EQUASYM 10 mg Modified-Release Hard Capsules

Зміст інструкції

1. Equasym 10 mg, 20 mg and 30 mg, 40 mg, 50 mg and 60 mg prolonged-release hard capsules
   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. Package Contents and Other Information

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

methylphenidate hydrochloride
The name of this medicine is Equasym; it contains the active ingredient “methylphenidate hydrochloride”. In this

Read this leaflet carefully before you or your child takes this medicine as 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, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell 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 takes 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 between the ages of 6 and 18 years.
• It is used only after trying treatments that do not involve the use of medicines, such as e.g. counseling and behavioral therapy. Equasym should not be used as a treatment for ADHD in children under 6 years of age or in adults. It is not known whether it is safe or beneficial in these people.

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

• psychological therapy
• educational and
• social Treatment with methylphenidate must be started exclusively by, and administered under the regular control of, a specialist in behavioral disorders of childhood and/or adolescence.

ADHD can be managed with treatment programs.

Information about ADHD
Children and adolescents with ADHD find:

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

Many children and adolescents strive to succeed. However, with ADHD they can cause problems
in everyday life. Children and adolescents with ADHD may have difficulty learning and doing
homework. They have difficulty behaving well at home, at school or in other places.
ADHD does not affect the intelligence of a child or adolescent.

2. What you need to know before you or your child take 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 problems with your thyroid
• have increased pressure in the eye (glaucoma)
• have a tumor of the adrenal gland (pheochromocytoma)
• have an eating problem where you do not feel hungry or do not want to eat, such as “anorexia nervosa”
• have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• have ever had heart problems, such as a heart attack, irregular heartbeat, chest pain and discomfort, heart failure, heart disease, or were born with a heart problem
• have had a problem with blood vessels in the brain, such as a stroke, swelling and weakening of a 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 (known as a monoamine oxidase inhibitor), see “Taking with other medicines”
• have mental health problems, such as:
• a “psychopathic” or “borderline personality” problem
• abnormal thoughts or visions, or a disease called “schizophrenia”
• signs of a serious mood problem, such as:
• wanting to kill yourself
• severe depression, with feelings of intense sadness, worthlessness and despair
• mania, with feelings of unusual excitability, hyperactivity and lack of inhibition.

Do not take methylphenidate if you or your child falls into one of the cases listed above. If you have any doubts, consult your
doctor or pharmacist before you or your child take methylphenidate, because methylphenidate can cause
a worsening of these problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking the treatment if you or your child:

• have problems with your liver or kidneys
• have had seizures (convulsions, epilepsy) or abnormalities in the electroencephalogram (EEG)
• have ever abused or been dependent on alcohol, drugs or substances
• are a woman and have started having periods (see the section below “Pregnancy and breastfeeding”)
• have repetitive and difficult-to-control tics in any part of 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”)
• the onset of aggressive or hostile behavior, or a worsening of aggression
• seeing, hearing or perceiving things that do not exist (hallucinations)
• believing things that are not true (delusions)
• feeling unusually suspicious (paranoia)
• feeling agitated, anxious or tense
• feeling depressed or guilty.

Tell your doctor or pharmacist before starting treatment if you or your child falls into one of the cases
above, because methylphenidate may worsen these problems. The doctor will need to
check how the medicine works on you or your child.

Checks carried out by the doctor before you or your child start taking methylphenidate
These checks are to decide whether methylphenidate is the right medicine for you or your child. The
doctor will discuss with you:

• medicines that you or your child are taking
• any family history of sudden unexplained death
• any other medical problems (e.g. 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 or your child have had these feelings in the past
• any family history of “tics” (repetitive and difficult-to-control spasms in any part of the body or repetitions of sounds and words)
• any mental or behavioral problems that you, your child or other family members have suffered in the past. The doctor will discuss with you whether you or your child are at risk of developing mood swings (from mania to depression, called “bipolar disorder”). They will check the mental health history of you or your child and check if any family member has had 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 right medicine for you or your child. The doctor may decide that further medical tests are needed before starting to take this medicine.

Other medicines and Equasym
Tell your doctor or pharmacist if you are taking, have recently taken or might 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. 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 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 medicines that can 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 have any doubts as to whether any of the medicines taken by you or your child 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 taking or have recently taken any other
medicines, including those without a prescription.

Surgery
Tell your doctor if you or your child is going to have surgery. Methylphenidate should not be taken
on the day of surgery if a certain type of anesthetic is used, because there is a possibility of a
sudden increase in blood pressure during the operation.

