METHYLPHENIDATE SANDOZ 54 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Methylphenidate Sandoz 18 mg prolonged-release tablets EFG

Methylphenidate Sandoz 36 mg prolonged-release tablets EFG

Methylphenidate Sandoz 54 mg prolonged-release tablets EFG

methylphenidate hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences 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 Sandoz and what is it used for
2. What you need to know before your child starts taking Methylphenidate Sandoz
3. How to take Methylphenidate Sandoz
4. Possible side effects
5. Storage of Methylphenidate Sandoz
6. Package contents and further information

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

What it is used for

Methylphenidate Sandoz is used to treat "Attention Deficit Hyperactivity Disorder" (ADHD):

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

Methylphenidate 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 this medicine until adulthood. Your doctor will advise your child on this.

How it works

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

This medicine is given as part of a comprehensive treatment program, which usually includes:

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

It is only prescribed by doctors who have experience in behavioral problems in children and adolescents. Although ADHD has no cure, it can be controlled using 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 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, and in other places.

Not all patients with ADHD need treatment with medication.

ADHD does not affect intelligence.

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

Do not take Methylphenidate Sandoz if your child:

• is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6),
• has a thyroid problem,
• has high eye pressure (glaucoma),
• has a tumor in the adrenal glands (pheochromocytoma),
• has an eating disorder, has no appetite, or does not want to eat, such as in "anorexia nervosa",
• has very high blood pressure or narrowing of the blood vessels, which can cause arm and leg pain,
• has ever had heart problems such as a heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease, or a heart problem at birth,
• has ever had a problem with the blood vessels in the brain such as a stroke, widening or weakness of part of a blood vessel (aneurysm), narrowing or blockage of the blood vessels, or inflammation of the blood vessels (vasculitis),
• is taking or has taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see "Other medicines and Methylphenidate Sandoz",
• has 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.

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

Warnings and precautions

Consult your doctor before starting treatment with Methylphenidate Sandoz if your child:

• has liver or kidney problems,
• has problems swallowing or swallowing whole tablets,
• has a narrowing or blockage of the throat or digestive tract,
• has had seizures (fits, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG),
• has ever abused or been dependent on alcohol, prescription medicines, or drugs,
• is a girl and has already started her period (see below the section on "Pregnancy and breastfeeding"),
• has difficulty controlling movements, repeats certain movements or sounds and words,
• has high blood pressure,
• has a heart problem not included in the previous section "Do not take Methylphenidate Sandoz",
• has a mental health problem not included in the previous section "Do not take Methylphenidate Sandoz".

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 unusually suspicious (paranoia),
• feeling agitated, anxious, or tense,
• feeling depressed or guilty.

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

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

Checks that your doctor will perform on your child before starting treatment with Methylphenidate Sandoz

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

• the medicines your child is taking,
• if there is a family history of sudden unexplained death,
• other diseases that your family may suffer from (such as heart problems),
• how your child is feeling, if they have mood swings, have unusual thoughts, or have had such feelings in the past,
• if there have been cases of tics in your family (difficulty controlling repeated movements of some parts of the body or repeated sounds and words),
• possible behavioral or mental health problems that your child or other family members have had. Your doctor will explain specifically if your child is at risk of experiencing mood changes (from being manic to being depressed, known as bipolar disorder). Your doctor will check your child's mental health history and check if any family member has a history of suicide, bipolar disorder, or depression.

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

Other medicines and Methylphenidate Sandoz

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

Do not take methylphenidate if your child:

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

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

• tricyclic antidepressant,
• selective serotonin reuptake inhibitor (SSRI),
• serotonin and noradrenaline reuptake inhibitor (SNRI).

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

If your child is taking other medicines, methylphenidate may affect how they 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 severe mental health problems,
• medicines for Parkinson's disease (such as levodopa),
• medicines for epilepsy,
• medicines used to lower or increase blood pressure,
• certain cough and cold remedies that contain medicines that can affect blood pressure. It is essential to consult your pharmacist when purchasing any of these medicines,
• medicines that thin the blood to prevent blood clots.

