Patient Information Leaflet

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 this leaflet carefully before giving this medicine to your child, as it contains important information for you.

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

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

3.How to take Methylphenidate Sandoz

4.Possible side effects

5.Storage of Methylphenidate Sandoz

6.Contents of the pack and additional information

What it is used for

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

Metilfenidato 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 medication until adulthood. Your doctor will advise you on this.

How it works

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

This medication is administered as part of a comprehensive treatment program, which usually includes:

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:

It is not their fault that they cannot do these things.

Many children and adolescents struggle to do them. However, patients with ADHD 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, and other places.

Not all patients with ADHD need medication treatment.

ADHD does not affect intelligence.

Do not give Metilfenidato Sandoz to your child if:

Do not give metilphenidate to your child if he presents any of the above. If you are unsure, inform your doctor or pharmacist before your child starts taking metilphenidate. This is because metilphenidate may worsen these problems.

Warnings and precautions

Consult your doctor before starting to take Metilfenidato Sandoz if your child:

• has liver or kidney problems,
• has trouble swallowing or swallowing the 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 alcohol, prescription medications, or drugs at any time,
• is a girl and has already started her period (see below the section "Pregnancy and breastfeeding"),
• has difficulty controlling movements, repetitive movements of some parts of the body, or repeats sounds and words,
• has high blood pressure,
• has a heart problem not included in the previous section "Do not give Metilfenidato Sandoz",
• has a mental health problem not included in the previous section "Do not give Metilfenidato Sandoz".

Other mental health problems include:

• mood swings (from being manic to being depressed, known as "bipolar disorder"),
• experiencing aggressive or hostile behavior, or that aggression worsens,
• 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.

Inform your doctor or pharmacist if your child presents any of the above before starting treatment. This is because metilphenidate may worsen these problems. Your doctor will want to monitor how the medication affects your child.

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

Checks your doctor will do on your child before starting treatment with Metilfenidato Sandoz

These checks are to decide if metilphenidate is the right medication for your child. Your doctor will talk to you about:

• the medications your child is taking,
• if he has a family history of sudden and unexplained death,
• other diseases that your family may suffer from (such as heart problems),
• how your child is, if he has mood swings, has abnormal thoughts, or has had thoughts 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 repeating sounds and words),
• possible behavior 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 developing mood swings (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 members have 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 metilphenidate is the right medication for your child. It is possible that your doctor will decide that your child needs other medical tests before starting to take this medication.

Other medicines and Metilfenidato Sandoz

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

Do not give metilphenidate to your child if he:

• is taking a medication called "monoamine oxidase inhibitor" (MAOI) that is used for depression or has taken an MAOI in the last 14 days. The use of an MAOI with metilphenidate may cause a sudden increase in blood pressure (see "Do not give Metilfenidato 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 metilphenidate with these types of medications may cause a potentially fatal increase in "serotonin" in the brain (serotonin syndrome), which can cause confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeats. If your child presents these adverse effects, seek medical attention immediately.

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

• medications for severe mental health problems,
• medications for Parkinson's disease (such as levodopa),
• medications for epilepsy,
• medications used to lower or raise blood pressure,
• some cough and cold remedies that contain medications that may affect blood pressure. It is essential to consult your pharmacist when purchasing any of these medications,
• medications that thin the blood to prevent blood clots.

If you have any doubts about whether any of the medications your child is taking are included in the above list, consult your doctor or pharmacist for advice before taking metilphenidate.

Inform your doctor or pharmacist if your child is using or has used recently any other medications, even those purchased without a prescription.

Before surgery

Inform your doctor if your child is undergoing surgery. Metilphenidate should not be taken on the day of surgery with certain types of anesthetics. This is because it may cause a sudden increase in blood pressure and heart rate during the procedure.

Use in athletes

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

Taking Metilfenidato Sandoz 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 congenital anomalies, although a small increased risk of cardiac malformations cannot be ruled out during its use in the first three months of pregnancy. Your doctor will give you more information about this risk. Consult your doctor or pharmacist before using metilphenidate if your daughter:

• is sexually active. Your doctor will talk to you about contraceptives,
• is pregnant or thinks she may be pregnant. Your doctor will decide if she should take metilphenidate,
• is breastfeeding or plans to breastfeed. Metilphenidate passes into breast milk. Therefore, your doctor will decide if your daughter should breastfeed while taking metilphenidate.

Driving and operating machinery

Your child may experience dizziness, difficulty focusing, or blurred vision when taking metilphenidate. If this occurs, it may be hazardous to perform certain activities such as driving, operating machinery, riding a bike or horse, or climbing trees.

Metilfenidato 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 (23 mg) of sodium per prolonged-release tablet; it is essentially "sodium-free".

How much to take

Your child must follow exactly the administration instructions of this medication indicated by their doctor. In case of doubt, consult their doctor or pharmacist again.

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

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

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

The tablet must 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 aged 6 and above

• The recommended initial dose of prolonged-release methylphenidate is 18 mg once a day 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 improve after 1 month of treatment

If your child does not improve after 1 month of treatment, inform their doctor. They may decide if your child needs a different treatment.

Abuse of Metilfenidato Sandoz

If this medication is not used properly, it may cause abnormal behavior. This may also mean that your child becomes dependent on the medication. Inform your doctor if your child has abused or has ever 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 too much Metilfenidato Sandoz

If your child takes too many tablets or in case of accidental ingestion, consult their doctor or pharmacist immediately, call an ambulance, or go to the nearest hospital emergency department 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.

