Equasym 20 mg modified-release hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

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

methylphenidate hydrochloride

The name of this medicine is Equasym, which contains the active substance 'methylphenidate hydrochloride'. In this leaflet, the name 'methylphenidate' will also be used.

Read the entire leaflet carefully before you or your child start taking this medicine, as it contains important information for you or your child.

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

Leaflet Contents

1. What Equasym is and what it is used for
2. What you need to know before you or your child take Equasym
3. How to take Equasym
4. Possible side effects
5. How to store Equasym
6. Contents of the pack and other information

1. What Equasym is and what it is used for

What it is used for

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 tried, such as psychological support and behavioural therapy.

Equasym is not used to treat ADHD in children under 6 years of age or in adults. It is unknown whether it is safe or beneficial for these individuals.

How it works

Equasym improves the activity of certain parts of the brain that have low activity. The medicine may help improve attention (attention span) and concentration, and reduce impulsive behaviours.

The medicine is given as part of a treatment programme, which usually includes:

• psychological,
• educational, and
• social therapy.

Treatment with methylphenidate should only be initiated by a specialist in childhood and/or adolescent behavioural disorders and must be used under their periodic supervision.

ADHD can be managed using treatment programmes.

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and sitting quietly, 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, because they have ADHD, they may experience problems in daily life. Children and adolescents with ADHD may have difficulties with learning and completing homework. They often find it very hard to behave appropriately at home, at school, or in other settings.

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

2. What you need to know before you or your child start taking Equasym.

Do not take Equasym if you or your child:

• are allergic to methylphenidate or to any of the other components of this medicine
  (listed in section 6);
• have a thyroid problem;
• have high eye pressure (glaucoma);
• have a tumour of the adrenal gland (pheochromocytoma);
• have an eating disorder in which you or your child have no appetite or do not want to eat (e.g., anorexia nervosa);
• have very high blood pressure or narrowing of the blood vessels, which may cause pain in arms and legs;
• have ever had heart problems (e.g., cardiac arrest, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or a congenital heart problem);
• have ever had a blood vessel problem in the brain (e.g., stroke, bulging and weakening of part of a blood vessel (aneurysm), narrowed or blocked blood vessels, or inflammation of the blood vessels (vasculitis));
• are currently taking or have taken within the last 14 days an antidepressant (called a monoamine oxidase inhibitor) – see Use with other medicines;
• have mental health problems such as:
• a 'psychopathic' or 'borderline personality disorder';
• abnormal thoughts or hallucinations or a condition called 'schizophrenia';
• signs of a severe mood disorder such as:
• suicidal thoughts;
• severe depression, when feeling sadness, worthlessness and hopelessness;
• mania, when feeling abnormally excitable, hyperactive and disinhibited.

Do not take methylphenidate if any of the above apply to you or your child. If you are in any doubt, consult your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these conditions.

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 epileptic seizures (epileptic fits, convulsions, epilepsy) or any abnormalities in a brain scan (EEG);
• have abused or been dependent on alcohol, prescription medicines or illegal drugs;
• are a woman who has started menstruation (see section 'Pregnancy and breastfeeding' below);
• have repetitive, difficult-to-control tics anywhere in the body or repeat sounds or words;
• have high blood pressure;
• have a heart condition not listed in the section above 'Do not take methylphenidate';
• have a mental health condition 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 worsening aggression;
• seeing, hearing or feeling things that are not real (hallucinations);
• believing things that are not true (delusions);
• feeling unusually suspicious (paranoia);
• feeling restless, 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 listed above. This is because methylphenidate may worsen these conditions. Your doctor will want to monitor how the medicine affects you or your child.

If you or your child experience blurred vision or other visual disturbances, contact your doctor. Your doctor may consider stopping treatment with Equasym.

