Follow exactly the administration instructions of this medication 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 entire contents of the capsule.
• Medikinet should not be taken very late in the morning, as it may cause sleep disturbances.

Use in adults

For adults who have taken Medikinet before

• If you have already taken Medikinet during childhood or adolescence, you can use the same daily dose (mg/day); your doctor will check regularly if it is necessary to adjust the dose
• Adult patients may require a higher daily dose, but your 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 by 10 mg per day as needed, based on 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 on 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 - you will be tested at least every 6 months, and even more often, also when the dose is changed.

• These tests will include:

• Appetite control
• Measurement of height and weight in children
• Measurement of weight in adults
• Measurement of blood pressure and heart rate
• Evaluation of mood-related problems, mental state, or any other infrequent feelings. Or if they have worsened while taking Medikinet.

How to take

This medication is for oral administration.

Medikinet should be administered to children in the morningwith or afterbreakfast.

Medikinet should be administered to adultswith or afterbreakfast and lunch.

Medikinet is a form of methylphenidate with a "controlled release" action, 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 the contents sprinkled over a small amount (a spoonful) 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 of time. In the case of children, the interruption can be made during school holidays. This allows you to demonstrate if you still need the medication.

Improper use ofMedikinet

If Medikinet is not used properly, it may 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 abused or have ever been dependent on alcohol, prescription medications, or illegal drugs.

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

If you or your child take moreMedikinetthan you should

In case of overdose or accidental ingestion, call your doctor, the nearest hospital emergency service, or the Toxicological Information Service, phone: 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, uncontrolled movements, muscle contractions, seizures (sometimes followed by coma), feeling extremely happy, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth, muscle spasms, fever, and darkening of urine to a reddish-brown color, which may be possible signs of abnormal muscle breakdown (rhabdomyolysis).

If you or your child forget to takeMedikinet

Do not take a double dose to make up for the missed 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 takingMedikinet

If you or your child stop taking this medication suddenly, you may experience a return of ADHD symptoms or unwanted effects, such as depression. Your doctor may want to gradually reduce 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Your doctor will inform you about these side effects.

Some side effects can be serious. If you or your child experience any of the following side effects, seek medical attention immediately:

Common: can affect up to 1 in 10 people

• Irregular heartbeats (palpitations)
• Changes in personality
• Excessive teeth grinding (bruxism)

Uncommon: can affect up to 1 in 100 people

• Mood changes
• Thoughts or feelings of suicide
• Feeling or hearing things that are not real, symptoms of psychosis
• Uncontrolled speech and body movements (Tourette's syndrome) or worsening of these symptoms
• Chest pain
• Signs of allergy such as hives, itching, or urticaria on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, difficulty or problems breathing

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

• Feeling exceptionally elated, more active than normal, and uninhibited (mania)

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

• Heart attack
• Seizure (attacks, epilepsy with convulsions)
• Peeling of the skin or purple patches
• Uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system, due to lack of blood flow to the brain
• Paralysis or problems with movement and vision, difficulty speaking (these may be signs of brain blood vessel problems), temporary lack of blood and oxygen supply to the brain
• Decreased number of blood cells (red blood cells, white blood cells, and platelets), which can increase the risk of infections and cause easy bruising and bleeding
• Sudden increase in body temperature, very high blood pressure, and severe convulsions ("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: the frequency cannot be estimated with the available data

• Unwanted thoughts that recur
• Unexplained fainting, shortness of breath (these may be signs of heart problems)

If you or your child experience any of the side effects listed above, seek medical attention immediately.

