Atenza

Package leaflet: Information for the user

Atenza, 18 mg, prolonged-release tablets
Atenza, 27 mg, prolonged-release tablets
Atenza, 36 mg, prolonged-release tablets
Atenza, 45 mg, prolonged-release tablets
Atenza, 54 mg, prolonged-release tablets
Methylphenidate hydrochloride
Please read all of this leaflet carefully before taking this medicine, either for yourself or for a child, 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 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

1. What Atenza is and what it is used for
2. Important information before taking Atenza
3. How to take Atenza
4. Possible side effects
5. How to store Atenza
6. Contents of the pack and other information

1. What Atenza is and what it is used for

What Atenza is used for
Atenza is used in the treatment of attention deficit hyperactivity disorder (ADHD).

• It is used in children and adolescents aged 6 years and older, as well as in adults.
• It is used only after previous attempts at non-pharmacological treatments, such as psychological counselling and behavioural therapy (behavioural training).

Atenza is not intended for the treatment of ADHD in children under 6 years of age.
How Atenza works
Atenza improves the function of certain parts of the brain that are less active. The medicine may help improve attention, concentration, and reduce impulsive behaviours.
It is used as part of a treatment programme which usually includes psychological, educational, and social therapies.
Atenza may only be prescribed by a doctor experienced in managing behavioural disorders in children, adolescents, or adults. In adults who have not previously been treated, a 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.

Information about ADHD
Children and adolescents with ADHD have difficulties with:

• sitting still for long periods
• concentrating.

This behaviour is not their fault, as they have no control over it.
Many children and adolescents experience such difficulties. However, ADHD can cause 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.
ADHD does not affect intelligence.
Adults with ADHD often have concentration difficulties. They may frequently feel restless, impatient, and inattentive. They may have problems organising their personal and professional lives.
Not all patients with ADHD require pharmacological treatment.

2. Important information before using Atenza

When not to use Atenza

• 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 chromaffin cell tumour of the adrenal gland (pheochromocytoma)
• if the patient has eating disorders – lack of appetite or need to eat, known as psychogenic anorexia (anorexia)
• if the patient has very high blood pressure or peripheral vascular constriction that may cause pain in the 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 disorders such as: stroke, aneurysm (localized dilation and weakening of the vessel wall), narrowing or blockage of blood vessels, or vasculitis (inflammation of blood vessels)
• if the patient is currently taking antidepressant medicines (known as monoamine oxidase inhibitors, MAOIs) or has taken such medicines within the last 14 days – see section "Atenza and other medicines"
• if the patient has psychiatric disorders such as:
  • psychopathic or emotionally unstable personality (borderline type)
  • delusions or hallucinations, or 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 used if any of the above conditions apply to the patient. If in doubt, consult a doctor or pharmacist before using methylphenidate, as it may worsen these conditions.

Warnings and precautions

Before starting treatment with Atenza, consult a doctor if the patient:

• has liver or kidney function disorders
• has difficulty swallowing or swallowing whole tablets
• has narrowing or obstruction of the intestines or oesophagus
• has had seizures (epileptic fits, convulsions, epilepsy) or abnormal electroencephalogram (EEG) findings
• has ever abused or been dependent on alcohol, prescription medicines, or drugs
• is a woman or girl who has started menstruation (see section below "Pregnancy, breastfeeding and contraception")
• has uncontrollable, repetitive movements or sounds (motor or vocal tics)
• has high blood pressure
• has heart diseases other than those listed above under "When not to use Atenza"
• if the patient or the patient's child develops blurred vision or other visual disturbances, contact a doctor. The doctor may consider discontinuing Atenza.
• has other psychiatric disorders not listed above under "When not to use Atenza"

Other psychiatric disorders include:

• mood swings (from mania to depression, known as "bipolar affective disorder")
• feelings of aggression or hostility
• seeing, hearing, or feeling things that are not there (hallucinations)
• believing in things that are not true (delusions)
• unusual suspiciousness (paranoia)
• feelings of agitation, anxiety, and tension
• feelings of depression or guilt.

Before starting treatment, inform the doctor or pharmacist if any of the listed symptoms or conditions apply to the patient, as methylphenidate may worsen these conditions.
The doctor will want to 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, contact a doctor immediately, especially if it is painful.

