MEDIKINET 50 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you or your child start taking Medikinet

Do not take Medikinet if you or your child

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor in the adrenal glands (pheochromocytoma)
• have an eating disorder, such as anorexia nervosa
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had heart problems, such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a congenital heart problem
• have had a problem with the blood vessels in the brain, such as a stroke, dilation or weakness of a blood vessel (aneurysm), narrowing or blockage of the blood vessels, or inflammation of the blood vessels (vasculitis)
• are taking or have taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see “Taking Medikinet with other medicines”
• have mental health problems, such as:

-a “psychopathic” or “borderline personality” disorder

• abnormal thoughts or visions or a disease called “schizophrenia”

-signs of a severe mood disorder, such as:

• suicidal thoughts
• severe depression, feeling very sad, worthless, and desperate
• mania, feeling exceptionally elated, more active than usual, and uninhibited
• has a history of pronounced lack of stomach acidity (low gastric acid) with pH values above 5.5
• is being treated with medicines to reduce stomach acid secretion or to treat excessive stomach acidity (H2 receptor blockers, proton pump inhibitors, or antacids)

Do not take methylphenidate if you or your child have any of the above. If you are not sure, tell your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these problems.

Warnings and precautions

Tell your doctor before you or your child start taking Medikinet if you or your child

• have liver or kidney problems
• have problems swallowing or swallowing whole tablets
• have had seizures (fits, convulsions, epilepsy) or any changes in the electroencephalogram (EEG, a brain study)
• have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs
• are female and have started your period (see below the section on “Pregnancy and breastfeeding”)
• have difficulty controlling repetitive movements of some parts of the body or repeating sounds and words (tics)
• have high blood pressure
• have a heart problem not listed in the previous “Do not take” section
• have a mental health problem not listed in the previous “Do not take” section. Other mental health problems include:

• mood changes (from being manic to being depressed, also known as “bipolar disorder”)
• experiencing aggressive or hostile behavior, or worsening aggression
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing things that are not real (delusions)
• feeling unusually suspicious (paranoia)
• feeling agitated, anxious, or tense
• feeling depressed or guilty

Tell your doctor or pharmacist if you or your child have any of the above before starting treatment. Methylphenidate may worsen these problems. Your doctor will want to monitor how the medicine affects you or your child.

During treatment, children and adolescents may unexpectedly experience prolonged erections. Erections can be painful and occur at any time. It is essential to contact the doctor immediately if the erection lasts more than 2 hours, especially if it is painful.

Checks that your doctor will make before you or your child start taking methylphenidate

To decide if methylphenidate is the right medicine for you or your child, your doctor will check the following with you:

• the medicines you or your child are taking
• if you or your child have a family history of sudden unexplained death
• other diseases that you or your family (such as heart problems) may have
• how you or your child are feeling; for example, if you or your child have mood swings, have had strange thoughts, or have had feelings like this in the past
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or repeating sounds and words)
• possible behavioral or mental health problems that you or your child or other family members have had.

Your doctor will explain specifically if you or your child are at risk of experiencing mood changes (from being manic to being depressed, also known as bipolar disorder). Your doctor will also check your or your child's mental health history and check if any family members have a history of suicide, bipolar disorder, or depression.

It is essential that you provide all the information you can. This will help your doctor decide if methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need other medical tests before starting to take this medicine. For adult patients starting to take Medikinet, your doctor may refer you to a heart specialist.

Drug tests

This medicine may give positive results in drug tests.

Athletes should be aware that this medicine may produce a positive result in doping tests.

Taking Medikinet with other medicines

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Do not take methylphenidate if you or your child

• are taking a medicine called a “monoamine oxidase inhibitor” (MAOI) used for depression, or have taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate can cause a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate may affect how they work or cause side effects. Tell your doctor if you or your child are taking medicines for:

• depression
• mental health problems
• epilepsy
• blood pressure problems
• cough and cold. Some remedies contain medicines that can affect blood pressure, so it is essential to consult your pharmacist when buying a product of this type
• medicines that thin the blood to prevent clot formation.

