Prospect: information for the user
Methylphenidate Tecnigen 36 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.
What it is used for
Methylphenidate Tecnigen is used to treat Attention Deficit Hyperactivity Disorder (ADHD)
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:
and its goal is to stabilize children with ADHD who have symptoms that may include chronic low-grade attention, 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:
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, school, or 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:
Do not take metilphenidate 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 metilphenidate, as metilphenidate may worsen these problems.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Metilfenidato Tecnigen if you or your child:
Other mental health problems include:
Inform your doctor or pharmacist if you or your child present any of the above before starting treatment, as metilphenidate 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 metilphenidate:
To be able to decide if metilphenidate is the right medication for you or your child, your doctor will talk to you about:
It is important that you provide all the information you can. This will help your doctor decide if metilphenidate 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 metilphenidate if you or your child:
If you or your child are taking other medications, metilphenidate 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 metilphenidate:
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 metilphenidate.
Before surgery
Inform your doctor if you or your child are to undergo surgery. Metilphenidate 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
Inform patients that this medication contains metilphenidate, 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 increase in the 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.
Consult your doctor or pharmacist before using metilphenidate if you or your daughter:
Driving and operating machinery
You or your child may experience dizziness, difficulty focusing or blurred vision when taking metilphenidate. 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 sacarose
This medication contains sacarose. 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; 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 Metilfenidato Tecnigen remains safe and beneficial. These will include:
Dose adjustment
Careful dose adjustment is necessary when starting treatment with metilfenidate. 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.
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 Metilfenidato Tecnigen.
Long-term treatment
Metilfenidato Tecnigen treatment does not need to be indefinite. If Metilfenidato 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 Metilfenidato 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 Metilfenidato Tecnigen
You should monitor your child for the risk of diversion to illicit traffic, misuse, or abuse of metilfenidate. Continued abuse of metilfenidate 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 Metilfenidato 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: being sick, 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 Metilfenidato 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 Metilfenidato 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 Metilfenidato Tecnigen.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Some side effects can be serious. If you or your child have any of the side effects listed below, seek immediate medical attention:
Common (may affect up to 1 in 10 patients)
Uncommon (may affect up to 1 in 100 patients)
Rare (may affect up to 1 in 1,000 patients)
Very rare (may affect up to 1 in 10,000 patients)
Frequency unknown (the frequency cannot be estimated from available data)
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 common (may affect more than 1 in 10 patients)
Common (may affect up to 1 in 10 patients)
Uncommon (may affect up to 1 in 100 patients)
Rare (may affect up to 1 in 1,000 patients)
Very rare (may affect up to 1 in 10,000 patients)
Frequency unknown (its frequency cannot be estimated from available data)
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
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 the Pharmacovigilance of Medicinal Products 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 (CAD) 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.
Composition of Metilfenidato Tecnigen
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.
Appearance of the product and contents of the packaging
Metilfenidato Tecnigen 36 mg are oblong, biconvex, white to off-white tablets of 11.3 x 5.3 mm with grooves on both sides. The tablet can be divided into equal doses.
The prolonged-release tablets are available in screw-top bottles with child-resistant closures.
Packaging sizes:
Bottles containing 28or 30 prolonged-release tablets.
Only some packaging sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
Tecnimede España Industria Farmaceutica, S.A.
Avda. de Bruselas, 13, 3rd floor. Building América. Arroyo de la Vega Industrial Estate,
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 on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
The average price of Metilfenidato tecnigen 36 mg comprimidos de liberacion prolongada efg in July, 2025 is around 20.01 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.