Methylphenidate Tecnigen 18 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Methylphenidate Tecnigen 18 mg prolonged-release tablets EFG

Methylphenidate hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only; do not pass it on to others, even if they have the same symptoms 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Methylphenidate Tecnigen is and what it is used for.
2. What you need to know before you or your child take Methylphenidate Tecnigen.
3. How to take Methylphenidate Tecnigen.
4. Possible adverse effects.
5. How to store Methylphenidate Tecnigen.
6. Contents of the pack and other information.

1. What Metilfenidato Tecnigen is and what it is used for

What it is used for

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

• It is used in children and adolescents aged between 6 and 18 years.
• It is used only after non-medication treatments, such as behavioral therapy and counseling, have been tried.

Metilfenidato Tecnigen is not indicated for the treatment of ADHD in children under 6 years of age or for initiating treatment in adults.

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

How it works

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

The medicine is administered as part of a comprehensive treatment program, which typically includes:

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

The goal is to stabilize children with ADHD who have symptoms that may include a chronic history of low attention span, distractibility, emotional instability, impulsivity, moderate to severe hyperactivity, mild neurological signs, and abnormalities in the electroencephalogram (EEG). Learning ability may or may not be affected. Diagnosis cannot be established solely on the presence of one or more symptoms. An appropriate diagnosis requires the use of specialized medical and psychological, educational, and social resources.

It is prescribed only by physicians experienced in managing behavioral problems in children or adolescents. Although ADHD cannot be cured, it can be managed using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have difficulties with:

• staying still,
• concentrating.

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

Many children and adolescents struggle with these tasks. However, patients with ADHD may experience problems in daily life. Children and adolescents with ADHD may have difficulties with learning and completing homework. They may have trouble behaving appropriately at home, at school, or in other settings.

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

Treatment with methylphenidate is not indicated for all children with ADHD, and the decision to use the medicine must be based on a thorough assessment of the severity and chronicity of the child's symptoms in relation to age. Methylphenidate must always be used in accordance with its authorized indications and in line with prescribing and diagnostic guidelines.

2. What you need to know before starting Metilfenidato Tecnigen

Do not take Metilfenidato Tecnigen if you or your child:

• are allergic to methylphenidate or any of the other ingredients of this medicine (see section 6),
• have a thyroid problem,
• have glaucoma (high eye pressure),
• have phaeochromocytoma (a tumor of the adrenal glands),
• have an eating disorder, lack of appetite, or do not want to eat, such as in "anorexia nervosa",
• have very high blood pressure or narrowing of blood vessels, which may cause pain in the arms and legs,
• have ever had heart problems such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or a congenital heart defect,
• have ever had a problem with blood vessels in the brain such as stroke, dilation or weakness of part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis),
• are taking or have taken within the last 14 days any antidepressant medicine (known as monoamine oxidase inhibitor) (see section “Taking Metilfenidato Tecnigen with other medicines”),
• have mental health problems such as:
  • a psychopathic disorder or borderline personality disorder,
  • abnormal thoughts or hallucinations or an illness called "schizophrenia",
  • signs of a serious mood disorder such as:
    • suicidal thoughts,
    • severe depression, feeling very sad, worthless, and hopeless,
    • mania, feeling unusually elated, more active than normal, and disinhibited,
  • diagnosis or history of severe and episodic bipolar (affective) disorder (type I).

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

Warnings and precautions

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

• have liver or kidney problems,
• have difficulty swallowing or problems with swallowing whole tablets,
• have narrowing or blockage in the digestive tract,
• have ever had seizures (fits, convulsions, epilepsy) or any abnormalities in the electroencephalogram (EEG/a study of brain activity),
• have ever abused or been dependent on alcohol, prescription medicines, or drugs,
• are a woman who has started menstruating (see section “Pregnancy and breastfeeding” below),
• have difficulty controlling repetitive movements of certain body parts (tics) or repeated sounds and words,
• have high blood pressure,
• have a heart problem not listed in the previous section “Do not take Metilfenidato Tecnigen if you or your child...”,
• have a mental health condition not listed in the previous section “Do not take Metilfenidato Tecnigen if you or your child...”,
• experience blurred vision or other visual disturbances, contact your doctor. Your doctor may consider stopping treatment with Metilfenidato Tecnigen.

Other mental health problems include:

• mood swings (from manic to depressed, known as "bipolar disorder"),
• displaying aggressive or hostile behavior, or worsening of aggression,
• seeing, hearing, or feeling things that are not there (hallucinations),
• believing things that are not true (delusions),
• feeling unusually suspicious (paranoia),
• feeling restless, anxious, or tense,
• feeling depressed or guilty.

Inform your doctor or pharmacist if you or your child experience any of the above before starting treatment, because methylphenidate may worsen these problems. Your doctor will want to monitor how the medicine affects you or your child.

