10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, modified- release capsule , hard 
methylphenidate hydrochloride

Read all of this leaflet carefully before you / your child starts taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you / your child only. Do not give it to others. It can harm them, even if they show signs of illness similar to your / your child’s.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information on: 
1. What Equasym Depot is and what it is used for 
What you need to know before you or your child use Equasym Depot 
3. How you or your child take Equasym Depot 
4. Possible side effects 
5. How Equasym Depot to be stored 
6. Contents of the packaging and other information 

1. What Equasym Depot is and what it is used for

What it is used for

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

  • It is used in children and adolescents aged 6 to 18 years.
  • It is used only after other drug-free treatment methods have been tried, such as talk therapy and behavioral therapy.

Equasym Depot is not used to treat ADHD in children under 6 years of age or adults. The safety and benefits of treatment have not been established in this patient population.

How it works

Equasym Depot improves the activity in certain areas of the brain, which are underactive. The drug can help to improve attention (to retain attention), the ability to content, rate, and reduce impulsive behavior.

The drug is given as part of a treatment program, which usually consists of:

  • Psychological therapy
  • Training
  • Social therapy

It is only prescribed by doctors who have experience with behavioral problems in children and adolescents. Although there is no cure for ADHD, the condition can be managed by using treatment programs.

About ADHD

Children and adolescents with ADHD may experience:

  • difficulty sitting still
  • difficulty concentrating

It’s not their fault that they can not do these things.

Many children and young people are struggling to cope with these things. In people with ADHD, problems in everyday life can occur. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, or elsewhere.

ADHD does not affect the intelligence of a child or adolescent.

Methylphenidate contained in Equasym Depot may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you or your child use Equasym Depot

Do not take Equasym Depot if you or your child:

  • is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
  • have thyroid problems
  • has increased pressure in the eye ( glaucoma )
  • has a tumor in the adrenal gland ( pheochromocytoma )
  • have an eating disorder that makes you not feel hungry or do not want to eat, such as “anorexia nervosa”
  • have very high blood pressure or have narrowing of the blood vessels, which can cause pain in the legs and arms
  • have or have had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or have a congenital heart problem
  • have had problems with the blood vessels in the brain, such as stroke, dilated or weakened blood vessels in the brain ( aneurysm ), narrowing or blocked blood vessels, or inflammation of the blood vessels ( vasculitis )
  • is currently taking an antidepressant, or has been doing so for the past 14 days (known as monoamine oxidase inhibitors – MAOIs ). See section Using other medicines
  • have mental health problems such as:
    • psychopathic or borderline personality disorder
    • psychotic symptoms or schizophrenia
    • suicidal thoughts
    • severe depression, where you feel very sad, useless, or have feelings of hopelessness
    • mania, where you feel unusually elated, overactive, and uninhibited.

Do not take Equasym Depot if any of the above apply to you or your baby. If you have any further questions, ask your doctor or pharmacist before taking Equasym Depot. This is because methylphenidate can aggravate these problems.

Warnings and cautions

Talk to your doctor or pharmacist before you or your child take Equasym Depot if you or your child:

  • have liver or kidney problems
  • have difficulty swallowing or have difficulty swallowing whole tablets
  • have a narrowing or obstruction in the gastrointestinal tract or esophagus
  • have had seizures (seizures, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
  • have ever abused or been addicted to alcohol, prescription drugs, or “party drugs”
  • is a woman and has started menstruating (see section “Pregnancy and breast-feeding” below)
  • has difficult-to-control repeated twitches in any part of the body or repeats sounds and words ( tics )
  • have high blood pressure
  • have a heart problem that is not mentioned in the section above “Do not take Equasym Depot if you or your child”
  • have a mental health problem that is not mentioned in the above section “Do not take Equasym Depot if you or your child.” Other mental health problems can be:
    • mood swings (from being manic to being depressed, so-called “bipolar disorder”)
    • exhibits aggressive or hostile behavior, or aggravated aggression
    • see, hear or feel things that do not exist (hallucinations)
    • believe in things that are not true (delusions)
    • feels unusually suspicious ( paranoid )
    • feeling agitated, anxious, or tense
    • feeling depressed or having unreasonable guilt feelings.

If any of the above applies to you or your child, talk to a doctor or pharmacist before you or your child starts treatment. This is because methylphenidate can aggravate these problems. Your doctor will want to check how the medicine is affecting you or your child.

