Medikinet cr 30 mg: detailed information

Package leaflet: Information for the user

Medikinet CR 5 mg modified-release capsules, hard
Medikinet CR 10 mg modified-release capsules, hard
Medikinet CR 20 mg modified-release capsules, hard
Medikinet CR 30 mg modified-release capsules, hard
Medikinet CR 40 mg modified-release capsules, hard
Medikinet CR 50 mg modified-release capsules, hard
Medikinet CR 60 mg modified-release capsules, hard
Methylphenidate hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Medikinet CR is and what it is used for
What you need to know before taking Medikinet CR
How to take Medikinet CR
Possible side effects
How to store Medikinet CR
Contents of the pack and other information

1. What Medikinet CR is and what it is used for

What Medikinet CR is used for
Medikinet CR is used to treat Attention Deficit Hyperactivity Disorder (ADHD).

It is used in children aged 6 years and above, as well as in adults.
It is used only after non-pharmacological treatment attempts, such as psychological counselling and behavioural therapy, have proved insufficient.

Medikinet CR should not be used in the treatment of ADHD in children under 6 years of age.
How Medikinet CR works
Medikinet CR improves the reduced activity of certain areas of the brain. This medicine may help to extend attention span, improve concentration, and reduce impulsive behaviours.
Medikinet CR is used as part of a treatment programme that usually includes psychotherapy, educational therapy, and social therapy.
Treatment with Medikinet CR may only be initiated and continued by a doctor specialised in the treatment of ADHD, such as a paediatric specialist, child and adolescent psychiatrist, or psychiatrist.
A thorough assessment by such a doctor is required. If the patient is an adult who has not previously been treated, the doctor will carry out an evaluation to confirm that ADHD has been present since childhood before initiating treatment with Medikinet CR.
Although there is no cure for ADHD, the condition can be managed with appropriate treatment programmes.
About ADHD
Children and adolescents with ADHD have difficulty:

sitting still, and
paying attention.

It is not their fault that these activities are so difficult for them.
ADHD can occur in patients with varying degrees of severity, with symptoms such as:

lack of concentration
restlessness
increased motor hyperactivity
impulsiveness
emotional instability
disorganised thinking

These may manifest, for example, as:

difficulty concentrating
forgetfulness
talking too much
difficulty planning and completing tasks
acting without thinking
impatience

ADHD does not negatively affect the patient's intelligence.

2. Important Information Before Using Medikinet CR

When not to use Medikinet CR
If the patient:

is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6);
has a thyroid disorder;
has increased intraocular pressure (glaucoma);
has a tumour of the adrenal gland (chromaffin tumour – phaeochromocytoma);
has eating disorders characterised by lack of appetite or desire to eat, e.g. anorexia nervosa;
has very high blood pressure or blood vessel narrowing, which may cause pain in the arms and legs;
has ever had heart problems, e.g. heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or congenital heart defects;
has cerebrovascular diseases – such as stroke, localised enlargement and weakening of the blood vessel wall (aneurysm), narrowing or blockage of a blood vessel, or inflammation of blood vessels;
is currently taking or has taken within the last 14 days antidepressant medicines (known as monoamine oxidase inhibitors – MAOIs) – see: "Medikinet CR with other medicines";
has psychiatric problems such as:
- psychopathic disorders or borderline personality;
- abnormal thoughts or hallucinations, or a condition known as "schizophrenia";
- symptoms of severe mood disorders, such as: suicidal thoughts; severe depression, when the patient feels profound sadness, worthlessness and hopelessness; mania, when the patient feels extremely excited, overly active and lacking in self-control;
- previously had a significant deficiency of gastric acid (achlorhydria) with pH above 5.5;
- is taking medicines intended to reduce gastric acid secretion or treat gastric hyperacidity (H\textsubscript{2} receptor antagonists, proton pump inhibitors or antacids).

