Package leaflet: Information for the user

Mindetra, 18 mg, prolonged-release tablets
Mindetra, 27 mg, prolonged-release tablets
Mindetra, 36 mg, prolonged-release tablets
Mindetra, 54 mg, prolonged-release tablets
Methylphenidati hydrochloridum
Please read 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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 Mindetra is and what it is used for
What you need to know before taking Mindetra
How to take Mindetra
Possible side effects
How to store Mindetra
Contents of the pack and other information

1. What Mindetra is and what it is used for

What Mindetra is used for
Mindetra is used to treat Attention Deficit Hyperactivity Disorder (ADHD):

in children aged 6 years and older and in adults.
only after non-pharmacological treatments (without medication) have been tried, such as psychological counselling or behavioural training (behavioural therapy). Mindetra is not used to treat ADHD in children under 6 years of age.

How Mindetra works
Mindetra improves the function of certain parts of the brain that are less active. It may help increase attention span, improve concentration, and reduce impulsive behaviours.
Mindetra is used as part of a treatment programme that usually includes:

psychological
educational
environmental therapies.
The medicine should only be prescribed by a specialist doctor experienced in managing behavioural disorders in children, adolescents, or adults. For adults who have not previously been treated, the specialist will carry out assessments to confirm that the patient has had ADHD since childhood. Although there is no cure for ADHD, the condition can be managed through therapeutic programmes.

ADHD
Children and adolescents with ADHD are characterised by:

difficulty sitting still for long periods
difficulty concentrating.
This behaviour is not their fault, as they have no control over it.

Many children and adolescents experience such difficulties. However, ADHD may lead to problems in everyday life. Children and adolescents with ADHD may have difficulties with learning and completing homework. They may find it hard to behave appropriately at home, at school, and in other settings.
Adults with ADHD often have trouble concentrating. They may often feel restless, impatient, and inattentive. They may have difficulties organising their personal and professional lives.
Not all patients with ADHD require pharmacological treatment.
ADHD does not affect intelligence.

2. Important information before using Mindetra

When not to use Mindetra:

if the patient is allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
if the patient has thyroid dysfunction
if the patient has increased intraocular pressure (glaucoma)
if the patient has a tumour of the adrenal gland (pheochromocytoma)
if the patient has appetite disorders – does not feel hungry or does not want to eat – such as psychogenic anorexia
if the patient has very high blood pressure or blood vessel narrowing that may cause pain in hands and feet
if the patient has ever had heart problems such as: heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease or congenital heart defects
if the patient has had cerebrovascular diseases such as: stroke, aneurysm (localized dilation and weakening of blood vessel wall), narrowing or blockage of blood vessels, or inflammation of blood vessels
if the patient is taking or has taken within the last 14 days antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) – see section "Mindetra with other medicines"
if the patient has psychiatric disorders such as:
- psychopathic or emotionally unstable personality (borderline type)
- unusual thoughts or hallucinations, or a condition called schizophrenia
- severe mood disorders with symptoms such as:
- suicidal thoughts or tendencies
- severe depression, when the patient feels very sad, worthless, and hopeless about the future
- mania, when the patient is extremely excited, excessively active, and uncontrolled in their behaviour.

Methylphenidate should not be given if any of the above conditions apply to the patient.
In case of doubt, consult a doctor or pharmacist before using methylphenidate,
as the medicine may worsen these conditions.
Warnings and precautions
Before starting treatment with Mindetra, discuss the following with a doctor:

if the patient has liver or kidney problems
if the patient has difficulty swallowing whole tablets
if the patient has had seizures (fits, epilepsy) or abnormal EEG (electroencephalogram – brain activity recording)
if the patient has ever abused or been dependent on alcohol, prescription medicines, or drugs
if the patient has started menstruation (see below "Pregnancy, breastfeeding and effects on fertility")
if the patient has uncontrollable, repetitive movements of body parts or repeats sounds or words
if the patient has high blood pressure
if the patient has heart diseases other than those listed above under "When not to use Mindetra"
if the patient has psychiatric disorders other than those listed above under "When not to use Mindetra". These disorders include:
o mood swings (from mania to depression – known as bipolar affective disorder)
o feelings of aggression or hostility
o seeing, hearing, or feeling things that are not there (hallucinations)
o beliefs in things that are not true (delusions)
o extreme suspiciousness (paranoia)
o feelings of agitation, anxiety, and tension
o feelings of depression or guilt.

