5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg modified- release capsules , hard
methylphenidate hydrochloride

What Medikinet is and what it is used for

What it is used for
Medikinet is used for the treatment of behavioral disorders called ADHD (Attention Deficit Hyperactivity Disorders)

  • in children and adolescents between 6 years and older and in adults.
  • after other treatments that do not involve drugs have been tried, for example, treatments such as talk therapy and behavioral therapy and which have been insufficient.

The medicine should not be used to treat children under 6 years of age.

How it works
Medikinet improves the activity in certain parts of the brain that are underactive. The drug can improve attention, concentration and reduce impulsivity.

The drug is used as part of a treatment program. which usually consists of psychological, educational, and social measures.

The treatment with Medikinet may only be initiated by and used under the supervision of a doctor who specializes in the treatment of ADHD, such as a pediatrician, a child, an adolescent psychiatrist, or a psychiatrist. A thorough examination is required by this physician. If you as an adult have not been treated before, your doctor will perform tests to confirm that you have had ADHD since childhood. Although there is no cure for ADHD, it can be managed with the help of treatment programs.

About ADHD

Children and adolescents with ADHD are characterized by the fact that they:

  • have difficulty sitting still
  • have difficulty concentrating.

It’s not their fault if they can not do it.

Patients may have ADHD to varying degrees with symptoms that include:

  • concentration difficulties
  • restlessness
  • hyperactivity
  • impulsivity
  • emotional instability
  • disorganized thoughts.

This is shown by, for example:

  • concentration difficulties
  • oblivion
  • talkative
  • difficulties in planning and completing things
  • “Actions in the blind”
  • impatience.

ADHD does not affect the intelligence of children and adolescents.

Methylphenidate hydrochloride contained in Medikinet may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 take Medikinet

Do not take Medikinet if you or your child:

  • is allergic to methylphenidate hydrochloride 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, which 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 e.g. heart attack, irregular heartbeat, chest pain and discomfort, heart failure , heart disease or congenital heart problems
  • have had diseases of the blood vessels of the brain such as stroke , swelling and weakened part of blood vessels ( aneurysm ), narrowing or blocked blood vessels or inflammation of blood vessels ( vasculitis )
  • takes or has during the last 14 days taken antidepressants, so-called monoamine oxidase inhibitors ( MAOIs ) (see Other medicines and Medikinet).
  • have psychiatric problems such as:
    • psychopathic or borderline personality changes
    • abnormal thoughts or visions or a disease called schizophrenia
    • signs of severe mood disorders such as:
      • suicidal thoughts,
      • severe depression, feeling great sadness, feeling of worthlessness and hopelessness
      • manic, is unusually elated, overactive or uninhibited.
  • has a history of disease with a pronounced lack of stomach acid (gastric juice in the stomach is not acidic) with a pH value above 5.5
  • take medicines to reduce gastric acid secretion or to treat excess stomach acid in the stomach (H2 receptor blockers, proton pump inhibitors or antacid treatment).

Do not take Medikinet if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before you or your child take Medikinet as these conditions may get worse.

Warnings and cautions

Talk to a doctor before you or your child use Medikinet if you or your child:

  • have liver or kidney problems
  • have difficulty swallowing or can not swallow whole tablets
  • have a narrowing or obstruction in the gastrointestinal tract
  • have had seizures (seizures, epilepsy ) or abnormal EEG (electroencephalogram)
  • has for some period abused or been addicted to alcohol, drugs or “party drugs”
  • is a woman and has started menstruating (see section Pregnancy and breastfeeding)
  • have motor or verbal tics (difficult to control, repeated twitching in any part of the body or repeated sounds and words)
  • have high blood pressure
  • have a heart problem that is not mentioned in the section “Do not take” above
  • have a mental illness that is not mentioned in the section “Do not take” above. Other mental illnesses can be:
    • mood swings (from manic to depressed, 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 ( paranoia )
    • feeling upset, anxious or tense
    • feeling depressed or guilty

Tell your doctor before starting treatment if any of the above conditions or symptoms apply to you or your child as these conditions may be aggravated by methylphenidate. Your doctor will check how the medicine is affecting you or your child.

