METHYLPHENIDATE VIATRIS 36 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you or your child take Methylphenidate Viatris

Do not take Methylphenidate Viatris if you or your child:

• Are allergic to methylphenidate or any of the other ingredients of this medicine (see section 6).
• Have a thyroid problem.
• Have high eye pressure (glaucoma).
• Have a tumor in the adrenal glands (pheochromocytoma).
• Have an eating disorder, have no appetite, or do not want to eat, such as in "anorexia nervosa".
• Have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs.
• Have had heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease, or a heart problem at birth.
• Have 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).

• Are taking or have taken in the last 14 days a certain type of antidepressant (known as a monoamine oxidase inhibitor), see "Other medicines and Methylphenidate Viatris".
• Have or have had a mental health problem 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 feelings.
    • Severe depression, feeling very sad, worthless, and desperate.
    • Mania, feeling exceptionally elated, more active than usual, and uninhibited.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Methylphenidate Viatris if you or your child:

• Have liver or kidney problems.
• Have problems swallowing or swallowing whole tablets.
• Have a narrowing or blockage in the digestive system.
• Have had seizures (fits, convulsions, epilepsy) or any alteration in the electroencephalogram (EEG).
• Are female and have started having periods (see the section "Pregnancy, breastfeeding, and fertility" below).
• Have ever abused or been dependent on alcohol, prescription medications, or drugs.
• Have repetitive movements that are difficult to control of 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 Methylphenidate Viatris if you or your child:".
• Have a mental health problem not included in the section "Do not take Methylphenidate Viatris if you or your child:".

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 strangely suspicious (paranoia).
• Feeling agitated, anxious, or tense.
• Feeling depressed or guilty.

Tell your doctor or pharmacist if you or your child have 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 you or your child.

Checks that your doctor will do before you or your child start treatment with methylphenidate

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

• The medications that you or your child are taking.
• If you have a family history of sudden unexplained death.
• Other medical problems (such as heart problems) that you, your child, or your family may have.
• How you are feeling, if you have mood swings, have strange thoughts, or have had feelings like this in the past.
• If there have been cases of tics in your family (repetitive movements that are difficult to control of some parts of the body or repetition of sounds and words).
• Possible behavioral or mental health problems that you, your child, or other family members may have or have had. Your doctor will specifically explain if you or your child are at risk of mood changes (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 important that you provide all the information you can. This will help your doctor decide if methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need other medical tests before starting to take this medicine. For adults who start taking methylphenidate, your doctor may refer you to a cardiologist.

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

Other medicines and Methylphenidate Viatris

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Do not take methylphenidate if you or your child:

• Are taking a medicine called a "monoamine oxidase inhibitor" (MAOI) for depression or have 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 Viatris").

Tell your doctor or pharmacist if you are 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 you experience these side effects, see your doctor immediately.

If you or your child are taking other medicines, methylphenidate may affect their efficacy or cause side effects. If you or your child are taking any of the following medicines, talk to your doctor or pharmacist before taking methylphenidate:

• Other medicines for depression, 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 that you 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 you or your child are taking are included in the list above, talk to your doctor or pharmacist for advice before taking methylphenidate.

Tell your doctor or pharmacist if you or your child are using or have recently used other medicines, including those bought without a prescription.

Before an operation

Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on the day of the operation with certain types of anesthetics, as it may cause a sudden increase in blood pressure during the procedure.

Drug tests/anti-doping tests

This medicine may give a positive result in drug tests.

This includes tests used in sports.

Taking Methylphenidate Viatris 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, 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 medicine.

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

Talk to your doctor or pharmacist before using methylphenidate if you or your daughter:

• Are having sex. Your doctor will discuss contraception with you.
• Are pregnant or think you may be pregnant. Your doctor will decide if you should take methylphenidate.
• Are breastfeeding or plan to breastfeed. It is possible that methylphenidate may pass into breast milk. Therefore, your doctor will decide if you or your daughter should breastfeed while taking methylphenidate.

Driving and using machines

Dizziness, concentration problems, or visual disturbances may occur during treatment with methylphenidate. If these side effects occur, it may be dangerous to perform activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

This medicine contains sucrose and sodium

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

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

3. How to Take Methylphenidate Viatris

How Much to Take

You or your child must follow the administration instructions for this medication exactly as indicated by your doctor. In case of 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 more than once a week if necessary. The goal should be the lowest dose that is effective for you. Your doctor will decide the maximum daily dose for you or your child.
• You or your child should take Methylphenidate 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 recommended initial dose of 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.

Use in Adults

For Adults Who Have Taken Methylphenidate Before:

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

For Adults Who Have Not Taken Methylphenidate Before:

• The recommended initial 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 ensure that methylphenidate is safe and beneficial.
• Once treatment has started, 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 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 demonstration of whether you still need the medication.

Inadequate Use of Methylphenidate Viatris

If this medication is not used properly, it can 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 ever abused or 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 Methylphenidate Viatris Than You 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 ingested. You may need medical treatment.

The 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, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeats (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nose and mouth.

