Patient Information Leaflet: Medicinal Product Information

Methylphenidate Viatris 54 mg Extended-Release Tablets EFG

methylphenidatehydrochloride

Please read this leaflet carefully before you or your child start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only and should not be given to others, even if they have the same symptoms of illness as you or your child, as it may harm them.
• If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What it is used for

Viatris Methylphenidateis used to treat “Attention Deficit Hyperactivity Disorder” (ADHD).

• It is used in children aged 6 years and above and in adults.
• It is used only after having tried other treatments that do not include medications, such as behavioral therapy and counseling.

Viatris Methylphenidate is not indicated for the treatment of ADHD in children under 6 years.

How it works

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

The medication is administered as part of a comprehensive treatment program, which typically includes therapy:

• psychological,
• educational, and
• social.

Only doctors with experience in behavioral problems in children or adolescents or adults prescribe it.If you are an adult and have not received treatment before, the specialist will perform tests to confirm that you had ADHD since childhood.Although ADHD has no cure, it can be controlled using comprehensive treatment programs.

About ADHD

Children and adolescents with ADHD have:

• Difficulty staying still.
• Difficulty concentrating.

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

Many children and adolescents struggle to do them. However, ADHD can present 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.

Adults with ADHD often have difficulty concentrating. They often feel restless, impatient, and distracted. They may have difficulty organizing their personal and work life.

Not all patients with ADHD need medication treatment.

ADHD does not affect intelligence.

Do not take MethyphenidateViatrisif you or your child:

• Are allergic to methyphenidate or any of the other components of this medication (see section 6).
• Have a thyroid problem.
• Have high eye pressure (glaucoma).
• Have a tumor in the adrenal glands (pheochromocytoma).
• Have a feeding disorder, are not hungry, or do not want to eat, such as in "nervous anorexia".
• Have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs.
• Have had any heart problems such as a heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease, or a congenital heart problem.
• Have or have 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).

• Are taking or have taken in the last 14 days any antidepressant (known as monoamine oxidase inhibitor), see "Other medications and Methyphenidate Viatris".
• Have or have had a mental health problem such as:
• • A "psychopathic" disorder or a "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, despised, and desperate.
    • Mania, feeling exceptionally excited, more active than normal, and uninhibited.

Do not take methyphenidate if you or your child present any of the above. If you are unsure, inform your doctor or pharmacist before you or your child take methyphenidate. This is because methyphenidate may worsen these problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Methyphenidate Viatris if you or your child:

• Have liver or kidney problems.
• Have trouble swallowing or swallowing the whole tablets.
• Have a narrowing or blockage in the digestive system.
• Have had seizures (attacks, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG).
• Are a woman and have started menstruating (see the section "Pregnancy, breastfeeding, and fertility" below).
• Have abused or been dependent on alcohol, prescription medications, or drugs.
• Have repetitive movements that are difficult to control in some parts of the body or repeat sounds and words (tics).
• Have high blood pressure.
• Have a heart problem not included in the section "Do not take Methyphenidate Viatris if you or your child:".
• Have a mental health problem not included in the section "Do not take Methyphenidate Viatris if you or your child:".

Other mental health problems include:

• Mood swings (from being manic to being depressed, known as "bipolar disorder").
• Experiencing aggressive or hostile behavior, or if 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 you or your child present any of the above before starting treatment. This is because methyphenidate may worsen these problems. Your doctor will want to monitor how the medication affects you or your child.

Checks your doctor will make before you or your child start taking methyphenidate

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

• The medications you or your child are taking.
• If you have a family history of sudden and unexplained death.
• Other medical problems (such as heart problems) you, your child, or your family may have.
• How you are, if you have mood swings, have abnormal thoughts, or have had thoughts like this in the past.
• If there have been cases of tics in your family (repetitive movements that are difficult to control in some parts of the body or repetition of sounds and words).
• Any mental health problems you, your child, or other family members have had. Your doctor will explain specifically if you or your child are at risk of developing mood swings (from being manic to being depressed, known as "bipolar disorder"). Your doctor will check your mental health history and 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 methyphenidate is the right medication for you or your child. It is possible that your doctor will decide that you or your child need other medical tests before starting to take this medication.For adults starting to take methyphenidate, your doctor may refer you to a cardiologist.

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.

Other medications and Methyphenidate Viatris

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medication.

Do not take methyphenidate if you or your child:

• Are taking a medication called "monoamine oxidase inhibitor" (MAOI), which is used for depression, or have taken an MAOI in the last 14 days. The use of an MAOI with methyphenidate may cause a sudden increase in blood pressure (see "Do not take Methyphenidate Viatris").

Inform your doctor or pharmacist if you are taking any of the following medications for depression or anxiety:

• Tricyclic antidepressant.
• Selective serotonin reuptake inhibitor (SSRI).
• Serotonin and norepinephrine reuptake inhibitor (SNRI).

Taking methyphenidate with these types of medications may produce 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 you experience these adverse effects, go to your doctor immediately.

If you or your child are taking other medications, methyphenidate may affect the efficacy of these medications or cause adverse effects. If you or your child are taking any of the following medications, consult your doctor or pharmacist before taking methyphenidate:

• Other medications for depression, 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 clotting.

