Tentin

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Tentin, 5 mg, tablets

Tentin, 10 mg, tablets

Tentin, 20 mg, tablets

Dexamphetamine sulfate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tentin and what is it 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 is Tentin and what is it used for

What is Tentin

Tentin tablets contain the active substance dexamphetamine sulfate. Tentin is a psychostimulant. It improves activity in certain parts of the brain. This medicine may help to prolong attention span, improve concentration, and reduce impulsive behavior.

What is it used for

Tentin is used to treat attention deficit hyperactivity disorder (ADHD).

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

Treatment with Tentin must be started and continued only under the supervision of a specialist in child or adolescent behavioral disorders. If there is no improvement or if the child feels worse after a month, consult your doctor. The doctor may decide to use another treatment.

2. Important information before taking Tentin

When not to take Tentin:

• if the child is allergic (hypersensitive) to dexamphetamine or other amphetamine compounds or any of the other ingredients of Tentin (listed in section 6)
• if the child has a thyroid disease
• if the child has increased eye pressure (glaucoma)
• if the child has an adrenal gland tumor (pheochromocytoma)
• if the child has eating problems, does not feel hungry, or does not want to eat (e.g., anorexia nervosa)
• if the child has very high blood pressure or narrowing of blood vessels that can cause pain in the arms and legs
• if the child has advanced arteriosclerosis
• if the child has 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 had a brain blood vessel disease, such as stroke, swelling and weakening of a blood vessel (aneurysm), narrowing or blockage of a blood vessel, or inflammation of blood vessels
• if the child has mental problems, such as:
• psychopathic disorders or borderline personality
• abnormal thoughts or visions or schizophrenia
• symptoms of severe mood disorders, such as suicidal thoughts, severe depression, mania, mood swings (from mania to depression, also known as bipolar disorder)
• if the child is currently taking or has taken a medicine called a monoamine oxidase inhibitor (MAOI) in the last 14 days - see "Tentin and other medicines" below
• if the child has ever abused or been dependent on alcohol, prescription drugs, or illegal psychoactive substances
• if the child has Tourette's syndrome or other motor or vocal tics
• if the child has uncontrollable, repetitive movements of different body parts or repeats sounds and words
• if the child has porphyria

Do not take this medicine if any of the above statements apply to the child. If in doubt, consult your doctor or pharmacist before starting Tentin. This is important because the medicine may worsen these problems.

Warnings and precautions

Before starting Tentin, discuss with your doctor or pharmacist if:

• the child has a blood disease or kidney or liver problems
• the child has an unstable personality
• the child has had seizures (convulsions, epilepsy) or abnormal brain test results (EEG)
• the child is a female who has started menstruating (see "Pregnancy and breastfeeding" below)
• the child has high blood pressure
• the child has a heart disease not listed in the "When not to take" section above
• the child has mental health problems not listed in the "When not to take" section above. This may include general mood swings, unusual aggression, hallucinations, delusions, paranoia, excitement, and anxiety, feelings of guilt or depression

Before starting treatment, inform your doctor or pharmacist if any of the above statements apply to the child. This is important because the medicine may worsen these problems. The doctor will monitor how the medicine affects the child.

Medical examination before taking Tentin

These examinations are intended to determine whether this medicine is suitable for the child. The doctor will discuss:

• any other medicines the child is taking
• cases of sudden and unexplained death in the family
• any other medical problems (e.g., heart disease) that the patient or their family members may have
• the child's well-being, such as depression or euphoria, abnormal thoughts or a history of such conditions
• tics (uncontrollable, repetitive movements of different body parts or repetition of sounds or words) in the patient's family members
• any mental health or behavioral problems that the child or their family members may have had

The doctor will discuss whether the child is at risk of mood swings (from mania to depression, also known as bipolar disorder). The doctor will also gather information about the child's mental health and determine if there have been any cases of suicide, bipolar disorder, or depression in the child's family. It is very important to provide the doctor with as much information as possible. Based on this information, the doctor will determine whether Tentin is a suitable medicine for the child. The doctor may also decide whether other medical examinations are necessary before starting Tentin.

Effect on weight/growth

Tentin may cause weight loss in some children and adolescents.

• The child may not gain weight.
• The doctor will carefully monitor the child's growth and weight, as well as their eating habits.
• If the child is not growing as expected, the doctor may interrupt Tentin treatment for a short period.

Surgery

Inform your doctor about any planned surgery for the child. Tentin should not be taken on the day of surgery if a certain type of anesthesia is used. This is due to the possibility of a sudden increase in blood pressure during surgery.

Test for the presence of illegal psychoactive substances

This medicine may cause a positive result in tests for the presence of illegal psychoactive substances.

Interactions with laboratory tests

This medicine may interfere with laboratory test results.

