Medanef 5 mg, 10 mg, 20 mg tablets of
methylphenidate hydrochloride

What Medanef is and what it is used for

Medanef contains the active substance methylphenidate hydrochloride.

What is it used for

Medanef a nvänds for treating ‘Attention Deficit Hyperactivity Disorders “( ADHD ).

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

How it works

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

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

  • psychological therapy
  • training
  • social therapy
    Medanef should only be initiated and used under the supervision of a doctor who specializes in behavioral problems in children and adolescents.  Although there is no cure for ADHD , it can be managed with the help of the treatment program.

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

What you need to know before you or your child use Medanef

Do not use Medanef if you or your child

  • is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
  • have problems with the thyroid gland
  • 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 narrowing of the blood vessels, which can cause pain in the arms and legs
  • have or have had heart problems, such as heart attack, irregular heartbeat, chest pain and discomfort, heart failure , heart disease or have a congenital heart defect
  • have had problems with the blood vessels in the brain, such as a stroke , dilated or weakened blood vessels ( aneurysm ), narrowing or blockage in the blood vessels or inflammation of the blood vessels ( vasculitis )
  • currently taking or have taken antidepressants called monoamine oxidase inhibitors ( MAOIs ) for the past 14 days , see section “Other medicines and Medanef”
  • have or have had mental problems such as:
  • psychopathic or borderline personality disorder
  • abnormal thoughts or visions or schizophrenia
  • signs of serious mental 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 Medanef if any of the above apply to you or your baby. If you are not sure, talk to your doctor or pharmacist before taking Medanef. This is because methylphenidate can aggravate these problems.

Warnings and cautions

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

  • have liver or kidney problems
  • have had seizures (seizures, epilepsy ) or abnormal findings when measuring brain activity ( EEC )
  • is a girl and has started menstruating (see section “Pregnancy, breast-feeding and fertility”)
  • have ever abused or been addicted to alcohol, prescription drugs or drugs
  • have difficult-to-control, repeated twitches in any part of the body or repeat sounds and words ( tics )
  • have high blood pressure
  • have heart problems not mentioned in the section “Do not use Medanef if you or your child”
  • have mental health problems not mentioned in the section “Do not use Medanef if you or your child”.

Other mental health problems include:

  • mood swings (from being manic to becoming depressed, so-called bipolar disorder )
  • incipient aggression or hostility or if aggression worsens
  • to believe in things that are not real (delusions)
  • to feel unusually suspicious ( paranoid )
  • to feel anxious, anxious or tense
  • to feel depressed or to have feelings of guilt

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. The doctor will want to follow up on how the medicine affects you or your child.

Checks that your doctor will do before you or your child start taking Medanef

These checks are to determine if Medanef is a suitable 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 unexplained deaths in the family
  • presence of other possible medical problems (such as heart problems) in you, your child 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 other family member has or has had a problem related to mental health or behavioral disorder. The 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 Medanef is a suitable medicine for you or your child. Your doctor may decide that more medical tests are needed before you or your child can start taking this medicine.

During treatment

If you or your child are taking this medicine for more than 12 months, your doctor may want to monitor your heart function, height, weight, appetite, or mental health. Your doctor may also ask you or your child to stop taking Medanef to see if treatment is still needed.

Tell your doctor if you or your child get any of the following:

  • uncontrolled speech or body movements
  • any changes or deterioration of your mood or behavior
  • breathing difficulties
  • respiratory distress
  • chest pain or palpitations (rapid heartbeat that feels throbbing in the chest).

Based on this, your doctor may decide to discontinue treatment. Your doctor may check this at each dose change, every six months, or at each visit.

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

Other medicines and Medanef

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

Do not take Medanef 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 methylphenidate:

  • other antidepressants such as tricyclic antidepressants (eg amitriptyline, clomipramine) or selective serotonin reuptake inhibitors (SSRIs eg citalopram , fluoxetine )
  • drugs for severe mental problems amisulpride, risperidone , lithium, haloperidol
  • DOPA – a drug for Parkinson’s disease
  • drugs against epilepsy (such as phenobarbital, phenytoin, primidone)
  • medicines used to lower or raise blood pressure (eg clonidine)
  • certain preparations for coughs or colds, which may contain substances which affect blood pressure . It is important to consult the pharmacy staff before buying any such product.
  • drugs that thin the blood to prevent blood clots. (eg coumarin or warfarin ).
    If you are not sure if any of the medicines you and your child are taking are listed above, ask your doctor or pharmacist for advice before taking Medanef.

