Patient Information Leaflet

MEDIKINET 5 mg modified-release hard capsules, 10 mg modified-release hard capsules, 20 mg modified-release hard capsules, 30 mg modified-release hard capsules, 40 mg modified-release hard capsules

methylphenidate hydrochloride
Please read all of this leaflet carefully before you or your child starts taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you or your child. Do not pass it on to others, even if their symptoms seem identical, as it could be harmful.
If you or your child experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What MEDIKINET is and what it is used for
What you need to know before taking or giving MEDIKINET to your child
How to take MEDIKINET
Possible side effects
How to store MEDIKINET
Contents of the pack and other information

1. WHAT MEDIKINET IS AND WHAT IT IS USED FOR

What it is used for
MEDIKINET is used to treat attention deficit hyperactivity disorder (ADHD).

It is used in children aged 6 years and older and in adults.
It is used only after non-pharmacological treatments, such as supportive and behavioral therapy, have been tried and have proven insufficient. MEDIKINET is not indicated for the treatment of ADHD in children under 6 years of age.

How it works
MEDIKINET enhances the activity of certain underactive areas of the brain.
The medicine can help improve attention span and concentration and reduce impulsive behavior.
The medicine is administered as part of a treatment program that usually includes psychological, educational, and social measures.
Treatment with MEDIKINET must be initiated exclusively by a physician specialized in the treatment of ADHD, such as an experienced pediatrician, a child and adolescent psychiatrist, or a psychiatrist, and must be used under their supervision. A careful evaluation by this physician is required. If you, as an adult, have not previously been treated, the physician will perform tests to confirm that you have had ADHD since childhood.
Although there is no cure for ADHD, it can be managed through therapeutic programs.

Information about ADHD
Children and adolescents with ADHD have:

difficulty sitting still
difficulty concentrating. It is not their fault if they cannot do so.

Patients may have ADHD to varying degrees, with symptoms including:

lack of concentration
restlessness
hyperactivity
impulsiveness
emotional instability
disorganized thinking.

This is demonstrated, for example, by:

difficulty concentrating
forgetfulness
excessive talking
difficulty in planning and carrying out tasks
"acting without thinking"
impatience. ADHD does not affect a child's or adolescent's intelligence.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OR GIVING THIS MEDICINE TO YOUR CHILD

MEDIKINET
Do not take MEDIKINET if you or your child:

are allergic to methylphenidate or to any of the other ingredients of this medicine (listed in section 6)
have thyroid problems
have increased internal eye pressure (glaucoma)
have a tumor of the adrenal gland (pheochromocytoma)
have eating disorders when not feeling hungry or when wanting to eat, such as "anorexia nervosa"
have very high blood pressure or narrowing of blood vessels that may cause pain in arms and legs
have had heart problems, such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or were born with heart problems
have had a problem with blood vessels in the brain, such as stroke, swelling or weakening of part of the blood vessels (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor): see section 'Other medicines and MEDIKINET'
have mental health problems such as:
- a "psychopathic" or "borderline" personality disorder
- abnormal thoughts or hallucinations or a condition called "schizophrenia"
- signs of a serious mood disorder such as: suicidal thoughts or severe depression, i.e. feeling very sad, worthless, and hopeless, or mania, i.e. feeling unusually excitable, hyperactive, and disinhibited
have a history of severe lack of gastric juices (achlorhydria of the stomach) with a pH value above 5.5
are taking medicines to reduce gastric juice secretion or to treat excessive stomach acidity (H2-receptor blockers, proton pump inhibitors, or antacid treatment).

Do not take methylphenidate if you or your child are in any of the above conditions. If
you have any doubts, consult your doctor or pharmacist before taking or giving methylphenidate to
your child, because methylphenidate may worsen these conditions.
Warnings and precautions
Talk to your doctor before taking MEDIKINET if you or your child:

have liver or kidney problems
have difficulty swallowing or problems swallowing whole capsules
have had seizures (fits, convulsions, epilepsy) or any abnormalities shown on electroencephalograms (EEG)
have ever abused or been dependent on alcohol, prescription medicines, or street drugs
are female and have started menstruating (see section “Pregnancy and breastfeeding”)
have repeated, uncontrollable muscle spasms anywhere in the body or repeat sounds and words (tics)
have high blood pressure
have a heart problem not listed in the previous section “Do not take”
have a mental health condition not listed in the previous section “Do not take”. Other mental health problems include:
- mood swings (from mania to depression: called “bipolar disorder”)
- aggression and hostility or worsening of aggression
- seeing, hearing, or sensing things that do not exist (hallucinations)
- believing things that are not true (delusions)
- irrational suspicions (paranoia)
- agitation, anxiety, or tension
- depression or feelings of guilt.