Medikinet should not be taken with H2 receptor blockers, proton pump inhibitors, or antacids (medicines to reduce stomach acid secretion or to treat excessive stomach acidity), as they may cause faster release of the total amount of active substance.

If you are unsure if any of the medicines you or your child are taking are included in the list above, consult your doctor or pharmacist for advice before taking methylphenidate.

Before an operation

Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on the day of the operation with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Taking methylphenidate with alcohol

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

Pregnancy and breastfeeding

Available data do not suggest an increased risk of total congenital anomalies, although a small increased risk of cardiac malformations during use in the first three months of pregnancy could not be ruled out. Your doctor will provide more information about this risk.

Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• are having sex. Your doctor will discuss contraception with you.
• are pregnant or think you may be pregnant. Your doctor will decide if you should take methylphenidate.
• are breastfeeding or plan to breastfeed. It is possible that methylphenidate may pass into breast milk. Therefore, your doctor will decide if you or your daughter should breastfeed while taking methylphenidate.

Driving and using machines

You or your child may experience dizziness, drowsiness, problems focusing, or blurred vision, have hallucinations, or other effects on the central nervous system when taking methylphenidate. If this happens, it may be dangerous to perform certain activities, such as driving, operating machines, riding a bicycle or horse, or climbing trees.

Medikinet contains sucrose

If your doctor has told you that you or your child have an intolerance to some sugars, consult them before taking this medicine.

Medikinet contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Medikinet

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

Use in children

The maximum daily dose is 60 mg.

• your doctor will normally start treatment with a low dose and gradually increase it as needed.
• your doctor will tell you what dose you need to take each day.
• do not divide the dose contained in a capsule; take the complete contents of the capsule.
• Medikinet should not be taken too late in the morning, as it may cause sleep disorders.

Use in adults

For adults who have taken Medikinet before

• adult patients may require a higher daily dose, but the doctor will try to give you the lowest effective dose
• the maximum daily dose is based, among other things, on your body weight (see below).

For adults who have not taken Medikinet before

The recommended initial dose is 10 mg per day.

• your doctor will increase your dose in increments of 10 mg per day according to your tolerance to the medication and its effectiveness
• the goal should be to administer the lowest effective dose
• the maximum daily dose is based, among other things, on your body weight (see below)
• your doctor will decide the maximum daily dose
• the daily dose is 1 mg/kg of body weight, up to a maximum of 80 mg of methylphenidate per day.

Things your doctor will do during your treatment or that of your child

Your doctor will perform some tests

• before you or your child start treatment - to ensure that Medikinet is safe and will be beneficial.
• once treatment has started - they will be performed at least every 6 months and even more often, also when the dose is changed.

• these tests will include:

• appetite control
• height and weight measurement in children
• weight measurement in adults
• blood pressure and heart rate measurement
• evaluation of mood-related problems, mental state, or any other unusual feeling. Or if it has worsened while taking Medikinet.

How to take

This medication is for oral administration.

Medikinet should be administered to children in the morning with or afterbreakfast.

Medikinet should be administered to adults with or afterbreakfast andlunch.

Medikinet is a controlled-release form of methylphenidate, which releases the medication gradually over a prolonged period. It is very important to take the capsule with or after meals to prolong its action.

The capsules can be swallowed whole with a little water or opened and their contents sprinkled on a small amount (one tablespoon) of apple sauce or yogurt, and taken immediately. Do not store it for future use.

The capsules and their contents should not be crushed or chewed.

If you or your child do not feel better after 1 month of treatment

If you or your child do not feel better after 1 month of treatment, inform your doctor. Your doctor may decide if you or your child need a different treatment.

Long-term treatment

Medikinet does not need to be taken indefinitely. If you or your child take Medikinet for more than a year, your doctor should interrupt treatment at least once a year for a short period. In the case of children, the interruption can be made during school vacations. This allows demonstrating if the medication is still needed.

