18 mg, 27 mg, 36 mg, 54 mg prolonged-release tablets are 
methylphenidate hydrochloride

1. What Concerta is and what it is used for

What is it used for

Concerta is used to treat ADHD (Attention Deficit Hyperactivity Disorders).

  • 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.

Concerta is not used to treat ADHD in children under 6 years of age or to start treatment in adults. If treatment was started at a younger age, it may be appropriate to continue taking Concerta when you grow up. Your doctor will advise you on this.

How it works

Concerta 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 concentrate and to 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 hydrochloride contained in Concerta 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.

2. What you need to know before you or your child take Concerta

Do not take Concerta 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 )
  • currently taking an antidepressant, or have been doing so for the past 14 days (known as monoamine oxidase inhibitors – MAOIs ). See the section “Other medicines and Concerta”
  • have mental health problems such as:
    • psychopathic or borderline personality disorder
    • psychotic symptoms or schizophrenia
    • signs of severe mental health problems such as:
      • 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 Concerta if any of the above apply to you or your baby. If you have any further questions, ask your doctor or pharmacist before taking Concerta. This is because methylphenidate can aggravate these problems.

Warnings and cautions

Talk to your doctor before you or your child take Concerta 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 Concerta if you or your child”
  • have a mental problem that is not mentioned in the above section “Do not take Concerta if you or your child”. Other mental health problems can be:
    • mood swings (from being manic to being depressed, so-called “bipolar disorder”)
    • feeling aggressive or hostile
    • 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, tell your doctor or pharmacist before starting treatment. This is because methylphenidate can aggravate these problems. Your doctor will want to check how the medicine is affecting you or your child.

During treatment, boys and adolescents may unexpectedly experience prolonged erections. It can be a painful condition that can occur at any time. It is important that you contact your doctor immediately if an erection lasts for more than 2 hours, especially if it is painful.

Checks that your doctor will do before starting treatment with Concerta

These checks are to determine if Concerta is the right medicine for you or your child. 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.

It is important that you provide as much information as you can. This will help your doctor decide if Concerta 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.

Other medicines and Concerta

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

Do not take Concerta 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.

Tell your doctor or pharmacist if you or your child are taking any of the following medicines for depression or anxiety:

  • tricyclic antidepressant drugs
  • selective serotonin reuptake inhibitors ( SSRIs )
  • serotonin and norepinephrine reuptake inhibitors ( SNRIs ).

Taking methylphenidate with these types of medicines can result in a life-threatening increase in serotonin in the brain (serotonergic syndrome), which can lead to a feeling of confusion or restlessness, sweating, tremors, muscle twitching, or rapid heartbeat. If you or your child develop these side effects, consult a doctor immediately.

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 Concerta:

  • medicines for serious mental problems
  • medicines for Parkinson’s disease (such as levodopa )
  • 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 are not sure if any of the medicines you or your child are taking are included in the list above, consult a physician or pharmacist before taking Concerta.

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

Operation

Tell your doctor if you or your child will undergo surgery. Concerta 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. This also applies to tests performed at sports events.

Concert 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 and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

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 Concerta 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 you should use Concerta.
  • breastfeeding or planning to breastfeed. Methylphenidate passes into breast milk. Therefore, your doctor will decide if you or your daughter should breast-feed during treatment with Concerta.

Driving and using machines

You or your child may feel dizzy, have difficulty focusing, or have blurred vision when using Concerta. 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.

Concerta contains lactose

This medicine contains lactose (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.

Concerta contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Concerta

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.

  • usually, the doctor starts treatment with a low dose and increases gradually as needed.
  • The highest recommended daily dose is 54 mg.
  • you or your child should take Concerta once daily in the morning with a glass of water. The tablet should be swallowed whole and not chewed, divided, or crushed. The tablet can be taken with or without food.

The tablet does not dissolve completely after all the contents have been released. Sometimes the tablet shell may accompany the stool out. This is normal.

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 Concerta properly

If Concerta 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 Concerta

Talk about how many tablets 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), sweating, redness 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 Concerta

Do not take a double dose of Concerta 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 using Concerta

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 taking Concerta.

Checks when starting treatment

Your doctor will do some checks

  • before you or your child start treatment. This is to ensure that Concerta 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 during Concerta.

Long-term treatment

Concerta does not have to be taken forever. If you or your child have been taking Concerta for more than a year, your doctor will stop the 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)

  • feel unusually excited, overactive, or uninhibited (mania)

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

  • myocardial infarction
  • sudden death
  • suicide attempt
  • seizures (seizures, epileptic seizures)
  • flaky skin or red, bluish rash
  • inflammation or clogging of blood vessels in the brain
  • temporary paralysis or difficulty moving, vision problems, speech difficulties (these may be signs of problems with the blood vessels in the brain)
  • uncontrollable muscle cramps that affect the eyes, head, neck, body, and nervous system.
  • 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 at the same time as 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).
  • paralysis or difficulty moving visual or speech difficulties (may be a sign of a problem with the blood vessels in the brain)
  • prolonged erections, sometimes painful, or increased number of erections.

