Tentin

Package leaflet: Information for the patient

Tentin, 5 mg, tablets
Tentin, 10 mg, tablets
Tentin, 20 mg, tablets
dexamfetamine sulfate
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Tentin is and what it is used for

What Tentin is
Tentin tablets contain the active substance dexamfetamine sulfate.
Tentin is a psychostimulant medicine. It enhances activity in certain parts of the brain. This medicine
may help prolong attention span, improve concentration, and reduce impulsive behaviors.

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

• It is used in children and adolescents aged 6 to 17 years.
• It is not indicated for all children with ADHD.
• It should be used only after another medicine called methylphenidate has not been sufficiently effective.
• It should be used as part of a treatment program that usually includes psychological, educational, and social interventions.

Treatment with Tentin must be initiated and continued under the supervision of a specialist in child or adolescent behavioral disorders.
If there is no improvement in the child after one month, or if the child feels worse, consult your doctor. The doctor may decide that a different treatment is necessary.

2. Important information before taking Tentin

When not to use Tentin:

• if the child is allergic (hypersensitive) to dexamfetamine or other amphetamine-related compounds, or to any of the other ingredients of Tentin (listed in section 6)
• if the child has a thyroid disorder
• if the child has increased intraocular pressure (glaucoma)
• if the child has a tumor of the adrenal gland (pheochromocytoma)
• if the child has eating problems, does not feel hungry, or refuses to eat (e.g. psychogenic anorexia)
• if the child has very high blood pressure or blood vessel narrowing that may cause pain in the arms and legs
• if the child has advanced atherosclerosis
• if the child has ever had heart problems such as heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or congenital heart defect
• if the child has ever had a cerebrovascular disorder such as stroke, brain swelling, weakening and bulging of a blood vessel (aneurysm), blood vessel narrowing or blockage, or blood vessel inflammation
• if the child has psychiatric disorders such as:
  • psychopathic disorders or borderline personality
  • abnormal thoughts or hallucinations, or schizophrenia
  • symptoms of severe mood disorders such as: suicidal thoughts, severe depression, mania, or mood swings (from mania to depression, known as bipolar disorder)
• if the child is currently taking or has taken within the last 14 days an antidepressant medicine called a monoamine oxidase inhibitor (MAOI) – see section "Tentin with other medicines" below
• if the child has ever abused or been dependent on alcohol, prescription medicines, or illegal psychoactive substances
• if the child has Tourette’s syndrome or other motor or verbal tics
• if the child has uncontrollable, repetitive movements of various body parts or repeats sounds and words
• if the child has porphyria.

Do not use this medicine if any of the above statements apply to the child. If in
doubt, speak with a doctor or
pharmacist before starting Tentin. This is important because this medicine may worsen these conditions.
Warnings and precautions
Before starting Tentin, discuss with the doctor or pharmacist if:

• the child has a blood disorder or problems with the kidneys or liver
• the child has an unstable personality
• the child has had seizures (fits, convulsions, epilepsy) or abnormal brain test results (EEG)
• the child is a girl who has started menstruating (see section "Pregnancy and breastfeeding" below)
• the child has high blood pressure
• the child has a heart condition not listed in the section "When not to use" above
• the child has psychiatric disorders not listed in the section "When not to use" above. This may include general mood swings, unusual aggression, hallucinations, delusions, paranoia, agitation, anxiety, feelings of guilt, or depression.

Inform the doctor or pharmacist if any of
the above statements apply to the child. This is important because this medicine may worsen these conditions. The doctor will monitor how the medicine affects the child.
Medical examination before taking Tentin
These examinations aim to determine whether this medicine is suitable for the child. The doctor
will discuss:

• any other medicines the child is taking
• any family history of sudden unexplained death
• any other medical problems (e.g. heart conditions) in the patient or family members
• the child’s emotional state, e.g. depression or euphoria, unusual thoughts, or such conditions in the past
• presence of tics (uncontrollable, repetitive movements of any body parts or repetition of sounds or words) in the patient’s family members
• any mental health or behavioral problems that have occurred in the child or family members.