Checks that your doctor will do before treatment with Equasym Depot begins

These checks are to determine if Equasym Depot is the right medicine for you or your baby. Your doctor will talk to you about the following:

  • if you or your child are taking other medicines
  • if there have been any sudden unresolved deaths in the family
  • if there is any other medical condition (such as heart problems) in you or other people in your family
  • how you or your child feel, e.g. if you are elated or depressed, have strange thoughts or if you or your child have had any such feelings in the past.
  • if there have been “tics” within the family (difficult to control repeated twitches in any part of the body or repetition of sounds and words).
  • if you or your child or any other family member has or has had a problem related to mental health or behavioral disorder. Your doctor will discuss whether you or your child are at risk of mood swings (from being manic to becoming depressed, so-called “bipolar disorder”). Your or your child’s previous mental health will be checked. It will also be checked if there has been suicide, bipolar disorder, or depression in your family.

You must provide as much information as you can. This will help your doctor decide if Equasym Depot is the right medicine for you or your child. Your doctor may decide that more medical examinations are needed before you or your child can start taking this medicine.

During treatment, boys and adolescents may unexpectedly experience prolonged erections. It can be a painful condition that can occur at any time. You must be contacted lately if an erection lasts for more than 2 hours, especially if it is painful.

Other medicines and Equasym Depot

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

Do not take Equasym Depot if you or your child:

  • take a medicine called ‘monoamine oxidase inhibitor’ ( MAOI ) for depression, or have been taking an MAOI for the last 14 days. Taking MAOIs together with methylphenidate can lead to a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate may affect how well they work or cause side effects. If you or your child are taking any of the following medicines, you must consult your doctor or pharmacist before taking Equasym Depot:

  • antidepressants
  • medicines for serious mental problems
  • antiepileptic drugs
  • medicines for high or low blood pressure
  • certain cough medicines and cold medicines that can affect blood pressure. It is important to consult the pharmacy staff before buying any such product.
  • blood-thinning drugs that prevent blood clots.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist for advice before taking Equasym Depot.

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

Operation

Tell your doctor if you or your child will undergo surgery. Equasym Depot should not be taken on the day of surgery if a special type of anesthetic/anesthetic is used. This is because there is a risk of sudden high blood pressure during surgery.

Drug tests

This medicine may give positive results in drug abuse tests.

Equasym Depot with alcohol

Do not drink alcohol during treatment with this medicine. Alcohol can aggravate the side effects of the drug. Keep in mind that certain foods and medicines may contain alcohol.

Pregnancy, breastfeeding, and fertility

Available data do not indicate an increased risk of malformations overall. However, it cannot be ruled out that there is a small increase in the risk of heart defects when used during the first three months of pregnancy. Your doctor may provide more information about this risk. Tell your doctor or pharmacist before using Equasym Depot if you or your daughter:

  • is sexually active. Your doctor will discuss contraception.
  • is pregnant or thinks you may be pregnant. Your doctor will decide if Equasym Depot should be used.
  • breastfeeding or planning to breastfeed. Methylphenidate may be transferred to breast milk. Therefore, your doctor will decide if you or your daughter should breast-feed during treatment with Equasym Depot 

Driving and using machines

You or your child may feel dizzy, have difficulty focusing, or have blurred vision when using Equasym Depot. If this happens, it can be risky to do things like drive a vehicle and use machines, bike, ride, or climb trees.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Equasym Depot contains sucrose (a type of sugar)

If you or your child cannot tolerate certain sugars, you should consult your or your child’s doctor before taking this medicine.

3. How you or your child takes Equasym Depot

How much medicine to take

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • Equasym Depot is a form of methylphenidate with “modified release”, which means that the drug is released gradually over a period of time 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 have not taken methylphenidate before, your doctor will usually start treatment with traditional methylphenidate tablets (immediate-release ). If your doctor thinks it is necessary, you can start treatment with methylphenidate with Equasym Depot 10 mg once daily before breakfast.
  • The doctor usually starts treatment with a low dose and gradually increases it as needed.
  • The maximum daily dose is 60 mg.

How it is taken

  • Equasym Depot should be given in the morning before breakfast. The capsules can be swallowed whole with a sip of water, alternatively opened and the capsule contents poured into a small amount (tablespoon) of apple puree and taken/given immediately and not saved for later use. If the medicine is taken/given with soft food, some liquid, e.g. water, is taken afterward. The capsules and capsule contents must not be crushed or chewed.

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

Tell your doctor if you or your child do not feel better. Your doctor may decide to use another treatment.

Not using Equasym Depot properly

If Equasym Depot is not used properly, it can lead to abnormal behavior. It can also be a sign of tolerance development for the drug. Tell your doctor if you or your child have ever abused or been addicted to alcohol, prescription drugs, or drugs.

This medicine is for you or your child only. Do not give it to others, even if they have symptoms similar to yours.