Children and adolescents

Tentin is not used to treat ADHD in children under 6 years old or in adults. It is not known whether it is safe or effective for these individuals.

Tentin and other medicines

Tell your doctor or pharmacist about all medicines the child is taking, has recently taken, or might take, including those obtained without a prescription. Monoamine oxidase inhibitors (MAOIs) Do not take this medicine if the child is taking a medicine called an MAOI (used to treat depression) or has taken an MAOI in the last 14 days. Taking an MAOI with dexamphetamine may cause a sudden increase in blood pressure. If the child is taking other medicines, Tentin may affect their action or cause side effects. Before taking Tentin, tell your doctor or pharmacist if the child is taking any of the following medicines:

• other antidepressants, such as tricyclic antidepressants and selective serotonin reuptake inhibitors
• medicines for severe mental disorders, such as phenothiazines and haloperidol
• medicines for epilepsy, such as anticonvulsants, such as phenobarbital, phenytoin, primidone, and ethosuximide
• products that help stop drinking, such as disulfiram
• medicines used to lower or increase blood pressure, such as guanethidine, clonidine, reserpine, or alpha-methyldopa, or beta-blockers, such as propranolol
• certain cough and cold medicines that contain substances that can affect blood pressure. When purchasing any such products, consult your pharmacist.
• blood-thinning medicines to prevent blood clots, such as coumarin anticoagulants
• any medicines containing hydrochloric acid, ascorbic acid, ammonium chloride, sodium acid phosphate, sodium bicarbonate, acetazolamide, or thiazides
• any of the following medicines: beta-blockers, antihistamines, lithium, noradrenaline, morphine, and meperidine

If you are unsure whether the child's medicine is on the above list, ask your doctor or pharmacist before taking Tentin.

Tentin with alcohol

Do not drink alcohol while taking this medicine. Remember that alcohol is also contained in some foods and medicines.

Pregnancy and breastfeeding

Available data on the use of Tentin in the first three months of pregnancy do not indicate an increased risk of congenital malformations in the child, but may increase the risk of pre-eclampsia (a condition that usually occurs 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 (changes in behavior, including excessive crying, unstable or irritable mood, overactivity, and marked fatigue). If the daughter is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

• The doctor will recommend appropriate contraception.
• If the daughter is pregnant, she may need to stop taking Tentin.
• It is possible that this medicine passes into breast milk. Therefore, the doctor will decide whether the daughter should stop breastfeeding or stop taking Tentin.

Driving and using machines

While taking this medicine, the child may experience dizziness, vision problems, or blurred vision. If these symptoms occur, performing activities such as driving, operating machinery, riding a bicycle, or horse riding, as well as climbing trees, may be dangerous.

Tentin contains isomalt (E953)

If the child has previously been diagnosed with intolerance to some sugars, the patient should consult their doctor before taking this medicine.

3. How to take Tentin

What dose to take

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. The recommended dose is from 5 mg to 20 mg.

• The doctor usually starts treatment with a small 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, up to 40 mg may be necessary).
• The doctor will decide whether to administer Tentin once or twice a day based on the course of symptoms at different times of 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. Essentially, the last dose should not be taken too late after lunch to avoid sleep disturbances. The tablets have a score line and can be divided if necessary. The score line on the tablet is only to facilitate breaking the tablet if the patient has difficulty swallowing it whole, and not to divide it into equal doses. To divide the tablet, place it on a hard surface with the convex side with the cross-score line facing down, and then gently push the index finger on the middle of its upper side. The tablet will then break into four parts. If the child does not feel better, tell your doctor. The doctor may decide to use another treatment.

Long-term treatment

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

Incorrect use of Tentin

Incorrect use of Tentin may lead to abnormal behavior. This may also mean that the child becomes dependent on the medicine. If the child has ever abused or been dependent on alcohol, prescription drugs, or illegal psychoactive substances, tell your doctor. This medicine is intended only for the child. Do not give this medicine to others, even if their symptoms seem similar.

If the child takes more Tentin than they should

Contact your doctor or emergency services immediately. Tell them how much medicine was taken. Show your doctor the packaging or this leaflet. Overdose of these tablets can be very serious. Symptoms of overdose may include: overstimulation, hallucinations, seizures leading to coma, irregular and rapid heartbeat, and slowed breathing.

If the child misses a dose of Tentin

Do not take a double dose to make up for a missed dose. If the child misses a dose, take the next dose at the usual time.

If the child stops taking Tentin

If the child suddenly stops taking this medicine, it may lead to extreme fatigue, depression, mood disturbances, overstimulation, sleep disturbances, increased appetite, or involuntary movements. Before completely stopping Tentin, consult your doctor. The doctor may recommend gradually reducing the dose of Tentin taken each day.

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

4. Possible side effects

Like all medicines, Tentin can cause side effects, although not everybody gets them. Your doctor will inform you about these side effects.