Incorrect use of Medikinet

If Medikinet is not used correctly, it can cause abnormal behavior. This can also mean that you or your child start to depend on the medication. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medications, or illegal drugs.

This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you.

If you or your child take more Medikinet than you should

In case of overdose or accidental ingestion, call your doctor, the emergency service of the nearest hospital, or the Toxicology Information Service immediately, telephone: 91 562 04 20, indicating the medication and the amount ingested. You may need medical treatment.

The signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (sometimes followed by coma), feeling of great happiness, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeats (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth, muscle spasms, fever, and darkening of the urine to a reddish-brown color, which could be possible signs of abnormal muscle breakdown (rhabdomyolysis).

If you or your child forget to take Medikinet

Do not take a double dose to make up for forgotten doses. If you or your child forget a dose, wait to take the next dose at the scheduled time.

If you or your child stop taking Medikinet

If you or your child suddenly stop taking this medication, the symptoms of ADHD or unwanted effects, such as depression, may reappear. Your doctor may want to gradually decrease the amount of medication you take each day before stopping it completely. Consult your doctor before stopping treatment with Medikinet.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. Your doctor will inform you about these side effects.

Some side effects can be serious. If you or your child have any of the following side effects, go to your doctor immediately:

Common: may affect up to 1 in 10 people

• irregular heartbeats (palpitations)
• personality changes
• excessive teeth grinding (bruxism)

Uncommon: may affect up to 1 in 100 people

• mood changes
• suicidal thoughts or feelings
• hearing or seeing things that are not real, symptoms of psychosis
• uncontrolled speech and body movements (Tourette's syndrome) or worsening of these
• chest pain
• allergy symptoms such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, difficulty or problems breathing

Rare: may affect up to 1 in 1,000 people

• feeling exceptionally excited, more active than normal, and uninhibited (mania)

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

• heart attack
• seizures (epilepsy with convulsions)
• skin peeling or red-purple spots
• uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system, as a result of lack of blood circulation to the brain
• paralysis or problems with movement and vision, difficulty speaking (these can be signs of blood vessel problems in the brain), temporary lack of blood and oxygen supply (ischemia) to the brain
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets), which can cause a higher risk of infections, and easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure, and severe seizures ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this side effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Unknown: frequency cannot be estimated from available data

• unwanted thoughts that recur
• unexplained fainting, shortness of breath (these can be signs of heart problems)

If you or your child have any of the above side effects, go to your doctor immediately.

The following side effects are also indicated, and if they become serious, please go to your doctor or pharmacist immediately:

Very common: may affect more than 1 in 10 people

• decreased appetite
• headache
• nervousness
• difficulty sleeping
• dry mouth
• nausea

Common: may affect up to 1 in 10 people

• depression or lack of feelings or emotions or demonstration of much interest
• joint pain
• fever
• hair loss or decrease in hair thickness (thinner hair)
• excessive somnolence or drowsiness
• loss of appetite
• panic attack
• decreased sexual desire
• toothache
• itching, rash, or increased itching of red skin rashes (hives)
• cough, sore throat, or irritation of the throat and nose, shortness of breath, or chest pain
• changes in blood pressure (usually high blood pressure)
• rapid heartbeat (tachycardia) or irregular heartbeat (arrhythmia), cold hands and feet
• agitation or tremors, feeling of dizziness
• uncontrolled movements, feeling of inner restlessness
• excessive activity
• aggression, agitation, restlessness, emotional instability, anxiety, depression, stress, irritability, and abnormal behavior, difficulty sleeping, fatigue
• stomach pain, diarrhea, stomach discomfort, indigestion, thirst, vomiting. These side effects usually occur at the start of treatment and may decrease when taking the medication with food
• loss of appetite/no desire to eat
• weight loss
• excessive sweating