If any of the situations listed above apply to you or your child, consult your doctor or pharmacist before starting or giving your child treatment. Methylphenidate may worsen these conditions. Your doctor will want to monitor the medicine’s effects on you or your child.
During treatment, boys and adolescents may unexpectedly experience prolonged erections that may be painful and can occur at any time. It is important to contact your doctor immediately if the erection lasts more than 2 hours, especially if it is painful.
If you or your child develops blurred vision or other visual disturbances, contact your doctor, who may consider stopping treatment with Medikinet.
Medical checks before starting treatment with methylphenidate
These checks are intended to determine whether methylphenidate is the right medicine for you or your child. Your doctor will discuss with you:

any other medicines you or your child are taking
any history of unexplained sudden death in your family
any other medical conditions (such as heart problems) that you or your family may have
how you or your child feel, whether you feel happy or depressed, if you have strange thoughts, and whether you or your child have ever experienced any of these feelings in the past
any family history of "tics" (repeated, uncontrollable muscle spasms anywhere in the body or repetition of sounds or words)
any history of mental or behavioral disorders in you, your child, or your family.

Your doctor will discuss whether you or your child are at risk of mood swings (from mania to depression: called “bipolar disorder”). They will review your or your child’s psychiatric history and check whether there have been cases of suicide, bipolar disorder, or depression in your family.
It is important that you provide as much information as possible so that the doctor can decide whether methylphenidate is suitable for you or your child. The doctor may decide to carry out further clinical tests before starting this medicine. For adult patients who are new to Medikinet, the prescribing doctor may refer them to a cardiologist.
Anti-doping tests
This medicine may give a positive result in anti-doping tests.
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and MEDIKINET
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Do not take methylphenidate if you or your child:

are currently taking or have taken within the last 14 days a medicine called a "monoamine oxidase inhibitor" (MAOI), used for depression. Taking an MAOI together with methylphenidate may cause a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate may affect how they work or may cause side effects. Inform your doctor if you or your child are taking medicines for:

depression
mental health conditions
epilepsy
blood pressure problems
cough or colds. Many remedies contain substances that may affect blood pressure. It is important to check with your pharmacist when purchasing any of these products
medicines that thin the blood to prevent clotting.

MEDIKINET must not be taken together with H2-receptor blockers, proton pump inhibitors, or antacids used to reduce gastric juice secretion or to neutralize excessive stomach activity, as this condition may lead to a faster release of the total amount of active ingredient.
If you are unsure whether any of the medicines you or your child are taking are included in the list above, ask your doctor or pharmacist before taking methylphenidate.
Surgery
Inform your doctor if you or your child are scheduled for surgery.
Methylphenidate must not be taken on the day of surgery if a certain type of anesthetic is used, as there is a risk of a sudden increase in blood pressure during the operation.
Taking methylphenidate with alcohol
Do not drink alcohol when taking this medicine. Alcohol may worsen the side effects of this medicine. Please note that some foods and medicines contain alcohol.
Pregnancy and breastfeeding
Available data do not indicate an increased overall risk of birth defects. However, a small increased risk of heart malformations following use during the first three months of pregnancy cannot be ruled out. Your doctor can provide further information about this risk. Inform your doctor or pharmacist before using methylphenidate if you or your daughter:

are sexually active. Your doctor will discuss contraceptive measures with you or your daughter;
are pregnant or suspect you may be pregnant. Your doctor will decide whether methylphenidate should be taken;
are breastfeeding or intend to breastfeed. Methylphenidate may be excreted in human breast milk. Therefore, your doctor will decide whether you or your daughter can breastfeed while taking methylphenidate.

Driving and using machines
You or your child may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other central nervous system side effects when taking methylphenidate. If this occurs, it may be dangerous to drive, operate machinery, ride a bicycle or a horse, or climb trees.
MEDIKINET contains sucrose
If your doctor has diagnosed you or your child with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. HOW TO TAKE MEDIKINET

You or your child must always take MEDIKINET exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage

Use in children
The maximum daily dose is 60 mg.