Medical evaluation before starting Atenza

The medical evaluation aims to determine whether methylphenidate is an appropriate medicine for the patient. The doctor will discuss with the patient:

• all other medicines the patient is taking
• any family history of sudden, unexplained death
• any other medical conditions (such as heart disease) in the patient or their family
• the patient's mental well-being, e.g. whether they experience mood swings, unusual thoughts, or such feelings in the past
• any family history of tics (uncontrollable, repetitive movements 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 a psychiatric interview regarding family history of suicide, bipolar affective disorder, or depression. 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 newly starting Atenza, the doctor may refer the patient to a heart specialist.

Atenza with other medicines

Tell the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.

Do not take methylphenidate if the patient:

• is taking a medicine called a "monoamine oxidase inhibitor" (MAOI) used to treat depression, or if such a medicine has been taken within the last 14 days. Taking this medicine together with methylphenidate may cause a sudden increase in blood pressure (see section "When not to use Atenza").

Tell the doctor or pharmacist if the patient is taking any of the following antidepressant or anxiolytic medicines:

• tricyclic antidepressants
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin-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 adverse effects, contact a doctor immediately.

If the patient is taking other medicines, methylphenidate may affect their action or cause adverse 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 in Parkinson's disease (such as levodopa)
• antiepileptic medicines
• medicines used to lower or raise blood pressure
• certain cough and cold medicines containing ingredients that may affect blood pressure. It is important to consult a pharmacist when purchasing such medicines.
• anticoagulant medicines (blood thinners).

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.

Tell the doctor or pharmacist about all medicines currently or recently taken, including those available without a prescription.

Before surgery

Inform the doctor about any planned surgical procedure. Do not take methylphenidate on the day of surgery if a certain type of anaesthetic will be used, due to the risk of sudden increase in blood pressure during the operation.

Drug testing

The medicine may cause a positive result in drug tests. This also applies to tests performed on athletes.

Atenza and alcohol

Do not drink alcohol while taking this medicine. Alcohol may worsen the adverse effects of this medicine. Note that some food products and medicines contain alcohol.

Pregnancy, breastfeeding and contraception

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.

Available data do not indicate an increased overall risk of developmental abnormalities, although a small increased risk of congenital heart defects during the first three months of pregnancy cannot be ruled out. The doctor may provide additional information about this risk. Before taking methylphenidate, consult a doctor or pharmacist if the patient:

• is sexually active. The doctor will discuss contraceptive methods (pregnancy prevention) with the patient
• 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, difficulty concentrating, and blurred vision may occur. If this happens, it may be dangerous to perform activities such as: driving, operating machinery, cycling, horse riding, or climbing trees.
This medicine may affect the ability to drive. Do not drive while taking this medicine until it is known how the medicine affects the patient. Driving may be an offence if the patient's ability to drive safely is impaired.

Atenza contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

Atenza contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Atenza

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

• Your doctor usually starts treatment with a low dose and, if necessary, gradually increases the daily dose by 18 mg, no more frequently than once a week. The goal is to find the lowest dose that is effective for the patient. Your doctor will decide what the maximum daily dose should be for you.
• Atenza should be taken once daily in the morning, with a glass of water. The tablet should be swallowed whole. Do not chew, divide, or crush the tablets. The tablet may be taken with or without food. The tablet does not dissolve completely after release of the active substance, and therefore its shell may occasionally be seen in the patient's stool. This is a normal phenomenon.

Use in children aged 6 years and older

• The recommended starting dose of Atenza is 18 mg once daily for children who are not currently taking methylphenidate or who are switching from another stimulant medication to methylphenidate.
• The maximum daily dose is 54 mg.

Use in adults
Adults who have previously taken Atenza:

• If the patient has previously taken Atenza as a child or adolescent, the same daily dose (mg/day) may be continued; however, the doctor will regularly check whether dose adjustment is necessary.
• Adult patients may require a higher daily dose, but the doctor will aim to use the lowest effective dose.

Adults who have not previously taken Atenza:

• The recommended starting dose is 18 mg per day.
• The maximum daily dose in adults is 72 mg.

If the patient does not feel better after one month of treatment
If the patient does not experience improvement after one month of treatment, inform the doctor, who may decide that a different treatment is necessary.

Misuse of Atenza
Misuse of Atenza may lead to abnormal behaviors and may also indicate the beginning of drug dependence. Inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or illicit drugs.
This medicine is intended only for the patient for whom it was prescribed. Do not give it to anyone else, even if they have similar symptoms.

Taking more than the recommended dose of Atenza
If too much medicine is taken, contact a doctor or call emergency services immediately. Inform them of the amount taken. Medical treatment may be necessary.
Symptoms of overdose may include: vomiting, feeling of overstimulation, chills, increased involuntary movements, muscle twitching, seizures (which may be followed by coma), feelings of euphoria, disorientation, seeing, feeling, or hearing things that are not real (hallucinations), excessive sweating, hot flushes, headache, high fever, changes in heart rhythm (slow, fast, or irregular), high blood pressure, dilated pupils, and dryness of the nasal and oral mucous membranes.

