EQUASYM 40 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

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

methylphenidate hydrochloride

The name of this medicine is Equasym, which contains the active ingredient '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, ask your doctor or pharmacist.
• This medicine has been prescribed to you or your child, and you should 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Equasym and what is it used for
2. What you need to know before you or your child start taking Equasym
3. How to take Equasym
4. Possible side effects
5. Storing Equasym
6. Package Contents and Further Information

1. What is Equasym and what is it used for

What is it used for

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

• It is used in children and adolescents from 6 to 18 years of age.
• It is used only after non-pharmacological treatments, such as psychological assistance and behavioral therapy, have been attempted.

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

How it works

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

The medicine is administered as part of a treatment program, which normally includes therapy:

• psychological,
• educational, and
• social.

Treatment with methylphenidate should only be initiated by a specialist in child and/or adolescent behavioral disorders and should be carried out under periodic supervision.

ADHD can be controlled using treatment programs.

About ADHD

Children and adolescents with ADHD have:

• difficulty remaining 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, they may have problems in daily life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have trouble behaving at home, at school, or in other places.

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 any of the other ingredients of this medicine (listed in section 6);

(including those listed in section 6);

• have a thyroid problem;
• have high eye pressure (glaucoma);
• have a tumor of the adrenal gland (pheochromocytoma);
• have an eating disorder in which 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 heart problems (e.g., 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 (e.g., stroke, dilation 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 in the last 14 days an antidepressant (called a monoamine oxidase inhibitor) - see "Using 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 problem such as:
• suicidal thoughts;
• severe depression, when you have feelings of sadness, uselessness, and hopelessness;
• mania, when you feel abnormally excited, overactive, and uninhibited.

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

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 (seizures, convulsions, epilepsy) or any abnormality in a brain scan (EEG);
• have abused or been dependent on alcohol, prescribed medications, or illegal drugs;
• are female and have started menstruating (see the section 'Pregnancy and breastfeeding' below);
• have repetitive and uncontrollable 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 previous section 'Do not take methylphenidate';
• have a mental health problem that is not listed in the previous section 'Do not take methylphenidate'. Other mental health problems include:
• mood changes (from manic to depressed, also called '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 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 worsen these problems. Your doctor will want to monitor how the medicine affects you or your child.

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

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

• any other medicine that you or your child are taking;
• if you have a family history of sudden unexplained death;
• any other medical problem (such as heart problems) that you or your family have;
• how you or your child feel, such as if you feel euphoric or depressed, if you have unusual thoughts or if you have had any of these thoughts in the past;
• if you have a family history of 'tics' (repetitive and uncontrollable muscle movements in any part of the body or repetition of sounds or words);
• any mental health or behavioral problem that you, your child, or other family members have had. Your doctor will inform you if you or your child are at risk of having mood changes (from manic to depressed, also called 'bipolar disorder'). They will check the mental health history of you or your child and check if any of your family members have a history of suicide, bipolar disorder, or depression.

It is essential 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 that other medical tests are necessary before starting this medicine.

Using Equasym with other medicines

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

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 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 efficacy 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 severe mental health problems,
• medicines for epilepsy,
• medicines used to lower or increase blood pressure,
• some cough and cold treatments that contain medicines that can affect blood pressure. It is essential to consult with the pharmacist when buying some of these medicines,
• medicines that prevent blood clots from forming.

If you have any doubts about 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.

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

Undergoing surgery

Tell your doctor if you or your child are going to have surgery. You should not take methylphenidate on the day of surgery if a specific type of anesthetic is used. This is because there is a possibility of a sudden increase in blood pressure during surgery.

Drug tests

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 worsen the side 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 total congenital anomalies, 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 more information about this risk. Tell your doctor or pharmacist before using methylphenidate if you or your daughter:

• are having sex. Your doctor will discuss the use of contraceptives with you;
• 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 unexpectedly experience prolonged erections. This may be painful and can occur at any time. It is essential that you or your child communicate immediately with your doctor if the erection lasts more than two hours, particularly if it is painful.

Driving and using machines

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

Equasym contains sucrose (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; this is, essentially "sodium-free".

3. How to take Equasym

How much to take

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

• Equasym is a "prolonged-release" form of methylphenidate that releases the medicine gradually over a period of time corresponding to the school day (8 hours). It is intended to replace the same daily total dose of traditional (immediate-release) methylphenidate taken with breakfast and lunch.
• If you or your child are already taking traditional (immediate-release) methylphenidate, your doctor may prescribe an equivalent dose of Equasym.
• If you or your child have not taken methylphenidate before, your doctor will normally start treatment with traditional (immediate-release) methylphenidate tablets. If your doctor considers it necessary, treatment with methylphenidate may begin with Equasym 10 mg once daily before breakfast.
• Your doctor will normally start treatment with a low dose and gradually increase it as necessary.
• 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 over a small amount (one tablespoon) of applesauce, and taken immediately without saving for later use. If the medicine is taken with soft foods, you should take some liquid, such as water, 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. They may decide that you need a different treatment.

Incorrect use of Equasym

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

This medicine has been prescribed to you or your child, and you should not give it to others.

If you or your child take more Equasym than you should

If you or your child take more than the prescribed dose of the medicine, consult a doctor or call an ambulance immediately. Inform them how much you have taken. You can also contact the Toxicology Information Service. Telephone 91 5620420.

