Leaflet: information for the user

Medikinet 5 mg modified-release hard capsules

metilphenidate hydrochloride

This medicine is subject to additional monitoring, which will speed up the detection of any new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

What it is used for

Medikinet is used to treat "attention deficit hyperactivity disorder" (ADHD).

• It is used in children aged 6 years and older and in adults.
• It is used only after trying treatments that do not include medication, such as behavior therapy and counseling, and have been insufficient.

Medikinet is not indicated for the treatment of ADHD in children under 6 years old.

How it works

Medikinet improves the activity of certain parts of the brain that are underactive. The medication may help improve attention and concentration levels and reduce impulsive behavior.

The medication is administered as part of an integrated treatment program, which usually includes psychological, educational, and social therapy.

The treatment with Medikinet should only be initiated by a doctor, a specialist in ADHD treatment, such as a pediatrician, a child and adolescent psychiatrist, or a psychiatrist, and should be used under their supervision. This doctor must perform a thorough medical examination. If you, as an adult, have not received this type of treatment before, the doctor will perform tests to confirm that you have had ADHD since childhood. Although ADHD has no cure, it can be controlled using integrated treatment programs.

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty concentrating.

It is not their fault that they cannot do these things.

Patients may present different degrees of ADHD with symptoms such as:

•lack of concentration

•restlessness

•hyperactivity

•impulsivity

•emotional instability

•disorganized thinking

Some external signs are:

•difficulty concentrating

•forgetfulness

•excessive use of words (verborrea)

•difficulty planning and executing tasks to completion

•impulsive actions

•impatience

ADHD does not affect the child's or adolescent's intelligence.

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 a feeding disorder, are not hungry or do not want to eat, such as in "anorexia nervosa"
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have had any heart problems, such as a heart attack, irregular heartbeat, chest pain and discomfort, 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 an antidepressant (known as a monoamine oxidase inhibitor), see "Taking Medikinet with other medicines"
• have mental health problems, such as:

-a "psychopathic" disorder or a "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, despised and desperate

-mania, feeling exceptionally excited, more active than normal and uninhibited.

• have a history of severe acid deficiency in the stomach (gastric acid deficiency) with pH values above 5.5
• are taking medications to reduce stomach acid secretion or to treat excessive stomach acid (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 unsure, inform your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these problems.

Warnings and precautions

Consult your doctor before starting to take Medikinet if you or your child

• have liver or kidney problems
• have difficulty swallowing or swallowing the whole tablets
• have had seizures (attacks, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG, a brain study)
• have abused alcohol, prescription medications, or illegal drugs at any time
• are a woman and have started menstruating (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 included in the previous section "Do not take"
• have a mental health problem not included in the previous section "Do not take". Other mental health problems include:

-mood swings (from being manic to being depressed, known as "bipolar disorder")

-aggressive or hostile behavior, or if aggression worsens

-seeing, hearing, or feeling things that are not there (hallucinations)

-believing things that are not real (delusions)

-feeling strangely suspicious (paranoia)

-feeling agitated, anxious, or tense

-feeling depressed or guilty.

Inform 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 medication affects you or your child.

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

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

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

• the medications you or your child are taking
• if you or your family have a history of sudden, unexplained death
• other health problems you or your family may have (such as heart problems)
• how you or your child are; for example, if you have mood swings, have strange thoughts, or have had thoughts 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)
• any past behavior or mental health problems you or your child have had or other family members have had.

Your doctor will explain specifically if you or your child are at risk of developing mood swings (from being manic to being depressed, 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 to provide all the information you can. This will help your doctor decide if methylphenidate is the right medication for you or your child. Your doctor may decide that you or your child need other medical tests before starting this medication.

Drug analysis

This medication may give positive results in drug tests.

Competitors should note that this medication may produce a positive result in doping control tests.

Taking Medikinet with other medicines

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medication.

Do not take metilfenidato if you or your child:

• are taking a medication called "monoamine oxidase inhibitor" (MAOI) that is used for depression, or have taken an MAOI in the last 14 days. The use of an MAOI with methylphenidate may cause a sudden increase in blood pressure.

If you or your child are taking other medications, methylphenidate may affect the mechanism of action of these medications or cause adverse effects. Inform your doctor if you or your child are taking medications to treat:

• depression
• mental health problems
• epilepsy
• blood pressure problems
• the common cold and flu. Some remedies contain medications that may affect blood pressure, so it is essential to consult your pharmacist when buying a product of this type
• blood thinners to prevent blood clots.