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

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

Before an operation

Inform your doctor if your child is going to have an operation. Methylphenidate should not be taken on the day of the operation with certain types of anesthetics. This is because a sudden increase in blood pressure and heart rate may occur during the procedure.

Use in athletes

This medicine may give a positive result in drug tests, even in tests used in sports.

Taking Methylphenidate 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 total congenital anomalies, although a small increase in the risk of cardiac malformations during use in the first three months of pregnancy could not be ruled out. Your doctor will provide more information about this risk. Consult your doctor or pharmacist before using methylphenidate if your daughter:

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

Driving and using machines

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 Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has told you that your child has 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; this is, essentially "sodium-free".

3. How to take Methylphenidate Sandoz

How much to take

Your child should follow their doctor's instructions for taking this medicine exactly. 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 sooner than once a week if necessary.

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

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

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

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

Use in children from 6 years

• the recommended initial dose of methylphenidate prolonged-release is 18 mg once daily for children who are not currently taking methylphenidate, or for children who are 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 if your child needs a different treatment.

Incorrect use of Methylphenidate Sandoz

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

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

If your child takes more Methylphenidate Sandoz than they should

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

Signs of overdose may include: being sick, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which can be followed by coma), feeling very happy, confusion, seeing, hearing, or feeling things that are not there (hallucinations), sweating, flushing, headache, high fever, changes in heartbeats (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth.

If your child forgets to take Methylphenidate Sandoz

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

If your child stops taking Methylphenidate Sandoz

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

What your doctor will do when your child is on treatment

Your doctor will perform some tests

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

They will also be performed when the dose is changed.

• These tests will include:
• appetite control,
• height and weight measurement,
• blood pressure and heart rate measurement,
• evaluation of mood-related problems, mental state, or any other unusual feelings. Or if 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 a year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows demonstration of whether they still need 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 all people suffer from them. Although some people present adverse effects, most people are helped by methylphenidate. Your doctor will inform you about these adverse effects.

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

Frequent(may affect up to 1 in 10 people)

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

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),
• allergic signs 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 exceptionally excited, more active than usual, and uninhibited (mania).

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

• heart attack,
• sudden death,
• suicide attempts,
• seizures (attacks, convulsions, epilepsy),
• skin peeling or purple red spots,
• inflammation or blockage of the brain's arteries,
• temporary paralysis or movement and vision problems, speech difficulties (these signs may be related to problems with blood vessels in the brain),
• uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system,
• 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 ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this adverse effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Unknown(frequency cannot be estimated from available data)

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

If your child has any of the above adverse effects, go to your doctor immediately.

The following are other adverse effects, and if they become severe, please inform your doctor or pharmacist:

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

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

Common(may affect up to 1 in 10 people)

• joint pain,
• blurred vision,
• tension headache,
• thirst,
• difficulty falling asleep,
• fever,
• altered sexual desire,
• hair loss due to unusual causes or decreased hair thickness,
• muscle weakness, muscle cramps,
• loss of appetite or decreased appetite,
• inability to have or maintain an erection,
• itching, rash, or increased itching of red hives (urticaria),
• excessive drowsiness or numbness, feeling of fatigue,
• excessive teeth grinding (bruxism),
• panic feeling,
• tingling, itching, or numbness of the skin,
• increased blood levels of alanine aminotransferase (a liver enzyme),
• cough, sore throat, and irritation of the throat or nose, upper respiratory tract infection, sinus infection,
• high blood pressure, rapid heartbeat (tachycardia),
• feeling of dizziness (vertigo), fatigue, uncontrolled movements, abnormal activity,
• aggression, agitation, anxiety, depression, irritability, tension, nervousness, and altered behavior,
• feeling of full stomach or indigestion, stomach pain, diarrhea, 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,
• loss of desire,
• agitation or tremor,
• increased need to urinate,
• muscle pain, muscle spasms,
• shortness of breath or chest pain,
• feeling of heat,
• increased liver test results (seen in a blood test),
• anger reaction (anger), restless or tearful, excessive talking, excessive awareness of the environment, sleep problems.

