Equasym

Patient Information Leaflet: Information for the User

Equasym 10 mg, 20 mg and 30 mg, 40 mg, 50 mg and 60 mg modified-release hard capsules

methylphenidate hydrochloride
This medicine is called Equasym and contains the active substance "methylphenidate hydrochloride". This

The package leaflet will also use the name "methylphenidate".

Read this leaflet carefully before you or your child take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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 in the treatment of "attention deficit hyperactivity disorder" (ADHD).

• It is used in children and adolescents aged between 6 and 18 years.
• It is used only after trying non-medication treatments, such as counselling and behavioural therapy. Equasym must not be used for the treatment of ADHD in children under 6 years of age or in adults. It is not known whether it is safe or beneficial in these individuals.

How it works
Equasym improves the activity of certain parts of the brain that are underactive. The medicine can help to
improve attention (attention capacity) and concentration, and to reduce impulsive behaviour.
The medicine is prescribed as part of a treatment programme, which usually includes:

• psychological
• educational and
• social interventions. Treatment with methylphenidate must be initiated exclusively by, and administered under the regular supervision of, a specialist in childhood and/or adolescent behavioural disorders.

ADHD can be managed with treatment programmes.
Information about ADHD
Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty concentrating. It is not their fault if they cannot do these things.

Many children and adolescents try hard to do so. However, with ADHD, these difficulties can cause problems
in daily life. Children and adolescents with ADHD may have difficulty learning and completing schoolwork.
They may have trouble behaving 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 takes Equasym

Do not take methylphenidate if you or your child:

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• have thyroid problems
• have increased eye pressure (glaucoma)
• have a tumor of the adrenal gland (pheochromocytoma)
• have an eating disorder where you do not feel hungry or have no desire to eat, such as "anorexia nervosa"
• have very high blood pressure or narrowed blood vessels, which can cause pain in the arms and legs
• have ever had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or were born with a heart problem
• have had a problem with blood vessels in the brain, such as stroke, swelling and weakening of part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• are taking or have taken within the last 14 days an antidepressant medicine (known as a monoamine oxidase inhibitor), see "Taking with other medicines"
• have mental health problems, such as:
• a "psychotic" or "borderline personality" disorder
• unusual thoughts or hallucinations, or a condition called "schizophrenia"
• signs of a serious mood problem, such as:
• thoughts of suicide
• severe depression, with intense feelings of sadness, worthlessness, and hopelessness
• mania, with feelings of unusual excitement, hyperactivity, and lack of inhibition.

Do not take methylphenidate if you or your child falls into any of the above categories. If you are unsure, consult your doctor or pharmacist before you or your child takes methylphenidate, because methylphenidate may worsen these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you or your child:

• have liver or kidney problems
• have had seizures (convulsive fits, convulsions, epilepsy) or abnormalities on electroencephalogram (EEG)
• have ever abused or been dependent on alcohol, medicines, or drugs
• are a woman who has started menstruation (see the section below “Pregnancy and breastfeeding”)
• have repeated, difficult-to-control tics anywhere in the body or repeat sounds and words
• have high blood pressure
• have a heart problem not listed in the previous section “Do not take”
• have a mental health problem not listed in the previous section “Do not take”. Other mental health problems include:
• mood swings (from mania to depression, called “bipolar disorder”)
• onset of aggressive or hostile behavior, or worsening of aggression
• seeing, hearing, or sensing things that are not there (hallucinations)
• believing things that are not true (delusions)
• feeling unusually suspicious (paranoia)
• feeling restless, anxious, or tense
• feeling depressed or guilty.

Inform your doctor or pharmacist before starting treatment if you or your child falls into any of the above categories, because methylphenidate could worsen these conditions. Your doctor will need to monitor how the medicine affects you or your child.

