Package Leaflet: Information for the User

Equasym 10 mg, 20 mg, 30 mg, 40 mg and 50 mg modified-release hard capsules

metilfenidato hidrocloruro

The name of this medicinal product is Equasym, it contains the active substance ‘metilfenidato hidrocloruro’. In this package leaflet, the name ‘metilfenidato’ will also be used.

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you or your child.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child. Do not pass it on to others even if their symptoms are the same as yours or your child’s. It may harm them.
• If any of the following happen to you, talk to your doctor or pharmacist. This includes possible side effects not listed in this package leaflet.

1. What Equasym is and what it is used for

2. What you need to know before you start taking Equasym

3. How to take Equasym

4. Possible side effects

5. Storage of Equasym

6. Contents of the pack and other information

Purpose

Equasym is used to treat Attention Deficit Hyperactivity Disorder (ADHD).

-It is used in children and adolescents aged 6 to 18 years.

-It is used only after non-pharmacological treatments have been attempted, such as psychological assistance and behavioral therapy.

Equasym is not used to treat ADHD in children under 6 years old or in adults. Its safety and effectiveness in these populations are unknown.

How it works

Equasym improves the activity of certain parts of the brain with low activity. The medication may help improve attention (attention time) and concentration, and reduce impulsive behaviors.

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

-psychological,

-educational, and

-social.

The treatment with methylphenidate should only be initiated by a specialist in behavioral disorders of childhood and/or adolescence and must be used under their periodic supervision.

ADHD can be controlled using treatment programs.

About ADHD

Children and adolescents with ADHD have:

-difficulty staying seated and quiet, and

-difficulty concentrating.

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

Many children and adolescents try hard to do these things. However, having ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving well at home, school, or other places.

ADHD does not affect a child's or adolescent's intelligence.

Do not take Equasym if you or your child:

-are allergic to methylphenidate or any of the other ingredients in this medicine (see section 6);

-have a thyroid problem;

-have high eye pressure (glaucoma);

-have a tumor of the adrenal gland (pheochromocytoma);

-have an eating disorder where you do not feel hungry or want to eat (e.g. anorexia nervosa);

-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 (e.g. heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease or a heart problem at birth);

-have had a problem with the blood vessels in the brain (e.g. stroke, dilation and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis);

-are currently taking or have taken in the last 14 days an antidepressant (called a monoamine oxidase inhibitor) – see Use of other medicines;

-have 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, when you feel sad, useless and hopeless;

-mania, when you feel abnormally excited, hyperactive and uninhibited.

Do not take methylphenidate if any of the above points apply to you or your child. If you are unsure, consult your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may make these problems worse.

Warnings and precautions

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

-have liver or kidney problems;

-have had seizures (epilepsy, convulsions) or any abnormality on a brain scan (EEG);

-have abused or been dependent on alcohol, prescribed medicines or illegal drugs;

-are a woman and have started to menstruate (see Pregnancy and breastfeeding below);

-have repetitive and difficult to control tics in any part of the body or repeat sounds or words;

-have high blood pressure;

-have a heart problem that is not listed in the section above ‘Do not take methylphenidate’;

-have a mental health problem that is not listed in the section above ‘Do not take methylphenidate’. Other mental health problems include:

-mood swings (from manic to depressed, known as ‘bipolar disorder’);

-becoming aggressive or hostile, or aggression worsening;

-seeing, hearing or feeling things that are not real (hallucinations);

-believing things that are not true (delusions);

-feeling unusually suspicious (paranoia);

-feeling agitated, anxious or tense;

-feeling depressed or guilty.

Before starting treatment, inform your doctor or pharmacist if you or your child have any of the problems mentioned above. This is because methylphenidate may make these problems worse. Your doctor will want to monitor how the medicine affects you or your child.

Checks your doctor will do before you or your child start taking methylphenidate

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

-any other medicine you are taking;

-if you have a family history of sudden death;

-any other medical problem (such as heart problems) you or your family have;

-how you or your child feel, for example if you feel euphoric or depressed, if you have strange thoughts or if you have had any of these thoughts in the past;

-if you have a family history of ‘tics’ (repetitive and difficult to control spasms in any part of the body or repetition of sounds or words);

-any mental health or behaviour problems you, your child or other family members have had. Your doctor will check your mental health history and check if any of your family members have a history of suicide, bipolar disorder or depression.

