METHYLPHENIDATE TECNIGEN 54 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Methylphenidate Tecnigen 54 mg prolonged-release tablets EFG

Methylphenidate hydrochloride

Read the entire package leaflet carefully before you or your child start taking this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you or your child only, and you should not give it to others, even if they have the same symptoms of illness as you or your child, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

What it is used for

Methylphenidate Tecnigen is used to treat Attention Deficit Hyperactivity Disorder (ADHD)

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

Methylphenidate Tecnigen is not indicated for the treatment of ADHD in children under 6 years of age 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 a comprehensive treatment program, which normally includes:

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

and its goal is to stabilize children with ADHD with symptoms that may include chronic low-grade attention, distractibility, emotional instability, impulsivity, moderate to severe hyperactivity, mild neurological signs, and anomalies in the electroencephalogram (EEG). Learning ability may or may not be affected. A diagnosis cannot be made solely based on the presence of one or more symptoms. An adequate diagnosis requires the use of specialized medical, psychological, educational, and social resources.

It is only prescribed by doctors who have experience in behavioral problems in children or adolescents.Although ADHD has no cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have difficulty:

• remaining still
• concentrating.

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

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

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

Treatment with methylphenidate is not indicated in all children with ADHD, and the decision to use the medication should be based on a thorough assessment 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 prescription and diagnosis guidelines.

2. What you need to know before starting to take Methylphenidate Tecnigen

Do not take Methylphenidate 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 pheochromocytoma (a tumor in the adrenal glands),
• have an eating disorder, loss of appetite, 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 heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a congenital heart problem,
• have had a problem with the blood vessels in the brain such as a stroke, dilation or weakness of 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 a certain type of antidepressant (known as a monoamine oxidase inhibitor) (see the section "Taking Methylphenidate Tecnigen with other medications"),
• have mental health problems such as:
• • a psychopathic or borderline personality disorder,
  • abnormal thoughts or visions or a disease called "schizophrenia",
  • signs of a severe mood disorder such as:
  • • suicidal thoughts,
    • severe depression, feeling very sad, worthless, and desperate,
    • mania, feeling exceptionally excited, more active than usual, and uninhibited,
  • 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. 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 Methylphenidate Tecnigen if you or your child:

• have liver or kidney problems,
• have problems swallowing or swallowing whole tablets,
• have a narrowing or blockage in the digestive tract,
• have had seizures (attacks, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG/brain study),
• have ever abused or been dependent on alcohol, prescription medications, or drugs,
• are a woman and have started your period (see below the section on "Pregnancy and breastfeeding"),
• have difficulty controlling repetitive movements of some parts of the body (tics) or repeated sounds and words,
• have high blood pressure,
• have a heart problem not included in the previous section "Do not take Methylphenidate Tecnigen if you or your child...",
• have a mental health problem not included in the previous section "Do not take Methylphenidate Tecnigen if you or your child...".

Other mental health problems include:

• mood changes (from being manic to being depressed, known as "bipolar disorder"),
• experiencing aggressive or hostile behavior, or worsening aggression,
• seeing, hearing, or feeling things that are not there (hallucinations),
• believing things that are not real (delusions),
• feeling 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, as methylphenidate may worsen these problems. Your doctor will want to monitor how the medications affect you or your child.

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

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

• the medications you or your child are taking,
• if you or your child have a family history of sudden unexplained death,
• other diseases that you or your family (such as heart problems) may have,
• how you or your child are feeling, if you or your child have mood swings, have had strange thoughts or have had such feelings in the past,
• if there have been cases of tics in your family (difficulty controlling repetitive movements of some parts of the body or repeated sounds and words),
• possible behavioral or mental health problems that you or your child or other family members have had. Your doctor will explain specifically if you or your child are at risk of experiencing mood changes (from being manic to being depressed, 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 chart.

It is essential 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. Your doctor may decide that you or your child need other medical tests before starting to take this medication.

Taking Methylphenidate Tecnigen with other medications

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

Do not take methylphenidate if you or your child:

• are taking a medication called a "monoamine oxidase inhibitor" (MAOI) used for depression or have taken an MAOI in the last 14 days. The use of an MAOI with methylphenidate can 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 side 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 decrease or increase blood pressure,
• certain cough and cold remedies that contain medications that can affect blood pressure. It is essential that you consult your pharmacist when purchasing any of these medications,
• medications that thin the blood to prevent clot formation.