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
  • dimsyn
  • tension headache
  • dry mouth, thirst
  • difficulty sleeping
  • fever
  • problems with sex drive
  • abnormal hair loss or hair thinning
  • muscle tension, muscle cramps
  • loss of appetite or decreased appetite
  • inability to get or maintain an erection
  • itching, rash, or raised red itchy hives
  • abnormal fatigue or lethargy, feeling tired
  • severe gnashing of teeth (bruxism)
  • panic
  • tingling, stinging sensation, or numbness in the skin
  • increased level of alanine aminotransferase (liver enzyme) in the blood
  • cough, sore throat or nose, and throat irritation; upper respiratory tract infection, sinusitis
  • high blood pressure, fast pulse ( tachycardia )
  • dizziness ( vertigo ), weakness, uncontrollable movements, hyperactivity
  • feel aggressive, agitated, anxious, depressed, irritated, tense, nervous, and exhibit abnormal behavior
  • stomach upset or digestive problems, stomach pain, diarrhea, nausea, stomach upset, and vomiting.

Uncommon (affects less than 1 user in 100)

  • dry eyes
  • constipation
  • the feeling of discomfort in the chest
  • blood in the urine
  • lethargy
  • shaking or trembling
  • increased need to urinate
  • muscle aches, muscle twitching
  • shortness of breath or chest pain
  • feeling of warmth
  • elevated liver values ​​(detected by a blood test)
  • anger, restlessness or weeping, talking too much, excessive attention to the environment, difficulty sleeping.

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

  • feel disoriented or confused
  • visual disturbances or double vision
  • swelling of the breasts in men
  • excessive sweating, reddening of the skin, red raised rash

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

  • muscle cramps
  • small red spots on the skin
  • abnormal liver function, including acute liver failure and coma
  • altered liver and blood levels
  • 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
  • dilated pupil is
  • very high fever
  • slow, fast or extra heartbeat
  • severe seizures ( grand mal cramps)
  • delusions
  • severe abdominal pain, usually with nausea and vomiting
  • 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 height and weight, 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Concerta

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 label. The expiration date is the last day of the specified month.

18 mg, 36 mg, and 54 mg: Close the package tightly. Moisture sensitive. Do not store above 30 ° C.

27 mg: Close the package tightly. Moisture sensitive.

The package contains one or two bags of desiccant. These keep the tablets dry and should not be eaten.

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

  • Concerta contains 18 mg of methylphenidate hydrochloride.
  • Concerta contains 27 mg of methylphenidate hydrochloride.
  • Concerta contains 36 mg of methylphenidate hydrochloride.
  • Concerta contains 54 mg of methylphenidate hydrochloride.

Other ingredients are:

  • butylhydroxytoluene (E321), cellulose acetate, hypromellose (E464), concentrated phosphoric acid, poloxamer 188, polyethylene oxides 200K and 7000K, povidone K29-32, sodium chloride, stearic acid, succinic acid, black iron oxide (E172), yellow iron oxide (E172 iron (E172)), only in the 27 and 54 mg tablets).
  • Film coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, yellow iron oxide (E172, only in the 18 and 54 mg tablets), red iron oxide (E172, only in the 54 mg tablet), black iron oxide (E172, only in the 27 mg tablet) and stearic acid (in the 18 mg tablet only).
  • Surface treatment: carnauba wax, hypromellose (E464), and macrogol 400.
  • Ink: black iron oxide (E172), hypromellose (E464), and propylene glycol.

What the medicine looks like and the contents of the pack

Concerta prolonged-release tablets are available in four different strengths:

18 mg, 27 mg, 36 mg and 54 mg. Each capsule-shaped tablet has individual labeling to facilitate identification:

  • 18 mg: yellow with black print, “alza 18”, on one side
  • 27 mg: gray with black print, “alza 27”, on one side
  • 36 mg: white with black print, “alza 36”, on one side
  • 54 mg: brownish red with black print, “alza 54”, on one side.

The medicine is available in cans containing 28 or 30 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

For more information about this medicine, please contact the Marketing Authorization Holder:

Janssen-Cilag AB

Box 4042

SE-169 04 Solna

Tel: +46 8 626 50 00

jacse@its.jnj.com

Manufacturer: Janssen Pharmaceutica NV, 30 Turnhoutseweg, B-2340 Beerse, Belgium

Muhammad Nadeem

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