The signs of overdose may include: vomiting, feeling agitated, tremors, increased uncontrollable movements, muscle spasms, epileptic seizures (which may be followed by a 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 make up for forgotten 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 suddenly stop taking this medicine, the symptoms of ADHD may return, or unwanted side effects may appear, such as depression. Your doctor may want to gradually reduce the amount of medicine you or your child take each day before stopping it completely. Consult your doctor before stopping Equasym. If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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

Your doctor will carry out some 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. These tests will also be carried out 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 problems, or any unusual feelings, or if 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 can be done during school holidays. This will check if the medicine is still necessary.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Although some people suffer from adverse effects, most feel that methylphenidate helps them. Your doctor will treat these adverse effects with you.

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

Frequent (affecting less than 1 person in 10)

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

Infrequent (affecting less than 1 person in 100)

• suicidal thoughts or wanting 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);
• allergy 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 (affecting less than 1 person in 1,000)

• feeling abnormally excited, more active than usual, and uninhibited (mania).

Very Rare (affecting less than 1 person in 10,000)

• cardiac arrest;
• epileptic seizures (epileptic crises, convulsions, epilepsy);
• skin peeling or purple-red areas;
• muscle spasms that cannot be controlled and affect the eyes, head, neck, body, and nervous system. These are due to a temporary lack of blood flow to the brain;
• paralysis or problems with movement and vision, difficulty speaking (these can 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) that could make you more prone to infections and make bleeding and bruising occur more easily;
• sudden increase in body temperature, very high blood pressure, and severe convulsions (‘malignant neuroleptic syndrome’). It is not certain that this adverse effect is due to methylphenidate or other medications that can be taken with methylphenidate.

Other Adverse Effects (frequency not known)

• unwanted thoughts that repeatedly come back;
• unexplained fainting, chest pain, shortness of breath (can be signs of heart problems).

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

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

Very Frequent (affecting more than 1 person in 10)

• headache;
• feeling nervous;
• difficulty sleeping.

Frequent (affecting less than 1 person in 10)

• joint pain;
• dry mouth;
• high temperature (fever);
• unusual or weakened hair loss;
• unusual feeling of sleepiness or drowsiness;
• loss of appetite or decreased appetite;
• itching, rash, or red, swollen hives (urticaria);
• cough, sore throat, or irritation of the nose and throat;
• high blood pressure, rapid heartbeat (tachycardia);

• dizziness, uncontrolled movements, abnormal activity;
• aggressiveness, agitation, anxiety, depression, irritability, and abnormal behavior;
• excessive teeth grinding (bruxism).

Infrequent (affecting less than 1 person in 100)

• 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 tests (observed in a blood test)
• anger, feeling impatient or wanting to cry, paying excessive attention to what happens around, sleep problems.

Rare (affecting less than 1 person in 1,000)

• changes in sexual appetite;
• feeling disoriented;
• dilated pupils, vision problems;
• breast swelling in men;
• excessive sweating, skin redness, skin rash with red, swollen spots.

Very Rare (affecting less than 1 person in 10,000)

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

Other Adverse Effects (frequency not known)

• migraine;
• excessive talkativeness;
• very high fever;
• slow, fast, or additional heartbeats;
• nosebleed
• severe epileptic seizure (‘tonic-clonic seizures’);
• believing things that are not true, confusion;
• severe stomach pain, often with dizziness and vomiting;
• prolonged, sometimes painful erections, or an increase in the number of erections;
• inability to develop or maintain an erection;
• problems with blood vessels in the brain (stroke, cerebral arteritis, or cerebral occlusion).
• bruises
• inability to control urine excretion (incontinence)
• spasm of the jaw muscles that makes it difficult to open the mouth (trismus)
• stuttering

Effects on Growth

If used for more than a year, methylphenidate may decrease growth in some children. This affects less than 1 in 10 children.

• It may prevent weight or height gain,
• Your doctor will closely monitor the height and weight of you or your child, as well as their diet;
• If you or your child do not grow as expected, treatment with methylphenidate may be suspended for a short period.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: http://www.aemps.gob.es/

5. Storage of Equasym

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and carton after EXP. The expiration 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 to be damaged.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Equasym

The active ingredient is methylphenidate hydrochloride.

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

The other ingredients are:

• Capsule content: 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.
• Capsule body: gelatin, titanium dioxide (E171),
  • The 10 mg capsule also contains carmine (E132), yellow iron oxide (E172)
  • The 20 mg capsule also contains carmine (E132)
  • The 30 mg capsule also contains carmine (E132), red iron oxide (E172)
  • The 40 mg capsule also contains yellow iron oxide (E172)
  • The 50 mg capsule also contains carmine (E132), red iron oxide (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 lacquer (20% esterified) in ethanol, propylene glycol, 28% ammonia, and black iron oxide (E172).

Appearance of the Product and Package Contents

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 reddish-brown 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 yellowish-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 mg, 20 mg, and 30 mg doses - 10, 28, 30, 60, or 100* modified-release hard capsules (only 10 mg and 20 mg capsules).

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

Not all package sizes or doses may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with 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 leaflet was approved inJanuary 2024

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