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

To decide whether methylphenidate is the right medicine for you or your child, your doctor will discuss with you:

• the medicines you or your child are taking,
• whether there is a family history of unexplained sudden death,
• other illnesses you or your family may have (such as heart problems),
• how you are feeling, whether you have mood swings, strange thoughts, or have had such feelings in the past,
• whether there is a family history of tics (difficulty controlling repetitive movements of certain body parts or repeated sounds and words),
• any possible behavioral or mental health problems you, your child, or other family members may have had. Your doctor will specifically explain whether you or your child are at risk of mood changes (from manic to depressed, known as "bipolar disorder"). Your doctor will review your or your child’s mental health history and check whether any family members have a history of suicide, bipolar disorder, or depression,
• measure and record your or your child’s height, weight, heart rate, and blood pressure on a chart.

It is important that you provide as much information as possible. This will help your doctor decide whether methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need further medical tests before starting this medicine.

Taking Metilfenidato Tecnigen with other medicines

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

Do not take methylphenidate if you or your child:

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

If you or your child are taking other medicines, methylphenidate may affect how these medicines work or cause adverse effects. If you or your child are taking any of the following medicines, consult your doctor or pharmacist before taking methylphenidate:

• other medicines for depression,
• medicines for serious mental health conditions,
• medicines for epilepsy,
• medicines used to lower or raise blood pressure,
• some cough and cold remedies containing medicines that may affect blood pressure. It is important to consult your pharmacist when purchasing any of these medicines,
• medicines that thin the blood to prevent clotting.

If you are unsure whether 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 surgery

Inform your doctor if you or your child are scheduled for surgery. Methylphenidate should not be taken on the day of surgery when certain types of anesthetics are used, as this may cause a sudden increase in blood pressure during the procedure.

Use in athletes

Patients should be advised that this medicine contains methylphenidate, which may result in a positive doping test.

Taking Metilfenidato Tecnigen with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Available data do not suggest an increased risk of overall congenital malformations, although a small increased risk of cardiac malformations during use in the first trimester of pregnancy cannot be ruled out. Your doctor will provide further information about this risk.

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

• are sexually active. Your doctor will discuss contraceptive methods with you,
• are pregnant or think you may be pregnant. Your doctor will decide whether you should use methylphenidate,
• are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while using methylphenidate.

Driving and using machines

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

Metilfenidato Tecnigen contains sucrose

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Metilfenidato Tecnigen

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

• Measurement and recording on a chart of blood pressure and heart rate, each time your or your child's dose is changed and at least every six months or at each visit.
• Measurement of height, weight, and appetite, recorded on a chart, each time your or your child's dose is changed and at least every six months or at each visit.
• Assessment of psychiatric problems, each time your or your child's dose is changed and at least every six months or at each visit.

Dose adjustment

It is necessary to carefully adjust the dose when starting treatment with methylphenidate. Dose adjustment should begin with the lowest possible dose.

How much to take

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

If you or your child do not feel better, inform your doctor. Your doctor may decide whether a different treatment is needed. Inform your doctor if you or your child do not notice improvement after 1 month of treatment with Metilfenidato Tecnigen.

Long-term treatment

Treatment with Metilfenidato Tecnigen does not need to be indefinite. If Metilfenidato Tecnigen is taken for more than one year, your doctor should interrupt your or your child's treatment for a short period once a year to assess whether the medicine is still needed. You or your child may continue to experience benefits when treatment with Metilfenidato is temporarily or permanently interrupted. This may occur during school holidays.

Patients on long-term treatment (e.g., 12 months) should be carefully monitored, particularly regarding cardiovascular status, growth, appetite, development of new psychiatric symptoms, or worsening of pre-existing ones.

Inappropriate use of Metilfenidato Tecnigen

You should monitor your child for the risk of illicit diversion, misuse, or abuse of methylphenidate. Continued abuse of methylphenidate may lead to marked tolerance, psychological dependence, abnormal behavior, and psychotic episodes.

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

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 915620420), stating the medicine and amount taken.

Signs of overdose may include: feeling unwell, agitation, tremors, increased uncontrolled movements, muscle twitching, 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 heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth.

If you or your child forget to take Metilfenidato Tecnigen

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

If you or your child stop taking Metilfenidato Tecnigen

This medicine should not be stopped suddenly. If you or your child stop taking this medicine suddenly, ADHD symptoms or unwanted effects such as depression may reappear. Your doctor may wish to gradually reduce the daily dose before stopping treatment completely. Consult your doctor before stopping treatment with Metilfenidato Tecnigen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. Although some people may experience adverse effects, methylphenidate helps most people. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If you or your child experience any of the following adverse effects, contact your doctor immediately:

Frequent (may affect up to 1 in 10 patients)

• irregular heartbeat (palpitations),
• changes or disturbances in mood or personality.

Uncommon (may affect up to 1 in 100 patients)

• suicidal thoughts or feelings,
• seeing, feeling, or hearing things that are not real (hallucinations); these are symptoms of psychosis,
• uncontrolled speech and body movements (Tourette’s syndrome),
• signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other body parts, shortness of breath, noisy breathing, difficulty or problems breathing.