Uncommon: may affect up to 1 in 100 people

• agitation or tremors
• muscle pain, muscle stiffness, muscle spasms
• constipation
• chest discomfort
• inflammation of the mucous membranes of the stomach and small intestine
• perception of extra heart sounds (based on scientific results)
• blood in the urine
• double vision or blurred vision
• increase in liver test results (seen in blood tests)
• anger, feeling tearful, excessive awareness of the environment, tension
• feeling very calm or drowsy
• generally, sleep problems
• fatigue

Rare: may affect up to 1 in 1,000 people

• changes or alterations in sexual desire
• feeling disoriented
• dilated pupils, vision problems
• breast enlargement in men
• skin redness, increased redness of skin rashes
• pain resulting from insufficient blood flow to the heart
• menstrual changes

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

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of the arteries in the brain
• abnormal liver function, including liver failure and coma
• changes in test results, including liver and blood tests
• suicidal intentions (including suicide), abnormal thoughts, loss of feelings or emotions, doing things over and over, obsession with something
• lack of energy
• feeling sad for a short period
• fingers and toes numb and cold, tingling, and color change with cold (from white to blue, then red) ("Raynaud's phenomenon")

Unknown: frequency cannot be estimated from available data

• migraine
• very high fever
• slow or fast heartbeats or palpitations
• major epileptic seizure ("grand mal" convulsions)
• believing things that are not true
• confusion
• sad/dark thoughts
• feeling a physical need for the medication or its absence
• problems with the blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion)
• erectile dysfunction
• prolonged or painful erections, or increased number of erections
• uncontrolled talkativeness
• after stopping the medication, ADHD symptoms or side effects, such as depression, may reappear
• tingling sensation
• language and speech problems
• hiccups
• attention disorders
• flu-like illness
• loss of energy/feeling of weakness
• thirst
• increases in thyroid-stimulating hormone levels in the blood
• pain in the mouth and throat area
• nasal bleeding
• heart problems
• dry eye
• higher than normal eye pressure
• stress with partner/family
• chest pain
• hot flashes/flushing
• ringing in the ears (tinnitus)
• abuse
• pancytopenia (abnormal decrease in the number of all blood cells)
• inability to control urine elimination (incontinence)
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• stuttering

Effects on growth

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

• it may prevent weight or height gain
• your doctor will carefully check the height and weight of you or your child, as well as their diet

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Medikinet

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and on the outer packaging after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect the medication from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container contents and additional information.

Composition ofMedikinet

The active ingredient is: methylphenidate hydrochloride.

Each modified-release hard capsule contains 50 mg of methylphenidate hydrochloride equivalent to 43.25 mg of methylphenidate.

The other ingredients are:

Capsule content:

Sugar spheres (contain sucrose and corn starch), methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, colloidal anhydrous silica, methylcellulose, sorbic acid, carmine, aluminum lake (E-132).

Capsule shell:

Gelatin, erythrosine (E-127), titanium dioxide (E-171), sodium lauryl sulfate, purified water, iron oxide black (E-172), carmine (E-132).

Appearance of theproductand container contents

Body of the capsule opaque violet, capsule cap opaque dark violet (18.0 mm) containing white and blue pellets.

Container sizes: Boxes of 20, 24, 27, 28, 30, 36, 40, 45, 48, 54, 60, 90, 96 or 99 modified-release hard capsules, packaged in PVC/PVdC aluminum blisters.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Manufacturer:

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Local representative:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Germany: Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Austria: Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Denmark: Medikinet CR 50 mg

Spain: Medikinet 50 mg cápsulas duras de liberación modificada

Finland: Medikinet CR 50 mg

Iceland: Medikinet CR 50 mg hart hylki með breyttan losunarhraða

Luxembourg: Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Netherlands: Medikinet CR 50 mg capsule met gereguleerde afgifte, hard

Norway: Medikinet 50 mg Kapsel med modifisert frisetting, hard

Poland: Medikinet CR 50 mg

Sweden: Medikinet 50 mg Kapsel med modifierad frisättning, hård

United Kingdom: Medikinet XL 50 mg modified-release capsules hard

(Northern Ireland)

Date of the last revision of this leaflet:May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es