It is very important that you provide as much information as possible. This will help your doctor decide if methylphenidate is the right medicine for you or your child. Your doctor may decide if any further medical tests are needed before starting this medicine.

Use of Equasym with other medicines

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

Do not take methylphenidate if you or your child:

-are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have taken an MAOI in the last 14 days. If you take an MAOI with methylphenidate, it may cause a sudden increase in blood pressure.

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

-other medicines for depression;

-medicines for serious mental health problems;

-medicines for epilepsy;

-medicines used to reduce or increase blood pressure;

-some treatments for coughs and colds that contain medicines that may affect blood pressure. It is important to consult the pharmacist when buying some of these medicines;

-medicines that prevent the formation of blood clots.

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

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

Having surgery

Inform your doctor if you or your child are going to have surgery. Do not take methylphenidate on the day of surgery if a certain type of anaesthetic is used. This is because there is a possibility of a sudden increase in blood pressure during the operation.

Drug testing

This medicine may give a positive result in a drug test. This includes tests used in sports.

Taking Equasym with alcohol

Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding and fertility

The available data do not suggest an increased risk of total congenital anomalies, although a small increased risk of cardiac malformations cannot be ruled out during the first three months of pregnancy. Your doctor will give you more information about this risk. Inform your doctor or pharmacist before using methylphenidate if you or your daughter:

• are sexually active. Your doctor will talk to you about the use of contraceptives;
• are pregnant or 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.

Prolonged erections

During treatment, children and adolescents may experience unexpected prolonged erections. This may be painful, and it can occur at any time. It is very important that you or your child inform your doctor immediately if the erection lasts more than two hours, especially if it is painful.

Driving and operating machinery

You or your child may feel dizzy, have difficulty focusing or have blurred vision when taking methylphenidate. If this happens, it may be dangerous to do tasks such as driving, using machines, riding a bike or horse, or climbing trees.

Equasym contains saccharose (a type of sugar)

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

Equasym contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per capsule; that is, it is essentially ‘sodium-free’.

How much to take

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

• Equasym is a form of "modified release" methylphenidate that releases the medication gradually over a period of time corresponding to the school day (8 hours). It aims to replace the same total daily dose of traditional methylphenidate (immediate release) taken with breakfast and lunch.
• If you or your child are already taking traditional methylphenidate (immediate release), your doctor may prescribe an equivalent dose of Equasym.
• If you or your child have not taken methylphenidate before, your doctor will usually start treatment with methylphenidate tablets (immediate release). If your doctor considers it necessary, treatment with methylphenidate may start with Equasym 10 mg once a day before breakfast.
• Your doctor will usually start treatment with a low dose and increase it gradually as needed.
• The maximum daily dose is 60 mg.

How to take it

• Equasym should be taken in the morning before breakfast. The capsules can be swallowed whole with water, or alternatively, the capsule can be opened and the contents poured onto a small amount (a spoonful) of apple sauce, and taken immediately without saving for later use. If the medication is taken with soft food, something to drink, such as water, should be taken afterwards.

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

If you or your child do not feel better, inform your doctor. Your doctor may decide that you need another treatment.

Incorrect use of Equasym

If Equasym is not used correctly, abnormal behaviors may occur. It may also mean that you or your child are starting to depend on the medication. Inform your doctor if you or your child have ever abused or become dependent on alcohol, prescribed medications, or illegal drugs.

This medication has been prescribed to you or your child and should not be given to others, even if they have the same symptoms.

If you or your child take more Equasym than you should

If you or your child take an excessive amount of the medication, consult a doctor or call an ambulance immediately. Inform them of how much you have taken. You can also consult the Toxicological Information Service. Phone 91 5620420.

The signs of overdose may include: vomiting, feeling agitated, trembling, increased uncontrolled movements, muscle spasms, epileptic seizures (which may be followed by coma), feeling extremely happy, confusion, seeing, hearing, or feeling things that are not real (hallucinations or psychosis), sweating, hot flashes, 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 Equasym

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

If you or your child stop taking Equasym

If you or your child stop taking this medication suddenly, you may experience a return of ADHD symptoms or unwanted side effects such as depression. Your doctor may want to gradually reduce the amount of medication you take each day before stopping it completely. Consult your doctor before stopping Equasym.If you have any other questions about the use of thismedication, ask your doctor, pharmacist, or nurse.

What your doctor will do while you or your child are receiving treatment

Your doctor will perform some tests

-before you or your child start treatment, to ensure that Equasym is safe and beneficial.

