Methylphenidate Sandoz 27 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Methylphenidate Sandoz 27 mg prolonged-release tablets EFG

methylphenidate hydrochloride

Read the entire leaflet carefully before your child starts 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, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only and must not be given to other people, even if they have the same symptoms as your child, because it may harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What it is used for

Metilfenidato Sandoz 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 trying non-medication treatments first, such as behavioral therapy and counseling.

Metilfenidato 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 this medicine into adulthood. Your doctor will advise you regarding your child.

How it works

Metilfenidato improves the activity of certain parts of the brain that are underactive. This medicine may help improve attention (attention span), concentration, and reduce impulsive behavior.

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

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

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

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty 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 learning and completing homework. They may have trouble behaving appropriately at home, at school, and in other settings.

Not all patients with ADHD require treatment with medication.

ADHD does not affect intelligence.

2. What you need to know before your child starts taking Metilfenidato Sandoz

Do not take Metilfenidato Sandoz if your child:

• is allergic to methylphenidate or to any of the other ingredients of this medicine (listed in section 6),

• has a thyroid problem,

• has high eye pressure (glaucoma),

• has a tumour of the adrenal glands (pheochromocytoma),

• has an eating disorder, lacks appetite, or does not want to eat, as in "anorexia nervosa",

• has very high blood pressure or narrowing of blood vessels, which may cause pain in the arms and legs,

• has ever had heart problems such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or a congenital heart defect,

• has ever had a blood vessel problem in the brain such as stroke, dilation or weakness in part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis),

• is taking or has taken within the last 14 days any antidepressant medicine (known as a monoamine oxidase inhibitor); see "Other medicines and Metilfenidato Sandoz",

• has mental health problems such as:

• a "psychopathic" disorder or "borderline personality disorder",

• abnormal thoughts or hallucinations or a condition known as "schizophrenia",

• signs of a severe mood disorder such as:

• suicidal thoughts,

• severe depression, feeling very sad, worthless, and hopeless,

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

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

Warnings and precautions

Talk to your doctor before starting Metilfenidato Sandoz if your child:

• has liver or kidney problems,
• has difficulty swallowing or problems swallowing whole tablets,
• has a narrowing or blockage in the throat or digestive tract,
• has ever had seizures (fits, convulsions, epilepsy) or any abnormalities in the electroencephalogram (EEG),
• has had high pressure in the eye (intraocular pressure),
• has ever abused or been dependent on alcohol, prescription medicines, or drugs,
• is a girl who has already started menstruating (see section "Pregnancy and breastfeeding" below),
• has difficulty controlling repetitive movements of certain body parts or repeats sounds and words,
• has high blood pressure,
• has a heart problem not listed in the section above "Do not take Metilfenidato Sandoz if",
• has a mental health condition not listed in the section above "Do not take Metilfenidato Sandoz if".

Other mental health problems include:

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

Inform your doctor or pharmacist if your child has any of the above symptoms before starting treatment. This is because methylphenidate may worsen these conditions. Your doctor will want to monitor how the medicine affects your child.

During treatment, children and adolescents may unexpectedly experience prolonged erections. These erections may be painful and can occur at any time. It is important to contact a doctor immediately if the erection lasts longer than 2 hours, especially if it is painful.

Checks your doctor will perform before starting treatment with Metilfenidato Sandoz

These checks are to determine whether methylphenidate is the right medicine for your child. Your doctor will discuss with you:

• the medicines your child is taking,

• whether there is a family history of unexplained sudden death,

• other illnesses that may run in the family (such as heart problems),

• how your child is feeling, whether they 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 behavioural or mental health problems your child or other family members may have had. Your doctor will specifically explain whether your child is at risk of mood changes (from mania to depression, known as bipolar disorder). Your doctor will review your child's mental health history and check whether any family members have a history of suicide, bipolar disorder, or depression.

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

Other medicines and Metilfenidato Sandoz

Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Do not take methylphenidate if your child:

• is taking a medicine called a "monoamine oxidase inhibitor" (MAOI) used for depression, or has taken an MAOI within the last 14 days. Using an MAOI with methylphenidate may cause a sudden increase in blood pressure (see "Do not take Metilfenidato Sandoz").

Inform your doctor or pharmacist if your child is taking any of the following medicines for depression or anxiety:

• tricyclic antidepressants,
• selective serotonin reuptake inhibitors (SSRIs),
• serotonin-noradrenaline reuptake inhibitors (SNRIs).

Taking methylphenidate with these medicines may cause a potentially life-threatening increase in "serotonin" in the brain (serotonin syndrome), which may lead to confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If your child experiences these side effects, seek medical help immediately.