Doping tests
This medicine may give a positive result in doping tests.
For athletes: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Methylphenidate with alcohol
Do not drink alcohol when taking this medicine. Alcohol can exacerbate the side effects of
this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy, breastfeeding and fertility
Available data do not indicate an increased risk of overall birth defects, while a small increase in the risk of heart defects following use during
the first three months of pregnancy could not be ruled out. Your doctor can provide you with more information about this risk. Before
using methylphenidate, tell your doctor or pharmacist if you or your daughter:

• are sexually active. The doctor will discuss contraceptive measures
• are or may 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
that may be painful and occur at any time. It is important to see a doctor
immediately if the erection lasts more than 2 hours, especially if it is painful.

Driving and using machines
You or your child may feel dizzy, have trouble focusing or have blurred vision while
being treated with methylphenidate. If this happens, it may be dangerous to perform activities such as driving
vehicles, using machinery, riding a bicycle or horseback riding or climbing trees.

Equasym contains sucrose (a type of sugar)
If you or your child have an intolerance to some 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 your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

• Equasym is a “modified-release” 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 traditional methylphenidate (immediate-release), taken at breakfast and lunch.
• If you or your child are already taking traditional methylphenidate (immediate-release), your doctor may prescribe an equivalent dose of Equasym instead.
• If you or your child have never taken methylphenidate before, your doctor will normally start treatment with traditional methylphenidate tablets (immediate-release). If the doctor deems it

necessary, treatment with Equasym 10 mg once a day may be started, before breakfast.

• The doctor will usually start treatment with a low dose and increase it gradually, if necessary.
• The maximum daily dose is 60 mg.

How to take
Equasym should be taken in the morning before breakfast. The capsules can be swallowed whole with a glass of water or, alternatively, they can be opened and the contents sprinkled on a small amount (spoonful) of applesauce and taken/administered immediately, without saving it for future use.
If the medicine is taken/administered with soft foods, liquids, 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, tell your doctor. They may decide that a different treatment is needed.

Incorrect use of Equasym
Incorrect use of Equasym can cause abnormal behavior. It can also mean that you or your child start to become dependent on the medicine. Tell your doctor if you or your child have ever abused or been dependent on alcohol, drugs or substances.
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 an excessive amount of medicine, consult 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 uncontrolled movements, muscle spasms, seizures (which may be followed by coma), feeling extremely happy, confusion, seeing, perceiving or hearing things that are not real (hallucinations or psychosis), sweating, flushing, 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 time of the next dose.

If you or your child stops taking Equasym
If you or your child suddenly stops taking this medicine, the symptoms of ADHD may return, or side effects such as depression may appear. The doctor may need to gradually reduce the amount of medicine taken each day, before stopping treatment completely. Consult your doctor before stopping treatment with Equasym. If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

Checks carried out by the doctor when you or your child is undergoing treatment
The doctor will perform some tests

• before you or your child starts treatment - to make sure that Equasym is safe and beneficial
• after you or your child has started treatment - will be performed at least every 6 months, but possibly more often. They 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
• checking for problems with mood, mental state or any other unusual feelings. Or any worsening of these during treatment with Equasym.

Long-term treatment
Equasym should not be taken forever. If you or your child takes Equasym for a prolonged period, the doctor should stop treatment for a certain period, at least once a year, possibly during school holidays. This will help to check whether the medicine is still needed.
If you have any doubts about using this medicine, ask 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 that methylphenidate is 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, seek immediate medical attention:
Common (affects less than 1 in 10 people)

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

Uncommon (affects less than 1 in 100 people)

• thinking about or trying to kill yourself
• seeing, sensing or hearing things that are not real; these are signs of psychosis
• uncontrolled body and speech tics (Tourette's syndrome)
• signs of allergy, 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 (affects less than 1 in 1,000 people)

• feeling unusually excited, hyperactive and lacking inhibition (mania)

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

• heart attack
• seizures (convulsions, fits, epilepsy)
• skin peeling or the appearance of red-purple spots
• muscle spasms that are impossible to control affecting the eyes, head, neck, body and nervous system - due to a temporary lack of blood supply to the brain
• paralysis or problems with movement and vision, difficulty speaking (these may be 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 can make infections more likely and cause easier bruising and bleeding
• a 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 by other medicines that may be taken in combination with methylphenidate. Other side effects (whose frequency is not known)
• recurring unwanted thoughts
• fainting without apparent cause, chest pain, shortness of breath (these may be signs of heart problems)

If any of the side effects listed above occur, seek immediate medical
attention.