Your doctor will usually start treatment with a low dose and then gradually increase it if necessary.
Your doctor will tell you which capsule dose to take each day.
Do not split the contents of a capsule; take the entire contents.
MEDIKINET should not be taken late in the morning, as it may cause sleep disturbances.

Use in adults

For adults who have previously taken MEDIKINET

If you previously took MEDIKINET as a child or adolescent, the same daily dose (mg/day) may be used; your doctor will monitor regularly to determine if dose adjustments are needed.
Adult patients may require a higher daily dose, but your doctor will aim to prescribe the lowest effective dose.
The maximum daily dose depends, among other factors, on your body weight (see below).

For adults who have not previously taken MEDIKINET
The recommended starting dose is 10 mg per day.

Your doctor will increase the dose in increments of 10 mg per day, depending on how well you tolerate the medicine and how effective it is.
The goal should be the lowest dose that proves effective for you.
The maximum daily dose depends, among other factors, on your body weight (see below).
Your doctor will determine your maximum daily dose, which is 1 mg per kg of body weight, up to a maximum of 80 mg of methylphenidate per day.

What your doctor will do while you or your child are on treatment
Your doctor will perform certain checks

Before you or your child start treatment, to ensure MEDIKINET is safe and appropriate.
After you or your child have started treatment, checks should be performed at least every 6 months, but possibly more frequently. They will also be carried out whenever the dose is changed.
These checks include:
- Monitoring of appetite
- Measurement of height and weight in children
- Measurement of weight in adults
- Monitoring of blood pressure and heart rate
- Assessment of mood changes, mental status, or any other unusual feelings, or whether such symptoms worsen during MEDIKINET treatment.

Method of administration
This medicinal product is for oral use.
Children should take MEDIKINET in the morning at breakfast or immediately afterwards.
Adults should take MEDIKINET at breakfast or immediately afterwards and at lunchtime.
MEDIKINET is a modified-release form of methylphenidate, which releases the drug gradually over an extended period of time. Taking the capsule with food or immediately after is very important to delay its onset of action. The capsules can be swallowed whole with water.
Alternatively, the capsules may be opened, and the contents sprinkled onto a small amount (one tablespoon) of applesauce and taken immediately. Do not store the mixture for later use.
The capsules and their contents must not be crushed or chewed.

If you or your child do not improve after 1 month of treatment
If you or your child do not improve after 1 month of treatment, inform your doctor. Your doctor may decide that you or your child need a different treatment.

Long-term treatment
MEDIKINET should not be taken indefinitely. If you or your child take MEDIKINET for more than one year, your doctor must interrupt treatment at least once a year for a short period. In children, this could occur during school holidays. This allows assessment of whether the medicine is still necessary.

Misuse of MEDIKINET
If MEDIKINET is not used correctly, it may cause abnormal behavior. It may also lead to you or your child becoming dependent on the medicine. Inform your doctor if you or your child have ever misused alcohol, prescription medicines, or street drugs, or have ever been dependent on them.
This medicine is intended only for you. Do not give this medicine to anyone else, even if their symptoms appear similar to yours.

If you or your child take more MEDIKINET than you should
If you or your child take more than the prescribed amount, contact your doctor immediately or call an ambulance. Inform them of the amount taken. Medical treatment may be necessary.
Signs of overdose may include: vomiting, agitation, tremor, increased involuntary movements, muscle spasms, seizures (which may be followed by coma), extreme feelings of happiness, confusion, visual disturbances, sensations or perceptions of things that are not real (hallucinations), sweating, hot flushes, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms, fever, and brownish-red urine, which could be possible signs of abnormal muscle breakdown (rhabdomyolysis).

If you or your child forget to take MEDIKINET
Do not take a double dose to make up for a missed dose. If you or your child forget a dose, wait until the next scheduled dose time.

If you or your child stop taking MEDIKINET
If you or your child stop treatment with this medicine suddenly, ADHD symptoms may return or side effects such as depression may occur. Your doctor may gradually reduce the daily dose before stopping treatment completely. Consult your doctor before stopping treatment with MEDIKINET.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Your doctor will talk to you about these side effects.
Some side effects can be serious. If you experience any of the following side effects,
seek medical advice immediately.
Common (may affect up to 1 in 10 people)

Irregular heartbeat (palpitations)
Changes in personality
Excessive teeth grinding (bruxism)

Uncommon (may affect up to 1 in 100 people)