Checks your doctor will carry out before you or your child start taking methylphenidate

These checks are performed to decide whether methylphenidate is the right medicine for you or your child. Your doctor will discuss with you:

• any other medicines you or your child are taking;
• whether there is a family history of unexplained sudden death;
• any other medical problems (such as heart problems) that you or your family may have;
• how you or your child feel, for example, whether you or your child feel euphoric or depressed, have strange thoughts, or have had any of these thoughts in the past;
• whether there is a family history of 'tics' (repetitive, difficult-to-control spasms anywhere in the body or repeating sounds or words);
• any history of mental health or behavioural problems in you, your child or other family members. Your doctor will inform you if you or your child are at risk of mood disturbances (from manic to depressed, known as 'bipolar disorder'). Your doctor will review your or your child's mental health history and check whether any of your relatives have a history of suicide, bipolar disorder or depression.

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

Taking Equasym with other medicines

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

Do not take methylphenidate if you or your child:

• are taking a medicine known as a 'monoamine oxidase inhibitor' (MAOI) used for depression, or have taken an MAOI within the last 14 days. If you take an MAOI with methylphenidate, a sudden increase in blood pressure may occur.

If you or your child are taking other medicines, methylphenidate may affect their effectiveness or may cause adverse 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 conditions;
• medicines for epilepsy;
• medicines used to lower or raise blood pressure;
• some cough and cold remedies containing medicines that may affect blood pressure. It is important to consult the pharmacist when purchasing any of these medicines;
• medicines that prevent blood clotting.

If you are unsure whether any of the medicines you or your child 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 recently used any other medicines, including those obtained without a prescription.

Undergoing surgery

Inform your doctor if you or your child are scheduled for surgery. Methylphenidate should not be taken on the day of surgery if a specific type of anaesthetic is to be used. This is because there is a possibility of a sudden increase in blood pressure during the procedure.

Drug testing

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

Taking Equasym with alcohol

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

Pregnancy, breastfeeding and fertility

Available data do not suggest an increased risk of overall congenital malformations, although a small increase in the risk of cardiac malformations during use in the first three months of pregnancy could not be ruled out. Your doctor will provide further information about this risk. Inform your doctor or pharmacist before using methylphenidate if you or your daughter:

• are sexually active. Your doctor will discuss the use of contraception;
• are pregnant or may be pregnant. Your doctor will decide whether you or your daughter should take methylphenidate;
• are breastfeeding or plan to breastfeed. Methylphenidate may pass into breast milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while taking methylphenidate.

Prolonged erections

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

Driving and using machines

You or your child may feel dizzy, have difficulty focusing or experience blurred vision when taking methylphenidate. If this occurs, it may be dangerous to perform tasks such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

Equasym contains sucrose (a type of sugar)

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

Equasym contains sodium

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

3. How to take Equasym

How much to take

Follow exactly the dosage instructions for this medicine as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

• Equasym is a "modified-release" form of methylphenidate that gradually releases the medicine over a period corresponding to the school day (8 hours). It is intended 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 never taken methylphenidate before, your doctor will normally start treatment with traditional methylphenidate tablets (immediate-release). However, if your doctor considers it necessary, treatment with methylphenidate may begin with Equasym 10 mg once daily before breakfast.
• Your doctor will usually start treatment with a low dose and gradually increase it as appropriate.
• The maximum daily dose is 60 mg.

How to take it

• Equasym should be taken in the morning before breakfast. The capsules may be swallowed whole with water, or alternatively, the capsule can be opened and the contents sprinkled onto a small amount (one tablespoon) of applesauce, and taken immediately without saving for later use. If the medicine is taken with soft food, a drink of liquid 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 a different treatment is needed.

Misuse of Equasym

If Equasym is not used correctly, abnormal behaviors may occur. It may also mean that you or your child begin to become dependent on the medicine. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs.

This medicine has been prescribed for you or your child and should not be given to other people, even if they have the same symptoms.

If you or your child take more Equasym than you should

If you or your child take too much of this medicine, consult a doctor or call an ambulance immediately. Inform them of how much has been taken. You may also contact the Toxicology Information Service. Telephone 91 5620420.

