Tentin 10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tentin 5mg tablets

Tentin 10mg tablets

Tentin 20mg tablets

dexanfetamine, sulfate

Read the entire leaflet carefully before your child starts taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only and must not be given to others, even if they have the same symptoms, as it could harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Tentin is and what it is used for
2. What you need to know before your child takes 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 dexamphetamine sulfate.

Tentin is a psychostimulant. It enhances activity in certain areas of the brain. This medicine can help improve attention, concentration, and reduce impulsive behavior.

What it is used for

Tentin is used to treat 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 is 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 measures.

Treatment with this medicine should only be initiated and managed under the supervision of a specialist in childhood and adolescent behavioral disorders.

You should consult a doctor if your child does not improve or worsens after one month. The doctor may decide that a different treatment is necessary.

2. What you need to know before starting Tentin

Do not use Tentin if your child:

• is allergic (hypersensitive) to dexamfetamine or to other amphetamine compounds or to any of the other ingredients of this medicine (listed in section 6)

• has a thyroid problem

• has increased intraocular pressure (glaucoma)

• has a tumor of the adrenal gland (pheochromocytoma)

• has an eating disorder, lacks appetite, or refuses to eat (e.g., anorexia nervosa)

• has very high blood pressure or narrowing of blood vessels, which may cause pain in arms and legs

• has advanced arteriosclerosis

• has ever had heart problems, such as myocardial infarction, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or was born with a heart condition

• has had a problem with blood vessels in the brain, such as stroke, swelling and weakening of part of a blood vessel (aneurysm), narrowed or blocked blood vessels, or inflammation of blood vessels (vasculitis)

• has mental health problems such as:

  • a psychopathic or borderline personality disorder
  • abnormal thoughts or hallucinations or schizophrenia
  • signs of a serious mood disorder such as:

• suicidal thoughts

• severe depression

• mania

• mood swings (from manic to depressed, known as bipolar disorder)

• is taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) – see section "Other medicines and Tentin" below

• has ever abused alcohol, prescription medicines, or drugs

• has Tourette's syndrome or other motor or verbal tics

• has repeated, difficult-to-control spasms anywhere in the body or repeats sounds and words

• has porphyria.

Do not use this medicine if your child has any of the conditions listed above. If you are unsure, consult your doctor or pharmacist before using dexamfetamine. The reason is that this medicine may worsen the conditions mentioned.

Warnings and precautions

Talk to your doctor or pharmacist before starting dexamfetamine if your child:

• has a blood, liver, or kidney disease
• has an unstable personality
• has had seizures (fits, convulsions, epilepsy) or abnormalities in any brain tests (EEG)
• is a girl who has started menstruation (see section "Pregnancy and breastfeeding" below)
• has high blood pressure
• has a heart condition not listed in the "Do not use" section above
• has a mental health condition not listed in the "Do not use" section above. This may include general mood changes, unusual aggression, hallucinations, delusional thoughts, paranoia, psychomotor excitement, anxiety, feelings of guilt, or depression.

Inform your doctor or pharmacist if your child is in any of these situations before starting treatment. The reason is that this medicine may worsen the conditions mentioned. Your doctor will want to monitor how the medicine affects your child.

Checks your doctor will perform before using Tentin

These checks are to determine whether this is the right medicine for your child. Your doctor will discuss with you:

• any other medicines your child is taking
• whether there is a family history of unexplained sudden death
• any other medical conditions (such as heart problems) that you or your family may have
• how your child feels, for example, whether they are euphoric or low, have strange thoughts, or have experienced any of these feelings in the past
• whether there is a family history of "tics" (repeated, difficult-to-control spasms anywhere in the body or repetition of sounds and words)
• any history of mental health or behavioral problems in you or other family members.

The doctor will assess whether your child is at risk of mood swings (from manic to depressed, known as "bipolar disorder"). The doctor will review your child’s mental health history and whether any family member has a history of suicide, bipolar disorder, or depression.

It is important to provide as much information as possible. This will help the doctor decide whether this medicine is suitable for your child. Your doctor may decide that further medical tests are needed before starting this medicine.

Effect on weight/growth

This medicine may cause weight reduction in some children and adolescents.

• There may be a lack of weight gain.
• Your doctor will closely monitor your child’s height, weight, and whether they are eating adequately.
• If your child does not grow as expected, your doctor may interrupt treatment with this medicine for a short period.

Surgical procedures

Inform your doctor if your child is scheduled for surgery. This medicine should not be taken on the day of surgery if a certain type of anesthesia is to be used. This is because there is a risk of a sudden increase in blood pressure during the operation.

Drug testing

This medicine may give a positive result in a drug test.

Pharmacological interactions in laboratory tests

This medicine may interfere with the results of laboratory tests.

Children and adolescents

This medicine should not be used to treat ADHD in children under 6 years of age or in adults. It is not known whether it is safe or beneficial for these individuals.

Other medicines and Tentin

Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those available without a prescription.