If you or your child have taken too much Equasym Depot

If you or your child has ingested too much medicine, or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Talk about how many capsules it is.

Signs of overdose may include the following: nausea, feeling of arousal, tremors, increased uncontrolled movements, muscle twitching, seizures (which may be followed by coma ), feeling of happiness, confusion, seeing, feeling or hearing things that do not exist (hallucinations or psychosis ) , sweating, reddening of the skin, headache, high fever, changes in heart rate (slow, fast or uneven), high blood pressure , dilated pupils or dry mucous membranes of the nose and mouth.

If you or your child have forgotten to take Equasym Depot

Do not take a double dose to make up for a forgotten dose . If you or your child misses a dose , wait until it is time for the next dose .

If you or your child stop taking Equasym Depot

If you or your child suddenly stop taking this medicine, symptoms of ADHD may return or side effects such as depression may occur. Your doctor may choose to gradually reduce the daily dose one, before the medication completely stops. Talk to your doctor before stopping Equasym Depot . If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

Checks when starting treatment

Your doctor will do some checks

  • before you or your child start treatment. This is to ensure that Equasym Depot is safe and that it will be useful.
  • after starting treatment. Checks will be made at least every 6 months, but possibly more often. They will also be done when dose one is changed.
  • the controls include the following:
    • control of appetite
    • measurement of height and weight
    • measurement of blood pressure and heart rate
    • control of mood, mood or other unusual emotions. Your doctor will also check to see if these feelings have worsened while taking Equasym Depot .

Long-term treatment

Equasym Depot does not need to be taken forever. If you or your child have been taking Equasym Depot for more than a year, your doctor will stop treatment for a short time. This can be done during a school holiday. This is to check if the medicine is still needed.

If you have any further questions on the use of this product, 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 people find that methylphenidate helps them. Your doctor will talk to you about these side effects .

Some side effects can be serious. If you or your child experience any of the side effects listed below, contact your healthcare provider immediately:

Common (may affect up to 1 in 10 people) :

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

Uncommon (may affect up to 1 in 100 people):

  • suicidal thoughts or feelings of suicide
  • see, feel or hear things that do not exist. This is a sign of psychosis .
  • uncontrollable speech or movement (Tourette’s disease)
  • signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing.

Rare (may affect up to 1 in 1,000 people):

  • feeling unusually excited, overactive or uninhibited (mania).

Very rare (may affect up to 1 in 10,000 people):

  • myocardial infarction
  • seizures (seizures, epileptic seizures)
  • flaky skin or red, bluish rash
  • uncontrollable muscle cramps that affect the eyes, head, neck, body and nervous system. This is due to a temporary lack of blood supply to the brain
  • paralysis or difficulty moving, visual or speech difficulties (may be a sign of a problem with the blood vessels in the brain)
  • decreased number of blood cells (red and white blood cells and platelets ), which can make you more susceptible to infections and make you bleed or get bruised more easily
  • a sudden increase in body temperature, very high blood pressure and severe seizures (neuroleptic malignant syndrome). This side effect may not be caused by methylphenidate or other medicines that may have been taken in combination with methylphenidate.

Has been reported (occurs in an unknown number of users):

  • recurring delusions
  • unexplained fainting, chest pain or shortness of breath (may be a sign of heart problems).

If you or your child get any of the above side effects , seek medical attention immediately.

Other side effects are as follows. If they become serious, consult a doctor or pharmacist:

Very common (may affect more than 1 user in 10):

  • headache
  • nervousness
  • difficulty sleeping.

Common (may affect up to 1 in 10 people):

  • joint pain
  • dry mouth
  • fever
  • abnormal hair loss or hair thinning
  • abnormal fatigue or lethargy
  • loss of appetite or decreased appetite
  • itching , rash or raised, red itchy hives
  • cough, sore throat or nose and throat irritation
  • high blood pressure , fast pulse ( tachycardia )
  • dizziness, uncontrollable movements, hyperactivity
  • feel aggressive, agitated, anxious, depressed, irritated and exhibit abnormal behavior
  • severe gnashing of teeth (bruxism).

Uncommon (may affect up to 1 in 100 people):

  • constipation
  • feeling of discomfort in the chest
  • blood in the urine
  • shaking or trembling
  • double vision or blurred vision
  • muscle aches, muscle twitching
  • shortness of breath or chest pain
  • elevated liver values ​​(detected by blood test)
  • anger, restlessness or weeping, excessive attention to the environment, difficulty sleeping.

Rare (may affect up to 1 in 1,000 people):

  • altered sexual desire
  • confusion
  • dilated pupils , visual disturbances
  • swelling of the breasts in men
  • excessive sweating, reddening of the skin, red raised rash.