Checks performed by the doctor before you or your child starts taking methylphenidate

These checks are intended to determine whether methylphenidate is the right medicine for you or your child. The doctor will discuss with you:

• any medicines you or your child are currently taking
• any family history of unexplained sudden death
• any other medical problems (e.g. heart problems) in you or your family
• how you or your child feel, for example, whether you feel euphoric or depressed, have unusual thoughts, or whether you or your child have previously experienced any of these feelings
• any family history of “tics” (repeated, difficult-to-control spasms anywhere in the body or repetition of sounds and words)
• any past mental or behavioral problems in you, your child, or other family members. The doctor will discuss whether you or your child may be at risk of developing mood swings (from mania to depression, called “bipolar disorder”). The doctor will review your or your child’s mental health history and check whether any family member has a history of suicide, bipolar disorder, or depression. It is important that you provide as much information as possible to help the doctor decide whether methylphenidate is the appropriate medicine for you or your child. The doctor may decide that further medical tests are needed before starting this medicine.

Other medicines and Equasym

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 called a "monoamine oxidase inhibitor" (MAOI), used for depression, or have taken an MAOI within the last 14 days. Taking an MAOI with methylphenidate can cause a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate may affect their effectiveness or cause unwanted 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 lower or raise blood pressure
• some cough and cold remedies containing ingredients that may affect blood pressure. It is important to consult your pharmacist when purchasing one of these medicines
• medicines that thin the blood to prevent clots

If you are unsure whether any of the medicines taken by you or your child fall into the list above, consult your doctor or pharmacist before taking methylphenidate.

Inform your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including those without a prescription.

Surgery

Inform your doctor if you or your child are scheduled to undergo surgery. Methylphenidate should not be taken on the day of surgery if a certain type of anesthetic is used, because there is a risk of a sudden increase in blood pressure during the operation.

Anti-doping tests

This medicine may result in a positive anti-doping test.

For people involved in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Methylphenidate and alcohol

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

Pregnancy, breastfeeding, and fertility

Available data do not indicate an increased overall risk of birth defects, but a small increase in the risk of heart malformations following use during the first three months of pregnancy cannot be ruled out. Your doctor can provide you with further information about this risk. Before using methylphenidate, inform your doctor or pharmacist if you or your daughter:

• are sexually active. The doctor will discuss contraceptive measures
• are or might be pregnant. The doctor will decide whether methylphenidate should be used
• are breastfeeding or plan to breastfeed. Methylphenidate may pass into human breast milk. The doctor will therefore decide whether you or your daughter can breastfeed while taking methylphenidate.

Prolonged erections

During treatment, boys and adolescents may unexpectedly experience prolonged erections, which may be painful and occur at any time. It is important to contact a doctor immediately if an erection lasts longer than 2 hours, especially if it is painful.

Driving and using machines

You or your child may experience dizziness, have difficulty focusing, or blurred vision during treatment with methylphenidate. If this occurs, it may be dangerous to perform activities such as driving vehicles, operating machinery, riding bicycles or horses, or climbing trees.

Equasym contains sucrose (a type of sugar)

If you or your child has an intolerance to certain sugars, contact your doctor before taking this medicine.

Equasym contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

3. How to take Equasym

Dosage
Take this medicine exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

• Equasym is a "modified-release" formulation of methylphenidate, which releases the medicine gradually over a period corresponding to the school day (8 hours). It is intended to replace the same total daily dose of conventional methylphenidate (immediate-release), previously taken at breakfast and lunch.
• If you or your child is already taking conventional methylphenidate (immediate-release), your doctor may prescribe an equivalent dose of Equasym instead.
• If you or your child has never taken methylphenidate before, your doctor will normally start treatment with conventional methylphenidate tablets (immediate-release). However, if your doctor considers it necessary, treatment with methylphenidate may be initiated with Equasym 10 mg once daily before breakfast.
• Your doctor will usually start treatment with a low dose and increase it gradually, if needed.
• The maximum daily dose is 60 mg.