Signs of overdose may include: vomiting, feeling agitated, tremors, increased involuntary movements, muscle spasms, epileptic seizures (possibly followed by coma), feeling extremely happy, confusion, seeing, hearing, or feeling things that are not real (hallucinations or psychosis), sweating, hot flushes, headache, high fever, changes in heartbeat (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 make up for missed doses. If you or your child miss a dose, wait until the next scheduled dose.

If you or your child stop taking Equasym

If you or your child suddenly stop taking this medicine, ADHD symptoms may return or unwanted adverse effects such as depression may occur. Your doctor may wish to gradually reduce the daily dose before stopping completely. Consult your doctor before discontinuing Equasym. If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

Tests your doctor will perform while you or your child are receiving treatment

Your doctor will carry out certain tests

• before you or your child start treatment, to ensure that Equasym is safe and beneficial;
• after you or your child start treatment, at least every 6 months, but possibly more frequently, and also when the dose is changed;
• these tests will include:
• checking appetite;
• measuring height and weight;
• measuring blood pressure and heart rate;
• assessing mood or mental state problems, or any other unusual feelings, or whether these have worsened while taking Equasym.

Long-term treatment

It is not necessary to take Equasym indefinitely. If you or your child take Equasym for a long period, your doctor should temporarily stop treatment at least once a year. This may be done during school holidays. This will help determine whether the medicine is still needed.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. While some people may experience adverse effects, most find that methylphenidate helps them. Your doctor will discuss any of these adverse effects with you.

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

Frequent (affects less than 1 in 10 people)

• irregular heartbeat (palpitations);
• changes or disturbances in mood or changes in personality.

Uncommon (affects less than 1 in 100 people)

• suicidal thoughts or desire to commit suicide;
• seeing, hearing, or feeling things that are not real—these are signs 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 (affects less than 1 in 1,000 people)

• feeling abnormally excited, more active than normal, and disinhibited (mania).

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

• cardiac arrest;
• epileptic seizures (epileptic fits, convulsions, epilepsy);
• skin peeling or areas of red-purple discoloration;
• muscle spasms that you cannot control, affecting the eyes, head, neck, body, and nervous system. These may be due to a temporary lack of blood supply to the brain;
• paralysis or problems with movement and vision, difficulty speaking (these may be signs of problems with blood vessels in the brain);
• reduction or increase in the number of blood cells (red blood cells, white blood cells, and platelets), which could make you more prone to infections and cause bleeding and bruising to occur more easily;
• sudden increase in body temperature, very high blood pressure, and severe convulsions (‘neuroleptic malignant syndrome’). It is not certain whether this adverse effect is due to methylphenidate or to other medicines taken together with methylphenidate.

Other adverse effects (frequency not known)

• unwanted thoughts that keep returning;
• unexplained fainting, chest pain, shortness of breath (these may be signs of heart problems).

If you experience any of the adverse effects listed above, consult a doctor immediately.

Other adverse effects include the following. If you consider any of these to be severe, inform your doctor or pharmacist:

Very frequent (affects more than 1 in 10 people)

• headache;
• feeling nervous;
• difficulty sleeping.

Frequent (affects less than 1 in 10 people)

• joint pain;

• dry mouth;

• high temperature (fever);

• hair loss or unusual thinning of hair;

• unusual drowsiness or sleepiness;

• loss of appetite or decreased appetite;

• itching, rash, or raised red itchy rash (urticaria);

• cough, sore throat, or irritation of nose and throat;

  • high blood pressure, rapid heartbeat (tachycardia);

• dizziness, uncontrolled movements, unusual activity;

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

• excessive teeth grinding (bruxism).

Uncommon (affects less than 1 in 100 people)

• constipation;
• chest discomfort;
• blood in the urine;
• tremors or shaking;
• double vision or blurred vision;
• muscle pain, muscle spasms;
• shortness of breath or chest pain;
• increased liver enzymes in liver function tests (seen in blood tests);
• anger, feeling restless or tearful, excessive focus on surroundings, trouble sleeping;
• dry eye.