If You or Your Child Forget to Take Methylphenidate Viatris

Do not take a double dose to make up for forgotten 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 Methylphenidate Viatris

If you or your child suddenly stop taking this medication, ADHD symptoms or unwanted effects such as depression may reappear. Your doctor may want to gradually decrease 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 the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not everyone will experience 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 You or Your Child Experience Any of the Following Adverse Effects, Go to Your Doctor Immediately:

Common (May Affect Up to 1 in 10 People)

• Irregular heartbeats (palpitations).
• Mood changes 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, which are symptoms of psychosis.
• Uncontrolled speech and body movements (Tourette's syndrome).
• Signs of allergy such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing.

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 attempt.
• Seizures (epileptic fits, convulsions, epilepsy).
• Peeling of the skin or red spots.
• Inflammation or blockage of the arteries in the brain.
• Temporary paralysis or problems with movement and vision, difficulty speaking (which can be signs of problems with the blood vessels in the brain).
• Uncontrolled muscle spasms that affect the eyes, head, neck, body, and nervous system, as a result of temporary lack of blood circulation to the brain.
• Decrease in the number of blood cells (red blood cells, white blood cells, and platelets), which can cause a higher risk of infection and easier bleeding and bruising.
• Sudden increase in body temperature, very high blood pressure, and severe seizures ("Neuroleptic Malignant Syndrome"). It is not entirely certain that this adverse effect is caused by methylphenidate or other medications taken in combination with methylphenidate.

Frequency Not Known (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 Adverse Effects Are Also Reported, 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.

Common (May Affect Up to 1 in 10 People)

• Joint pain.
• Blurred vision.
• Tension headache.
• Dry mouth, thirst.
• Difficulty staying asleep.
• High temperature (fever).
• Decreased sexual desire.
• Excessive hair loss or decreased hair thickness.
• Muscle tension, muscle cramps.
• Lack of appetite or decreased appetite.
• Difficulty having or maintaining an erection.
• Itching, rash, or red itchy patches (hives).
• Unusual sleepiness or drowsiness, feeling tired.
• Excessive teeth grinding (bruxism), feeling of panic.
• Feeling of tingling, itching, or numbness of the skin.
• Increased levels of alanine aminotransferase (liver enzyme) in blood.
• Cough, sore throat, and irritation of the throat or nose; upper respiratory tract infection, sinusitis.
• High blood pressure, fast heart rate (tachycardia).
• Dizziness (vertigo), feeling of weakness, uncontrolled movements, abnormal activity.
• Aggression, agitation, anxiety, depression, irritability, tension, nervousness, and abnormal behavior.
• Stomach upset or indigestion, stomach pain, diarrhea, feeling sick, stomach discomfort, and vomiting.
• Excessive sweating.
• Weight loss.

Uncommon (May 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 twitches.
• Shortness of breath or chest pain.
• Feeling of heat.
• Increased liver test results (seen in a blood test).
• Anger reaction (being angry), restlessness, or tearfulness, excessive talking, excessive awareness of surroundings, sleep problems.

Rare (May Affect Up to 1 in 1,000 People)

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

Very Rare (May Affect Up to 1 in 10,000 People)

• Muscle cramps.

• Small red spots on the skin.
• Abnormal liver function, including 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 feeling numb, tingling, and changing color (from white to blue, then red) with cold ("Raynaud's phenomenon").

Frequency Not Known (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, often with feeling unwell 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.
• 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.

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

Reporting Adverse Effects

If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Methylphenidate Viatris

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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 prolonged-release tablets should be kept in their original child-resistant packaging.

Do not use this medication if you notice that the tablet is damaged.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Methylphenidate Viatris

• The active ingredient is methylphenidate hydrochloride. Each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride, equivalent to 31.13 mg of methylphenidate.

• Other ingredients 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), colloidal anhydrous 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).

Appearance of the Product and Package Contents

Methylphenidate Viatris 36 mg are white to off-white, oblong, and biconvex tablets, 11.3 x 5.3 mm in size with dividing lines on both sides. The tablet can be divided into equal doses.

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

Package sizes: 28 or 30 prolonged-release tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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

United Kingdom

Viatris UK Healthcare Limited

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

United Kingdom

Mylan Hungary Kft

Mylan utca 1, Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Germany Methylphenidathydrochlorid Mylan 36 mg Retardtabletten

Belgium Methylphenidate Retard Viatris 36 mg tabletten met verlengde afgifte

Denmark Methylphenidate Viatris

Spain Metilfenidato Viatris 36 mg comprimidos de liberación prolongada EFG

Finland Methylphenidate Viatris 36 mg depottabletit

France METHYLPHENIDATE VIATRIS LP 36 mg, comprimé pelliculé à libération prolongée

Norway Methylphenidate Viatris 36 mg depottabletter

Netherlands Methylfenidaat HCl Viatris Retard 36 mg, tabletten met verlengde afgifte

Portugal Metilfenidato Mylan

United Kingdom Xenidate XL 36 mg prolonged-release tablets

Sweden Methylphenidate Viatris 36 mg depottabletter

Date of Last Revision of This Leaflet: November 2023

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