Checks that the doctor will make before treatment with Medikinet:

To determine if Medikinet is the right medicine for you or your child, your doctor will discuss the following with you:

  • any medication that you or your child is taking.
  • if there is a history of sudden unresolved deaths in the family.
  • if there is any other medical condition (eg heart problem) that you, your child or your family may have.
  • how you or your child feel, e.g. is overly emotional, has strange thoughts and has had some such feelings in the past.
  • if tics occur within the family (difficult to control, repeated twitching in any part of the body or repeated sounds and words).
  • if you or your child or other family member has or has had a problem related to mental health or behavioral disorders.

The doctor will especially discuss whether you or your child is at risk of mood swings (from being manic to becoming depressed – called bipolar disorder). This includes a review of mental health, including the incidence of suicide, bipolar disorder, and depression in the family.
You must provide as much information as you can. It makes it easier for the doctor to decide if Medikinet is the right medicine for you or your child. Your doctor may decide that more medical examinations are needed before you or your child are treated with 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 contact your doctor immediately if an erection lasts for more than 2 hours, especially if it is painful.

Surveys

This drug can give positive results in drug abuse tests.

Other medicines and Medikinet

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

Do not take Medikinet if you or your child:

  • take so-called monoamine oxidase inhibitors ( MAOIs ) for depression, or have taken MAOIs for the past 14 days. Concomitant intake of MAO inhibitors and Medikinet modified- release capsules may cause a sudden increase in blood pressure.

If you or your child are taking other medicines at the same time, Medikinet may affect the effectiveness of these or cause side effects. Tell your doctor if you or your child are taking medicines to treat:

  • Depression
  • psychiatric illnesses
  • epilepsy
  • problems with blood pressure et
  • cough and colds. Some medicines and colds can affect blood pressure . It is important to consult your pharmacist when purchasing such a product
  • blood-thinning drugs that prevent blood clots.

Medikinet capsules, modified- release should not be taken with H 2 receptor blocking agents, proton pump inhibitors, or antacids used to reduce the hydrochloric acid production or counteract an excess of acid in the stomach, as it can lead to faster release of the total amount of active substance.

If you are unsure whether any of the medicines you or your child are taking belong to the list above, consult your doctor or pharmacist before taking Medikinet.

Surgery
Tell your doctor if you or your child are having surgery. The medicine should not be taken on the day of surgery if a certain anesthetic is used. Otherwise, there is a risk of a sudden increase in blood pressure during the operation.

The medicine with alcohol

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

Pregnancy and breastfeeding

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. Talk to your doctor or pharmacist before using Medikinet if you or your daughter:

– is sexually active. The doctor will discuss contraception

– is pregnant or thinks you or your daughter may be pregnant. Your doctor will decide if Medikinet should be used.

– breastfeeding or planning to breastfeed. Incomplete data are indicating that methylphenidate hydrochloride is transferred to breast milk. Therefore, your doctor will decide if breastfeeding can be done during treatment with Medikinet.

Driving and using machines

You or your child may experience dizziness, difficulty focusing your eyes, or blurred vision during treatment with Medikinet. If this happens, it can be dangerous to perform such activities as driving a vehicle, using machines, riding, cycling, or climbing 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.

The modified-release medicine capsules contain sucrose and sodium

If you or your child cannot tolerate certain sugars, talk to your doctor before using this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.

How you or your child takes Medikinet

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

Dosage

Use in children

The maximum daily dose is 60 mg.

  • your doctor will probably start treatment with a low dose of Medikinet and gradually increase your dose as needed.
  • the doctor will tell you which strength of the capsules to take each day.
  • do not divide the dose one into one capsule, take the entire contents.
  • The modified- release capsule should not be taken too late in the morning as it may cause sleep disturbances.