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

• changes in sexual appetite;
• feeling disoriented;
• dilated pupils, vision problems;
• breast enlargement in men;
• excessive sweating, skin redness, skin rash with raised red spots;
  • obsessive-compulsive disorder (OCD) (including an irresistible urge to pull out body hair, pinch the skin, have repeated unwanted thoughts, feelings, images, or impulses in the mind (obsessive thoughts), or perform repeated behaviors or mental rituals (compulsions)).

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

• cardiac arrest;
• sudden death;
• muscle cramps;
• small red spots on the skin;
• inflammation or blockage of arteries in the brain;
• abnormal liver function, including liver failure and coma;
• changes in test results, including liver function tests and blood tests;
• suicide attempt, completed suicide, abnormal thoughts, lack of sensation or emotion;
• numbness in fingers and toes, tingling, and color changes in cold conditions (from white to blue, then red) (‘Raynaud’s phenomenon’).

Other adverse effects (frequency unknown)

• migraine;
• excessive talkativeness;
• very high fever;
• slow, fast, or extra heartbeats;
• nosebleeds;
• severe epileptic seizure (‘tonic-clonic seizures’);
• believing things that are not true, confusion;
• severe stomach pain, often with dizziness and vomiting;
• prolonged erections, sometimes painful, or an increase in the number of erections;
• inability to achieve or maintain an erection;
• problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion);
• bruising;
• inability to control urination (incontinence);
• spasm of jaw muscles making it difficult to open the mouth (trismus);
• stuttering;
• increased eye pressure;
• eye diseases that may cause vision loss due to optic nerve damage.

Effects on growth

When used for more than one year, methylphenidate may reduce growth in some children. This affects fewer than 1 in 10 children.

• It may prevent weight or height gain.
• Your doctor will closely monitor your or your child’s height, weight, and eating habits.
• If you or your child do not grow as expected, treatment with methylphenidate may be temporarily stopped.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Equasym

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Do not use this medicine if you notice that the capsules appear damaged.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Equasym

The active substance is methylphenidate hydrochloride.

• Each 10 mg capsule contains 10 mg of methylphenidate hydrochloride, equivalent to 8.65 mg of methylphenidate.
• Each 20 mg capsule contains 20 mg of methylphenidate hydrochloride, equivalent to 17.30 mg of methylphenidate.
• Each 30 mg capsule contains 30 mg of methylphenidate hydrochloride, equivalent to 25.94 mg of methylphenidate.
• Each 40 mg capsule contains 40 mg of methylphenidate hydrochloride, equivalent to 34.59 mg of methylphenidate.
• Each 50 mg capsule contains 50 mg of methylphenidate hydrochloride, equivalent to 43.24 mg of methylphenidate.

The other components are:

• Capsule contents: sugar spheres (sucrose and maize starch), povidone K29-K32, Opadry YS-1-7006 clear (hypromellose, polyethylene glycol 400 and polyethylene glycol 8000), aqueous ethylcellulose dispersion and dibutyl sebacate.

• Capsule shell: gelatin, titanium dioxide (E171),

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

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

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

Appearance of the product and contents of the pack

Modified-release hard capsules.

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

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

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

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

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

Pack sizes:

10 mg, 20 mg and 30 mg doses - 10, 28, 30, 60 or 100* modified-release hard capsules (only 10 mg and 20 mg capsules available in all pack sizes).

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

Only certain pack sizes or strengths may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2, D02 HW68
Ireland

Manufacturer:

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland

Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2,
D02 HW68
Ireland

Local representative:

Takeda Farmacéutica España S.A.
Calle Albacete, 5, 9th floor
Edificio Los Cubos
28027 Madrid
Spain
Tel: +34 91 790 42 22

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Germany: Equasym Retard
Belgium: Equasym XR
Denmark: Equasym Depot
Spain: Equasym
Finland: Equasym Retard
France: Quasym
Iceland: Equasym Depot
Ireland: Equasym XL
Italy: Equasym
Luxembourg: Equasym XR
Norway: Equasym Depot
Netherlands: Equasym XL
Portugal: Quasym
United Kingdom (Northern Ireland): Equasym XL

This patient information leaflet was approved in November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/