If any of the above situations apply to the patient, methylphenidate should not be used.
In case of doubt, consult a doctor or pharmacist before using
methylphenidate. This is important because methylphenidate may worsen the conditions
listed above.
Warnings and precautions
Before using Medikinet CR, speak with a doctor if:

the patient has liver or kidney problems;
the patient has difficulty swallowing or taking whole tablets;
the patient has had seizures (fits, convulsions, epilepsy) or abnormal brain test results (e.g. EEG);
the patient has ever abused or been dependent on alcohol, prescription medicines or illicit drugs;
the patient is a woman who has started menstruating (see: "Pregnancy and breastfeeding", below);
the patient has uncontrollable repetitive movements of various body parts or repeats sounds and words (tics);
the patient has high blood pressure;
the patient has heart diseases not listed in the section "When not to use Medikinet CR", above;
the patient has psychiatric disorders not listed in the section "When not to use Medikinet CR", above. Other psychiatric disorders include:
- mood swings (from mania to depression – a condition known as "bipolar disorder");
- emergence of aggressive or hostile behaviours, or increased aggression;
- seeing, hearing or feeling things that are not real (hallucinations);
- belief in unreal things (delusions);
- excessive suspicion (paranoia);
- feelings of restlessness, anxiety or tension;
- feelings of sadness or guilt. Before starting treatment, inform the doctor or pharmacist if any of the above conditions are present. Methylphenidate may worsen them. The doctor will monitor how the medicine affects the patient.

During treatment, boys and young men may experience unexpected prolonged
erections. This may be painful and can occur at any time. If an erection lasts longer than
2 hours, and especially if it is painful, contact a doctor immediately.
If the patient develops vision disturbances or other visual problems, contact a
doctor. The doctor may consider discontinuing Medikinet CR.
Medical examination before using methylphenidate
This examination aims to determine whether methylphenidate is suitable for the patient. The doctor
will discuss with the patient:

all other medicines being taken;
any family history of sudden unexplained death;
any other medical problems (e.g. heart diseases) that may affect the patient or family members;
the patient's mental state, e.g. depression or euphoria, unusual thoughts, and whether such conditions occurred in the past;
presence of tics (uncontrollable, repetitive movements of various body parts or repetition of sounds or words) in the patient's family members;
any mental health or behavioural problems that have occurred in the patient or family members.

The doctor will discuss with the patient the risk of mood swings (from mania to depression – so-called
"bipolar disorder"). The doctor will also take a psychiatric history and determine
whether there have been cases of suicide, bipolar disorder or depression in the patient's family.
It is very important to provide the doctor with as complete information as possible. Based on this, the doctor will decide
whether methylphenidate is suitable for the patient. The doctor will also decide whether additional
medical tests are necessary before starting treatment. For adult patients who are just beginning to use Medikinet CR, the doctor may
refer the patient to a heart specialist.
Drug testing
This medicine may cause a positive result in drug tests.
Athletes should be aware that this medicine may lead to positive results in anti-doping tests.
Medikinet CR with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not use methylphenidate if the patient:

is taking a medicine known as a monoamine oxidase inhibitor (MAOI) used to treat depression, or has taken an MAOI within the last 14 days. Concurrent use of MAOIs with methylphenidate may cause a sudden increase in blood pressure.

If the patient is taking other medicines, methylphenidate may affect their action or cause
unwanted effects. Inform the doctor or pharmacist if the patient, adult or child, is taking medicines used to treat:

depression;
psychiatric disorders;
epilepsy;
blood pressure problems;
cough and cold. Some of these products contain substances that may affect blood pressure. When purchasing any such product, consult a pharmacist.
medicines that thin the blood and prevent blood clots.