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

• medicines for serious mental health conditions,
• medicines for Parkinson's disease (such as levodopa),
• 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 these remedies,
• medicines that thin the blood to prevent clots.

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

Inform your doctor or pharmacist if your child is using or has recently used any other medicines, including those obtained without a prescription.

Before surgery

Inform your doctor if your child is scheduled for surgery. Methylphenidate should not be taken on the day of surgery when certain types of anaesthetics are used. This is because a sudden increase in blood pressure and heart rate may occur during the procedure.

Use in athletes

This medicine may result in a positive drug test, including those used in sports.

Taking Metilfenidato Sandoz 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, 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 the first three months of pregnancy cannot be ruled out. Your doctor will provide further information about this risk. Consult your doctor or pharmacist before using methylphenidate if your daughter:

• is sexually active. Your doctor will discuss contraception with you,
• is pregnant or thinks she may be pregnant. Your doctor will decide whether she should take methylphenidate,
• is breastfeeding or plans to breastfeed. Methylphenidate passes into breast milk. Therefore, your doctor will decide whether your daughter should breastfeed while using methylphenidate.

Driving and using machines

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 or horse, or climbing trees.

Metilfenidato Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has diagnosed your child with an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet; hence, it is essentially "sodium-free".

3. How to take Metilfenidato Sandoz

How much to take

Your child must follow exactly the dosage instructions for this medicine as given by their doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will usually start treatment with a low dose and increase the daily dose by 18 mg no more frequently than once a week, if necessary.

The goal is the lowest dose that is effective for your child. Your doctor will decide the maximum daily dose for your child.

Your child should take extended-release methylphenidate once daily in the morning with a glass of water.

The tablet must be swallowed whole and must not be chewed, broken, or crushed. The tablet can be taken with or without food.

The tablet does not dissolve completely after all the active substance has been released, and sometimes the tablet may appear in the stools. This is normal.

Use in children aged 6 years and older

• The recommended initial dose of extended-release methylphenidate is 18 mg once daily for children who are not currently taking methylphenidate, or for children switching from another stimulant to methylphenidate.
• The maximum daily dose is 54 mg.

If your child does not feel better after 1 month of treatment

If your child does not feel better after 1 month of treatment, inform your doctor. They may decide whether your child needs a different treatment.

Inappropriate use of Metilfenidato Sandoz

If this medicine is not used appropriately, it may cause abnormal behavior. This may also mean that your child may start to become dependent on the medicine. Inform your doctor if your child has ever abused or been dependent on alcohol, prescription medicines, or drugs.

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

If your child takes more Metilfenidato Sandoz than they should

If your child takes too many tablets or in case of accidental ingestion, contact your doctor or pharmacist immediately, call an ambulance, or go to the nearest hospital emergency department, and tell them how many tablets have been taken. Medical treatment may be necessary. You may also call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount ingested.

Signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle twitching, seizures (which may be followed by coma), feelings of extreme happiness, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth.

If your child forgets to take Metilfenidato Sandoz

Do not take a double dose to make up for a missed dose. If your child forgets a dose, they should wait and take the next dose at the scheduled time.

If your child stops taking Metilfenidato Sandoz

If your child stops taking this medicine suddenly, symptoms of ADHD or unwanted effects such as depression may return. Your doctor may require gradually reducing the amount of medicine taken each day before stopping completely. Consult your doctor before stopping treatment with this medicine.

What your doctor will do while your child is on treatment

Your doctor will carry out certain tests

• before your child starts treatment to ensure that this medicine is safe and beneficial,
• once your child has started treatment, these tests will be performed at least every 6 months, and even more frequently if needed.

They will also be performed when the dose is changed.

• These tests will include:
• monitoring of appetite,
• measurement of height and weight,
• measurement of blood pressure and heart rate,
• assessment of mood-related problems, mental state, or any other unusual feelings, or whether these have worsened while taking methylphenidate.

Long-term treatment

Methylphenidate does not need to be taken indefinitely. If your child takes methylphenidate for more than one year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows assessment of whether your child still needs the medicine.

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

Some adverse effects may be serious. If your child experiences any of the following adverse effects, contact your doctor immediately:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• suicidal thoughts or feelings,
• seeing, feeling, or hearing things that are not real (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, difficulty or problems breathing.

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

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

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

• heart attack,
• sudden death,
• suicide attempts,
• seizures (fits, convulsions, epilepsy),
• skin peeling or purplish red spots,
• inflammation or blockage of the brain's arteries,
• temporary paralysis or movement problems, vision difficulties, speech problems (these signs may indicate problems with blood vessels in the brain),
• uncontrolled muscle spasms affecting the eyes, head, neck, body and nervous system,
• 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.