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

If you have any doubts about whether any of the medications you or your child are taking are included in the above list, consult your doctor or pharmacist for advice before taking methylphenidate.

Before surgery

Inform your doctor if you or your child are undergoing surgery. Do not take methylphenidate on the day of surgery with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Taking metilfenidato with alcohol

Do not drink alcohol while taking this medication. Alcohol may worsen the adverse effects of this medication. Remember that some foods and medications contain alcohol.

Pregnancy and breastfeeding

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

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

• are sexually active. Your doctor will discuss birth control methods.
• are pregnant or think they 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 operating machines

You or your child may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other central nervous system effects when taking methylphenidate. If this occurs, it may be hazardous to perform certain activities, such as driving, operating machines, riding a bike or horse, or climbing trees.

Medikinet contains saccharose

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

Medikinet contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; that is, it is essentially "sodium-free".

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 your child's treatment

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 rare feelings. Or if they have worsened while taking Medikinet.

How to take

This medication is for oral administration.

Medikinet should be taken by children in the morningwith or afterbreakfast.

Medikinet should be taken by 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 Toxicology 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: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• mood changes
• suicidal thoughts or feelings
• 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
• allergic signs 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: may affect up to 1 in 1,000 people

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

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

• heart attack
• seizure (attacks, epilepsy with convulsions)
• skin peeling 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
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets), which may 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 medicines 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 consult your 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 excessive interest
• joint pain
• high temperature (fever)
• excessive hair loss or thinning of hair (hair becomes finer)
• excessive drowsiness or drowsiness
• loss of appetite
• panic attack
• decreased libido
• toothache
• 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)
• rapid heartbeat (tachycardia) or irregular heart rhythm (arrhythmia), cold hands and feet
• agitation or tremor, feeling of dizziness
• uncontrolled movements, feeling of internal restlessness
• excessive activity
• aggressiveness, 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 medicine with food
• loss of appetite/no desire to eat
• weight loss
• excessive sweating

Uncommon: may affect up to 1 in 100 people

• agitation 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
• double vision or blurred vision
• increase in liver function test results (seen in blood tests)
• anger,feeling tearful, excessive awareness of the environment, tension
• feeling extremely calm or drowsy
• general 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
• 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: may 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 function tests and blood tests
• suicidal intent (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
• numbness or coldness in the fingers and toes, 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
• problems with brain blood vessels (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 may occur, such as depression
• tingling sensation
• problems with language and speech
• arcades
• 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
• dry eye
• increased intraocular pressure
• family or partner relationship stress
• chest pain
• flushing/rubefaction
• tinnitus (ringing in the ears)
• abuse
• pancytopenia (abnormal decrease in the number of all blood cells)
• inability to control urination (incontinence)
• jaw muscle spasm 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 leaflet. 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 medicine

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.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE point of your pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofMedikinet

The active ingredient is: methylphenidate hydrochloride.

Each modified-release hard capsule contains 5 mg of methylphenidate hydrochloride equivalent to 4.35 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, titanium dioxide (E-171), sodium lauryl sulfate, purified water.

Appearance of theproductand contents of the package

Body of the hard capsule opaque white/cap of the hard capsule opaque white (15.9 mm) containing white and blue pellets.

Package sizes: Boxes of 20, 24, 27, 30, 36, 45, 48, 50, 54, 60, 63, 90, 96 or 99 modified-release hard capsules, packaged in PVC/PVdC aluminum blisters.

Only some package 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 with the following names:

Germany:Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Austria:Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Denmark:Medikinet CR 5 mg

Spain:Medikinet 5 mg modified-release hard capsules

Finland:Medikinet CR 5 mg

Island:Medikinet CR 5 mghard hylki með breyttan losunarhraða

Luxembourg:Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Netherlands:Medikinet CR 5 mg capsule met gereguleerde afgifte, hard

Norway:Medikinet 5 mg Kapsel med modifisert frisetting, hard

Poland:Medikinet CR 5 mg

Sweden:Medikinet 5 mg Kapsel med modifierad frisättning,hård

United Kingdom:Medikinet XL 5 mg modified-release capsules hard

Last review date of this leaflet:June 2022

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