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

• feeling unusually elated, more active than normal and disinhibited (mania)

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

• heart attack,
• sudden death,
• suicidal ideation,
• seizures (fits, convulsions, epilepsy),
• skin peeling or purplish-red spots,
• inflammation or blockage of arteries in the brain,
• uncontrolled muscle spasms affecting the eyes, head, neck, body and nervous system as a result of reduced blood flow to the brain,
• decreased number of blood cells (red blood cells, white blood cells and platelets), which may increase the risk of infections and make bleeding and bruising more likely,
• sudden increase in body temperature, very high blood pressure and severe convulsions (“Neuroleptic Malignant Syndrome”). It is not entirely certain whether this adverse effect is caused by methylphenidate or by other medicines taken in combination with methylphenidate.

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

• unwanted thoughts that keep recurring,
• 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 blood vessel problems in the brain).

If you or your child experience any of the adverse effects listed above, contact your doctor immediately.

The following adverse effects are also reported; if they become severe, please inform your doctor or pharmacist:

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

• headache,
• feeling nervous,
• difficulty sleeping.

Frequent (may affect up to 1 in 10 patients)

• joint pain,
• blurred vision,
• tension headache,
• dry mouth, thirst,
• difficulty falling asleep,
• high temperature (fever),
• decreased sexual interest,
• abnormal hair loss or reduced hair thickness (thinner hair),
• muscle tension, muscle cramps,
• loss of appetite or decreased appetite,
• inability to achieve or maintain an erection,
• itching, rash or red itchy eruptions (hives),
• drowsiness or unusual drowsiness, feeling tired,
• teeth grinding or clenching, feeling of panic,
• tingling, itching or numbness of the skin,
• increased levels of alanine aminotransferase in blood (liver enzyme),
• cough, sore throat and throat or nasal irritation; upper respiratory tract infection, sinusitis,
• elevated blood pressure, rapid heartbeat (tachycardia),
• dizziness (vertigo), feeling weak, uncontrolled movements, unusual activity,
• aggression, agitation, anxiety, depression, irritability, tension, nervousness and abnormal behaviour,
• stomach discomfort or indigestion, stomach pain, diarrhoea, feeling nauseous, stomach discomfort and vomiting,
• excessive teeth grinding (bruxism),
• excessive sweating.

Uncommon (may affect up to 1 in 100 patients)

• dry eyes,
• constipation,
• chest discomfort,
• blood in urine,
• apathy,
• restlessness or tremor,
• muscle pain, muscle jerks,
• shortness of breath or chest pain,
• feeling of warmth,
• increased liver test results (seen in blood tests),
• angry outbursts, restlessness or tearfulness, excessive awareness of surroundings, difficulty sleeping,
• dry eyes.

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

• feeling disoriented or confused,
• vision problems or double vision,
• breast swelling in males,
• skin redness, increased redness of skin rashes,
• obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, skin picking, having repetitive unwanted thoughts, feelings, images or impulses in the mind [obsessive thoughts], performing repetitive behaviours or mental rituals [compulsions]).

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,
• numbness, tingling and colour changes in toes and fingers when exposed to cold (from white to blue, then red) (“Raynaud’s phenomenon”).

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

• migraine,
• dilated pupils,
• very high fever,
• slow, fast or irregular heartbeats, palpitations,
• major epileptic seizure (“generalized tonic-clonic seizures”),
• believing things that are not true,
• severe stomach pain with nausea and vomiting,
• inability to control urination (incontinence),
• jaw muscle spasm making it difficult to open the mouth (trismus),
• stuttering,
• nosebleeds,
• increased eye pressure,
• eye diseases that may cause vision loss due to optic nerve damage (glaucoma).

Effects on growth

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

• it may prevent weight or height gain,
• your doctor will carefully monitor your or your child’s height, weight and nutrition,
• if you or your child do not grow as expected, treatment with methylphenidate may be interrupted for a short period of time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Methylphenidate Tecnigen

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

Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the tablet is damaged.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Methylphenidate Tecnigen

• The active substance is methylphenidate hydrochloride. Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride, equivalent to 15.57 mg of methylphenidate.

• The other components are:

Tablet core: Sugar spheres (sucrose, corn starch), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, hydroxypropyl methylcellulose acetate succinate, sodium carboxymethylcellulose, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, hydrochloric acid.

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

Appearance of the product and contents of the container

Methylphenidate Tecnigen 18 mg are round, biconvex tablets, pale yellow to yellow in colour, 6.3 mm in diameter.

The prolonged-release tablets are available in bottles with child-resistant screw caps.

Pack sizes:

Bottles containing 28 or 30 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmaceutica, S.A.
Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,
28108– Alcobendas (Madrid)
Spain

Manufacturer:

Develco Pharma GmbH
Grienmatt 42
79650 Schopfheim
Germany

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/