinet MR is safe and effective for your child (listed in the section “Medical history before taking methylphenidate”);
• after starting treatment - at least every 6 months, but possibly more often, as well as when changing the dose. The tests will include:
• checking appetite;
• measuring your child’s height and weight;
• measuring the weight of adult patients;
• measuring blood pressure and heart rate;
• assessing mood, mental state, or any other abnormalities, and whether they have worsened while taking Symkinet MR.

Method of administration

Symkinet MR is for oral use.

Symkinet MR should be taken once a day, 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 your child cannot swallow the capsule, the contents can be sprinkled on a small amount of food, as follows:

• Open the capsule carefully and sprinkle the contents on a small amount of food (such as 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 with food. The sprinkled contents of the capsule should not be stored for later use.

Instructions for opening the blister pack

The medicine is available in child-resistant blister packs. The following are instructions for opening the blister pack.

• 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 up and bend it backwards along the perforated line, then bend it in the opposite direction, and repeat this action several times. Then, tear the blister pack along the perforation to separate a single dose.

• 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 your child has been taking Symkinet MR for more than a year, the doctor may stop treatment for a short period every year. In children, this can be done during school holidays. This will help assess whether the medicine is still needed.

If your child’s condition does not improve after 1 month of treatment

If your child’s condition does not improve after 1 month of treatment, you should tell your doctor. The doctor may decide to change the treatment.

Misuse of Symkinet MR

Misusing Symkinet MR can lead to abnormal behavior. It can also cause dependence on the medicine. If your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs, you should tell your doctor. This medicine is only for the person it has been prescribed for. Do not give it to others, even if their symptoms are the same.

Overdose of Symkinet MR

If your child takes too much of this medicine, they should see a doctor or go to the hospital immediately. They should tell the doctor how much medicine was taken.

Symptoms of overdose may include: vomiting, feeling overexcited, trembling, increased involuntary movements, muscle twitching, seizures (which may be followed by coma), feeling euphoric, disoriented, or hallucinating, sweating, flushing, headache, high fever, changes in heart rhythm (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the mouth, muscle stiffness, weakness, and dark urine.

Missing a dose of Symkinet MR

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

Stopping treatment with Symkinet MR

Suddenly stopping treatment with this medicine may cause a return of ADHD symptoms or unexpected symptoms, such as depression. Before stopping treatment with Symkinet MR, your child should consult their doctor. The doctor will gradually reduce the daily dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Your doctor will inform your child about these side effects.

Some side effects can be serious. If your child experiences any of the following, they should see a doctor immediately:

Common (may affect up to 1 in 10 people)

• irregular heartbeat (palpitations);
• changes in personality;
• excessive grinding of the teeth (bruxism).

Uncommon (may affect up to 1 in 100 people)

• suicidal thoughts or attempts;
• seeing, hearing, or feeling things that are not there (psychotic episodes);
• uncontrollable movements or sounds (Tourette’s syndrome);
• allergic reactions, such as a rash, itching, or hives;
• mood swings.

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

• feeling overexcited, overactive, and uncontrollable (mania).

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

• heart attack;
• seizures (fits or convulsions);
• peeling of the skin 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 temporary lack of blood flow to the brain;
• paralysis or problems with movement and vision, difficulty with speech (which may be symptoms of problems with blood vessels in the brain);
• reduced number of blood cells (red blood cells, white blood cells, and platelets), which can increase the risk of infections, and can also cause bleeding and bruising;
• sudden increase in body temperature, very high blood pressure, and severe convulsions (neuroleptic malignant syndrome). It is not certain if this side effect is caused by methylphenidate or other medicines that may be taken with it.

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

• repeated, unwanted thoughts;
• loss of consciousness for no known reason, chest pain, shortness of breath (which 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 your 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 adult patients;
• panic attacks;
• reduced sex drive;
• toothache;
• itching, rash, or hives;
• excessive sweating;
• cough, sore throat, or nose and throat irritation;
• changes in blood pressure (usually high blood pressure);
• rapid heartbeat (tachycardia);
• cold hands and feet;
• trembling and shaking, dizziness, involuntary movements, feeling anxious or tense;
• increased activity, aggression, 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 start of treatment and can 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 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, crying, increased awareness of surroundings, tension.

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

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

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), abnormal thinking, lack of feelings or emotions, repetitive behaviors, obsessive focus on one thing;
• numbness of fingers and toes, feeling cold, discoloration of the skin from pale to blue, and then to red, in response to cold (Raynaud’s phenomenon).

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

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

Effect on growth and weight

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

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

Reporting of side effects

If your child experiences any side effects, tell your doctor or pharmacist. Side effects can also be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card scheme.

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 pack.

There are no special storage instructions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 prolonged-release hard capsules contain 10 mg of methylphenidate hydrochloride, which corresponds to 8.65 mg of methylphenidate. Symkinet MR 20 mg prolonged-release hard capsules contain 20 mg of methylphenidate hydrochloride, which corresponds to 17.3 mg of methylphenidate. Symkinet MR 30 mg prolonged-release hard capsules contain 30 mg of methylphenidate hydrochloride, which corresponds to 25.95 mg of methylphenidate. Symkinet MR 40 mg prolonged-release hard capsules 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-methyl methacrylate copolymer (1:1), povidone K30, sucrose, spheres, talc, triethyl citrate. Capsule shell: gelatin, titanium dioxide (E 171). Additionally, Symkinet MR 10 mg, 30 mg, and 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 prolonged-release hard capsules

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

Symkinet MR 20 mg prolonged-release hard capsules

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

Symkinet MR 30 mg prolonged-release hard capsules

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

Symkinet MR 40 mg prolonged-release hard capsules

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

The medicine is available in child-resistant blister packs (Aclar/PVC/Aluminum/PET) in a cardboard box.

Available 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 authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.

ul. Koszykowa 65

00-667 Warszawa

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