Other side effects include the following; if they become severe, tell 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
• hair loss or thinning
• feeling sleepy or unusually drowsy
• loss or decrease of appetite
• itching, skin rash or raised red bumps, with itching (urticaria)
• cough, sore throat or irritation of the nose and throat
• high blood pressure, fast heartbeat (tachycardia)
• dizziness, uncontrollable movements, feeling of unusual activity
• feeling aggressive, agitated, anxious, depressed, irritable and abnormal behavior
• excessive teeth grinding (bruxism)

Uncommon (affects less than 1 in 100 people)

• constipation
• chest discomfort
• blood in the urine
• tremor or shaking
• double vision or blurred vision
• muscle pain, muscle spasm
• shortness of breath or chest pain
• increased liver test results (observed in a blood test)
• anger, restlessness or wanting to cry, excessive awareness of the surroundings, problems sleeping.

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

• changes in sexual drive
• feeling disoriented
• dilated pupils, difficulty with vision
• breast enlargement in men
• excessive sweating, skin flushing, raised red 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
• abnormal liver function, including liver failure and coma
• changes in test results - including liver function tests and blood tests
• attempt to commit suicide, suicide, abnormal thoughts, absence of sensations or emotions, continuous repetition of activities, obsession with a single object
• numbness, tingling and colour change (from white to blue, then red) of the fingers and toes when cold (“Raynaud’s phenomenon”).

Other side effects (whose frequency is not known)

• migraine
• excessive talkativeness
• very high fever
• slowed, accelerated heartbeat or extra heartbeats
• major seizure (“grand mal seizure”)
• believing things that are not true, confusion
• severe stomach pain, often with nausea and feeling unwell
• prolonged, sometimes painful, erections or increased number of erections, inability to develop or maintain an erection
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
• inability to control urination (incontinence)
• spasm of the jaw muscles making it difficult to open the mouth (trismus)
• stammering (stuttering)

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

• There may be a failure to gain weight or height.
• The doctor will carefully monitor height and weight, as well as appetite, yours or your child’s.
• If you or your child is not growing as expected, treatment with methylphenidate may be interrupted for a short period.

If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the address of
adverse-reactions. By reporting side effects you can help to 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 which is stated on the blister and the carton after Exp. The
expiry date refers to the last day of that month.
Store at a temperature 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 in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

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

The other ingredients are:

• Capsule content:sugar spheres (sucrose and corn starch), povidone from K29 to K32, Opadry Clear Ys-1-7006 (hypromellose, macrogol 400 and macrogol 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(only 10, 20, 30 and 50 mg capsules): shellac, propylene glycol, sodium hydroxide, povidone K16 and titanium dioxide (E171)
• The black inkcontains polishing shellac 45% (20% esterified) in ethanol, propylene glycol, ammonium hydroxide 28% and black iron oxide (E172).

Description of the appearance of Equasym and package contents
Modified-release hard capsules
The modified-release hard capsules of 10 mg have a dark green opaque cap, imprinted with “S544” in
white, and a white opaque body imprinted with “10 mg” in black.
The modified-release hard capsules of 20 mg have a blue opaque cap, imprinted with “S544” in white, and
a white opaque body imprinted with “20 mg” in black.
The modified-release hard capsules of 30 mg have a reddish-brown opaque cap, imprinted with “S544”
in white, and a white opaque body imprinted with “30 mg” in black.
The modified-release hard capsules of 40 mg have an ivory yellow opaque cap, imprinted with “S544” in
black, and a white opaque body imprinted with “40 mg” in black.
The modified-release hard capsules of 50 mg have a purple opaque cap, imprinted with “S544” in white, and
a white opaque body imprinted with “50 mg” in black.
The modified-release hard capsules of 60 mg have a white opaque cap, imprinted with “S544” in black, and
a white opaque body imprinted with “60 mg” in black.
Packs:
Dosages of 10 mg, 20 mg, 30 mg - 10, 28, 30, 60 or 100* modified-release hard capsules (*Only 10 mg and
20 mg capsules).
Dosages of 40 mg, 50 mg, 60 mg - 28 or 30 modified-release hard capsules.
Not all pack sizes or dosages 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 Member States of the European Economic Area under the following
denominations:
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

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency:
https://www.aifa.gov.it/