The doctor will discuss whether the child is at risk of mood swings (from mania to depression – so-called
"bipolar disorder"). The doctor will also take a psychiatric history of the child and determine whether there have been cases of suicide, bipolar disorder, or depression in the family.
It is very important to provide the doctor with as complete information as possible. Based on this, the doctor will decide
whether Tentin is an appropriate medicine for the child. The doctor may also decide whether additional medical tests are necessary before starting this medicine.
Effect on weight/growth
Tentin may cause weight loss in some children and adolescents.

• The child may not gain weight.
• The doctor will closely monitor the child’s growth, weight, and eating habits.
• If the child is not growing as expected, the doctor may temporarily discontinue treatment with Tentin.

Surgical procedure
Inform the doctor about any planned surgical procedure for the child. Tentin should not be taken on the day of surgery if a certain type of anesthesia is to be used. This is due to the risk of sudden increase in blood pressure during the procedure.
Test for illegal psychoactive substances
This medicine may cause a positive result in tests for illegal psychoactive substances.
Interaction between the medicine and laboratory tests
This medicine may interfere with laboratory test results.
Children and adolescents
Tentin is not used in the treatment of ADHD in children under 6 years of age or in adults. It is not known whether it is safe or beneficial for these individuals.
Tentin with other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking or has recently taken, as well as any medicines the child plans to take, including those available without a prescription.
Monoamine oxidase inhibitors
Do not use this medicine if the child is taking a medicine called a "monoamine oxidase inhibitor" (MAOI) used to treat depression, or has taken an MAOI within the last 14 days.
Concomitant use of MAOIs with dexamfetamine may cause a sudden increase in blood pressure.
If the child is taking other medicines, this medicine may affect their action or cause adverse effects. Before taking Tentin, inform the doctor or
pharmacist if the child is taking any of the following medicines:

• other antidepressants, e.g. tricyclic antidepressants and selective serotonin reuptake inhibitors
• medicines for serious psychiatric disorders, e.g. phenothiazines and haloperidol
• medicines for epilepsy, e.g. anticonvulsants such as phenobarbital, phenytoin, primidone, and ethosuximide
• medicinal products used to help stop alcohol use, e.g. disulfiram
• medicines used to lower or raise blood pressure, e.g. guanethidine, clonidine, reserpine, or alpha-methyldopa, or beta-blockers such as propranolol
• certain cough and cold remedies containing substances that may affect blood pressure. When purchasing any such product, consult the pharmacist.
• blood-thinning medicines to prevent blood clots, e.g. coumarin anticoagulants
• any medicines containing glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, sodium bicarbonate, acetazolamide, thiazides
• any of the following medicines: beta-blockers, antihistamines, lithium, noradrenaline, morphine, and meperidine.

If there is any doubt whether a medicine taken by the child is on the
above list, ask the doctor or pharmacist before taking this medicine.
Tentin and alcohol
Do not consume alcohol while taking this medicine. Remember that alcohol is also present in certain food products and medicines.
Pregnancy and breastfeeding
Available data on the use of Tentin during the first three months of pregnancy do not indicate an increased risk of congenital developmental defects in the child, but it may increase the risk of pre-eclampsia (a condition usually occurring after 20 weeks of pregnancy, characterized by high blood pressure and protein in the urine) and premature birth. Newborns exposed to amphetamines during pregnancy may experience withdrawal symptoms (behavioral changes, including excessive crying, unstable or irritable mood, hyperirritability, and marked exhaustion).
If your daughter is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

• The doctor will recommend appropriate contraception.
• If your daughter is pregnant, she may be required to discontinue taking this medicine.
• This medicine may pass into human milk. Therefore, the doctor will decide whether your daughter should discontinue breastfeeding or stop taking this medicine.

Driving and operating machinery
While taking this medicine, the child may experience dizziness, problems with visual focus, or blurred vision. If such symptoms occur, performing activities such as driving vehicles, operating machinery, cycling, horse riding, or climbing trees may be dangerous.
Tentin contains isomalt (E953)
If the child has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before using this medicine.

3. How to take Tentin

What dose should be taken
This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The recommended dose ranges from 5 mg to 20 mg.