How to take
Equasym should be taken in the morning, before breakfast. The capsules may be swallowed whole with a glass of water or, alternatively, opened and the contents sprinkled onto a small amount (a spoonful) of applesauce and taken/administered immediately, without storing for future use. If the medicine is taken/administered with soft food, fluids (e.g. water) should be taken afterwards.
If you or your child does not improve after 1 month of treatment
If you or your child does not improve, inform your doctor. The doctor may decide that a different treatment is needed.
Misuse of Equasym
Misuse of Equasym can lead to abnormal behaviour. It may also mean that you or your child may become dependent on the medicine. Inform your doctor if you or your child has ever abused or been dependent on alcohol, medicines or drugs.
This medicine is prescribed only for you or your child. Do not give this medicine to other people, even if their symptoms seem similar.
If you or your child takes more Equasym than you should
If you or your child takes too much medicine, contact your doctor or call an ambulance immediately. Tell them how much medicine has been taken.
Signs of overdose may include: feeling unwell, agitation, tremor, increased involuntary movements, muscle spasms, seizures (which may be followed by coma), extreme feelings of happiness, confusion, seeing, sensing or hearing things that are not real (hallucinations or psychosis), sweating, hot flushes, headache, high fever, changes in heart rate (slow, fast or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth.
If you or your child forgets to take Equasym
Do not take a double dose to make up for a missed dose. If you or your child forgets a dose, wait until the next scheduled dose.
If you or your child stops taking Equasym
If you or your child stops treatment with this medicine suddenly, ADHD symptoms may return, or unwanted effects such as depression may occur. Your doctor may need to gradually reduce the daily dose before stopping treatment completely. Consult your doctor before stopping treatment with Equasym. If you have any doubts about using this medicine, speak to your doctor, pharmacist or nurse.
Monitoring by your doctor during treatment
Your doctor will carry out certain tests

• before you or your child starts treatment – to ensure that Equasym is safe and beneficial
• after you or your child starts treatment – at least every 6 months, but possibly more frequently, and also whenever the dose is changed.
• These tests will include:
• monitoring of appetite
• measurement of height and weight
• measurement of blood pressure and heart rate
• monitoring of mood, mental state or any other unusual sensations, or any worsening of these during treatment with Equasym.

Long-term treatment
Equasym should not be taken indefinitely. If you or your child takes Equasym for a prolonged period, your doctor should interrupt treatment for a certain period, at least once a year, preferably during school holidays, to assess whether the medicine is still necessary.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some people experience side effects, most find methylphenidate helpful. Your doctor will discuss these side effects with you.
Some side effects can be serious. If you or your child has any of the side effects listed below, contact your doctor immediately:
Common (affects less than 1 in 10 people)

• irregular heartbeat (palpitations)
• mood changes or mood swings or changes in personality

Uncommon (affects less than 1 in 100 people)

• thoughts or desire to kill oneself
• seeing, sensing or hearing things that are not real; these are signs of psychosis
• uncontrolled speech and body movements (Tourette’s syndrome)
• signs of allergy, such as skin 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)

• unusual feeling of excitement, hyperactivity and lack of inhibition (mania)

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

• heart attack
• epileptic seizures (convulsive fits, convulsions, epilepsy)
• peeling of the skin or appearance of red-purple spots
• muscle spasms that cannot be controlled affecting the eyes, head, neck, body and nervous system – due to temporary lack of blood supply to the brain
• paralysis or movement and vision problems, difficulty speaking (these may be due to problems with blood vessels in the brain)
• decrease or increase in the number of blood cells (red blood cells, white blood cells and platelets), which may make infections more likely and cause increased tendency to bleed and bruise
• sudden increase in body temperature, very high blood pressure and severe convulsions (“Neuroleptic Malignant Syndrome”). It is not certain whether this side effect is caused by methylphenidate or by other medicines that may be taken together with methylphenidate. Other side effects (frequency not known)
• recurrent unwanted thoughts
• fainting without apparent cause, chest pain, shortness of breath (may be signs of heart problems)

If any of the side effects listed above occur, contact your doctor immediately.
Other side effects include the following; if they become severe, inform your doctor or pharmacist:
Very common (affects more than 1 in 10 people)

• headache
• nervousness
• insomnia

Common (affects less than 1 in 10 people)

• joint pain
• dry mouth
• fever
• unusual hair loss or thinning
• feeling drowsy or unusual drowsiness
• loss or decrease in appetite
• itching, skin rash or raised red itchy rash (urticaria)
• cough, sore throat or irritation of the nose and throat
• high blood pressure, fast heartbeat (tachycardia)
• dizziness, uncontrolled movements, feeling of unusual activity
• feeling of aggression, restlessness, anxiety, depression, irritability and abnormal behaviour
• excessive teeth grinding (bruxism)

