TENTIN 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Tentin 5mg tablets

Tentin 10mg tablets

Tentin 20 mg tablets

dexanfetamine, sulfate

Read this entire leaflet carefully before your child starts taking this medication, 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 medication has been prescribed to your child only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If your child experiences side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tentin and what is it used for
2. What you need to know before taking Tentin
3. How to take Tentin
4. Possible side effects
5. Storage of Tentin
6. Package Contents and Additional Information

1. What is Tentin and what is it used for

What is Tentin

Tentin tablets contain the active ingredient dexanfetamine, sulfate.

Tentin is a psychostimulant. It improves activity in parts of the brain. This medication may help improve attention and 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 in all children with ADHD.
• It is used only after another medication 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 this medication should only be initiated and used under the supervision of a specialist in child and adolescent behavioral disorders.

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

2. What you need to know before taking Tentin

Do not use Tentin if your child:

• is allergic (hypersensitive) to dexanfetamine or other amphetamine compounds or to any of the other ingredients of this medication (listed in section 6)
• has a thyroid problem
• has increased eye pressure (glaucoma)
• has a tumor of the adrenal gland (pheochromocytoma)
• has an eating disorder, lacks appetite, or does not want to eat (e.g., anorexia nervosa)
• has very high blood pressure or narrowing of blood vessels, which can cause pain in arms and legs
• has advanced arteriosclerosis
• has had heart problems, such as myocardial infarction, irregular heartbeat, chest pain, heart failure, heart disease, or was born with a heart problem
• has had a problem with blood vessels in the brain, such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of blood vessels (vasculitis)
• has mental health problems such as:
• • a psychopathic or borderline personality disorder
  • abnormal or psychotic thoughts or schizophrenia
  • signs of a severe mood disorder such as:

• suicidal thoughts
• severe depression
• mania
• mood swings (from manic to depressed, also known as bipolar disorder)

• is taking or has taken in the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) - see the section "Other medications and Tentin" below
• has ever excessively consumed alcohol, prescription medications, or drugs
• has Tourette's syndrome or other motor or vocal tics
• has repeated and uncontrollable spasms in any part of the body or repeats sounds and words
• has porphyria.

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take dexanfetamine if your child:

• has a blood or liver disease, or kidney problems
• has an unstable personality
• has had seizures (attacks, convulsions, epilepsy) or abnormalities in a brain scan (EEG)
• is female and has started menstruating (see the section "Pregnancy and Breastfeeding" below)
• has high blood pressure
• has a heart problem not listed in the "Do not use" section above
• has a mental health problem not listed in the "Do not use" section above. This may include mood swings in general, unusual aggression, hallucinations, delusional ideas, paranoia, psychomotor excitement, and anxiety, feelings of guilt or depression.

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

Checks your doctor will perform before using Tentin

These checks are to decide if this medication is suitable for your child. Your doctor will discuss with you:

• any other medication your child is taking
• if there is a family history of sudden unexplained death
• any other medical problem (such as heart problems) that you or your family may have
• how your child feels, for example, if they are euphoric or depressed, if they have had unusual thoughts or have had any of these feelings in the past
• if there is a family history of "tics" (repeated and uncontrollable spasms in any part of the body or repetition of sounds and words)
• any mental health or behavioral problem that you or other family members have had.

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

It is essential that you provide all possible information. This will help the doctor decide if this medication is suitable for your child. Your doctor may decide that other medical tests are necessary before starting this medication.

Effect on weight/growth

This medication may cause weight loss in some children and adolescents.

• There may be a lack of weight gain.
• Your doctor will closely monitor your child's height and weight and if they are eating enough.
• If your child is not growing as expected, your doctor may interrupt treatment with this medication for a short period.

Surgical Interventions

Inform your doctor if your child is going to undergo surgery. This medication should not be taken on the day of surgery if a specific type of anesthesia is used. This is because there is a possibility of a sudden increase in blood pressure during surgery.

Drug Tests

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

Pharmacological Interactions in Laboratory Tests

This medication may interfere with laboratory test results.