Monoamine oxidase inhibitors (MAOIs)

Do not use this medicine if your child is taking a medicine called a "monoamine oxidase inhibitor" (MAOI) used for depression, or if they have taken an MAOI within the last 14 days. Taking an MAOI with dexamfetamine may cause a sudden increase in blood pressure.

If your child is taking other medicines, this medicine may affect their effectiveness or cause adverse effects. If your child is taking any of the following medicines, consult your doctor or pharmacist before using this medicine:

• other medicines for depression, such as tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs)
• medicines for serious mental health problems, e.g., phenothiazines and haloperidol
• medicines for epilepsy, e.g., anticonvulsants such as phenobarbital, phenytoin, primidone, and ethosuximide
• medicines used to help stop drinking alcohol, e.g., disulfiram
• medicines used to lower or raise blood pressure, e.g., guanethidine, clonidine, reserpine, or alpha-methyltyrosine, or beta-blockers such as propranolol
• some cough and cold treatments containing medicines that may affect blood pressure

It is important to consult your pharmacist when purchasing any of these medicines.

• medicines that thin the blood to prevent blood clots, such as coumarin anticoagulants
• any medicine containing glutamic acid hydrochloride, 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 you are unsure whether any of the medicines your child is taking are included in the list above, consult your doctor or pharmacist before taking this medicine.

Use of Tentin with alcohol

Alcohol should not be consumed while taking this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy and breastfeeding

Available data on the use of this medicine during the first three months of pregnancy do not indicate an increased risk of congenital malformations in the child, but may increase the risk of preeclampsia (a condition that usually appears after 20 weeks of pregnancy and is 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, hyperexcitability, and marked fatigue).

If your daughter is pregnant or breastfeeding, thinks she might be pregnant, or plans to become pregnant, consult your doctor or pharmacist before using this medicine.

• Your doctor will consider contraception.
• If your daughter is pregnant, she may need to stop taking this medicine.
• This medicine may be excreted in breast milk. Therefore, your doctor will decide whether your daughter should stop breastfeeding or stop taking this medicine.

Driving and using machines

Your child may feel dizzy, have difficulty concentrating, or experience blurred vision when taking this medicine. If so, it may be dangerous to perform activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

Tentin contains isomalt (E953)

If your doctor has informed you that your child has an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tentin

How much to take

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist.

The usual recommended dose is between 5 mg and 20 mg.

• Your doctor will usually start 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 (on rare occasions, 40 mg may be required).

How to take it

This medicine is administered orally.

Your child should take the tablets with a glass of water, preferably with or immediately after meals. Tentin tablets should be taken at the same time in relation to meals. In general, the last dose should not be taken too late after a meal to avoid difficulty falling asleep.

The tablets have a cross-score and can be divided if necessary. The score line is intended solely to help divide the tablet if it is difficult to swallow whole. To split the tablet, place it on a hard surface with the smooth, cross-scored side facing down, then gently press with your index finger on the center of the upper face. The tablet will split into four parts.

If your child does not feel better, inform your doctor. Your doctor may decide that a different treatment is needed.

Long-term treatment

Your doctor will decide the duration of treatment. If your child takes this medicine for more than one year, the doctor should interrupt treatment for a brief period, for example during a school holiday. This will indicate whether the medicine is still necessary.

Incorrect use of Tentin

If this medicine is not used correctly, it may cause abnormal behavior. It may also mean that your child begins to become dependent on the medicine. Inform your doctor if your child has ever misused or been dependent on alcohol, prescription medicines, or drugs.

This medicine is for your child only. Do not give it to other people, even if their symptoms seem similar.

If your child takes more Tentin than they should

In case of overdose or accidental ingestion, contact a doctor, pharmacist, or call the Toxicology Information Service immediately at 915620420, stating the medicine and the amount ingested.

Show the doctor the packaging or this leaflet. Overdosing on these tablets may have very serious consequences.

Signs of overdose may include: agitation, hallucinations, seizures leading to coma, irregular and rapid heartbeat, and reduced breathing.

If your child forgets to take Tentin

Do not take a double dose to make up for missed doses. If your child forgets a dose, wait until it is time for the next dose.

If your child stops taking Tentin

If your child stops taking this medicine abruptly, they may experience extreme tiredness, depression, mood disturbances, psychomotor agitation, sleep disturbances, increased appetite, or involuntary movements. Your doctor may wish to gradually reduce the daily dose before stopping it completely. Consult your doctor before stopping treatment with this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Your doctor will discuss these possible adverse effects with you.

Stop administering Tentin and seek immediate medical advice or go to a hospital emergency department if your child experiences any of the following symptoms:

• hallucinations, psychosis/psychotic reactions, suicidal behaviour (very rare: may affect 1 in 10,000 people)
  • severe allergic reactions causing swelling of the face, tongue or throat; difficulty swallowing; hives; and breathing difficulties (angioedema/anaphylaxis) (frequency not known [cannot be estimated from available data])
  • abnormal muscle breakdown with symptoms such as unexplained muscle pain, muscle cramps, or muscle weakness (rhabdomyolysis) (frequency not known [cannot be estimated from available data])

Other adverse effects

Very common: may affect more than 1 in 10 people

• decreased appetite, reduced weight gain, and weight loss during prolonged use in children
• difficulty sleeping
• nervousness

Common: may affect up to 1 in 10 people

• irregular or increased heart rate, more noticeable heartbeats
• abdominal pain and/or cramps, nausea, vomiting, dry mouth

These effects usually occur at the beginning of treatment and may be relieved by taking the medicine with food.