Suicidal thoughts or urges
Perceiving or hearing things that do not exist; these are signs of psychosis
Uncontrolled speech and body movements (Tourette’s syndrome) or worsening of these
Chest pain
Signs of allergy such as skin rash, itching or hives, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing
Mood changes or mood swings

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

Feeling unusually excited, hyperactive or disinhibited (mania)

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

Heart attack
Seizures (fits, epileptic attacks with convulsions)
Skin peeling or red-purple patches
Uncontrollable muscle spasms affecting the eyes, head, neck, body and nervous system, due to temporary lack of blood supply to the brain
Paralysis or movement and vision problems, difficulty speaking (these may be signs of problems with blood vessels in the brain), temporary lack of adequate blood and oxygen (ischaemia) to the brain
Reduced number of blood cells (red blood cells, white blood cells and platelets), which may increase susceptibility to infections and cause easier bleeding and bruising
Sudden increase in body temperature, very high blood pressure and severe convulsions (“neuroleptic malignant syndrome”). It is unclear whether this side effect is caused by methylphenidate or by other medicines that may be taken together with methylphenidate.

Not known (frequency cannot be estimated from the available data)

Unwanted thoughts that keep recurring
Unexplained fainting, chest pain, shortness of breath (these may be signs of heart problems). If you experience any of these side effects, seek medical advice immediately.

Other side effects include the following. If they worsen, inform your doctor or
pharmacist:
Very common: may affect more than 1 in 10 people

Decreased appetite
Headache
Nervousness
Inability to sleep
Dry mouth
Malaise

Common: may affect up to 1 in 10 people

Feeling depressed or emotionally numb or showing little interest
Joint pain
High temperature (fever)
Unusual hair loss or thinning
Unusual drowsiness or dizziness
Loss of appetite
Panic attack
Reduced sex drive
Toothache
Itching, skin rash or increased itchy red bumps (urticaria)
Cough, sore throat or irritation of nose and throat, shortness of breath or chest pain
Changes in blood pressure (usually high blood pressure)
Fast heartbeat (tachycardia), cold hands and feet
Trembling and shaking, dizziness, uncontrollable movements, feeling of inner restlessness
Unusual activity
Aggression, agitation, restlessness, emotional instability, anxiety, depression, stress, irritability and abnormal behaviour, sleep problems, fatigue
Stomach pain, diarrhoea, stomach ache, indigestion, thirst, vomiting. These usually occur at the beginning of treatment and may be reduced by taking the medicine with food.
Lack of appetite/no desire to eat
Weight loss
Excessive sweating

Uncommon: may affect up to 1 in 100 people

Muscle pain, muscle spasms, muscle tension
Constipation
Chest discomfort
Inflammation of the mucous membranes of the stomach and small intestine
Extra heart sound during heartbeat (based on test results)
Blood in urine
Double or blurred vision
Dry eyes
Increased liver function test levels (from blood tests)
Anger, feeling like crying, excessive awareness of surroundings, tension
Feeling very calm or drowsy
General sleep problems
Fatigue

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

Changes in libido
Disorientation
Dilated pupils, vision problems
Breast swelling in men
Skin redness, increased red skin rash
Pain due to insufficient blood flow to the heart
Problems/changes in menstruation
Obsessive-compulsive disorder (OCD) (including irresistible urge to pull out body hair, skin picking, recurring and unwanted thoughts, sensations, images or impulses in the mind (obsessive thoughts), performance of repetitive behaviours or mental rituals (compulsions))

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

Heart attack
Sudden death
Muscle cramps
Small red spots on the skin
Inflammation or blockage of brain arteries
Abnormal liver function, including liver failure and coma
Changes in test results, including blood tests and liver function tests
Suicide attempt (including completed suicide), unusual thoughts, absence of feelings or emotions
Lack of energy
Feeling sad for a short period of time
Numb, cold fingers and toes with tingling and colour change (from white to blue, then red) in cold conditions (Raynaud’s phenomenon)

