METHYLPHENIDATE TECNIGEN 36 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you start taking Methylphenidate Tecnigen

Do not take Methylphenidate 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 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 medicines"),
• 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 elated, more active than usual, and uninhibited,
  • diagnosis or history of severe bipolar (affective) disorder, episodic (type I).

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

Warnings and precautions

Tell your doctor or pharmacist before you or your child start taking 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.

Tell 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 do before you or your child start treatment with methylphenidate:

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

• the medications you or your child are taking,
• if you or your child have a family history of sudden unexplained death,
• other illnesses 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 feelings 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 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 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 members have a history of suicide, bipolar disorder, or depression,
• determining your or your child's height, weight, heart rate, and blood pressure, and recording the results in a chart.

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

Taking Methylphenidate Tecnigen with other medicines

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

Do not take methylphenidate if you or your child:

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

If you or your child are taking other medicines, methylphenidate may affect how they work or cause side effects. If you or your child are taking any of the following medicines, talk to your doctor or pharmacist before taking methylphenidate:

• other medicines for depression,
• medicines for severe mental health problems,
• medicines for epilepsy,
• medicines used to lower or increase blood pressure,
• some cough and cold remedies that contain medicines that can affect blood pressure. It is important that you talk to your pharmacist when you buy any of these medicines,
• medicines that thin the blood to prevent clots.

If you are not sure if any of the medicines you or your child are taking are included in the list above, talk to your doctor or pharmacist before taking methylphenidate.

Before an operation

Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on the day of the operation with certain types of anesthetics, as this can cause a sudden increase in blood pressure during the procedure.

Use in athletes

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

Taking Methylphenidate Tecnigen with alcohol

Do not drink alcohol while taking this medicine. Alcohol may worsen the side 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, talk to your doctor before using this medicine.

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 cannot be ruled out. Your doctor will give you more information about this risk.

Talk to 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 passes 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 feel dizzy, have problems focusing, or have blurred vision when taking methylphenidate. If this happens, 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 medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

This medicine 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 do several checks at each dose change, then every six months or at each visit, to make sure that Methylphenidate Tecnigen continues to be safe and beneficial. These will include:

• Measuring and recording in a chart your 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.
• Measuring your height, weight, and appetite, recording them in a chart, each time your dose or your child's dose changes and at least every six months or at each visit.
• Evaluating psychiatric problems, each 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 adjust the dose carefully when starting treatment with methylphenidate. The dose adjustment should start with the lowest possible dose.

How much to take

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are not sure, talk to 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, tell your doctor. They may decide if a different treatment is needed. Tell your doctor if you or your child do not notice an 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 your treatment or your child's treatment for a short period of time once a year to check if the medicine is still needed. You or your child may continue to observe a benefit when treatment with Methylphenidate is temporarily or permanently interrupted. This may happen during school vacations.

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

Inappropriate use of Methylphenidate Tecnigen

You should monitor your child for the risk of diversion to illicit traffic, 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 medicine is only for you or your child. Do not give this medicine 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, talk to your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 915620420), indicating the medicine 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 medicine should not be stopped suddenly. If you or your child stop taking this medicine suddenly, the symptoms of ADHD may return or unwanted effects such as depression may occur. Your doctor may want to gradually reduce the amount of medicine you take each day before stopping it completely. Talk to your doctor before stopping treatment with Methylphenidate Tecnigen.

If you have any other 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 all people suffer from them. Although some people present adverse effects, most people metilfenidato helps. Your doctor will inform you about these adverse effects.

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

Frequent (may affect up to 1 in 10 patients)

• irregular heartbeats (palpitations),
• changes or alterations in mood or mood swings 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, difficulty or problems 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),
• peeling of the skin 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 as a result of 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 infections and easier bleeding and bruising,
• sudden increase in body temperature, very high blood pressure, and severe convulsions ("Malignant Neuroleptic Syndrome"). It is not entirely certain that this adverse effect is caused by metilfenidato or other medications taken in combination with metilfenidato.

Frequency Not Known (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 problems with movement and vision, difficulties in speech (may be signs of problems with blood vessels in the brain).

If you or your child have any of the above adverse effects, go to your doctor immediately.

Other adverse effects are indicated below; and 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,
• headache due to muscle tension,
• dry mouth, thirst,
• problems 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 reddish eruptions that itch (hives),
• drowsiness or excessive drowsiness, feeling tired,
• grinding or clenching teeth, feeling of panic,
• tingling, itching, or numbness of the skin,
• increase in alanine aminotransferase levels 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 tremors,
• muscle pain, muscle twitches,
• shortness of breath or chest pain,
• feeling of heat,
• increase in liver test results (seen in a blood test),
• anger reaction (angry), restless or tearful, 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,
• chest swelling 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 emotion, doing things over and over, obsession with something,
• fingers and toes numb, 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, palpitations,
• 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, metilfenidato 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Metilfenidato Tecnigen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date (CAD) that appears 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 thrown away through wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Metilfenidato Tecnigen

• The active ingredient is metilfenidato hydrochloride. Each prolonged-release tablet contains 36 mg of metilfenidato hydrochloride equivalent to 31.13 mg of metilfenidato.

• Other components 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.

Coating of the tablet:Opadry II white consisting of: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350.

Appearance of the Product and Package Contents

Metilfenidato Tecnigen 36 mg are oblong, biconvex, white to off-white tablets, 11.3 x 5.3 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 the Last Revision of this Prospectus: 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/