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

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

Before surgery

Inform your doctor if you or your child are to undergo surgery. Methyphenidate should not be taken on the day of surgery with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Drug analysis/antidoping

This medication may give a positive result in drug tests.

This includes tests used in sports.

Taking Methyphenidate Viatris 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

The available data do not suggest an increased risk of total congenital anomalies, although a small increase in the risk of cardiac malformations during the first three months of pregnancy cannot be ruled out. Your doctor will provide more information about this risk.

Consult your doctor or pharmacist before using methyphenidate if you or your daughter:

• Have sex. Your doctor will talk to you about contraceptives.
• Are pregnant or think you may be pregnant. Your doctor will decide if you should take methyphenidate.
• Are breastfeeding or plan to breastfeed. It is possible that methyphenidate may pass into breast milk. Therefore, your doctor will decide if you or your daughter should breastfeed while taking methyphenidate.

Driving and operating machinery

You may experience dizziness, difficulty concentrating, or visual disturbances during treatment with methyphenidate. If these adverse effects occur, it may be hazardous to perform activities such as driving, operating machinery, riding a bike, horseback riding, or climbing trees.

This medication contains saccharose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

How much to take

You or your child must follow exactly the administration instructions of this medication indicated by your doctor. In case of 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, if necessary, not more than once a week. The goal should be the lowest effective dose for you. Your doctor will decide the maximum daily dose for you or your child.
• You or your child must take Metilfenidato Viatris once a day in the morning with a glass of water.The tablet can be divided into equal doses. The tablet (or half tablet) should not be chewed or crushed.The tablet can be taken with or without food.

Use in children from 6 years old

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

Use in adults

For adults who have taken methylphenidate before:

• If you have already taken methylphenidate as a child or adolescent, the same daily dose (mg/day) can be used; your doctor will check regularly if any adjustment is needed.
• Adult patients may need a higher daily dose, but your doctor will try to give you the lowest effective dose.

For adults who have not taken methylphenidate before:

• The initial recommended dose is 18 mg per day.
• The maximum daily dose is 72 mg in adults.

If you or your child do not feel better after 1 month of treatment

If you or your child do not feel better after a month of treatment, inform your doctor. Your doctor may decide if you need a different treatment.

What your doctor will do when you or your child are taking the treatment

Your doctor will perform some tests

• Before you or your child start treatment, to make sure methylphenidate is safe and beneficial.
• Once treatment has started, you will be tested at least every 6 months, and more often if necessary. You will also be tested when the dose is changed.
• These tests will include:
• • Appetite control,
  • Height and weight measurement,
  • Blood pressure and heart rate measurement,
  • Mental state evaluation, mood, or any other rare feeling. Or if this has worsened while taking methylphenidate.

Long-term treatment

This medication does not need to be taken indefinitely.If you or your child take this medication for more than a year, your doctor should interrupt treatment for a short period, such as during school holidays. This allows you to demonstrate if you still need the medication.

Abuse of Metilfenidato Viatris

If this medication is not used properly, it may cause abnormal behavior.This can also mean that you or your child start to depend on the medication. Inform your doctor if you or your child have abused or have ever been dependent on alcohol, prescription medications, or drugs.

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

If you or your child take more Metilfenidato Viatris than they should

If you or your child have taken too much medication, talk to a doctor, call the Toxicology Information Service, phone: 91 562 04 20, or call an ambulance immediately. Indicate the medication and the amount taken. Medical treatment may be necessary.

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, and dryness of the nose and mouth.

If you or your child forget to take Metilfenidato Viatris

Do not take a double dose to compensate for the missed doses. If you or your child forget a dose, wait to take the next dose at the scheduled time.

If you or your child stop taking Metilfenidato Viatris

If you or your child stop taking this medication suddenly, the symptoms of ADHD or unwanted effects such as depression may reappear. Your doctor may want to gradually reduce the amount of medication you take each day before stopping it completely. Consult your doctor before stopping treatment with this 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 you or your child experience any of the following side effects, seek immediate medical attention:

Frequent (can affect up to 1 in 10 people)

• Irregular heartbeats (palpitations).
• Changes or mood alterations or changes in personality.

Less frequent (can affect up to 1 in 100 people)

• Thoughts or suicidal 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, wheezing, or 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)

• Myocardial infarction.
• Sudden death.
• Attempted suicide.
• Crisis (seizures, convulsions, epilepsy).
• Peeling of the skin or red, purpuric patches.
• Inflammation or blockage of the arteries in the brain.
• Temporal paralysis or problems with movement and vision, difficulty speaking (which can be signs of brain blood vessel problems).
• Uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system, due to temporary lack of blood circulation to the brain.
• Decreased blood cell count (red blood cells, white blood cells, and platelets), which can increase the risk of infection and cause 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 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 (which can be signs of heart problems).
• Prolonged erections, sometimes painful, or increased number of erections.

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.