Children and Adolescents

This medication should not be used to treat ADHD in children under 6 years old or in adults. It is not known if it is safe or beneficial for these individuals.

Other Medications and Tentin

Inform your doctor or pharmacist if your child is taking, has recently taken, or may need to take any other medication, including those without a prescription.

Monoamine Oxidase Inhibitors

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

If your child is taking other medications, this medication may affect their efficacy or cause side effects. If your child is taking any of the following medications, consult your doctor or pharmacist before using this medication:

• other medications for depression, such as tricyclic antidepressants and selective serotonin reuptake inhibitors
• medications for severe mental health problems, e.g., phenothiazines and haloperidol
• medications for epilepsy, e.g., anticonvulsants such as phenobarbital, phenytoin, primidone, and ethosuximide
• medications to help stop drinking, e.g., disulfiram
• medications used to reduce or increase blood pressure, e.g., guanethidine, clonidine, reserpine, or alpha-methyldopa, or beta-blockers such as propranolol
• some cough and cold treatments that contain medications that can affect blood pressure

It is essential that you consult your pharmacist when purchasing any of these medications.

• medications that thin the blood to prevent blood clots, such as coumarin anticoagulants
• any medication that contains glutamic acid hydrochloride, ascorbic acid, ammonium chloride, sodium acid phosphate, sodium bicarbonate, acetazolamide, thiazides
• any of the following medications: beta-blockers, antihistamines, lithium, norepinephrine, morphine, and meperidine.

If you are unsure if any medication your child is taking is included in the above list, consult your doctor or pharmacist before your child takes this medication.

Using Tentin with Alcohol

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

Pregnancy and Breastfeeding

Available data on the use of this medication 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 disease 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 that include excessive crying, unstable or irritable mood, hyperexcitability, and pronounced exhaustion).

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

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

Driving and Using Machines

Your child may feel dizzy, have concentration problems, or blurred vision when taking this medication. If so, it may be dangerous to do things like driving, using machines, riding a bicycle or horse, or climbing trees.

Tentincontains isomalt (E953)

If your doctor has told you that your child has an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Tentin

How much to take

Follow your doctor's instructions for taking this medication exactly. If you are unsure, ask your doctor or pharmacist.

The recommended dose is between 5 mg and 20 mg.

• Usually, your doctor will start treatment with a low dose of one 5 mg tablet. If necessary, it will be gradually increased by one 5 mg tablet at weekly intervals.

• The maximum daily dose is 20 mg (in rare cases, 40 mg may be necessary).

How to take it

The medication is administered orally.

Your child should take the tablets with a glass of water, preferably with meals or immediately after them. Tentin tablets should be taken at the same time with respect to meals. In general, the last dose should not be taken too late after a meal to avoid sleep problems.

The tablets have a score line and can be divided if necessary. The score line is only for breaking the tablet if it is difficult to swallow whole. To break it, place the tablet on a hard surface with the smooth and scored face down and press gently with your index finger in the center of the top face. The tablet will break into four parts.

If your child does not feel better, tell your doctor. The doctor may decide that a different treatment is necessary.

Long-term Treatment

Your doctor will decide the duration of treatment. If your child takes this medication for more than a year, the doctor may interrupt treatment for a brief period, e.g., during school vacations. This will indicate if the medication is still necessary.

Incorrect Use of Tentin

If this medication is not used correctly, it can cause abnormal behavior. It can also mean that your child starts to depend on the medication. Inform your doctor if your child has ever had excessive use or dependence on alcohol, prescription medications, or drugs.

This medication is only for your child. Do not give it to others, even if the symptoms seem similar.

If your child takes more Tentin than they should

In case of overdose or accidental ingestion, consult a doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount taken.

Show the doctor the package or this leaflet. Overdose of these tablets can have very serious consequences.

Signs of overdose may include: excitement, hallucinations, convulsions 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 forgotten doses. If your child forgets a dose, wait until it is time for the next one.