If a dose of Atenza is missed
Do not take a double dose to make up for a missed tablet. If the patient forgets to take a dose, wait until it is time to take the next scheduled dose.

Stopping Atenza treatment
If the patient suddenly stops taking the medicine, ADHD symptoms may return or adverse effects such as depression may occur. The doctor may recommend gradually reducing the dose daily before completely stopping the medicine. Talk to your doctor before stopping Atenza.

Examinations performed by the doctor during treatment
The doctor will carry out several examinations:

• Before starting treatment – to ensure that Atenza is safe and beneficial for the patient;
• After starting treatment, at least once every 6 months, but possibly more frequently, and also with any dose change;
• Examinations will include:
  • Checking appetite
  • Measuring height and body weight
  • Measuring blood pressure and pulse
  • Assessing mood disorders, mental state, or any other abnormalities present in the patient, and whether they have worsened during treatment with Atenza.

Long-term treatment
Treatment with Atenza does not necessarily need to be indefinite. If Atenza is taken for longer than 1 year, the doctor should temporarily discontinue treatment, for example during school holidays. This will allow assessment of whether the medicine is still needed.

If you have any further 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 will experience them.
Although some people may experience side effects, most patients report that
methylphenidate helps them. The doctor will discuss these side effects with the patient.
Some side effects may be serious. If the patient experiences any of the side effects listed below,
contact the doctor immediately.
Common side effects (may occur in fewer than 1 in 10 people)

• Palpitations (pounding or racing heartbeat)
• Mood changes or mood swings, or changes in personality.

Uncommon side effects (may occur in fewer than 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 skin rash, itching or hives, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing.

Rare side effects (may occur in fewer than 1 in 1,000 people)

• Feelings of excessive excitement, excessive physical activity and lack of inhibition (mania).

Very rare side effects (may occur in fewer than 1 in 10,000 people)

• Heart attack
• Sudden death
• Suicide attempts
• Seizures (convulsions, epilepsy)
• Skin peeling or purple-red skin patches
• Inflammation or blockage of cerebral arteries
• Transient paralysis or disturbances in movement, vision and speech (may be symptoms of cerebrovascular disorders)
• Involuntary muscle contractions of the eyes, head, neck, body, and other neurological symptoms
• Decreased blood cell counts (red blood cells, white blood cells and platelets), which may increase susceptibility to infections, bleeding and bruising
• Sudden high 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 that may be taken simultaneously with methylphenidate.

Side effects with unknown frequency (frequency cannot be estimated from available data)

• Recurrent unwanted thoughts
• Unexplained fainting, chest pain, shortness of breath (may sometimes be symptoms of heart disease)
• Prolonged erections, sometimes painful, or increased frequency of erections.

If any of these side effects occur in the patient, contact the doctor immediately.
Inform the doctor or pharmacist if any of the following side effects worsen:
Very common side effects (may occur in more than 1 in 10 people)

• Headache
• Nervousness
• Insomnia.

Common side effects (may occur in fewer than 1 in 10 people)

• Joint pain
• Blurred vision
• Pressure-type headache
• Dry mouth, thirst
• Difficulty falling asleep
• High body temperature (fever)
• Decreased libido
• Unusual hair loss or thinning of hair
• Muscle tension, muscle cramps
• Loss of appetite or reduced appetite
• Difficulty achieving or maintaining erection
• Itching, rash or raised, red, itchy rash (urticaria)
• Unusual drowsiness, feeling of tiredness
• Excessive teeth grinding (bruxism)
• Panic feelings
• Skin prickling, tingling or numbness
• Increased alanine aminotransferase (liver enzyme) activity in blood
• Cough, sore throat, or irritation of the nose and throat; upper respiratory tract infections, sinus infection
• High blood pressure, rapid heartbeat (tachycardia)
• Dizziness, feeling of weakness, involuntary movements, excessive psychomotor activity
• Aggression, restlessness, anxiety, depression, irritability, tension, tremor and behavioural disturbances
• Indigestion, abdominal pain, diarrhoea, nausea, abdominal discomfort and vomiting
• Excessive sweating
• Weight loss.