Frequent (can affect up to 1 in 10 people)

• Joint pain.
• Blurred vision.
• Headache due to muscle tension.
• Dry mouth, thirst.
• Difficulty falling asleep.
• Elevated body temperature (fever).
• Decreased libido.
• Excessive hair loss or decreased hair thickness.
• Muscle tension, muscle cramps.
• Loss of appetite or decreased appetite.
• Inability to achieve or maintain an erection.
• Itching, red, itchy rashes (urticaria).
• Excessive drowsiness or drowsiness, feeling tired.
• Excessive tooth grinding (bruxism), feeling anxious.
• Sensation of tingling, itching, or numbness of the skin.
• Increased levels of alanine aminotransferase (liver enzyme) in the blood.
• Cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection, sinusitis.
• High blood pressure, rapid heartbeat (tachycardia).
• Dizziness (vertigo), feeling weak, uncontrolled movements, excessive activity.
• Aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior.
• Stomach discomfort or indigestion, stomach pain, diarrhea, feeling dizzy, stomach discomfort, and vomiting.
• Excessive sweating.
• Weight loss.

Less frequent (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.
• Sensation of heat.
• Increased liver test results (seen in a blood test).
• Anger reaction (angry), restless, or tearful, excessive talkativeness, excessive awareness of the environment, difficulty sleeping.

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

• Changes in sexual desire.
• Feeling disoriented or confused.
• Eye problems or double vision.
• Swelling of the breasts in men.
• Redness of the skin, skin rash with redness and inflammation.

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

• Muscle cramps.

• Small red patches on the skin.
• Abnormal liver function, including liver failure and coma.
• Changes in test results, including liver tests and blood tests.
• Abnormal thinking, absence of feelings or emotions, doing things repeatedly, obsession with something.
• Fingers and toes numb, tingling, and color change (from white to blue, then red) with cold ("Raynaud's phenomenon").

Unknown frequency (cannot be estimated from available data)

• Migraine.
• Dilated pupils.
• Very high fever.
• Irregular heartbeats, slow, rapid, or palpitations.
• Major seizure (grand mal seizure).
• Believing things that are not true.
• Intense stomach pain, often with discomfort and vomiting.
• Problems with brain blood vessels (stroke, cerebral arteritis, or cerebral occlusion).
• Inability to control urination (incontinence).
• Jaw muscle spasm that makes it difficult to open the mouth (trismus).
• Stuttering.
• Nasal bleeding.

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.

• It may prevent weight gain or height gain.
• Your doctor will carefully check the height and weight of you or your child, as well as your diet.
• If you or your child do not grow as expected, the treatment with methylphenidate may be interrupted for a short period of time.

Reporting side effects

If you or your child experience any type of side effect, consult your doctor or pharmacist,even if it is a side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 packaging, after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. However, the extended-release tablets must be kept in their original child-resistant packaging.

Do not use this medication if you observe that the tablet is deteriorated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Methylphenidate Viatris Composition

• The active ingredient is methylphenidate hydrochloride. Each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride, which is equivalent to 46.7 mg of methylphenidate.

• The other components are:

• Tablet core: sugar spheres (sucrose [see section 2, “Methylphenidate Viatris contains sucrose”] and cornstarch), hypromellose, talc (E-553b), ethylcellulose (E-462), hydroxypropylcellulose (E-463), triethyl citrate (E-1505), hypromellose acetate succinate, sodium carmellose, microcrystalline cellulose (E-460ii), magnesium stearate (E-572), anhydrous colloidal silica, hydrochloric acid (E-507) (to adjust pH).
• Tablet coating: polyvinyl alcohol (E-1203), macrogol 3350, talc (E-553b), hydrochloric acid (E-507) (to adjust pH), titanium dioxide (E-171), iron oxide red (E-172).

Appearance of the product and contents of the package

Methylphenidate Viatris 54 mg are reddish to red, oval, biconvex tablets, 13.3 x 6.4 mm with score lines on both faces. The tablet can be divided into equal doses.

The prolonged-release tablets are available in child-resistant screw-top bottles.

Package sizes: 28 or 30 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Person

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Generics [UK] Limited

Station Close, Potters Bar, EN6 1TL

UK

Viatris UK Healthcare Limited

Building 20, Station Close, Potters Bar, EN6 1TL

UK

Mylan Hungary Kft

Mylan utca 1, Komárom, 2900

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyMethylphenidathydrochlorid Mylan 54 mg Retardtabletten

BelgiumMethylphenidate Retard Viatris 54 mg tabletten met verlengde afgifte

DenmarkMethylphenidate Viatris

SpainMetilfenidato Viatris 54 mg comprimidos de liberación prolongada EFG

FinlandMethylphenidate Viatris54 mg depottabletit

FranceMETHYLPHENIDATE VIATRIS LP 54 mg, comprimé pelliculé à libération prolongée

NorwayMethylphenidate Viatris54 mg depottabletter

NetherlandsMethylfenidaat HCl Viatris Retard 54 mg,tabletten met verlengde afgifte

PortugalMetilfenidato Mylan

UKXenidate XL 54 mg prolonged-release tablets

SwedenMethylphenidate Viatris54 mg depottabletter

Last review date of this leaflet: November 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).