Not known: frequency cannot be estimated from the available data

Migraine
Very high fever
Slow, fast or irregular heartbeat (extrasystoles)
Major epileptic seizures (“grand mal convulsions”)
Seeing things that do not exist, confusion
Sad/dark thoughts
Feeling a physical need for the medicine or feeling its absence
Problems with brain blood vessels (stroke, cerebral arteritis or cerebral occlusion)
Erectile dysfunction
Prolonged, sometimes painful erections, or increased number of erections
Excessive, uncontrollable talking
After stopping treatment, ADHD symptoms may return or side effects such as depression may occur
Tingling sensation
Problems with language and speech
Nausea
Attention disorder
Flu-like illness
Loss of energy/feeling weak
Feeling thirsty
Increased levels of thyroid-stimulating hormone in the blood
Pain in the mouth and throat area
Nosebleed
Heart discomfort
Increased eye pressure
Eye diseases that may cause vision loss due to damage to the optic nerve (glaucoma)
Stress with partner/family
Breast pain
Hot flush/flushing
Ringing in the ears (tinnitus)
Abuse
Pancytopenia (abnormal decrease in levels of all types of blood cells)
Inability to hold urine (incontinence)
Jaw muscle spasm making it difficult to open the mouth (trismus)
Stuttering

Effects on growth
If used for more than one year, methylphenidate may cause delayed growth in some children. This occurs in fewer than 1 in 10 children.

You may notice lack of weight or height gain.
Your doctor will carefully monitor your or your child’s height, weight and diet.
If you or your child does not grow as expected, treatment with methylphenidate may be interrupted for a short period of time.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MEDIKINET

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.:". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What MEDIKINET contains:
The active substance is: methylphenidate hydrochloride.
MEDIKINET 5 mg modified-release hard capsules
Each modified-release hard capsule contains 5 mg of methylphenidate hydrochloride,
equivalent to 4.35 mg of methylphenidate.
MEDIKINET 10 mg modified-release hard capsules
Each modified-release hard capsule contains 10 mg of methylphenidate hydrochloride,
equivalent to 8.65 mg of methylphenidate.
MEDIKINET 20 mg modified-release hard capsules
Each modified-release hard capsule contains 20 mg of methylphenidate hydrochloride,
equivalent to 17.30 mg of methylphenidate.
MEDIKINET 30 mg modified-release hard capsules
Each modified-release hard capsule contains 30 mg of methylphenidate hydrochloride,
equivalent to 25.95 mg of methylphenidate.
MEDIKINET 40 mg modified-release hard capsules
Each modified-release hard capsule contains 40 mg of methylphenidate hydrochloride,
equivalent to 34.60 mg of methylphenidate.

The other ingredients (excipients) are:
Capsule contents:
Sugar spheres (containing sucrose and maize starch), methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, anhydrous colloidal silica, methylcellulose, sorbic acid, aluminium lake containing indigotine (E 132).

Capsule shell:
Gelatin, titanium dioxide (E 171), sodium lauryl sulfate, purified water.
Additionally, in the shell of MEDIKINET 10 mg and 20 mg capsules:
Erythrosine (E 127), patent blue V (E 131).
Additionally, in the shell of MEDIKINET 30 mg and 40 mg capsules:
Erythrosine (E 127), iron oxide black (E 172), indigotine (E 132).

Description of the appearance of MEDIKINET and pack contents
MEDIKINET 5 mg modified-release hard capsules
Opaque white capsule body/opaque white capsule cap (15.9 mm), containing white and blue granules.
MEDIKINET 10 mg modified-release hard capsules
Opaque white capsule body/opaque mauve capsule cap (15.9 mm), containing white and blue granules.
MEDIKINET 20 mg modified-release hard capsules
Opaque mauve capsule body/opaque mauve capsule cap (15.9 mm), containing white and blue granules.
MEDIKINET 30 mg modified-release hard capsules
Opaque light grey capsule body/opaque dark violet capsule cap (15.9 mm), containing white and blue granules.
MEDIKINET 40 mg modified-release hard capsules
Opaque grey capsule body/opaque dark violet capsule cap (18.0 mm), containing white and blue granules.

Pack sizes:
Cartons containing 28 or 30 modified-release hard capsules, packaged in blisters made of PVC/PVdC with aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

Marketing Authorization Holder in Italy (Concessionario di vendita):
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milano
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Belgium: Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg Capsule met gereguleerde afgifte, hard
Estonia: Medikinet XL 5 mg, 10 mg, 20 mg, 30 mg, 40 mg
France: Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg Gélule à libération modifiée
Ireland: Medikinet MR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg modified release capsules, hard
Italy: Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg Capsule rigide a rilascio modificato
Latvia: Medikinet XL 5 mg, 10 mg, 20 mg, 30 mg, 40 mg ilgstošās darbības cietās kapsulas
Lithuania: Medikinet XL 5 mg, 10 mg, 20 mg, 30 mg, 40 mg modifikuoto atpalaidavimo kietos kapsulės
Portugal: Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg Cápsula de libertação modificada