Stop taking Tentin and contact your doctor or go to the emergency department immediately if you experience any of the following symptoms:

• hallucinations, psychosis/psychotic reactions, suicidal behavior (very rare: may occur in less than 1 in 10,000 people)
• severe allergic reactions causing swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (angioedema/anaphylaxis) (unknown: frequency cannot be estimated from available data)
• abnormal muscle breakdown with symptoms such as unexplained muscle pain, muscle spasms, or muscle weakness (rhabdomyolysis) (unknown: frequency cannot be estimated from available data)

Other side effects

Very common: may occur in more than 1 in 10 people

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

Common: may occur in less than 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 meals.
• changes in blood pressure and heart rate (usually increased)
• joint pain
• feeling of dizziness or "spinning", sudden or involuntary movements, headache, overactivity
• abnormal behavior, aggression, overstimulation, anorexia, anxiety, depression, irritability

Rare: may occur in less than 1 in 1000 people

• angina pectoris
• difficulty focusing and blurred vision, dilated pupils
• decreased growth during long-term use in children
• fatigue
• rash, hives

Very rare: may occur in less than 1 in 10,000 people

• decreased red blood cell count, which can cause pale skin and weakness or shortness of breath, changes in blood cell count (leukopenia, thrombocytopenia, aplastic anemia)
• cardiac arrest
• Tourette's syndrome
• abnormal liver function, from increased liver enzyme activity to liver coma
• muscle spasms
• seizures, involuntary movements (choreoathetoid movements), intracranial bleeding (intracranial hemorrhage)
• suicidal thoughts, tics, worsening of existing tics
• itchy red skin lesions (erythema multiforme) or scaly skin lesions (exfoliative dermatitis), recurring rash that appears in the same place each time the medicine is taken (fixed drug eruption), rash that can cause widespread skin peeling, redness, and blistering
• inflammation of blood vessels in the spinal cord and brain (cerebral vasculitis) and/or their blockage

Unknown: frequency cannot be estimated from available data

• heart muscle disease (cardiomyopathy), heart attack, sudden death
• inflammation of a part of the large intestine with reduced blood flow (ischemic colitis), diarrhea
• chest pain, elevated body temperature, allergic reactions
• imbalance of acid-base balance in the body (acidosis)
• difficulty controlling movements (ataxia), dizziness, abnormal or disturbed sense of taste, difficulty concentrating, hyperreflexia, stroke, tremors
• confusion, dependence, dysphoria, emotional instability, euphoria, cognitive function disorders, changes in libido, night fears, obsessive-compulsive behaviors, panic attacks, paranoia, anxiety
• kidney damage
• impotence
• sweating, hair loss
• circulatory failure
• numbness of fingers and toes, tingling, and color change of the skin (from pale to blue and then to red) due to cold (Raynaud's phenomenon)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tentin

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated. 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tentin contains:

• The active substance of Tentin is dexamphetamine sulfate.

Tentin, 5 mg:

One tablet contains 5 mg of dexamphetamine sulfate.

Tentin, 10 mg:

One tablet contains 10 mg of dexamphetamine sulfate.

Tentin, 20 mg:

One tablet contains 20 mg of dexamphetamine sulfate.

• Other ingredients are: isomalt (E953) (see section 2), magnesium stearate, crospovidone, in Tentin, 5 mg, iron oxide yellow (E 172), in Tentin, 10 mg, iron oxide red (E 172), in Tentin, 20 mg

What Tentin looks like and contents of the pack

Tentin, 5 mg, tablets

White, round tablets in the shape of a cloverleaf, with a scored, cross-score line on the upper side and a cross-score line with the letter "S" embossed on each quarter on the lower side. The score line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses. Packs contain 20, 28, 30, 40, 50, 56, 98, or 100 tablets. Packs contain tablets in blisters of PVC/PE/PVDC/Aluminum.

Tentin, 10 mg, tablets

Yellow, round tablets in the shape of a cloverleaf, with a scored, cross-score line on the upper side and a cross-score line with the letter "M" embossed on each quarter on the lower side. The score line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses. Packs contain 20, 28, 30, 40, 48, 50, or 56 tablets. Packs contain tablets in blisters of PVC/PVDC/Aluminum.

Tentin, 20 mg, tablets

Reddish, round tablets in the shape of a cloverleaf, with a scored, cross-score line on the upper side and a cross-score line with the letter "L" embossed on each quarter on the lower side. The score line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses. Packs contain 20, 28, 30, 40, or 56 tablets. Packs contain tablets in blisters of PVC/PVDC/Aluminum. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany, Tel: +48 (22) 370 21 05

This medicine is authorized in the Member States of 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 tablets

Date of last revision of the leaflet: 04/2025

This leaflet is also available in a format suitable for the blind and partially sighted.