Uncommon (affects less than 1 in 100 people)

• constipation
• chest discomfort
• presence of blood in urine
• tremor or shaking
• double vision or blurred vision
• muscle pain, muscle spasm
• shortness of breath or chest pain
• increased liver test results (seen in a blood test)
• anger, restlessness or desire to cry, excessive awareness of surroundings, sleep problems

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

• changes in sex drive
• feeling disoriented
• dilated pupils, vision problems
• breast swelling in males
• excessive sweating, skin flushing, raised red skin rash

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

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of arteries in the brain
• liver function abnormalities, including liver failure and coma
• changes in test results – including liver function tests and blood tests
• suicide attempt, suicide, abnormal thoughts, absence of feelings or emotions, repetitive behaviour, obsession with a single object
• numbness, tingling and colour change (from white to blue, then red) in fingers and toes when exposed to cold (“Raynaud’s phenomenon”)

Other side effects (frequency not known)

• migraine
• excessive talkativeness
• very high fever
• slowed, rapid or extra heartbeats
• major epileptic seizure (“generalized tonic-clonic convulsions”)
• believing things that are not true, confusion
• severe stomach pain, often with nausea and feeling unwell
• prolonged erections, sometimes painful, or increased number of erections, inability to achieve or maintain an erection
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
• inability to hold urine (incontinence)
• spasm of jaw muscles making it difficult to open the mouth (trismus)
• stuttering

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

• There may be lack of increase in weight or height.
• Your doctor will closely monitor height and weight, as well as appetite, in you or your child.
• If you or your child is not growing as expected, treatment with methylphenidate may be interrupted for a short period.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the adverse reactions website. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 carton after Exp. The
expiry date refers to the last day of that month.
Store below 25°C.
Do not use this medicine if you notice that the capsules are damaged in any way.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Equasym contains
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.
• Each 60 mg capsule contains 60 mg of methylphenidate hydrochloride, equivalent to 51.89 mg of methylphenidate.

The other components are:

• Capsule content: sugar spheres (sucrose and maize starch), povidone K29-K32, Opadry Clear Ys-1-7006 (hypromellose, polyethylene glycol 400 and polyethylene glycol 8000), aqueous dispersion of ethylcellulose and dibutyl sebacate
• Capsule shell: gelatin, titanium dioxide (E171)
• The 10 mg capsule also contains indigo carmine (E132), yellow iron oxide (E172)
• The 20 mg capsule also contains indigo carmine (E132)
• The 30 mg capsule also contains indigo carmine (E132), red iron oxide (E172)
• The 40 mg capsule also contains yellow iron oxide (E172)
• The 50 mg capsule also contains indigo carmine (E132) and red iron oxide (E172)
• White printing ink (for 10 mg, 20 mg, 30 mg and 50 mg capsules only): shellac, propylene glycol, sodium hydroxide, povidone K16 and titanium dioxide (E171)
• Black printing ink contains 45% polished shellac (20% esterified) in ethanol, propylene glycol, 28% ammonium hydroxide and black iron oxide (E172).

Description of the appearance of Equasym and package contents
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.
The 60 mg modified-release hard capsules have an opaque white cap printed with “S544” in black, and an opaque white body printed with “60 mg” in black.

Pack sizes:
10 mg, 20 mg, 30 mg strengths – 10, 28, 30, 60 or 100* modified-release hard capsules (*Only for 10 mg and 20 mg capsules).
40 mg, 50 mg, 60 mg strengths – 28 or 30 modified-release hard capsules.
Not all pack sizes or strengths may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2, Ireland
Tel: +800 66838470
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Equasym XR
Denmark Equasym Depot
Finland Equasym Retard
France Quasym
Germany Equasym Retard
Ireland Equasym XL
Iceland Equasym Depot
Italy Equasym
Luxembourg Equasym XR
Netherlands Equasym XL
Norway Equasym Depot
Portugal Quasym
Spain Equasym

Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): https://www.aifa.gov.it/