Before starting treatment, inform the doctor or pharmacist if the patient has any of the
symptoms or diseases listed above, as methylphenidate may worsen these
conditions. The doctor will want to monitor how the medicine affects the patient.
If the patient develops visual disturbances or other vision problems, contact the
doctor. The doctor may consider discontinuing treatment with Mindetra.
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, contact a doctor immediately, especially if it is painful.
Medical interview before starting treatment with Mindetra
The interview helps determine whether methylphenidate is an appropriate medicine for the patient. The doctor
will talk to the patient about:

all medicines the patient is taking
any family history of sudden unexplained death
any other health problems (such as heart problems) affecting the patient or their family
the patient's mental state, e.g. whether they have mood swings, strange thoughts, or whether such feelings occurred in the past
family history of tics (uncontrollable, repetitive movements of body parts or repeated sounds or words)
any psychiatric or behavioural disorders ever present in the patient or other family members. The doctor will assess the risk of mood swings (from mania to depression – known as bipolar affective disorder). This will involve conducting a psychiatric interview with the patient and checking whether there have been cases of suicide, bipolar affective disorders, or depression in the family.

It is important to provide as much information as possible. This will help the doctor decide whether
methylphenidate is the right medicine for the patient. Before starting treatment, the doctor may
decide that further tests are necessary. For adult patients who are just starting treatment with Mindetra, the doctor may
refer the patient to a heart specialist.
Mindetra with other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Do not take methylphenidate if the patient:

is taking a medicine known as a "monoamine oxidase inhibitor" (MAOI) used to treat depression

or if such a medicine was taken within the last 14 days. Taking this medicine together with
methylphenidate may cause a sudden increase in blood pressure
(see "When not to use Mindetra").
Tell the doctor or pharmacist if the patient is taking any of the following
antidepressant or anti-anxiety medicines:

tricyclic antidepressants
selective serotonin reuptake inhibitors (SSRIs)
serotonin and norepinephrine reuptake inhibitors (SNRIs). Taking methylphenidate with these medicines may lead to a life-threatening increase in serotonin levels in the brain (serotonin syndrome), which may manifest as confusion or restlessness, sweating, chills, muscle spasms, or rapid heartbeat. If the patient experiences these side effects, they must immediately see a doctor.

If the patient is taking other medicines, methylphenidate may affect their action or cause
side effects. Before taking methylphenidate, inform the doctor or pharmacist
if the patient is taking any of the following medicines:

medicines used for severe psychiatric disorders
medicines used for Parkinson's disease (such as levodopa)
antiepileptic medicines
medicines used to lower or raise blood pressure
certain cough and cold medicines containing ingredients affecting blood pressure. It is important to ask the pharmacist when purchasing such medicines
anticoagulant medicines preventing blood clots.

If in doubt whether any of the medicines taken by the patient are on the
above list, consult a doctor or pharmacist before taking methylphenidate.
Before a surgical procedure
Inform the doctor about any planned surgery. Do not take
methylphenidate on the day of surgery if certain types of anaesthetic medicines are to be used,
due to the risk of sudden increase in blood pressure during the operation.
Drug tests
The medicine may cause a positive result in drug tests. This also applies to tests performed on athletes.
Using Mindetra with alcohol
Do not consume alcohol while taking this medicine. Alcohol may worsen
side effects of the medicine. Remember that some food products and medicines contain alcohol.
Pregnancy, breastfeeding and contraception
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor before using this medicine.
Available data do not indicate an increased risk of congenital malformations overall, although a small
increase in the 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 taking methylphenidate, tell the doctor or pharmacist if the patient:

is sexually active. The doctor will discuss methods of contraception
is pregnant or suspects she may be pregnant. The doctor will decide whether methylphenidate should be used
is breastfeeding or plans to breastfeed. Methylphenidate passes into human milk. Therefore, the doctor will decide whether breastfeeding should continue during treatment with methylphenidate.