Use in adults

For adults who have taken Medikinet before

  • if you have already taken Medikinet as a child or adolescent, you can use the same daily dose (mg / day); your doctor will check you regularly to see if any adjustments need to be made
  • Adult patients may require a higher daily dose but the goal is for you to receive the lowest effective dose
  • the maximum daily dose one is i.a. based on your body weight (see below).

For adults who have not taken Medikinet before

The recommended starting dose is 10 mg daily

  • your doctor will increase the dose one by 10 mg daily, depending on how well you tolerate the medicine and how effective it is
  • The goal is for you to get the lowest dose that is effective for you
  • the maximum daily dose one is i.a. based on body weight (see below)
  • your doctor will determine your maximum daily dose
  • the daily dose is 1 mg per kg body weight, up to a maximum of 80 mg methylphenidate daily.

Your doctor will do the following when you or your child receive treatment

The doctor will do some checks

• before you or your child start treatment, to ensure that Medikinet is safe and has benefits

• after starting treatment, at least every 6 months, possibly more often. Checks will also be made when changing dose one.

• the controls include the following:

  • control of appetite
  • measurement of height and weight in children
  • measurement of weight in adults
  • measurement of blood pressure and heart rate
  • assessment of mood, thoughts or other unusual emotions. If these have worsened after Medikinet treatment has started.

Method of administration The
drug is intended to be taken orally.

Children take Medikinet modified-release capsules in the morning with or after breakfast.

Adults take Medikinet modified-release capsules with or after breakfast and lunch.

The drug is a type of methylphenidate with “controlled release” which means that the drug is released for a longer time. It is very important to take the capsule with or after a meal so that the effect is delayed.

The capsules can be swallowed whole with a glass of water.

Alternatively, the capsule can be opened and the contents distributed over a small amount (tablespoon) of apple puree or yogurt, which is taken immediately. May not be saved to be given at a later time.

The capsules or capsule contents should not be crushed or chewed.

If no improvement occurs after 1 month of treatment
If you or your child does not feel better, talk to your doctor. The doctor may decide to give another treatment.

Long-term treatment

Treatment with Medikinet does not have to be forever. If treatment with Medikinet lasts for more than one year, the doctor should discontinue treatment at least once a year for a short time. In children, this could be done during a school holiday. This is to check if the medicine is still needed.

Improper use of Medikinet
If Medikinet is not used properly, it may cause 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, drugs, or narcotics.

If you or your child have taken too much Medikinet

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital.

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

If you or your child have forgotten to take Medikinet

Do not take a double dose to make up for a forgotten dose. If you or your child has missed a dose, take the next dose at the usual time.

If you or your child stop taking Medikinet

If you or your child suddenly stops taking the medicine, ADHD symptoms may return or side effects such as depression may occur. The doctor gradually reduces the amount of medicine taken each day, before stopping treatment completely. Talk to your doctor before stopping treatment with Medikinet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will tell you about these side effects.

Some side effects can be serious. If you get any of the side effects listed below, seek medical attention immediately:

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

  • palpitations (irregular heartbeat

Common (may affect up to 1 in 10 people)

  • mood swings

ess common (may affect up to 1 in 100)

  • Mood swings
  • personality changes
  • see, feel or hear things that are not real, signs of psychosis
  • uncontrolled speech and uncontrolled body movements (Tourette’s syndrome) or worsening of it
  • chest pain
  • signs of allergy , such as rash, itching or hives, swelling of the face, lips and tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing.
  • suicidal thoughts

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

  • feeling of being unusually excited, overactive and uninhibited (manic).

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

  • heart attack
  • seizures (epileptic seizures, convulsions)
  • skin flaking or red, bluish rash
  • muscle cramps that can not be controlled and affect the eyes, head, neck, body and nervous system due to temporary reduction of blood supply to the brain, temporary lack of adequate blood and oxygen supply ( ischemia ) to the brain.
  • paralysis or movement and vision difficulties, speech difficulties (may be a sign of affecting blood vessels in the brain)
  • lowering the number of blood cells (red, white and platelets ) that can make you more susceptible to infection and to make bleeding and bruising easier
  • sudden increase in body temperature, very high blood pressure and severe seizures (neuroleptic malignant syndrome). It has not been established with certainty whether this side effect is caused by Medikinet or by other medicines taken at the same time as Medikinet.