-after you or your child start treatment, tests will be performed at least every 6 months, but possibly more frequently. Tests will also be performed when the dose is changed.

-these tests will include:

-checking appetite;

-measuring height and weight;

-measuring blood pressure and heart rate;

-evaluating mood or mental state problems, or any other unusual sensation, or if these have worsened while taking Equasym.

Long-term treatment

You do not need to take Equasym indefinitely. If you or your child take Equasym for a long time, your doctor should suspend treatment temporarily, at least once a year. This can be done during school holidays. This will check if the medication is still needed.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them. Although some people experience side effects, most people find that methylphenidate helps them. Your doctor will treat these side effects with you.

Some side effects could be serious. If you or your child experience any of the following side effects, consult a doctor immediately:

Frequent (affect less than 1 in 10 people)

-irregular heartbeat (palpitations);

-mood or personality changes.

Less frequent (affect less than 1 in 100 people)

-suicidal thoughts or wanting to commit suicide;

-seeing, hearing, or feeling things that are not real, which are signs of psychosis;

-uncontrolled speech and body movements (Tourette's syndrome);

-allergic signs such as skin rash, itching, or hives, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing.

Rare (affect less than 1 in 1,000 people)

-feeling abnormally excited, more active than normal, and uninhibited (mania).

Very rare (affect less than 1 in 10,000 people)

-cardiac arrest;

-seizures (epilepsy);

-skin peeling or purple-red patches;

-uncontrollable muscle spasms that affect the eyes, head, neck, body, and nervous system, caused by temporary lack of blood flow to the brain;

-paralysis or problems with movement and vision, difficulty speaking (these may be signs of brain blood vessel problems);

-reduced or increased number of blood cells (red blood cells, white blood cells, and platelets) that may make you more prone to infections, and make bleeding and bruising easier;

-sudden increase in body temperature, very high blood pressure, and severe convulsions (neuroleptic malignant syndrome). It is not certain that this side effect is caused by methylphenidate or other medications taken with methylphenidate.

Other side effects (unknown frequency)

-unwanted thoughts that keep recurring;

-unexplained fainting, chest pain, shortness of breath (may be signs of heart problems).

If you experience any of the side effects mentioned above, consult a doctor immediately.

Other side effects include the following. If you consider any of them to be serious, inform your doctor or pharmacist:

Frequent (affect more than 1 in 10 people)

-headache;

-nervousness;

-difficulty sleeping.

Less frequent (affect less than 1 in 10 people)

-joint pain;

-dry mouth;

-high temperature (fever);

-unusual hair loss or thinning;

-unusual drowsiness or somnolence;

-loss of appetite or decreased appetite;

-itching, rash, or red, raised, itchy patches (urticaria);

-cough, sore throat, or irritation of the nose and throat;

• high blood pressure, rapid heartbeat (tachycardia);

-dizziness, uncontrolled movements, excessive activity;

-aggression, agitation, anxiety, depression, irritability, and abnormal behavior;

-excessive tooth grinding (bruxism).

Less frequent (affect less than 1 in 100 people)

-constipation;

-chest discomfort;

-blood in the urine;

-tremors or shakiness;

-double vision or blurred vision;

-muscle pain, muscle spasms;

-shortness of breath or chest pain;

-increased liver enzymes in liver tests (observed in blood tests)

-irritability, feeling impatient or wanting to cry, paying excessive attention to what is happening around you, difficulty sleeping.

Rare (affect less than 1 in 1,000 people)

-changes in sexual appetite;

-feeling disoriented;

-dilated pupils, vision problems;

-swelling of the breasts in men;

-excessive sweating, skin redness, skin rash with red, raised patches.

Very rare (affect less than 1 in 10,000 people)

-cardiac arrest;

-sudden death;

-muscle cramps;

-small red spots on the skin;

-inflammation or blockage of brain blood vessels;

-abnormal liver function, including liver failure and coma;

-changes in test results, including liver tests and blood tests;

-suicidal thoughts, completed suicide, abnormal thoughts, lack of feeling or emotion, doing things repeatedly, becoming obsessed with something;

-numbness of the fingers and toes, tingling, and color changes with cold (white to blue, then red) (Raynaud's phenomenon).