• The doctor usually starts treatment with a low dose of one 5 mg tablet. If necessary, the dose will be gradually increased by one 5 mg tablet at weekly intervals.
• The maximum daily dose is 20 mg (in rare cases, a dose of 40 mg may be required).
• Your doctor will decide whether Tentin should be administered once or twice daily based on the pattern of symptoms throughout the day.

How to take the medicine
This medicine is intended for oral use.
The child should take Tentin tablets with water, preferably during or immediately after a meal.
Tentin tablets should be taken at the same time in relation to meals.
Generally, the last dose should not be administered too late after lunch to avoid sleep disturbances.
The tablets have a score line and can be divided if necessary. The score line is intended solely to facilitate breaking the tablet if the patient has difficulty swallowing it whole, and not for dividing into equal doses. To divide the tablet, place it on a hard surface with the convex side bearing the crossed score line facing down, then gently press with the index finger at the center of its upper surface. The tablet will then split into four parts.
If the child does not feel better, inform the doctor. The doctor may decide that alternative treatment is necessary.

Long-term treatment
The doctor will decide how long treatment should continue. If the child has been taking this medicine for more than
one year, the doctor should interrupt treatment for a short period, e.g., during school holidays. This will allow assessment of whether continued use of the medicine is necessary.

Improper use of Tentin
Improper use of Tentin may lead to unusual behaviors. It may also indicate that the child is becoming dependent on the medicine. If the child has ever misused or been dependent on alcohol, prescription medicines, or illegal psychoactive substances, inform the doctor.
This medicine is intended only for the child. Do not give this medicine to others, even if their symptoms appear similar.

Accidental overdose of Tentin by the child
Contact a doctor immediately or call emergency services. Inform them of the amount of medicine taken. Show the doctor the packaging or this leaflet. Overdose of these tablets may be very serious.
Symptoms of overdose may include: agitation, hallucinations, seizures leading to coma, irregular and rapid heartbeat, and slowed breathing.

Missed dose of Tentin by the child
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the usual time.

Stopping Tentin treatment by the child
If the child suddenly stops taking this medicine, it may lead to extreme fatigue, depression, mood disturbances, agitation, sleep disturbances, increased appetite, or involuntary movements. Before completely discontinuing Tentin, the doctor may recommend gradually reducing the daily dose. Always consult the doctor before stopping Tentin treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The doctor will inform the patient about such adverse reactions.
Treatment with Tentin must be discontinued and the patient should immediately contact a doctor or go to
the emergency department if any of the following symptoms occur:

• hallucinations, psychosis/psychotic reactions, suicidal behaviour (very rare: may occur in no more than 1 in 10,000 people)
• severe allergic reactions causing swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties (angioedema/anaphylaxis) (unknown frequency: frequency cannot be determined from available data)
• abnormal muscle breakdown with symptoms such as unexplained muscle pain, muscle cramps or muscle weakness (rhabdomyolysis) (unknown frequency: frequency cannot be determined from available data)

Other adverse reactions
Very common: may affect more than 1 in 10 people

• decreased appetite, reduced weight gain and weight loss during long-term use in children
• sleep disturbances
• nervousness

Common: may affect up to 1 in 10 people

• irregular or rapid heartbeat, more noticeable heartbeat
• abdominal pain and (or) cramps, nausea, vomiting, dry mouth. These effects usually occur at the beginning of treatment and can be alleviated by taking the medicine with food.
• changes in blood pressure and heart rate (usually increased)
• joint pain
• dizziness or sensation of spinning, sudden or involuntary movements, headache, hyperactivity
• abnormal behaviour, aggression, agitation, anorexia, anxiety, depression, irritability

Uncommon: may affect up to 1 in 1000 people

• angina pectoris
• difficulty focusing or blurred vision, blurred vision, pupil dilation
• reduced growth during long-term use in children
• fatigue
• rash, urticaria