The following side effects are listed below, and if they become serious, please seek medical attention or contact your pharmacist immediately:

Very common: can affect more than 1 in 10 people

• Decreased appetite
• Headache
• Nervousness
• Difficulty sleeping
• Dry mouth
• Nausea

Common: can affect up to 1 in 10 people

• Depression or lack of feelings or emotions or excessive interest
• Joint pain
• Elevated temperature (fever)
• Excessive hair loss or thinning of hair (hair becomes finer)
• Excessive drowsiness or drowsiness
• Decreased appetite
• Panic attack
• Decreased libido
• Dental pain
• Itching, hives, or increased itching of red hives (urticaria)
• Cough, sore throat, or irritation of the throat and nose, shortness of breath, or chest pain
• Changes in blood pressure (usually high blood pressure)
• Fast or irregular heartbeat (tachycardia) or arrhythmia, cold hands and feet
• Restlessness or tremor, feeling dizzy
• Uncontrolled movements, feeling of internal unrest
• Excessive activity
• Aggression, agitation, restlessness, emotional instability, anxiety, depression, stress, irritable and abnormal behavior, difficulty sleeping, fatigue
• Stomach pain, diarrhea, indigestion, nausea, vomiting. These side effects usually occur at the beginning of treatment and may decrease by taking the medication with food
• Loss of appetite/no desire to eat
• Weight loss
• Excessive sweating

Uncommon: can affect up to 1 in 100 people

• Restlessness or tremor
• 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
• Dual vision or blurred vision
• Increased liver enzyme results (seen in blood tests)
• Irritability, feeling tearful, excessive awareness of the environment, tension
• Feeling extremely calm or sleepy
• General sleep problems
• Fatigue

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

• Changes or alterations in sexual desire
• Feeling disoriented
• Dilated pupils, vision problems
• Swelling of the chest in men
• Redness of the skin, increased redness of skin hives
• Pain resulting from insufficient blood flow to the heart
• Menstrual changes or problems

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

• Heart attack
• Sudden death
• Muscle cramps
• Small red patches on the skin
• Inflammation or blockage of brain blood vessels
• Abnormal liver function, including liver failure and coma
• Changes in test results, including liver and blood tests
• Intention to commit suicide (including suicide), abnormal thinking, loss of feelings or emotions, doing things repeatedly, obsession with something
• Lack of energy
• Feeling sad for a short period of time
• Fingers and toes numb and cold, tingling, and color change with cold (Raynaud's phenomenon)

Unknown: the frequency cannot be estimated with the available data

• Migraine
• Very high fever
• Slow or rapid heartbeat or palpitations
• Major seizure (grand mal seizure)
• Believing things that are not true
• Confusion
• Dark or sad thoughts
• Feeling a physical need for the medication or its absence
• Brain blood vessel problems (stroke, cerebral arteritis, or cerebral occlusion)
• Erectile dysfunction
• Prolonged erections, sometimes painful, or increased number of erections
• Uncontrolled talkativeness
• After stopping the medication, symptoms of ADHD may reappear or side effects such as depression may occur
• Feeling tingling
• Language and speech problems
• Cramps
• Attention disorders
• Illness similar to the flu
• Loss of energy/feeling weak
• Thirst
• Increased levels of thyroid-stimulating hormone in the blood
• Pain in the mouth and throat area
• Nasal bleeding
• Chest discomfort
• Eye dryness
• Higher than normal eye pressure
• Stress with partner/family
• Chest pain
• Flushes/rubefaction
• Tinnitus (ringing in the ears)
• Abuse
• Pancytopenia (abnormal decrease in the number of all blood cells)
• Inability to control urination (incontinence)
• Spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• Stuttering

Effects on growth

Methylphenidate may reduce growth in some children when taken for more than a year. This affects less than 1 in 10 children.

• May prevent weight gain or height increase
• Your doctor will carefully check your or your child's height and weight, as well as their diet
• If you or your child do not grow as expected, the treatment with methylphenidate may be interrupted for a short period of time.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

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 components are:

Capule content:

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

Capule coating:

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

Appearance of theproductand contents of the package

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

Packaging 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 packaging 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 medicine is authorized in the member states of the European Economic Area with 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 modified-release hard capsules

Finland:Medikinet CR 50 mg

Island:Medikinet CR 50 mghard 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

Last review date of this leaflet:June 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es