The signs of overdose may include: nausea, agitation, tremors, increased uncontrolled movements, muscle contractions, seizures (which may be followed by coma), feeling extremely happy, confusion, seeing, feeling, or hearing 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 Metilfenidato Sandoz

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

If your child stops taking Metilfenidato Sandoz

If your child stops taking this medication suddenly, their ADHD symptoms or unwanted effects such as depression may return. Their doctor may require them to gradually reduce the amount of medication they take each day before stopping it completely. Consult their doctor before stopping treatment with this medication.

What their doctor will do when their child is on treatment

Their doctor will perform some tests

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

They will also be done 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 rare 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, their doctor should stop treatment for a short period, such as during school holidays. This allows them to demonstrate if they still need the medication.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Although some people may experience side effects, methylphenidate helps most people. Your doctor will inform you about these side effects.

Some side effects can be serious. If your child has any of the side effects listed below, go to your doctor immediately:

Frequent(can affect up to 1 in 10 people)

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

Infrequent(can 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 signs such as hives, itching, or urticaria on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, difficulty breathing.

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

• feeling exceptionally excited, more active than normal, and uninhibited (mania).

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

• heart attack,
• sudden death,
• suicide attempts,
• crisis (seizures, convulsions, epilepsy),
• skin peeling or purple spots,
• inflammation or blockage of the brain's arteries,
• temporary paralysis or movement and vision problems, speech difficulties (these signs may be due to problems with blood vessels in the brain),
• uncontrolled muscle spasms affecting the eyes, head, neck, body, and nervous system,
• decreased blood cell count (red blood cells, white blood cells, and platelets) that may increase the risk of infections and cause easy bruising and bleeding,
• sudden increase in body temperature, very high blood pressure, and severe convulsions ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this side effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Unknown(frequency cannot be estimated from available data)

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

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

The following side effects are listed below, and if they become serious, please inform your doctor or pharmacist:

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

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

Frequent(can affect up to 1 in 10 people)

• joint pain,
• blurred vision,
• headache due to muscle tension,
• thirst,
• difficulty falling asleep,
• high temperature (fever),
• alteration of sexual desire,
• unusual hair loss or thinning,
• muscle weakness, muscle cramps,
• loss of appetite or decreased appetite,
• difficulty achieving or maintaining an erection,
• itching, hives, or increased itching of red hives (urticaria),
• excessive drowsiness or drowsiness, feeling tired,
• excessive tooth grinding (bruxism),
• feeling of panic,
• tingling, itching, or numbness of the skin,
• increased levels of alanine aminotransferase (a liver enzyme) in the blood,
• cough, sore throat, and irritation of the throat or nose, upper respiratory tract infection, nasal sinus infection,
• high blood pressure, rapid heartbeat (tachycardia),
• feeling of dizziness (vertigo), fatigue, uncontrolled movements, excessive activity,
• aggression, agitation, anxiety, depression, irritability, tension, nervousness, and altered behavior,
• feeling of a full stomach or indigestion, stomach pain, diarrhea, stomach upset, and nausea,
• excessive sweating,
• weight loss.

Infrequent(can affect up to 1 in 100 people)

• dry eyes,
• constipation,
• chest discomfort,
• blood in the urine,
• apathy,
• agitation or tremor,
• increased need to urinate,
• muscle pain, muscle spasms,
• shortness of breath or chest pain,
• feeling of heat,
• increased liver enzyme results (seen in a blood test),
• anger reaction (anger), restlessness, or crying, excessive talking, excessive awareness of the environment, difficulty sleeping.

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

• alteration of sexual desire,
• feeling disoriented or confused,
• vision problems or double vision,
• swelling of the chest in men,
• skin redness, increased redness of skin rashes.

Very rare(can 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, doing things repeatedly, obsession with something,
• numbness, tingling, or change in color with cold (white to blue, then red) ("Raynaud's phenomenon").

Unknown(frequency cannot be estimated from available data)

• migraine,
• enlarged pupils,
• very high fever,
• slow, rapid, or irregular heartbeats,
• major seizures (convulsions),
• 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),
• jaw muscle spasm 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 gain or height increase,
• your doctor will closely monitor your child's height and weight, as well as their diet,
• if your child does not grow as expected, the treatment with methylphenidate may be interrupted for a short period of time.

Reporting side effects

If your child experiences 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 Spanish System for the Vigilance of Medicines for Human Use:https://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 that appears on the label and packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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 thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

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 components are:

Drug 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.

Coating with film: mixture of coating with film: 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 of the product and contents of the package

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

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

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

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

Package sizes:

28, 30 prolonged-release tablets, or

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

This medicinal product is authorized in the Member States of the European Economic Area with 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

MethylfenidaatRetard Sandoz 36 mg tabletten met verlengde afgifte

MethylfenidaatRetard 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

MethylfenidaatHCl Sandoz retard 36 mg, tabletten met verlengde afgifte

MethylfenidaatHCl Sandoz retard 54 mg, tabletten met verlengde afgifte

Norway:Methylphenidate Sandoz 18 mg depottabletter

MethylphenidateSandoz 36 mg depottabletter

MethylphenidateSandoz 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:MatorideXL18 mg Prolonged-release Tablets

Matoride XL 36 mg Prolonged-release Tablets

Matoride XL 54 mg Prolonged-release Tablets

Last review date of this leaflet:November 2023.

For more detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/