Uncommon side effects (may occur in fewer than 1 in 100 people)

• Dry eyes
• Constipation
• Chest discomfort
• Haematuria (blood in urine)
• Apathy
• Trembling
• Need to urinate frequently
• Muscle pain, muscle cramps
• Shortness of breath or chest pain
• Feeling of warmth
• Elevated liver function test results (in blood tests)
• Anger, impatience or tearfulness, pressured speech, hyper-vigilance, sleep disturbances.

Rare side effects (may occur in fewer than 1 in 1,000 people)

• Disorders of sexual drive
• State of disorientation or confusion
• Visual disturbances or double vision
• Breast enlargement in males
• Erythema, red raised rash
• Obsessive-compulsive disorder (OCD) (including uncontrollable hair-pulling, skin-picking, recurrent, unwanted thoughts, feelings, images or impulses occurring in the patient’s mind [obsessions], and repetition of specific behaviours or mental acts).

Very rare side effects (may occur in fewer than 1 in 10,000 people)

• Muscle spasms
• Small red spots on the skin
• Liver function disorders, including acute liver failure and hepatic encephalopathy
• Changes in additional test results – including liver function tests and blood tests
• Thought disturbances, apathy
• Numbness or tingling in fingers and toes, and skin colour changes (from pale to blue, then red) upon cooling (Raynaud’s phenomenon).

Side effects with unknown frequency (frequency cannot be estimated from available data)

• Migraine
• Pupil dilation
• Very high fever
• Slow or fast heartbeat or extra beats
• Major seizures (grand mal seizures)
• Hallucinations
• Severe abdominal pain, often with nausea and vomiting
• Disorders affecting blood vessels in the brain (stroke, cerebral arteritis or cerebral vessel blockage)
• Inability to control urination (urinary incontinence)
• Jaw muscle spasm making it difficult to open the mouth (trismus)
• Stuttering
• Nosebleeds
• Increased eye pressure
• Eye disease that may cause vision deterioration due to optic nerve damage (glaucoma).

Effect on physical development
Long-term use of methylphenidate (longer than one year) may cause some children to experience slowed physical growth. This occurs in fewer than 1 in 10 children.

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 .
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Atenza

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Keep the bottle tightly closed to protect it from moisture.
No special storage temperature requirements apply.
Medicines must 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 Atenza contains
The active substance is methylphenidate hydrochloride.

• Each tablet contains 18 mg, 27 mg, 36 mg, 45 mg, or 54 mg of methylphenidate hydrochloride. The other ingredients are:
• Tablet core: hypromellose, polyethylene glycol, succinic acid, magnesium stearate, sodium chloride, colloidal anhydrous silica, iron oxide black (E 172).
• Coating: cellulose acetate, polyethylene glycol.
• Colourless coating: hypromellose, polyethylene glycol, phosphoric acid (for pH adjustment).
• Coloured coating: lactose, hypromellose, triacetin, titanium dioxide (E 171), iron oxide yellow (E 172) (18 mg tablet), iron oxide red (E 172) (18 mg, 27 mg, and 54 mg tablets), iron oxide black (E 172) (27 mg tablet), indigo carmine (E 132) (45 mg tablet).

What Atenza looks like and contents of the pack

• 18 mg: Round, biconvex, yellow coated tablets with a diameter of approximately 9 mm, with a small hole on one side of the tablet.
• 27 mg: Round, biconvex, grey coated tablets with a diameter of approximately 9 mm, with a small hole on one side of the tablet.
• 36 mg: Round, biconvex, white coated tablets with a diameter of approximately 10 mm, with a small hole on one side of the tablet.
• 45 mg: Round, biconvex, blue coated tablets with a diameter of approximately 10 mm, with a small hole on one side of the tablet.
• 54 mg: Round, biconvex, pink coated tablets with a diameter of approximately 10 mm, with a small hole on one side of the tablet.

The medicine is available in a plastic bottle with a child-resistant plastic cap, containing 2 desiccant containers. The desiccant containers, which must not be swallowed, help keep the tablets dry. The bottle is enclosed in a cardboard carton.
Pack sizes: 30 tablets, 60 tablets (2 x 30), or 90 tablets (3 x 30).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
e-mail: [email protected]

Manufacturer
LABORATORIOS LICONSA S.A.
Avda. Miralcampo, Nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicine is authorised for marketing in the European Economic Area under the following names:
Sweden: Phenichem 18 mg, 27 mg, 36 mg, 45 mg, 54 mg depottablett
United Kingdom: Phenichem XL 18 mg, 27 mg, 36 mg, 54 mg prolonged release tablets
Spain: Atenza 18 mg, 27 mg, 36 mg, 45 mg, 54 mg comprimidos de liberación prolongada
Poland: Atenza