Do not take Medikinet CR together with H\textsubscript{2} receptor antagonists, proton
pump inhibitors or antacids used to reduce gastric acid secretion or counteract hyperacidity, as this may lead to
faster release of the entire active substance into the body.
If there are any doubts whether a medicine being taken is on the above list, ask the doctor or pharmacist before using methylphenidate.
Surgery
Inform the doctor about any planned surgical procedure. Methylphenidate should not be taken on the day of surgery if a certain type of anaesthesia will be used. This is due to the risk of a sudden increase in blood pressure during the procedure.
Using methylphenidate with alcohol
Do not consume alcohol while taking this medicine. Alcohol may intensify the unwanted effects of this medicine. Remember that alcohol is also present in certain food products and medicines.
Pregnancy and breastfeeding
Available data do not indicate an increased risk of congenital malformations overall, although a small increased risk of heart developmental defects cannot be ruled out during use of the medicine in the first three months of pregnancy. The doctor can provide the patient with additional information about this risk. Before using methylphenidate, inform the doctor or pharmacist if the patient:

is sexually active. The doctor will recommend appropriate contraception.
is pregnant or may be pregnant. The doctor will decide whether to continue methylphenidate treatment.
is breastfeeding or plans to breastfeed. Methylphenidate may pass into breast milk. Therefore, the doctor will decide whether breastfeeding is possible during treatment with methylphenidate.

Driving and operating machinery
During treatment with methylphenidate, dizziness, drowsiness, difficulty focusing vision, blurred vision, hallucinations or other adverse effects on the central nervous system may occur. If such symptoms occur, activities such as driving vehicles, operating machinery, cycling, horse riding, or climbing trees may be dangerous.
Medikinet CR contains sucrose
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Medikinet CR

Medikinet CR must always be taken exactly as prescribed by your doctor. If you have any doubts,
please 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 gradually increase it, as needed.
Your doctor will inform you which strength of capsule to take each day.
The dose contained in the capsule must not be divided. The entire contents must always be taken.
Medikinet CR should not be taken too late in the morning, as it may cause sleep disturbances.

Use in adults
Adult patients previously treated with Medikinet CR

If you have previously taken Medikinet CR as a child or adolescent, the same daily dose (mg/day) may be used. Your doctor will monitor your condition regularly to determine whether the dose needs adjustment.
Adult patients may require a higher daily dose than children, but your doctor will aim to prescribe the lowest effective dose.
The maximum daily dose is determined based on, among other factors, the patient's body weight (see below).

Adult patients not previously treated with Medikinet CR
The recommended starting dose is 10 mg per day.

Your doctor will increase your dose by 10 mg per day, depending on your tolerance and response to the medication.
The goal is to find the lowest effective dose for you.
The maximum daily dose is determined based on, among other factors, the patient's body weight (see below).
Your doctor will decide the maximum daily dose for you.
The daily dose is 1 mg per kg of body weight, up to a maximum of 80 mg of methylphenidate per day.

Procedures to be performed by the doctor before and during treatment (for adult or child patients)
The doctor will perform certain examinations

before starting treatment – to ensure that Medikinet CR is safe and appropriate for you.
after starting treatment – at least every 6 months, but possibly more frequently. These examinations will also be performed whenever the dose of the medication is changed.
during the examination, the doctor will:
- ask about your appetite;
- measure height and weight in children;
- weigh adult patients;
- measure blood pressure and pulse;
- ask about your mood, mental state, or any unusual feelings, and determine whether such problems have worsened during Medikinet CR treatment.