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

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

If you get any of the side effects listed above, seek medical attention immediately.

Other side effects are as follows, if any of these become serious, talk to your doctor or pharmacist:

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

  • headache
  • nervousness
  • insomnia

Common side effects (may affect up to 1 in 10 people)

  • reduced appetite
  • agitation
  • depression or numbness or lack of emotion or showing great interest
  • dry mouth
  • nausea
  • joint pain
  • fever
  • hair loss
  • abnormally sleepy and tired
  • panic attack
  • toothache
  • itching , rash or hives
  • cough, sore throat or nose and throat irritation
  • high blood pressure or other changes in blood pressure ,
  • fast heart rhythm ( tachycardia ) or irregular heart rhythm ( arrhythmia )
  • dizziness
  • uncontrolled movements
  • hyperactive
  • aggression, emotional instability, anxiety, stress, irritability,
  • abnormally behaved
  • abdominal pain, diarrhea, stomach discomfort, indigestion, thirst, vomiting
  • decreased appetite / unwillingness to eat
  • weight loss
  • severe gnashing of teeth (bruxism)
  • excessive sweating

Uncommon side effects (may affect up to 1 in 100 people)

  • tremors or tremors
  • dimsyn
  • muscle aches
  • constipation
  • inflammation of the mucous membranes of the stomach and small intestine
  • extra heartbeat sound (based on examination findings)
  • blood in the urine
  • double vision
  • muscle twitching
  • muscle tension
  • shortness of breath or chest pain
  • increase in liver values ​​(detected by blood tests)
  • anger
  • weeping
  • restlessness
  • extremely aware of the environment,
  • feeling of extreme calm or drowsiness
  • problems with sleep in general
  • fatigue
  • tension

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

  • altered sexual desire
  • confusion
  • dilated pupils are, visual difficulties
  • breast swelling in men
  • reddening of the skin, red raised skin rash
  • pain as a result of the heart not getting enough blood
  • problems / changes in menstruation.

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

  • heart attack
  • 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, test results including liver and blood values
  • suicide attempt
  • disturbed thoughts
  • repeated acts of coercion
  • obsessions about individual things
  • lack of energy
  • feeling sad for a short period of time
  • loss of sensation and cold in fingers and toes, tingling and discoloration (from white to blue, then red) on cold (Raynaud’s syndrome)

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

  • migraine
  • very high fever
  • slow, fast or extra heartbeat
  • severe convulsions ( grand mal convulsions)
  • delusions
  • confusion
  • sad / dark thoughts
  • feel a physical need for the medicine or feel its absence
  • changes in the blood vessels of the brain ( stroke , inflammation and blockage of the blood vessels of the brain)
  • dry skin.
  • impotence
  • long lasting erection you, sometimes painful, or number of erections you
  • quickly incoherent talk
  • voltage
  • gnashing of teeth in sleep
  • ADHD symptoms may return or side effects such as depression may occur after stopping treatment
  • knitting
  • language and speech problems
  • nausea
  • attention deficit disorders
  • flu-like illness
  • lack of energy / weakness
  • thirst
  • increase in thyroid stimulating hormone in the blood
  • pain in the mouth and throat
  • nosebleed
  • heart pleasure
  • dry eyes
  • higher blood pressure in the eye than normal
  • stress with partner / family
  • chest pain
  • hemorrhage / redness
  • ear ringing ( tinnitus )
  • abuse
  • pancytopenia (abnormal decrease in the levels of all types of blood cells )
  • inability to control urinary incontinence ( incontinence )
  • spasm in the jaw muscles that makes it difficult to open the mouth (trismus)
  • stuttering

Effects on growth
If methylphenidate hydrochloride is used for more than a year, it may lead to slower growth in some children. Less than 1 in 10 children are affected.

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

How to store Medikinet

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 expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

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

The active substance is methylphenidate hydrochloride

Medikinet 5 mg, modified-release capsules, hard

One modified-release hard capsule contains 5 mg

methylphenidate hydrochloride, equivalent to 4.35 mg methylphenidate.

