Prospect: information for the user

Methylphenidate Tecnigen 54 mg prolonged-release tablets EFG

Methylphenidate hydrochloride

Read this prospect carefully before you or your child start taking this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you or your child, and you must not give it to other people even if they have the same symptoms of illness as you or your child, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

What it is used for

Methylphenidate Tecnigen is used to treat attention deficit hyperactivity disorder (ADHD)

• It is used in children and adolescents agedbetween 6 and 18 years
• It is used only after having tried treatments that do not include medications, as well as behavioral therapy and counseling.

Methylphenidate Tecnigen is not indicated for the treatment of ADHD in children under 6 years or for the initiation of treatment in adults.

When treatment is started at a young age, it may be appropriate to continue taking Methylphenidate Tecnigen until adulthood. Your doctor will advise you on this.

How it works

Methylphenidate Tecnigen improves the activity of certain parts of the brain that are underactive. The medication may help improve attention (level of attention), concentration, and reduce impulsive behavior.

The medication is administered as part of an integrated treatment program, which typically includes:

• psychological therapy,
• educational therapy, and
• social therapy

and its goal is to stabilize children with ADHD who have symptoms that may include chronic mild attention deficits, distractibility, emotional instability, impulsivity, moderate to severe hyperactivity, mild neurological signs, and EEG abnormalities. Learning ability may be affected or not affected. A diagnosis cannot be established solely on the presence of one or more symptoms. An adequate diagnosis requires the use of specialized medical, psychological, educational, and social resources.

Only prescribed by doctors with experience in children's or adolescents' behavioral problems.Although ADHD has no cure, it can be controlled using integrated treatment programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• staying still
• concentrating.

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

Many children and adolescents struggle to do them. However, ADHD patients may experience problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, in school, or in other places.

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

The methylphenidate treatment is not indicated for all children with ADHD, and the decision to use the medication should be based on a very comprehensive evaluation of the severity and chronicity of the child's symptoms in relation to their age. Methylphenidate should always be used in accordance with its authorized indication and in accordance with the guidelines for prescription and diagnosis.

Do not take Metilfenidato Tecnigen if you or your child:

• are allergic to methylphenidate or any of the other components of this medication (see section 6),
• have a thyroid problem,
• have glaucoma (high eye pressure),
• have phaeochromocytoma (a tumor in the adrenal glands),
• have an eating disorder, are not hungry or do not want to eat, such as in “anorexia nervosa”,
• have very high blood pressure or a narrowing of the blood vessels, which can cause pain in the arms and legs,
• have had any time 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 part 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 any antidepressant (known as monoamine oxidase inhibitor) (see the section “Taking Metilfenidato Tecnigen with other medications”),
• have mental health problems such as:
• • a psychotic 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,
  • diagnosis or history of severe and episodic bipolar (affective) disorder (type I).

Do not take methylphenidate if you or your child present any of the above. If you are unsure, inform your doctor or pharmacist before you or your child take methylphenidate, as methylphenidate may worsen these problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metilfenidato Tecnigen if you or your child:

• have liver or kidney problems,
• have difficulty swallowing or swallowing the whole tablets,
• have a narrowing or blockage in the digestive system,
• have had seizures or any alteration in the electroencephalogram (EEG/a brain study),
• have ever abused or been dependent on alcohol, prescription medications or drugs,
• 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 (tics) or sounds and words repeated,
• have high blood pressure,
• have a heart problem not included in the previous section “Do not take Metilfenidato Tecnigen if you or your child...”,
• have a mental health problem not included in the previous section “Do not take Metilfenidato Tecnigen if you or your child...”.

Other mental health problems include:

• mood swings (from being manic to being depressed, known as “bipolar disorder”),
• experiencing aggressive or hostile behavior, or that 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 present any of the above before starting treatment, as methylphenidate may worsen these problems. Your doctor will want to monitor how the medication affects you or your child.

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

To be able to decide if methylphenidate is the right medication for you or your child, your doctor will talk to you about:

• the medications you or your child are taking,
• if you or your family have a history of sudden and unexplained death,
• other health problems you or your family (such as heart problems) may have,
• how you are, if you have mood swings, have abnormal thoughts or have had such thoughts in the past,
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or sounds and words repeated),
• possible behavior or mental health problems you or your child have ever 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 check your or your child’s mental health history and check if any family member has a history of suicide, bipolar disorder or depression,
• determine your or your child’s height, weight, heart rate and blood pressure, and record the results in a table.

It is important that you provide all the information you can. This will help your doctor decide if methylphenidate is the right medication for you or your child. It is possible that your doctor will decide that you or your child need other medical tests before starting to take this medication.