Not known (frequency cannot be estimated from available data)

• unwanted thoughts that reappear,
• unexplained fainting, chest pain, shortness of breath (may be signs of heart problems),
• prolonged erections, sometimes painful, or increased number of erections.

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

The following other adverse effects are listed. If they become severe, please inform your doctor or pharmacist:

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

• headache,
• feeling nervous,
• difficulty sleeping,
• nausea,
• dry mouth.

Frequent (may affect up to 1 in 10 people)

• joint pain,
• blurred vision,
• tension-type headache,
• thirst,
• difficulty falling asleep,
• high temperature (fever),
• change in sexual desire,
• unusual hair loss or thinning of hair,
• muscle weakness, muscle cramps,
• loss of appetite or decreased appetite,
• inability to achieve or maintain an erection,
• itching, rash or increased itching of red, raised skin (urticaria),
• drowsiness or unusual drowsiness, feeling tired,
• excessive teeth grinding (bruxism),
• feeling of panic,
• tingling, itching or numbness of the skin,
• increased blood levels of alanine aminotransferase (an enzyme in the liver),
• cough, sore throat, throat or nasal irritation, upper respiratory tract infection, sinus infection,
• high blood pressure, rapid heartbeat (tachycardia),
• dizziness, tiredness, uncontrolled movements, unusual activity,
• aggression, agitation, anxiety, depression, irritability, tension, nervousness and altered behaviour,
• feeling of fullness in the stomach or indigestion, stomach pain, diarrhoea, stomach discomfort and nausea,
• excessive sweating,
• weight loss.

Uncommon (may affect up to 1 in 100 people)

• dry eyes,
• constipation,
• chest discomfort,
• blood in the urine,
• lack of interest,
• restlessness or tremor,
• increased need to urinate,
• muscle pain, muscle jerks,
• shortness of breath or chest pain,
• feeling of warmth,
• increased liver test results (seen in blood tests),
• angry outbursts (irritability), restlessness or tearfulness, excessive talking, excessive awareness of surroundings, sleep problems.

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

• disturbances in sexual desire,
• feeling disoriented or confused,
• vision problems or double vision,
• breast swelling in males,
• skin redness, increased redness of skin rashes.

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

• muscle cramps,
• small red spots on the skin,
• abnormal liver function including sudden liver failure and coma,
• changes in test results, including liver and blood tests,
• abnormal thinking, absence of feelings or emotions, repetitive actions, obsession with something,
• numbness, tingling and colour change in fingers and toes when exposed to cold (from white to blue, then red) ("Raynaud's phenomenon").

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"),
• increased eye pressure,
• damage to the optic nerve caused by high pressure due to obstruction of fluid drainage channels,
• damage to the optic nerve caused by a rapid increase in intraocular pressure due to inability to drain fluid,
• believing things that are not true,
• severe stomach pain, sometimes with nausea and vomiting,
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion),
• inability to control urination (incontinence),
• spasm of jaw muscles making it difficult to open the mouth (trismus),
• stuttering,
• nosebleeds.

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 gain or height increase,
• your doctor will carefully monitor your height, weight and nutrition,
• if growth is less than 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 Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Methylphenidate Sandoz

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

Do not use this medicine after the expiry date stated on the label and packaging after CAD/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Storage conditions after first opening of the bottle:

Store below 25°C.

Shelf life after first opening of the bottle:

6 months.

The container contains a desiccant. The desiccant is used to keep the prolonged-release tablets dry and must not be ingested.

Medicines must not be disposed of via wastewater or household waste. Medicines and their containers should be taken to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Methylphenidate Sandoz

The active substance is methylphenidate hydrochloride.

Each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride.

The other components are:

Medicinal layer: polyethylene oxide, succinic acid, povidone (K25), butylhydroxytoluene and stearic acid.

Release layer: polyethylene oxide, sodium chloride, povidone (K25), butylhydroxytoluene, red iron oxide (E172) and stearic acid.

Membrane layer: cellulose acetate and poloxamer 188.

Active substance coating: hypromellose and succinic acid.

Film coating: film coating mixture: white (lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000 and black iron oxide (E172)).

Appearance of the product and contents of the container

Methylphenidate Sandoz are film-coated, round, light grey tablets, with a small orifice (visible round hole) on one side.

The prolonged-release tablets are supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure (polypropylene screw cap) and a desiccant pouch.

Container sizes:

28, 30, 50, 56, 98, 100 or 120 prolonged-release tablets.

Only certain container sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

Or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava,

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

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

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