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

Before an operation

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

Use in athletes

Patient should be warned that this medication contains methylphenidate, which may produce a positive result in doping tests

Taking Methylphenidate Tecnigen with alcohol

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

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

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

• are having sex. Your doctor will discuss birth control methods with you,
• 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 using machines

You or your child may experience dizziness, problems 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 bicycle or horse, or climbing trees.

Methylphenidate Tecnigen contains sucrose

This medication contains sucrose. 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 (1mmol) per tablet; this is, essentially "sodium-free".

3. How to take Methylphenidate Tecnigen

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

• Measuring and recording blood pressure and heart rate in a chart, every time your dose or your child's dose changes and at least every six months or at each visit.
• Measuring height, weight, and appetite, recording them in a chart, every time your dose or your child's dose changes and at least every six months or at each visit.
• Evaluating psychiatric problems, every time your dose or your child's dose changes 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. The dose adjustment should start with the lowest possible dose.

How much to take

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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 Methylphenidate 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 1 month of treatment

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

Long-term treatment

Treatment with Methylphenidate Tecnigen does not need to be indefinite. If Methylphenidate Tecnigen is taken for more than a year, your doctor should interrupt 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 observe benefits when treatment with Methylphenidate is temporarily or permanently interrupted. This may happen during school vacations.

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

Incorrect use of Methylphenidate Tecnigen

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

Tell your doctor if you or your child have ever abused or 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 Methylphenidate Tecnigen than you should

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

Signs of overdose may include: being sick, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which may be followed by coma), feeling very happy, confusion, hallucinations (seeing, hearing, or feeling 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 Methylphenidate Tecnigen

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

If you or your child stop taking Methylphenidate Tecnigen

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Although some people experience adverse effects, most people find that methylphenidate helps. 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, seek medical attention immediately:

Frequent (may affect up to 1 in 10 patients)

• irregular heartbeats (palpitations),
• changes or alterations in mood or humor or personality changes.

Infrequent (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 parts of the body, shortness of breath, wheezing, or difficulty breathing.

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

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

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

• heart attack,
• sudden death,
• suicidal intention,
• seizures (attacks, convulsions, epilepsy),
• skin peeling or red purpuric spots,
• inflammation or blockage of the arteries in the brain,
• uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system due to lack of blood circulation to the brain,
• decrease in the number of blood cells (red blood cells, white blood cells, and platelets) that can cause a higher risk of infection and easier bleeding and bruising,
• sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this adverse effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Frequency Not Known (frequency cannot be estimated from available data)

• unwanted recurring thoughts,
• unexplained fainting, chest pain, shortness of breath (may be signs of heart problems),
• paralysis or problems with movement and vision, speech difficulties (may be signs of blood vessel problems in the brain).

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

Other adverse effects are indicated below; if they become severe, please inform your doctor or pharmacist:

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

• headache,
• feeling of nervousness,
• difficulty sleeping.

Frequent (may affect up to 1 in 10 patients)

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

Infrequent (may affect up to 1 in 100 patients)

• dry eyes,
• constipation,
• chest discomfort,
• blood in the urine,
• apathy,
• agitation or tremor,
• muscle pain, muscle twitches,
• shortness of breath or chest pain,
• feeling of heat,
• increased liver test results (seen in a blood test),
• anger reaction (being angry), restlessness or tearfulness, excessive awareness of the environment, sleep problems.

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

• feeling disoriented or confused,
• vision problems or double vision,
• breast swelling in men,
• skin redness, 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 emotion, doing things over and over, obsession with something,
• fingers and toes numbness, tingling, and color change with 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,
• major epileptic seizure ("grand mal convulsions"),
• believing things that are not true,
• severe stomach pain with feeling of discomfort and vomiting.
• inability to control urine elimination (incontinence)
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• stuttering
• Nosebleed

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 or height gain,
• your doctor will carefully check the height and weight of you or your child, as well as nutrition,

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use 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 expiration date (CAD) shown on the packaging. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Methylphenidate Tecnigen

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

• The other ingredients are:

Core of the tablet:Sugar spheres (sucrose, cornstarch), hypromellose, talc, ethylcellulose, hydroxypropylcellulose, triethyl citrate, hypromellose acetate succinate, 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 Package Contents

Methylphenidate Tecnigen 54 mg are oblong, biconvex, reddish to red tablets, 13.3 x 6.4 mm in size, with score lines on both sides. The tablet can be divided into equal doses

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

Package sizes:

Bottles containing 28 or 30 prolonged-release tablets.

Not all package 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 Last Revision of this Leaflet: September 2022

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