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

• decreased number of red blood cells, which may cause pale skin, weakness or shortness of breath, changes in blood cell counts (leukopenia, thrombocytopenia, thrombocytopenic purpura)
• cardiac arrest
• Tourette's syndrome
• abnormal liver function, from increased liver enzyme activity to hepatic encephalopathy
• muscle spasms
• seizures, involuntary movements (choreoathetoid movements), bleeding within the skull (intracranial haemorrhage)
• suicide, tics, worsening of pre-existing tics
• itchy red skin lesions (erythema multiforme) or scaly skin patches (exfoliative dermatitis), recurrent rash appearing in the same location each time the medicine is taken (fixed drug eruption)
• inflammation of blood vessels of the spinal cord and brain (cerebral vasculitis) and (or) their occlusion

Unknown frequency: frequency cannot be determined from available data

• heart muscle disease (cardiomyopathy), myocardial infarction, sudden death
• inflammation of the large intestine due to reduced blood flow (ischaemic colitis), diarrhoea
• chest pain, elevated body temperature, allergic reactions
• disturbance of the body's acid-base balance (acidosis)
• difficulty controlling movements (ataxia), dizziness, abnormal or disturbed sense of taste, difficulty concentrating, hyperreflexia, stroke, tremor
• confusion, dependence, dysphoria, emotional instability, euphoria, cognitive dysfunction, changes in libido, night terrors, obsessive-compulsive behaviour, panic attacks, paranoia, restlessness
• kidney damage
• impotence
• sweating, hair loss
• circulatory failure
• numbness of fingers and toes, tingling and skin colour changes (from pale to blue, then to red) triggered by cold (Raynaud's phenomenon).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to:
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
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tentin

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:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 25°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. These measures will help
protect the environment.

6. Contents of the pack and other information

What Tentin contains:

• The active substance is dexamfetamine sulfate.
  Tentin 5 mg: One tablet contains 5 mg of dexamfetamine sulfate.
  Tentin 10 mg: One tablet contains 10 mg of dexamfetamine sulfate.
  Tentin 20 mg: One tablet contains 20 mg of dexamfetamine sulfate.
• The other ingredients are: isomalt (E953) (see section 2), magnesium stearate, crospovidone, in Tentin 5 mg: yellow iron oxide (E172), in Tentin 10 mg: red iron oxide (E172), in Tentin 20 mg.

What Tentin looks like and contents of the pack
Tentin 5 mg tablets
White, round cloverleaf-shaped tablets, scored with a cross-shaped breakline on the upper side and a cross-shaped breakline with an embossed letter "S" on each quarter on the reverse side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Packs contain 20, 28, 30, 40, 50, 56, 98 or 100 tablets.
Packaging contains tablets in blisters made of PVC/PE/PVDC/Aluminium foil.

Tentin 10 mg tablets
Yellow, round cloverleaf-shaped tablets, scored with a cross-shaped breakline on the upper side and a cross-shaped breakline with an embossed letter "M" on each quarter on the reverse side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Packs contain 20, 28, 30, 40, 48, 50 or 56 tablets.
Packaging contains tablets in blisters made of PVC/PVDC/Aluminium foil.

Tentin 20 mg tablets
Reddish, round cloverleaf-shaped tablets, scored with a cross-shaped breakline on the upper side and a cross-shaped breakline with an embossed letter "L" on each quarter on the reverse side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Packs contain 20, 28, 30, 40 or 56 tablets.
Packaging contains tablets in blisters made of PVC/PVDC/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 (22) 370 21 05

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Philla 5 mg/10 mg/20 mg
Belgium: Attentin 5 mg/10 mg/20 mg
Denmark: Attentin 5 mg/10 mg/20 mg
Estonia: Tentin 5 mg/10 mg/20 mg
Finland: Attentin 5 mg/10 mg/20 mg
France: Tentin 5 mg/10 mg/20 mg
Iceland: Attentin 5 mg/10 mg/20 mg
Italy: Amfexa 5 mg/10 mg/20 mg
Luxembourg: Attentin 5 mg/10 mg/20 mg
Norway: Attentin 5 mg/10 mg/20 mg
Poland: Tentin 5 mg/10 mg/20 mg
Portugal: Tentin 5 mg/10 mg/20 mg
Spain: Tentin 5 mg/10 mg/20 mg
Sweden: Attentin 5 mg/10 mg/20 mg
United Kingdom (Northern Ireland): Amfexa 5 mg/10 mg/20 mg tablet

This patient information leaflet is also available in a format suitable for blind and partially sighted people.