Operation

Tell your doctor if you or your child will undergo surgery. Medanef 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 drug can give positive results in drug abuse tests.

Medanef with food and alcohol

Taking Medanef with food may relieve abdominal pain, nausea, or vomiting.

Do not drink alcohol while using this medicine. Alcohol can aggravate the side effects of the drug. Keep in mind that some dishes and medicines may contain alcohol.

Pregnancy, breastfeeding and fertility

Available data do not indicate an increased risk of malformations overall. However, it can not 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 can provide more information about this risk. Methylphenidate is transferred to breast milk.

Talk to your doctor or pharmacist if you or your daughter:

  • is sexually active. The doctor will discuss contraception.
  • is pregnant or suspects pregnancy. Your doctor will decide if Medanef should be used.
  • breastfeeding or planning to breastfeed. It is possible that methylphenidate is transferred to breast milk. Therefore, your doctor will decide if breast-feeding can be done during treatment with Medanef.If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel dizzy, have trouble focusing your eyes, or have blurred vision when using Medanef. If this happens, it can be dangerous to drive, use machines, cycle, 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.

How you or your child use Medanef

Your doctor will do some tests before you or your child start treatment when the dose is changed and during the treatment at least every 6 months or at each doctor’s visit. This is to ensure that the treatment is still safe and beneficial for you or your child. These surveys will include:

  • Measurement of blood pressure and heart rate recorded in a table
  • Measurement of height and weight, control of appetite recorded in a table
  • Assessment of mental symptoms. (see section 2 “Warnings and Precautions”)

How much to take

You or your child should always take this medicine according to the doctor’s or pharmacist’s instructions. Ask your doctor or pharmacist if you are unsure.

  • The doctor usually starts treatment with a low dose that is gradually increased as needed
  • The highest recommended daily dose is 60 mg
  • You or your child should take Medanef once or twice daily (for breakfast and / or lunch), with a glass of water
  • The notch on the tablet is intended for splitting the tablet if you have difficulty swallowing the whole tablet (only 10 mg and 20 mg)

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

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

Long-term treatment

Medanef does not need to be taken forever. If you have been taking Medanef 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.

Not using Medanef properly

If Medanef is not used properly, it can lead to abnormal behavior. It can also mean that you / your child may become addicted to the drug. Tell your doctor if you / your child has ever abused or been addicted to alcohol, drugs, or narcotics.

This medicine has only been prescribed for you / your child. Do not give it to others even if they have symptoms similar to yours.

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 very 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)

  • irregular heartbeat ( arrhythmia ) or throbbing heartbeat (palpitations)
  • changes in blood pressure or heart rate (usually an increase)

Uncommon (may affect up to 1 in 100 people)

  • suicidal thoughts or feelings
  • signs of allergic reaction 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)

  • heavy or pressing sensation over the chest with chest pain and shortness of breath during physical activity (this may be a sign of angina)

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

  • sudden chest pain that can spread to the neck and arm with shortness of breath and cold sweats. It may be a sign of a heart attack.
  • sudden death
  • suicide attempt (including completed suicide)
  • seizures
  • uncontrollable muscle cramps that affect the eyes, head, neck, body and nervous system. Due to a temporary lack of blood supply to the brain.
  • sudden collapse, numbness or weakness in the arms and legs, dizziness or confusion, visual disturbances, difficulty swallowing, slurred speech, confusion or loss of speech. These can be signs of a stroke or mini- stroke caused by a blockage or bleeding that affects the blood supply to a part of 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 more easily or get bruises
  • yellowing of the skin and eyes, dark urine, fatigue, fever, malaise, weakness, drowsiness and abdominal pain. These can be signs of serious liver problems.
  • forgetfulness, poor judgment, fragrant breath, sleep disturbances, worsening of hand movements or tremors in hands and arms. These are signs of brain problems caused by the liver not working.
  • 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 by other medicines that may have been taken in combination with methylphenidate.
    No known frequency (can not be calculated from the available data)
  • a decrease in the number of other blood cells such as red blood cells or platelets which may cause fatigue, shortness of breath, pale skin or cause unexplained bruising or bleeding for longer than normal

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)

  • aggression, agitation, anxiety, depression or behavior change
  • weight loss
  • slow growth. You or your child, who is on long-term treatment, may grow more slowly when compared to others of the same sex and age (growth retardation).