Method of administration
This medicine is for oral use.
Children should take Medikinet CR during or after breakfast.
Adults should take Medikinet CR during or after breakfast and during or after a midday meal (lunch).
Medikinet CR is a formulation of methylphenidate with "controlled release," meaning the medicine is
released into the body gradually over a longer period. Taking the capsule during or after meals is very important to achieve this prolonged, delayed effect.
Capsules may be swallowed whole with water. Alternatively, the capsule may be opened, its contents mixed with a small amount (one tablespoon) of mashed apple or yoghurt, and taken immediately. The contents of the capsule must not be stored for later use.
Capsules and their contents must not be crushed or chewed.
If there is no improvement in the patient's health condition after 1 month of treatment
If there is no improvement in the patient's health condition after 1 month of treatment, this should be reported to the treating doctor. The doctor may decide to change the treatment approach.
Long-term treatment
There is no need to take Medikinet CR indefinitely. If a patient has been taking Medikinet CR for more than one year, the doctor should discontinue treatment at least once a year. In children, it is advisable to plan this treatment break during school holidays. This will allow assessment of whether continued treatment is necessary.
Misuse of Medikinet CR
Misuse of Medikinet CR may lead to abnormal behavior and may result in dependence on the medicine. If you have ever abused or been dependent on alcohol, prescription medicines, or drugs, you must inform your doctor. This medicine is intended only for the person to whom it was prescribed. It must not be shared with others, even if their symptoms are similar.
Taking more than the recommended dose of Medikinet CR
If you take too much medicine, contact your doctor immediately or call emergency services. Inform them of the amount of medicine taken. Treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling of overstimulation, tremors, increased involuntary movements, muscle twitching, seizures (which may lead to coma), extreme euphoria, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), sweating, facial flushing, headache, high fever, changes in heart rate (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nasal and oral mucous membranes, muscle spasms, fever, and reddish-brown urine, which may indicate abnormal muscle breakdown (rhabdomyolysis).
Missing a dose of Medikinet CR
Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at your usual time.
Stopping treatment with Medikinet CR
Suddenly stopping treatment with this medicine may lead to a recurrence of ADHD symptoms or unexpected symptoms such as depression. Before completely discontinuing the medicine, your doctor will gradually reduce the daily dose. You must consult your doctor before stopping Medikinet CR.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The doctor will inform the patient about such adverse effects.
Some adverse effects may be serious. If any of the following occur,
seek medical attention 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

Mood swings, changes in mood
Thoughts of suicide or desire to harm oneself
Sensing or hearing things that do not exist – these are symptoms of psychosis
Uncontrolled speech and body movements (Tourette's syndrome) or worsening of existing symptoms
Chest pain
Allergic reactions 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

Unusual excitement, excessive activity and lack of inhibition (mania)

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

Heart attack
Seizures (epileptic fits, convulsive epilepsy)
Skin peeling or purple-red skin spots
Uncontrollable muscle spasms affecting the eyes, head, neck or other parts of the body, and neurological symptoms associated with transient cerebral ischaemia
Paralysis or problems with movement and vision, speech difficulties (these may be symptoms of brain vascular problems), transient lack of sufficient blood and oxygen (ischaemia) supplied to the brain
Decrease in blood cell count (red blood cells, white blood cells and platelets), which may lead to increased susceptibility to infections and may also predispose to bleeding and bruising
Sudden rise in body temperature, very high blood pressure and severe convulsions (neuroleptic malignant syndrome). It is uncertain whether this adverse effect is caused by methylphenidate or by other medicines that may be used concomitantly with methylphenidate.

Unknown: frequency cannot be estimated from available data

Recurrent unwanted thoughts
Loss of consciousness for unknown reasons, chest pain, shortness of breath (these may be symptoms of heart disease)

If any of the above adverse effects occur,
seek medical attention immediately.
Below is a list of other adverse effects. If they become severe, inform your doctor or pharmacist:
Very common: may affect more than 1 in 10 people

Decreased appetite
Headache
Nervousness
Insomnia
Dry mouth
Nausea

Common: may affect up to 1 in 10 people

Feeling depressed, lack of feelings or emotions, or showing excessive interest
Joint pain
High body temperature (fever)
Excessive hair loss or thinning
Feeling unusually sleepy or sluggish
Loss of appetite
Anxiety attacks
Decreased sex drive
Toothache
Itching, rash or raised, red, itchy skin eruptions (urticaria)
Cough, sore throat or nasal pain, throat irritation, shortness of breath, chest pain
Changes in blood pressure (usually high blood pressure)
Rapid heartbeat (tachycardia), cold hands and feet
Tremor and shaking, dizziness
Involuntary movements, feeling of inner restlessness
Unusual activity
Aggression, agitation, anxiety, emotional instability, anxiety, depression, stress, irritability, abnormal behaviour, difficulty falling asleep, fatigue
Abdominal pain, diarrhoea, abdominal discomfort, indigestion, thirst, vomiting. These symptoms usually occur at the beginning of treatment and may be reduced by taking the medicine with food
Loss of appetite/aversion to food
Weight loss
Excessive sweating