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

• altered sexual desire,
• 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 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, lack 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").

Unknown(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 sometimes with feeling of discomfort and vomiting,
• problems with the blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion),
• 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 your child's height and weight, as well as their diet,

Reporting Adverse Effects

If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date shown on the label and packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Storage conditions after the first opening of the bottle:

Store below 25°C.

Expiration after the first opening of the bottle:

6 months.

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

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Methylphenidate Sandoz

The active ingredient is methylphenidate hydrochloride.

Methylphenidate Sandoz 18 mg: Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride.

Methylphenidate Sandoz 36 mg: Each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride.

Methylphenidate Sandoz 54 mg: Each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride.

The other ingredients are:

Medicinal coating: polyethylene oxide, succinic acid, povidone (K 25), butylhydroxytoluene, and stearic acid.

Release coating: polyethylene oxide, sodium chloride, povidone (K 25), butylhydroxytoluene, iron oxide red (E 172), and stearic acid.

Membrane coating: cellulose acetate and poloxamer 188.

Active ingredient coating: hypromellose and succinic acid.

Film coating: film coating mixture: white (lactose monohydrate, hypromellose, titanium dioxide (E 171), and macrogol 4000).

The 18 mg tablets also contain:

Iron oxide yellow (E 172).

The 54 mg tablets also contain:

Iron oxide red (E 172).

Iron oxide yellow (E 172).

Appearance and Package Contents

Methylphenidate Sandoz 18 mg: yellowish prolonged-release tablets, round (8 mm diameter), with a small hole (small round hole visible) on one side.

Methylphenidate Sandoz 36 mg: white prolonged-release tablets, round (10 mm diameter), with a small hole (small round hole visible) on one side.

Methylphenidate Sandoz 54 mg: red prolonged-release tablets, round (10 mm diameter), with a small hole (small round hole visible) on one side.

The prolonged-release tablets are packaged in high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) screw caps and a desiccant.

Package sizes:

28, 30 prolonged-release tablets, or

Multipacks: 60 (2 x 30) or 90 (3 x 30) prolonged-release tablets.

Not all package sizes may be marketed.

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 dd

Verovškova 57,

1526 Ljubljana

Slovenia

Or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava,

Slovenia

Or

Salutas Pharma GmbH

Otto-von-Guericke-Alle 1

39179 Barleben

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten

Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten

Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten

Belgium: Methylfenidaat Retard Sandoz 18 mg tabletten met verlengde afgifte

Methylfenidaat Retard Sandoz 36 mg tabletten met verlengde afgifte

Methylfenidaat Retard Sandoz 54 mg tabletten met verlengde afgifte

Cyprus: Methylphenidate Sandoz

Denmark: Methylphenidate Sandoz

Finland: Methylphenidate Sandoz 18 mg depottabletit

Methylphenidate Sandoz 36 mg depottabletit

Methylphenidate Sandoz 54 mg depottabletit

Iceland: Methylphenidate Sandoz, 18 mg, forðatöflur

Methylphenidate Sandoz, 36 mg, forðatöflur

Methylphenidate Sandoz, 54 mg, forðatöflur

Netherlands: Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte

Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte

Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte

Norway: Methylphenidate Sandoz 18 mg depottabletter

Methylphenidate Sandoz 36 mg depottabletter

Methylphenidate Sandoz 54 mg depottabletter

Portugal: Metilfenidato Sandoz 18 mg prolonged release tablets

Metilfenidato Sandoz 36 mg prolonged release tablets

Metilfenidato Sandoz 54 mg prolonged release tablets

Sweden: Methylphenidate Sandoz 18 mg depottabletter

Methylphenidate Sandoz 36 mg depottabletter

Methylphenidate Sandoz 54 mg depottabletter

United Kingdom: Matoride XL 18 mg Prolonged-release Tablets

Matoride XL 36 mg Prolonged-release Tablets

Matoride XL 54 mg Prolonged-release Tablets

Date of the last revision of this leaflet:November 2023.

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