METHYLPHENIDATE SANDOZ 27 mg PROLONGED-RELEASE TABLETS

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 medication (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 pain in the arms and legs,
• has had heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a congenital heart problem,
• has 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),
• is taking or has taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see "Other medications 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 (attacks, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG),
• has abused or been dependent on alcohol, prescription medications, or drugs,
• is a girl and has already started her period (see below the section on "Pregnancy and breastfeeding"),
• has difficulty controlling movements, repeats sounds and words,
• has high blood pressure,
• has a heart problem not included in the previous section "Do not take Methylphenidate Sandoz if",
• has a mental health problem not included in the previous section "Do not take Methylphenidate Sandoz if".

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 medication affects 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 medication for your child. Your doctor will discuss with you:

• the medications 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 repetitive movements of some body parts 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 medication for your child. Your doctor may decide that your child needs other medical tests before starting to take this medication.

Other medications and Methylphenidate Sandoz

Inform your doctor or pharmacist if your child is taking, has recently taken, or may need to take any other medication.

Do not take methylphenidate if your child:

• is taking a medication called a "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 medications for depression or anxiety:

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

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

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

• medications for severe mental health problems,
• medications for Parkinson's disease (such as levodopa),
• 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 to 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 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 medications, including those purchased 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 medication 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 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 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 medication contains lactose. If your doctor has told you that your child has an intolerance to certain sugars, consult with them before taking this medication.

This medication 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 the administration instructions for this medication exactly as indicated by their doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will normally 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 old

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

This medication is only for your child. Do not give this medication 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 medication 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 real (hallucinations), sweating, flushing, headache, high fever, changes in heart rate (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 to take the next dose at the scheduled time.

If your child stops taking Methylphenidate Sandoz

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

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 medication is safe and beneficial,
• once your child has started treatment, they will be performed at least every 6 months and even more frequently.

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 demonstrating if they still need the medication.

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 your child experiences any of the following adverse effects, seek medical attention immediately:

Frequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• suicidal thoughts or feelings,
• seeing, feeling, or hearing things that are not real, which are symptoms of psychosis,
• uncontrolled speech and body movements (Tourette's syndrome),
• allergic reactions 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 breathing or breathing problems.

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

• feeling exceptionally excited, more active than normal, 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 difficulties, speech difficulties (these signs may be related to problems with the blood vessels in the brain),
• uncontrolled muscle spasms that affect 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(frequency cannot be estimated from available data)

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

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

The following adverse effects are also indicated, and 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 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 sleepiness, 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),
• dizziness (vertigo), fatigue, uncontrolled movements, abnormal activity,
• aggression, agitation, anxiety, depression, irritability, tension, nervousness, and altered behavior,
• feeling of fullness or indigestion, stomach pain, diarrhea, stomach discomfort, and nausea,
• excessive sweating,
• weight loss.

Infrequent(may affect up to 1 in 100 people)

• dry eyes,
• constipation,
• chest discomfort,
• blood in the urine,
• lack of interest,
• agitation or tremors,
• increased need to urinate,
• muscle pain, muscle twitches,
• shortness of breath or chest pain,
• feeling of heat,
• increased liver test results (seen in a blood test),
• anger reaction (anger), restlessness or tearfulness, excessive talking, excessive awareness of the surroundings, 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,
• redness of the skin, 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 repeatedly, obsession with something,

• numbness, tingling, and color change in fingers and toes with cold (from white to blue, then red) ("Raynaud's phenomenon").

Unknown frequency(frequency cannot be estimated from available data)

• migraine,
• dilated pupils,
• very high fever,
• slow, rapid, or irregular heartbeats,
• major epileptic seizure ("grand mal convulsions"),
• believing things that are not true,
• severe stomach pain, sometimes with a feeling of discomfort and vomiting,
• problems with the blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion),
• inability to control urination (incontinence),
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus),
• stuttering,
• nosebleeds.

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 monitor your height, weight, and nutrition,

Reporting 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 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 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 date 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 disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Methylphenidate Sandoz

The active ingredient is methylphenidate hydrochloride.

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

The other ingredients 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 ingredient 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 and Package Contents of the Product

Methylphenidate Sandoz is a film-coated, round, pale gray tablet with a small hole (small round hole visible) on one side.

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

Package sizes:

28, 30, 50, 56, 98, 100, or 120 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

Salutas Pharma GmbH

Otto-von-Guericke-Alle 1

39179 Barleben

Germany

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/