Uncommon: may affect up to 1 in 100 people

Muscle pain, muscle cramps, muscle stiffness
Constipation
Chest discomfort
Inflammation of the mucous membrane of the stomach and small intestine
Additional heart sound (detected during examinations)
Presence of blood in urine
Double vision or blurred vision
Dry eye syndrome
Elevated liver function test results (in blood tests)
Anger, tearfulness, excessive awareness of surroundings
Feeling very calm or sleepy
General sleep problems
Fatigue

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

Changes in sexual drive
Feeling of disorientation
Dilated pupils, difficulty seeing
Breast swelling in men
Skin redness, red raised rash on the skin
Pain due to insufficient blood flow to the heart
Problems/changes related to menstruation
Obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, skin picking, repetitive unwanted thoughts, feelings, images or desires (obsessive thoughts), performing repetitive behaviours or mental rituals (compulsions))

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

Heart attack
Sudden death
Muscle spasms
Small red spots on the skin
Arterial inflammation or blockage in the brain
Liver function abnormalities, including liver failure and coma
Changes in laboratory test results – including liver function and blood tests
Suicide attempts (including completed), disturbances in thinking, lack of feelings or emotions
Lack of energy
Brief feeling of sadness
Numbness in fingers of hands and feet, feeling cold, tingling and change in skin colour (from pale to blue, then to red) triggered by cold (Raynaud's phenomenon)

Unknown: frequency cannot be estimated from available data

Migraine
Very high fever
Slow, fast or irregular heartbeat
Worsening seizures (major epileptic seizure – "grand mal")
Belief in things that are not true
Confusion
Sad/depressing thoughts
Feeling that the body needs the medicine or feeling its absence
Problems with brain blood vessels (stroke, cerebral arteritis or cerebral artery blockage)
Erectile dysfunction
Prolonged, sometimes painful erections, or increased number of erections
Excessive, uncontrollable talking
After stopping the medicine: return of ADHD symptoms or occurrence of adverse effects such as depression
Tingling sensation
Problems with speech and talking
Vomiting reflex
Attention disturbances
Flu-like symptoms
Loss of energy/feeling of weakness
Feeling thirsty
Increased activity of thyroid-stimulating hormone in blood
Pain in the mouth and throat
Nosebleeds
Heart discomfort
Increased intraocular pressure
Eye diseases that may cause worsening of vision due to damage to the optic nerve (glaucoma)
Tension (stress) in partner relationships, family tension
Breast pain
Hot flushes/flushing of the face
"Ringing" in the ears (tinnitus)
Medicinal product abuse
Pancytopenia (decrease in all blood cell counts)
Inability to control urination (urinary incontinence)
Jaw muscle spasm making it difficult to open the mouth (trismus)
Stuttering

Effect on growth and body weight
When methylphenidate is used for longer than one year, in some children this medicine
may suppress growth. This affects fewer than 1 in 10 children.

The child may not gain weight or grow at the expected rate.
The treating doctor will carefully monitor the child's growth, body weight and food intake.
If the patient does not grow as expected, treatment with methylphenidate may be temporarily interrupted.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, tell your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of using the medicine can be collected.

5. How to store Medikinet CR

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

6. Contents of the Pack and Other Information

What the medicine Medikinet CR contains:
The active substance is: methylphenidate hydrochloride
Medikinet CR 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 CR 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 CR 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 CR 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 CR 40 mg modified-release, hard capsules
Each modified-release, hard capsule contains 40 mg of methylphenidate hydrochloride, equivalent to 34.60 mg of methylphenidate.
Medikinet CR 50 mg modified-release, hard capsules
Each modified-release, hard capsule contains 50 mg of methylphenidate hydrochloride, equivalent to 43.25 mg of methylphenidate.
Medikinet CR 60 mg modified-release, hard capsules
Each modified-release, hard capsule contains 60 mg of methylphenidate hydrochloride, equivalent to 51.90 mg of methylphenidate.