Other side effects (unknown frequency)

-migraine;

-excessive talkativeness;

-very high fever;

-slow, rapid, or additional heartbeats;

-nosebleed

-severe seizure (tonic-clonic seizure);

-believing things that are not true, confusion;

-severe stomach pain, often with dizziness and vomiting;

-prolonged erections, sometimes painful, or increased frequency of erections;

-difficulty developing or maintaining an erection;

-problems with brain blood vessels (stroke, cerebral arteritis, or cerebral occlusion).

-bruising

-difficulty controlling urine (incontinence)

-spasm of the jaw muscles that makes it difficult to open the mouth (trismus)

-stuttering

Growth effects

If 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 closely monitor your height and weight, as well as your diet;

-If you or your child do not grow as expected, the methylphenidate treatment may be suspended for a brief period.

Reporting side effects

If you experience 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Do not use this medication if you observe that the capsules appear to be deteriorated.

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

Composition of Equasym

The active ingredient is methylphenidate hydrochloride.

-Each 10 mg capsule contains 10 mg of methylphenidate hydrochloride corresponding to 8.65 mg of methylphenidate.

-Each 20 mg capsule contains 20 mg of methylphenidate hydrochloride corresponding to 17.30 mg of methylphenidate.

-Each 30 mg capsule contains 30 mg of methylphenidate hydrochloride corresponding to 25.94 mg of methylphenidate.

-Each 40 mg capsule contains 40 mg of methylphenidate hydrochloride corresponding to 34.59 mg of methylphenidate.

-Each 50 mg capsule contains 50 mg of methylphenidate hydrochloride corresponding to 43.24 mg of methylphenidate.

The other components are:

-Fill of the capsule:sugar spheres (sucrose and cornstarch), povidone K29-K32, Opadry YS-1-7006 clear (hypromellose, macrogol 400 and macrogol 8000), aqueous dispersion of ethylcellulose and dibutyl sebacate.

-Body of the capsule:gelatin, titanium dioxide (E171),

• The 10 mg capsule also containsindigo carmine (E132),iron oxide yellow (E172)
• The 20 mg capsule also containsindigo carmine (E132)
• The 30 mg capsule also containsindigo carmine (E132),iron oxide red (E172)
• The 40 mg capsule also containsiron oxide yellow (E172)
• The 50 mg capsule also containsindigo carmine (E132),iron oxide red (E172)

-White printing ink(only in 10, 20, 30 and 50 mg capsules):shellac, propylene glycol, sodium hydroxide, povidone K16 and titanium dioxide (E171).

-Black printing ink:contains shellac 45% (20% esterified) in ethanol, propylene glycol, ammonium hydroxide 28% and iron oxide black (E172).

Appearance of the product and contents of the package

Modified-release hard capsules.

The 10 mg modified-release hard capsules have a dark green opaque cap with “S544” printed in white and a white opaque body with “10 mg” printed in black.

The 20 mg modified-release hard capsules have a blue opaque cap with “S544” printed in white and a white opaque body with “20 mg” printed in black.

The 30 mg modified-release hard capsules have a brown-red opaque cap with “S544” printed in white and a white opaque body with “30 mg” printed in black.

The 40 mg modified-release hard capsules have a yellow ivory opaque cap with “S544” printed in black and a white opaque body with “40 mg” printed in black.

The 50 mg modified-release hard capsules have a purple opaque cap with “S544” printed in white and a white opaque body with “50 mg” printed in black.

Package sizes:

10, 20 and 30 mg dose - 10, 28, 30, 60 or 100 modified-release hard capsules (only 10 mg and 20 mg capsules).

40 mg, 50 mg, 60 mg dose - 28 or 30 modified-release hard capsules.

Only some package sizes or doses may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50 – 58 Baggot Street Lower

Dublín 2, D02 HW68

Ireland

Manufacturer responsible:

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50-58 Baggot Street Lower

Dublín 2

Ireland

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50 – 58 Baggot Street Lower

Dublín 2,

D02 HW68

Ireland

Local representative:

Takeda Farmacéutica España S.A.

Calle Albacete, 5, planta 9ª,

Edificio Los Cubos

28027 Madrid

Spain

Tel: +34 91 790 42 22

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

GermanyEquasym Retard

BelgiumEquasym XR

DenmarkEquasym Depot

SpainEquasym

FinlandEquasym Retard

FranceQuasym

IcelandEquasym Depot

IrelandEquasym XL

ItalyEquasym

LuxembourgEquasym XR

NorwayEquasym Depot

NetherlandsEquasym XL

PortugalQuasym

United Kingdom (Northern Ireland) Equasym XL

This leaflet has been approved inJanuary 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/