Driving and operating machinery
While taking methylphenidate, dizziness, concentration disturbances, and blurred
vision may occur. If this happens, it may be dangerous to perform activities such as: driving
a vehicle, operating machinery, riding a bicycle, horseback riding, or climbing trees.
Mindetra contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, contact the doctor before starting treatment.

3. How to take Mindetra

What dose to take
This medicine should always be taken as directed by the doctor. If in doubt, consult your
doctor or pharmacist.

The doctor usually starts treatment with a low dose and then, if necessary, gradually increases the daily dose by 18 mg, no more frequently than once a week. The goal should be the lowest dose that is effective for the patient. The doctor will determine the maximum daily dose for the patient.
Mindetra is taken orally. The tablet should be taken once daily in the morning, with a glass of water. The tablet should be swallowed whole. Tablets must not be chewed, broken, split, or crushed. The tablet may be taken with or without food.

Use in children aged 6 years and older
The recommended initial dose of Mindetra is 18 mg once daily for children who are not currently taking
methylphenidate or for children switching from another stimulant medication to
methylphenidate.
The maximum daily dose is 54 mg.
Use in adults

For adults who have previously taken Mindetra:
- If the patient has previously taken Mindetra as a child or adolescent, the same daily dose (mg/day) may be used; the doctor will regularly check whether dose adjustment is necessary.
- Adult patients may require a higher daily dose, but the doctor will aim to prescribe the lowest effective dose.
For adults who have not previously taken Mindetra:
- The recommended initial dose is 18 mg per day.
- The maximum daily dose in adults is 72 mg.

If there is no improvement after 1 month of treatment, inform the doctor,
who may decide whether alternative treatment is necessary.
Examinations performed by the doctor during treatment
The doctor will carry out several assessments:

before starting treatment – to ensure that Mindetra is safe and beneficial for the patient
after starting treatment – at least every 6 months, but possibly more frequently, and also with any dose change
assessments will include:
- monitoring of appetite
- measurement of height and body weight
- measurement of blood pressure and heart rate
- evaluation of mood disorders, mental status, or any other abnormalities,

and whether these have worsened during treatment with Mindetra.
Long-term treatment
Treatment with Mindetra does not necessarily need to be indefinite. If Mindetra is taken for
longer than 1 year, the doctor should interrupt treatment for a short period. This may occur during holidays.
This break will help assess whether the medicine is still needed.
Misuse of Mindetra
Misuse of Mindetra may lead to abnormal behaviors. It may also indicate that the patient is becoming dependent on the medicine. Inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or drugs.
The medicine is intended for the patient for whom it was prescribed only. It must not be given to another person, even if they have similar symptoms.
Taking more than the recommended dose of Mindetra
If too much medicine is taken, contact your doctor immediately or call emergency services and inform them of the amount taken. Treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling of restlessness, chills, increased uncontrolled movements, muscle twitching, seizures (which may be followed by coma), feeling of euphoria, confusion, seeing, feeling, or hearing unreal things (hallucinations), sweating, facial flushing, headache, high fever, changes in heart rhythm (slow, fast, irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle swelling, weakness, tenderness and muscle pain, dark urine.
Missed dose of Mindetra
Do not take a double dose to make up for a missed dose. If a dose is missed, wait until it is time to take the next dose.
Stopping Mindetra treatment
If the patient suddenly stops taking this medicine, ADHD symptoms may return or adverse effects such as depression may occur. The doctor may recommend gradually reducing the dose daily before completely discontinuing the medicine. Talk to your doctor before stopping treatment with Mindetra.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Despite the occurrence of adverse effects, most patients' condition improves. The doctor
will discuss these adverse effects with the patient.
Some adverse effects may be serious. Immediately inform the doctor
if any of the following adverse effects occur:
Common adverse effects (may affect up to 1 in 10 people)

irregular heartbeat (palpitations)
mood changes or mood swings, or changes in personality.