If your child stops taking Tentin

If your child suddenly stops taking this medication, they may experience extreme fatigue, depression, mood disorders, psychomotor excitement, sleep disturbances, increased appetite, or involuntary movements. Your doctor may want to gradually reduce the amount of medication taken each day before stopping it completely. Consult your doctor before stopping treatment with this medication.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Your doctor will discuss these adverse effects with you.

Stop administering Tentin and consult a doctor or go to an emergency center immediately if your child experiences the following symptoms:

• hallucinations, psychosis/psychotic reactions, suicidal behavior (very rare: may affect 1 in 10,000 people)
  • severe allergic reactions that cause 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, decreased 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 heartbeats, more noticeable heartbeats
• abdominal pain and/or cramps, nausea, vomiting, dry mouth

These effects usually occur at the start 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", spasmodic or involuntary movements, headache, hyperactivity
• abnormal behavior, aggression, excitement, anorexia, anxiety, depression, irritability

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

• chest pain
• problems with visual acuity and focus, blurred vision, dilated pupils
• reduced growth rate during prolonged use in children
• fatigue
• skin rash, hives

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

• decrease in red blood cells, which can cause paleness of the skin and lead to weakness or difficulty breathing, changes in blood cell count (leukopenia, thrombocytopenia, thrombocytopenic purpura)
• cardiac arrest
• Tourette's syndrome

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

• muscle cramps
• seizures, involuntary movements (choreoathetotic movements), bleeding within the skull (intracranial hemorrhage)
• suicide, tics, worsening of existing tics
• red, itchy skin lesions (erythema multiforme) or scaly skin patches (exfoliative dermatitis), recurrent rash, which occurs in the same place each time the medicine is taken (fixed drug eruption)

• inflammation of the 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 (ischemic colitis), diarrhea
• chest pain, increased body temperature, allergic reactions

• disruption of the body's acid-base balance (acidosis)

• problems controlling movements (ataxia), dizziness, abnormal or altered sense of taste, concentration problems, hyperreflexia, apoplexy, tremor
• confusion, addiction, dysphoria, emotional instability, euphoria, impaired cognitive performance, altered libido, nightmares, obsessive-compulsive behavior, panic states, paranoia, restlessness

• kidney damage
• impotence
• excessive sweating, hair loss
• circulatory failure
• numbness, tingling, and color change (from white to blue and then to red) in the fingers and toes when they become cold (Raynaud's phenomenon)

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

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. Dispose of packaging and unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packaging and medicines no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

What Tentin contains:

• The active ingredient 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

• Other ingredients are:

isomalt (E953), see section 2

magnesium stearate

crospovidone in 5 mg tablets

yellow iron oxide (E 172) in 10 mg tablets

red iron oxide (E 172) in 20 mg tablets

Appearance and Package Contents:

Tentin 5 mg tablets

White, round, cloverleaf-shaped tablets with a cross-shaped score on the upper surface and a cross-shaped score and a raised "S" on each quarter of the lower surface.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Package sizes: 20, 28, 30, 50, 98, or 100 tablets

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

Tentin 10 mg tablets

Yellow, round, cloverleaf-shaped tablets with a cross-shaped score on the upper surface and a cross-shaped score and a raised "M" on each quarter of the lower surface.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Package sizes: 20, 28, 30, 48, or 50 tablets

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

Tentin 20 mg tablets

Reddish, round, cloverleaf-shaped tablets with a cross-shaped score on the upper surface and a cross-shaped score and a raised "L" on each quarter of the lower surface.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Package sizes: 20, 28, or 30 tablets

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

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 tablets

Belgium: Attentin 5 mg/10 mg/20 mg tablets

Estonia: Tentin 5 mg/10 mg/20 mg tablets

Spain: Tentin 5 mg/10 mg/20 mg tablets

France: Tentin 5 mg/10 mg/20 mg tablets

Italy: Amfexa 5 mg/10 mg/20 mg tablets

Poland: Tentin 5 mg/10 mg/20 mg tablets

Portugal: Tentin 5 mg/10 mg/20 mg tablets

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 tablets

This leaflet is also available in formats suitable for the blind and visually impaired.

Date of the last revision 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/).