Very rare (may affect up to 1 in 10,000 people):

  • myocardial infarction
  • sudden death
  • muscle cramps
  • small red spots on the skin
  • inflammation or clogging of blood vessels in the brain
  • abnormal liver function, including liver failure and coma
  • altered liver and blood levels
  • suicide attempts, abnormal thoughts, lack of emotions, repeated compulsions, obsessions about individual things
  • loss of sensation in fingers and toes, tingling and change in color (from white to blue, then red) on cold (Raynaud’s phenomenon).

Has been reported (occurs in an unknown number of users):

  • migraine
  • excessive talkativeness
  • very high fever
  • slow, fast or extra heartbeat
  • severe seizures ( grand mal cramps)
  • to believe in things that are not real (delusions), confusion
  • severe abdominal pain, usually with nausea and vomiting
  • prolonged erections , sometimes painful, or increased number of erections , inability to get and maintain an erection
  • gnashing of teeth
  • changes in the blood vessels of the brain ( stroke , inflammation and blockage of the blood vessels of the brain)
  • heart muscle disease
  • inability to control urinary incontinence ( incontinence )
  • spasm in the jaw muscles that makes it difficult to open the mouth (trismus)
  • stuttering.

Effects on growth

As methylphenidate has been used for over a year, it can lead to slower growth in some children. This occurs in less than 1 in 10 children.

  • Lack of weight gain and height growth may occur
  • The doctor will closely monitor your or your child’s development in terms of weight and height, as well as how well you or your child eats.
  • If you or your child does not grow as expected, treatment with methylphenidate may be stopped for a short time.

5. How to store Equasym Depot

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 after EXP and on the carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not use this medicine if the capsules look damaged in any way.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is methylphenidate hydrochloride.

  • One 10 mg capsule contains 10 mg of methylphenidate hydrochloride equivalent to 8.65 mg of methylphenidate.
  • One 20 mg capsule contains 20 mg of methylphenidate hydrochloride equivalent to 17.30 mg of methylphenidate.
  • One 30 mg capsule contains 30 mg of methylphenidate hydrochloride equivalent to 25.94 mg of methylphenidate.
  • One 40 mg capsule contains 40 mg of methylphenidate hydrochloride equivalent to 34.59 mg of methylphenidate.
  • One 50 mg capsule contains 50 mg of methylphenidate hydrochloride equivalent to 43.24 mg of methylphenidate.
  • One 60 mg capsule contains 60 mg of methylphenidate hydrochloride equivalent to 51.89 mg of methylphenidate.

Other ingredients are:

  • Capsule contents: Sugar spheres (sucrose and maize starch), povidone, Opadry Clear YS-1-7006 (hypromellose, macrogol), ethylcellulose-water dispersion (ethylcellulose, sodium lauryl sulphate, cetyl alcohol) and dibutyl sebacate
  • Capsule shell: Gelatin, titanium dioxide (E171).
  • The 10 mg capsule also contains indigo carmine (E132) and yellow iron oxide (E172)
  • The 20 mg capsule also contains indigo carmine (E132)
  • The 30 mg capsule also contains indigo carmine (E132) and 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 ink  (only applies to 10, 20, 30 and 50 mg capsules): shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171)
  • Black ink contains shellac, propylene glycol, ammonium hydroxide and black iron oxide (E172)

What the medicine looks like and the contents of the pack

Capsules with modified release , hard.

10 mg hard capsules with modified-release have a dark green opaque top labeled “S544” in white and a white opaque saucer labeled “10 mg” in black.

Hard- release capsules of 20 mg with modified release have a blue opaque upper part marked “S544” in white and a white opaque lower part marked “20 mg” in black.

Hard- release capsules of 30 mg with modified release have a reddish-brown opaque top labeled “S544” in white and a white opaque base labeled “30 mg” in black.

Hard- release capsules of 40 mg with modified release have an off-white opaque upper part marked “S544” in black and a white opaque lower part marked “40 mg” in black.

Hard release capsules of 50 mg with modified release have a purple opaque upper part marked “S544” in white and a white opaque lower part marked “50 mg” in black.

Hard 60 mg modified- release capsules have a white opaque body labeled “S544” in black and a white opaque body labeled “60 mg” in black.

Pack sizes: 30 capsules with modified release , hard.

Not all pack sizes or strengths may be marketed.

Marketing Authorization Holder and Manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

Ireland

Local representative

Takeda Pharma AB

Vasagatan 7, 6 tr

111 20 Stockholm

Tel: 08-731 28 00

Muhammad Nadeem

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