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

suicidal thoughts or tendencies
seeing, feeling or hearing things that are not real – these are symptoms of psychosis
uncontrollable sounds or body movements (Tourette’s syndrome)
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 breathing difficulties.

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

feeling excessively excited, hyperactivity and impulsiveness (mania).

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

heart attack
sudden death
suicide attempts
seizures (fits, epilepsy)
exfoliative skin inflammation or erythema multiforme
inflammation or blockage of cerebral arteries
transient paralysis or problems with movement and vision, difficulty speaking (may be symptoms of problems with blood vessels in the brain)
involuntary spasms of the eye muscles, head, neck, body and nervous system
reduction in blood cell count (red blood cells, white blood cells and platelets), which may increase susceptibility to infections, bleeding and bruising
sudden increase in body temperature, very high blood pressure and severe convulsions (neuroleptic malignant syndrome). It is not certain whether this effect is caused by methylphenidate or by other medicines taken together with methylphenidate.

Frequency not known (frequency cannot be determined from available data)

recurring, unwanted thoughts
unexplained fainting, chest pain, shortness of breath (may be symptoms of heart problems)
prolonged erections, sometimes painful, or increased frequency of erections.

Immediately contact the doctor if any of the above adverse effects occur in the patient.
Inform the doctor or pharmacist if any of the adverse effects listed below worsen:
Very common adverse effects (may affect more than 1 in 10 people)

headache
nervousness
insomnia.

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

joint pain
blurred vision
tension-type headache
dry mouth, thirst
difficulty falling asleep
high temperature (fever)
problems with libido
excessive hair loss or thinning
muscle tension, muscle cramps
loss or decrease in appetite
difficulty achieving or maintaining erection
itching, rash or raised, red, itchy rash on the skin (urticaria)
feeling excessively sleepy or fatigued, feeling tired
excessive teeth grinding (bruxism)
feeling of panic
sensation of pricking, tingling or numbness of the skin
increased alanine aminotransferase activity (liver enzyme) in blood
cough, sore throat or nasal and throat irritation; upper respiratory tract infection,
sinusitis
high blood pressure, rapid heartbeat (tachycardia)
dizziness, feeling weak, uncontrolled movements, excessive psychomotor activity
aggression, agitation, anxiety, depression, irritability, tension, tremor and unusual behaviour
stomach upset or indigestion, abdominal pain, diarrhoea, nausea, discomfort in the abdominal cavity, vomiting
excessive sweating
weight loss.

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

dry eye syndrome
constipation
chest discomfort
haematuria (blood in urine)
apathy
trembling or shaking
increased need to urinate
muscle pain, muscle cramps
shortness of breath or chest pain
feeling of heat
increased liver enzyme activity (in blood tests)
anger, restlessness or tearfulness, talkativeness, hyperalertness, sleep problems.

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

problems with libido
state of disorientation or confusion
visual disturbances or double vision
breast gland swelling in men
skin redness, red raised skin rash
Obsessive-compulsive disorder (OCD) (including irresistible urge to pull out hair, skin picking, recurring unwanted thoughts, feelings, images or impulses (obsessions), performing repetitive behaviours or mental rituals (compulsions)).

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

muscle spasms
small red spots on the skin
liver function abnormalities, including sudden liver failure and coma
abnormal test results – including liver function tests and blood tests
thought disorders, lack of feelings or emotions
feeling of coldness in hands and feet
numbness of fingers and toes, tingling and skin colour changes (from white to blue, then to red) after cooling (Raynaud’s phenomenon).