Taking Metilfenidato Tecnigen with other medications

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

Do not take methylphenidate 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. If you or your child are taking any of the following medications, consult your doctor or pharmacist before taking methylphenidate:

• other medications for depression,
• medications for severe mental health problems,
• medications for epilepsy,
• medications used to lower or raise blood pressure,
• some cold and flu remedies that contain medications that can affect blood pressure. It is important that you consult your pharmacist when purchasing any of these medications,
• medications that thin the blood to prevent the formation of blood clots.

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 to undergo surgery. Methylphenidate should not be taken on the day of surgery with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Use in athletes

Warn patients that this medication contains methylphenidate, which may produce a positive result in doping control tests

Taking Metilfenidato Tecnigen 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

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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

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

• are having sex. Your doctor will talk to you about birth control methods,
• are pregnant or think you may be pregnant. Your doctor will decide if you should use 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 using methylphenidate.

Driving and operating machinery

You or your child may experience dizziness, difficulty focusing or blurred vision when taking methylphenidate. If this occurs, it may be dangerous to perform certain activities such as driving, operating machinery, riding a bike or horse or climbing trees.

Metilfenidato Tecnigen contains saccharose

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

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

Before you or your child start treatment, your doctor will perform several checks at each dose change, after every six months, or at each visit to ensure that Metilphenidate Tecnigen remains safe and beneficial. These will include:

• Measurement and recording on a graph of blood pressure and heart rate, each time your dose or your child's dose changes and at least every six months or at each visit.
• Measurement of height, weight, and appetite, recording them on a graph, each time your dose or your child's dose changes and at least every six months or at each visit.
• Evaluation of psychiatric problems, each time your dose or your child's dose changes and at least every six months or at each visit.

Dose adjustment

The dose must be adjusted carefully when starting treatment with metilphenidate. Dose adjustment should begin with the lowest possible dose.

How to take

Follow exactly the administration instructions for this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• Your doctor will usually start treatment with a low dose and increase it gradually as needed.gradually as needed.
• The maximum daily dose is 54milligrams.
• You or your child should take Metilphenidate Tecnigen once a day in the morning with a glass of water.The tablet should be swallowed whole and not chewed or crushed.The tablet can be taken with or without food.

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

If you or your child do not feel better, inform your doctor. He may decide if a different treatment is needed. Inform your doctor if you or your child do not notice improvement after one month of treatment with Metilphenidate Tecnigen.

Long-term treatment

Metilphenidate Tecnigen treatment does not need to be indefinite. If Metilphenidate Tecnigen is taken for more than a year, your doctor should interrupt your treatment or your child's treatment for a short period of time once a year to check if the medication is still needed. You or your child may continue to benefit when Metilphenidate treatment is temporarily or permanently interrupted. This may occur during school vacations.

Patients on long-term treatment (for example, 12 months) should be monitored carefully, especially regarding their cardiovascular status, growth, appetite, development of new psychiatric symptoms or worsening of existing ones.

Abuse of Metilphenidate Tecnigen

You should monitor your child for the risk of diversion to illicit traffic, misuse, or abuse of metilphenidate. Continuous abuse of metilphenidate may cause marked tolerance, psychological dependence, abnormal behavior, and psychotic episodes.

Inform your doctor if you or your child have abused or have been dependent on alcohol, prescription medications, or drugs.

This medication is only for you or your child. Do not give this medication to anyone else, even if they have similar symptoms.

If you or your child take more Metilphenidate Tecnigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 915620420), indicating the medication and the amount taken.

The signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which may be followed by coma), feeling extremely happy, confusion, hallucinations (seeing, feeling, or hearing things that are not real), 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.

If you or your child forget to take Metilphenidate Tecnigen

Do not take a double dose to compensate 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 taking Metilphenidate Tecnigen

This medication should not be stopped abruptly. If you or your child stop taking this medication abruptly, the symptoms of ADHD or unwanted effects such as depression may reappear. Your doctor may want to gradually reduce the amount of medication taken each day before stopping it completely. Consult your doctor before stopping treatment with Metilphenidate Tecnigen.

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. Although some people may experience side effects, methylphenidate helps most people. Your doctor will inform you about these side effects.

Some side effects can be serious. If you or your child have any of the side effects listed below, seek immediate medical attention:

Frequent (may affect up to 1 in 10 patients)

• Irregular heartbeats (palpitations),
• Changes or mood swings or changes in personality.

Less frequent (may affect up to 1 in 100 patients)

• Thoughts or suicidal feelings,
• Seeing, feeling, or hearing things that are not real (hallucinations); these are symptoms of psychosis,
• Uncontrolled speech and body movements (Tourette's syndrome),
• 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, wheezing, difficulty breathing.