Uncommon (may affect up to 1 in 100 people)

  • see, feel or hear things that are not real, signs of psychosis
  • uncontrolled speech and uncontrolled body movements. If you already have these symptoms or Tourette’s syndrome, they may get worse.
  • mood swings and personality changes

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

  • is unusually elated, overactive or uninhibited 

No known frequency (can not be calculated from the available data)

  • difficulty thinking or not thinking clearly
  • long lasting erection you, sometimes painful, or number of erections you

Other side effects are as follows:

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

  • headache
  • nausea
  • dry mouth
  • nervousness
  • insomnia
  • decreased appetite

Common (may affect up to 1 in 10 people)

  • joint pain
  • fever
  • cold hands and feet
  • respiratory distress
  • abnormal hair loss or thinning
  • fatigue
  • thirst
  • abnormal fatigue or drowsiness
  • loss of appetite
  • cough, sore throat or nose and throat irritation, inflammation of the airways
  • toothache
  • severe gnashing of teeth (bruxism)
  • high blood pressure
  • dizziness, uncontrollable movements, hyperactivity
  • shaking or trembling
  • feeling stressed, irritated, restless
  • feeling nervous
  • excessive sweating
  • instability, rapid mood swings
  • panic attack
  • difficulty sleeping
  • decreased sexual desire
  • indigestion
  • stomach pain, diarrhea, stomach discomfort and vomiting. These usually occur at the beginning of treatment and can be reduced by taking the medicine with food.

Uncommon (may affect up to 1 in 100 people)

  • constipation
  • blood in the urine
  • feeling of discomfort in the chest
  • difficulty sitting or standing still
  • blisters, flaking, redness or flaking of the skin
  • double vision or blurred vision
  • muscle tension, muscle aches, muscle twitching,
  • chest pain
  • elevated liver values ​​(detected by blood test)
  • anger, tension, weeping, excessive attention to the environment,

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

  • altered sex drive
  • feel lost, confused about time, space or personality (disoriented)
  • dilated pupil er, difficult to focus the gaze
  • swelling of the breasts in men

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

  • muscle cramps
  • lack of feelings, interests or commitment
  • repetitive behaviors
  • overfocusing
  • changes in test results, such as increase in alkaline phosphatase or bilirubin , low platelet count or abnormal white blood cell levels
  • loss of sensation in fingers and toes, tingling and change in color (from white to blue, then red) on cold (Raynaud’s phenomenon).

No known frequency (can not be calculated from the available data)

  • migraine
  • chest discomfort
  • confusion
  • very high fever
  • slow or extra heartbeat
  • depending on this medicine
  • problems getting or maintaining an erection
  • inability to control urinary incontinence ( incontinence )
  • spasm in the jaw muscles that makes it difficult to open the mouth (trismus)
  • stuttering

How to store Medanef

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

Do not store above 30 ° C.

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.

Contents of the pack and other information

Content declaration

Medanef 5 mg tablets

The active substance is methylphenidate hydrochloride. Each tablet contains 5 mg of methylphenidate hydrochloride.

Medanef 10 mg tablets

The active substance is methylphenidate hydrochloride. Each tablet contains 10 mg of methylphenidate hydrochloride.

Medanef 20 mg tablets

The active substance is methylphenidate hydrochloride. Each tablet contains 20 mg of methylphenidate hydrochloride.

Other ingredients are:

Microcrystalline cellulose, corn starch, magnesium stearate, and calcium hydrogen phosphate dihydrate.

What the medicine looks like and contents of the pack

Medanef 5 mg tablets are white, round, flat, marked with “RU” on one side and “5” on the other side.

Medanef 10 mg tablets are white, round, flat, tablet marked with “RU10” on one side.

Medanef 20 mg tablets are white, round, flat, tablet marked with “RU20” on one side.

Medanef has the following blister packs available

5 mg: 20, 30, 60, 100 tablets.

10 mg: 20, 30, 60, 100, 200 tablets.

20 mg: 20, 30, 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Laboratorios Rubió, SA, Industria, 29, Pol. Ind. Comte de Sert, 08755 Castellbisbal, Barcelona

Spain

Muhammad Nadeem

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