• changes in blood pressure and heart rate (usually increases)

• joint pain

• dizziness or sensation of spinning, spasmodic or involuntary movements, headache, hyperactivity

• abnormal behaviour, aggression, excitement, anorexia, anxiety, depression, irritability

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

• angina pectoris
• visual disturbances and focusing problems, blurred vision, pupil dilation
• reduced height growth during prolonged use in children
• fatigue
• skin rash, urticaria

Rare: may affect up to 1 in 10,000 people

• decrease in red blood cells, which may cause paleness of the skin and lead to weakness or difficulty breathing, changes in blood cell counts (leucopenia, thrombocytopenia, thrombocytopenic purpura)

• cardiac arrest

• Tourette’s syndrome

• abnormal liver function, ranging from elevated liver enzymes to hepatic coma

• muscle cramps

• seizures, involuntary movements (choreoathetoid movements), bleeding within the skull (intracranial haemorrhage)

• suicide, tics, worsening of existing tics

• itchy red skin lesions (erythema multiforme) or scaly skin patches (exfoliative dermatitis), recurrent rash occurring in the same location each time the medicine is taken (fixed drug eruption)

• inflammation of blood vessels in the spinal cord and brain (cerebral vasculitis) or occlusion

Frequency not known: cannot be estimated from available data

• heart muscle disease (cardiomyopathy), myocardial infarction, sudden death

• inflammation of parts of the large intestine when blood flow is reduced (ischaemic colitis), diarrhoea

• chest pain, increased body temperature, allergic reactions

• disturbance in the body's acid-base balance (acidosis)

• difficulty controlling movements (ataxia), dizziness, abnormal or altered sense of taste, difficulty concentrating, hyperreflexia, stroke, tremor

• confusion, addiction, dysphoria, emotional instability, euphoria, impaired performance in cognitive tests, altered libido, night terrors, obsessive-compulsive behaviour, panic states, paranoia, restlessness

• kidney injury

• impotence

• excessive sweating, hair loss

• circulatory failure

• sensation of numbness, tingling, and colour change (from white to blue then to red) in fingers and toes when exposed to cold (Raynaud’s phenomenon)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Tentin contains:

• The active substance 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.

• The other ingredients are:

isomalt (E953), see section 2

magnesium stearate

crospovidone in the 5 mg tablets

yellow iron oxide (E 172) in the 10 mg tablets

red iron oxide (E 172) in the 20 mg tablets

What the medicine looks like and contents of the pack:

Tentin 5 mg tablets

White, round, clover-leaf-shaped tablets with a cross-shaped score on the upper side and on the reverse side a cross-shaped score and a raised "S" embossed in relief in each quarter.

The score is intended solely to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack sizes: 20, 28, 30, 40, 50, 56, 98 or 100 tablets

Boxes containing tablets packaged in PVC/PE/PVdC blisters with aluminum foil

Tentin 10 mg tablets

Yellow, round, clover-leaf-shaped tablets with a cross-shaped score on the upper side and on the reverse side a cross-shaped score and a raised "M" embossed in relief in each quarter.

The score is intended solely to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack sizes: 20, 28, 30, 40, 48, 50 or 56 tablets

Boxes containing tablets packaged in PVC/PVdC blisters with aluminum foil

Tentin 20 mg tablets

Reddish, round, clover-leaf-shaped tablets with a cross-shaped score on the upper side and on the reverse side a cross-shaped score and a raised "L" embossed in relief in each quarter.

The score is intended solely to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack sizes: 20, 28, 30, 40 or 56 tablets

Boxes containing tablets packaged in PVC/PVdC blisters with aluminum foil

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

This medicinal product is authorized in the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:

Austria: Philla 5 mg/10 mg/20 mg Tablette
Belgium: Attentin 5 mg/10 mg/20 mg Tablets
Estonia: Tentin 5 mg/10 mg/20 mg Tablett
Spain: Tentin 5 mg/10 mg/20 mg tablets
France: Tentin 5 mg/10 mg/20 mg comprimé
Italy: Amfexa 5 mg/10 mg/20 mg compressa
Poland: Tentin 5 mg/10 mg/20 mg Tabletka
Portugal: Tentin 5 mg/10 mg/20 mg comprimido
Denmark: Attentin 5 mg/10 mg/20 mg
Finland: Attentin 5 mg/10 mg/20 mg
Iceland: Attentin 5 mg/10 mg/20 mg
Luxembourg: Attentin 5 mg/10 mg/20 mg
Norway: Attentin 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 leaflet is also available in formats suitable for blind and visually impaired people.

Date of latest review of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).