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

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

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

• Myocardial infarction,
• Sudden death,
• Intention to commit suicide,
• Crisis (seizures, convulsions, epilepsy),
• Peeling of the skin or purpuric spots,
• Inflammation or blockage of cerebral arteries,
• Uncontrolled muscle spasms, affecting the eyes, head, neck, body, and nervous system due to lack of blood flow to the brain,
• Decreased number of blood cells (red blood cells, white blood cells, and platelets) that may increase the risk of infection 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 frequency (frequency cannot be estimated from available data)

• Unwanted thoughts that recur,
• Unexplained fainting, chest pain, shortness of breath (may be signs of heart problems),
• Paralysis or movement and vision problems, speech difficulties (may be signs of cerebral vessel problems).

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

The following side effects are listed below; and if they become serious, please inform your doctor or pharmacist:

Very frequent (may affect more than 1 in 10 patients)

• Headache,
• Nervousness,
• Difficulty sleeping.

Frequent (may affect up to 1 in 10 patients)

• Joint pain,
• Blurred vision,
• Headache due to muscle tension,
• Dry mouth, thirst,
• Difficulty falling asleep,
• High fever,
• Decreased libido,
• Excessive hair loss or thinning of hair,
• Muscle tension, muscle cramps,
• Loss of appetite or decreased appetite,
• Inability to achieve or maintain an erection,
• Itching, red rashes that itch (hives),
• Excessive drowsiness or drowsiness, feeling tired,
• Grinding or clenching teeth, panic sensation,
• Sensation of tingling, itching, or numbness of the skin,
• Increased levels of alanine aminotransferase in the blood (liver enzyme),
• Cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection, sinusitis,
• High blood pressure, rapid heartbeat (tachycardia),
• Dizziness (vertigo), feeling weak, uncontrolled movements, excessive activity,
• Aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior,
• Stomach discomfort or indigestion, stomach pain, diarrhea, feeling dizzy, stomach discomfort, and vomiting.
• Excessive tooth grinding (bruxism)
• Excessive sweating

Less frequent (may affect up to 1 in 100 patients)

• Dry eyes,
• Constipation,
• Chest discomfort,
• Blood in the urine,
• Apathy,
• Agitation or tremor,
• Muscle pain, muscle spasms,
• Shortness of breath or chest pain,
• Sensation of heat,
• Increased liver enzyme results (seen in a blood test),
• Irritability (angry), restless, or tearful, excessive awareness of the environment, difficulty sleeping.

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

• Feeling disoriented or confused,
• Vision problems or double vision,
• Swelling of the chest in men,
• Redness of the skin, increased redness of skin rashes.

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

• Muscle cramps,
• Small red spots on the skin,
• Abnormal liver function, including liver failure and coma,
• Changes in test results; including liver and blood tests,
• Abnormal thoughts, absence of feelings or emotions, doing things repeatedly, obsession with something,
• Hands and feet numbness, tingling, and color change with cold (white to blue, then red) ("Raynaud's phenomenon").

Unknown frequency (frequency cannot be estimated from available data)

• Migraine,
• Dilated pupils,
• Very high fever,
• Slow, rapid, or irregular heartbeats,
• Major epilepsy seizures ("grand mal seizures"),
• Believing things that are not true,
• Severe stomach pain, with discomfort and vomiting.
• Inability to control urination (incontinence)
• Spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• Stuttering
• Nasal bleeding

Effects on growth

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicines for Human Use. Website: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 (EXP) that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe that the tablet is damaged.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Metilfenidato Tecnigen

• The active ingredient is hydrochloride of metilfenidato. Each prolonged-release tablet contains 54mg of hydrochloride metilfenidato equivalent to 46.70mg of metilfenidato.

• The other components are:

Tablet core:Sugar spheres (sacarosa, cornstarch), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, acetate succinate of hypromellose, sodium carmellose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, hydrochloric acid.

Tablet coating:Opadry II white consisting of: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350. Opadry II red consisting of: polyvinyl alcohol, talc, iron oxide red (E172), macrogol 3350, hydrochloric acid.

Appearance of the product and content of the container

Metilfenidato Tecnigen 54 mg are oblong, biconvex, reddish to red tablets of 13.3 x 6.4 mm with grooves on both sides. The tablet can be divided into equal doses

The prolonged-release tablets are available in screw-top containers with child-resistant closures.

Container sizes:

Containers containing 28 or 30 prolonged-release tablets.

Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmaceutica, S.A.

Avda. de Bruselas, 13, 3rd D. Edificio América. Polígono Arroyo de la Vega,

28108– Alcobendas (Madrid)

Spain

Responsible manufacturer:

Develco Pharma GmbH

Grienmatt 42

79650 Schopfheim

Germany

Last review date of this leaflet: September 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http: //www.aemps.gob.es/