Other ingredients are:
Capsule contents:
Sucrose, pellets (containing sucrose and maize starch), methacrylic acid and ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, colloidal anhydrous silica, methylcellulose, sorbic acid, indigotine (E 132)

Capsule shell:
Gelatin, titanium dioxide (E 171), sodium lauryl sulfate, purified water
Additionally in the capsule shell of the medicinal products Medikinet CR 10 mg/20 mg:
erythrosine (E 127), patent blue V (E 131)
Additionally in the capsule shell of the medicinal products Medikinet CR 30 mg/40 mg/50 mg/60 mg:
erythrosine (E 127), iron oxide black (E 172); indigotine (E 132).

What Medikinet CR looks like and contents of the pack
Medikinet CR 5 mg modified-release, hard capsules
White, opaque capsule body/white opaque cap (15.9 mm), capsule contains white and blue pellets.
Medikinet CR 10 mg modified-release, hard capsules
White, opaque capsule body/violet-pink opaque cap (15.9 mm), capsule contains white and blue pellets.
Medikinet CR 20 mg modified-release, hard capsules
Violet-pink, opaque capsule body/violet-pink opaque cap (15.9 mm), capsule contains white and blue pellets.
Medikinet CR 30 mg modified-release, hard capsules
Light grey, opaque capsule body/dark violet opaque cap (15.9 mm), capsule contains white and blue pellets.
Medikinet CR 40 mg modified-release, hard capsules
Grey, opaque capsule body/dark violet opaque cap (18.0 mm), capsule contains white and blue pellets.
Medikinet CR 50 mg modified-release, hard capsules
Violet, opaque capsule body/dark violet opaque cap (18.0 mm), capsule contains white and blue pellets.
Medikinet CR 60 mg modified-release, hard capsules
Dark violet, opaque capsule body/dark violet opaque cap (19.4 mm), capsule contains white and blue pellets.

Pack sizes:
Medikinet CR 5 mg modified-release, hard capsules
Boxes containing 20, 24, 27, 30, 36, 45, 48, 50, 54, 60, 63, 90, 96 or 99 modified-release capsules in hard blisters made of PVC/PVdC foil heat-sealed with aluminium foil.
MEDIKINET CR 10 mg/20 mg modified-release, hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, 60, 63, 90, 96 or 99 modified-release capsules in hard blisters made of PVC/PVdC foil heat-sealed with aluminium foil.
MEDIKINET CR 30 mg/40 mg modified-release, hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 45, 48, 50, 54, 60, 63, 90, 96 or 99 modified-release capsules in hard blisters made of PVC/PVdC foil heat-sealed with aluminium foil.
Medikinet CR 50 mg modified-release, hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 40, 45, 48, 54, 60, 90, 96 or 99 modified-release capsules in hard blisters made of PVC/PVdC foil heat-sealed with aluminium foil.
Medikinet CR 60 mg modified-release, hard capsules
Boxes containing 20, 24, 27, 28, 30, 36, 40, 45, 48, 54, 60, 90, 96 or 99 modified-release capsules in hard blisters made of PVC/PVdC foil heat-sealed with aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37, 58638 Iserlohn
Germany
Tel.: +48 885 050 178

This medicine is authorised for marketing in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Germany: Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hartkapseln mit veränderter Wirkstofffreisetzung
Austria: Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hartkapseln mit veränderter Wirkstofffreisetzung
Denmark: Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Spain: Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg cápsulas duras de liberación modificada
Finland: Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Iceland: Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg hart hylki með breyttan losunarhraða
Luxembourg: Medikinet retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Hartkapseln mit veränderter Wirkstofffreisetzung
Netherlands: Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg capsule met gereguleerde afgifte, hard
Norway: Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Kapsel med modifisert frisetting, hard
Poland: Medikinet CR 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Sweden: Medikinet 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Kapsel med modifierad frisättning, hård
United Kingdom: Medikinet XL 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg modified-release capsules, hard
(Northern Ireland)