Medikinet 10 mg, capsules, modified- release hard
A capsule modified release, hard contains 10 mg methylphenidate hydrochloride, corresponding to 8.65 mg of methylphenidate.

Medikinet 20 mg, capsules, modified- release hard
A capsule modified release, hard contains 20 mg methylphenidate hydrochloride, corresponding to 17.30 mg of methylphenidate.

Medikinet 30 mg, capsules, modified- release hard
A capsule modified release, hard contains 30 mg of methylphenidate hydrochloride, corresponding to 25.95 mg of methylphenidate.

Medikinet 40 mg, capsules, modified- release hard
A capsule modified release, hard contains 40 mg of methylphenidate hydrochloride, corresponding to 34.60 mg of methylphenidate.

Medikinet 50 mg, modified-release capsules, hard

A modified-release hard capsule contains 50 mg of methylphenidate hydrochloride, equivalent to 43.25 mg of methylphenidate.

Medikinet 60 mg, modified-release capsules, hard

A modified-release hard capsule contains 50 mg of methylphenidate hydrochloride, equivalent to 51.90 mg of methylphenidate.

Other ingredients:

Capsule contents:
Sugar spheres (containing sucrose and corn starch
Methacrylic acid-ethyl acrylate copolymer (1: 1)
Talc
Triethyl
Poly (vinyl alcohol)
Macrogol 3350
Polysorbate 80
Sodium hydroxide
Sodium

Simethicone
Silica, colloidal, anhydrous
Methylcellulose
Sorbic acid
Indigo carmine, aluminum lacquer (E132)

Capsule shell:
Gelatin
Titanium dioxide (E127)
Sodium lauryl sulfate
Purified water

Other excipients in Medikinet modified- release capsules 10 mg / 20 mg:
Erythrosin (E127), patent blue V (E131)
Other excipients in Medikinet modified- release capsules 30 mg / 40 mg / 50 mg / 60 mg:
Erythrosine (E127), black iron oxide (E172), indigo carmine (E132)

What the medicine looks like and contents of the pack

Medikinet 5 mg modified-release capsule, hard

White opaque capsule body / white opaque top (15.9 mm) containing white and blue grains.

Medikinet 10 mg modified-release capsules, hard
White opaque capsule body / purple opaque body (15.9 mm) containing white and blue grains.

Medikinet 20 mg modified-release hard capsules

Purple opaque capsule body / purple opaque upper part (15.9 mm) containing white and blue grains.

Medikinet 30 mg modified-release hard capsules

Light gray opaque capsule body / dark violet opaque upper part (15.9 mm) containing white and blue grains.

Medikinet 40 mg modified-release capsules, hard
Gray opaque capsule body / dark violet opaque body (18.0 mm) containing white and blue granules.

Medikinet 50 mg modified-release capsule, hard

Violet opaque capsule body / dark violet opaque top (18 mm) containing white and blue grains.

Medikinet 60 mg modified-release capsule, hard

Dark violet opaque capsule body / dark violet opaque top (19.4 mm) containing white and blue grains.

Pack sizes:

Medikinet 5 mg modified-release capsule, hard

Carton with 20, 30, or 50 hard capsules with modified-release in PVC / PVdC blisters sealed with aluminum foil.

Medikinet 10 mg, 20 mg, 30 mg, or 40 mg modified-release capsule, hard

Carton with 20, 28, 30, and 50 hard capsules with modified-release in PVC / PVdC blisters sealed with aluminum foil.

Medikinet 50 mg / 60 mg modified-release capsule , hard

Carton with 20, 28, 30, or 40 hard capsules with modified-release in PVC / PVdC blister sealed with aluminum foil.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MEDICE Arzneimittel
Pütter GmbH & Co. KG

Kuhloweg 37-39

DE-58638
Iserlohn, Germany

Agent:
Evolan Pharma AB
Box 120
182 12 Danderyd

Muhammad Nadeem

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