Frequency not known (frequency cannot be determined from available data)

migraine
pupil dilation
increased intraocular pressure
eye diseases that may lead to worsening of vision due to optic nerve damage (glaucoma)
very high fever
slow or fast heartbeat or extra beats
major convulsive seizures (grand mal type)
belief in things that are not true (delusions)
severe abdominal pain, often with nausea and vomiting
problems with cerebral blood vessels (stroke, cerebral arteritis or
cerebral vessel occlusion)
inability to control urination (urinary incontinence)
jaw muscle spasm making it difficult to open the mouth (trismus)
stuttering
nosebleeds.

Effect on physical development
If methylphenidate is used for longer than one year, physical development may slow down
in some children. This affects fewer than 1 in 10 children.

Lack of weight gain or growth may occur.
The doctor will closely monitor the patient’s growth, body weight and diet.
If a child’s development is slower than expected, treatment with methylphenidate may be temporarily interrupted.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 responsible entity.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store the medicine Mindetra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Shelf-life after first opening of the bottle:
Tablets 18 mg: 3 months
Tablets 27 mg: 6 months
Tablets 36 mg: 6 months
Tablets 54 mg: 6 months
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 protect the environment.

6. Contents of the pack and other information

What Mindetra contains
The active substance is methylphenidate hydrochloride.
Mindetra 18 mg: Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride, equivalent to 15.6 mg of methylphenidate.
Mindetra 27 mg: Each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride, equivalent to 23.3 mg of methylphenidate.
Mindetra 36 mg: Each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride, equivalent to 31.1 mg of methylphenidate.
Mindetra 54 mg: Each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride, equivalent to 46.7 mg of methylphenidate.

Other ingredients are:
Tablet core:
Monohydrate lactose, hypromellose, anhydrous colloidal silicon dioxide, magnesium stearate, fumaric acid, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), triethyl citrate, talc.

Tablet coating:
18 mg tablets: partially hydrolyzed polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
27 mg tablets: partially hydrolyzed polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine, aluminium lake (E 132), black iron oxide (E 172).
36 mg tablets: partially hydrolyzed polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171).
54 mg tablets: partially hydrolyzed polyvinyl alcohol, polyethylene glycol 3350, talc, titanium dioxide (E 171), red iron oxide (E 172).

Printing ink:
Shellac, black iron oxide (E 172), propylene glycol.

What Mindetra looks like and contents of the pack
18 mg tablet: yellow, biconvex capsule-shaped tablet, 6.6 mm x 11.9 mm, with a black "2392" imprint on one side.
27 mg tablet: grey, biconvex capsule-shaped tablet, 6.7 mm x 12.0 mm, with a black "2393" imprint on one side.
36 mg tablet: white, biconvex capsule-shaped tablet, 6.7 mm x 12.0 mm, with a black "2394" imprint on one side.
54 mg tablet: reddish-brown, biconvex capsule-shaped tablet, 6.8 mm x 12.0 mm, with a black "2395" imprint on one side.

Mindetra is available in bottles with a closure containing a desiccant, child-resistant packaging, containing 28, 30 or 90 prolonged-release tablets (18 mg tablets) or 28, 30 or 100 prolonged-release tablets (27 mg, 36 mg and 54 mg tablets), packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Methylphenidate Actavis
Netherlands: Methylfenidaat HCl retard Teva 18 mg, tabletten met verlengde afgifte
Methylfenidaat HCl retard Teva 27 mg, tabletten met verlengde afgifte
Methylfenidaat HCl retard Teva 36 mg, tabletten met verlengde afgifte
Methylfenidaat HCl retard Teva 54 mg, tabletten met verlengde afgifte
Iceland: Metylfenidat Actavis
Germany: Methylphenidat-HCl-ratiopharm 18 mg Retardtabletten
Methylphenidat-HCl-ratiopharm 27 mg Retardtabletten
Methylphenidat-HCl-ratiopharm 36 mg Retardtabletten
Methylphenidat-HCl-ratiopharm 54 mg Retardtabletten
Norway: Delmosart
Poland: Mindetra
Sweden: Metylfenidat Actavis