Atomoxetine Tarbis 80 mg hard capsules EFG

Spain
Brand name Atomoxetine Tarbis 80 mg hard capsules EFG
Form capsules, hard
Active substance / Dosage
ATOMOXETINE HYDROCHLORIDE · 91,422 mg
Prescription type Prescription Only Medicine
ATC code
N06B N06BA N06BA09
Registration number 89298
Manufacturer Tarbis Farma S.L.

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atomoxetina Tarbis 10 mg hard capsules EFG

Atomoxetina Tarbis 18 mg hard capsules EFG

Atomoxetina Tarbis 25 mg hard capsules EFG

Atomoxetina Tarbis 40 mg hard capsules EFG

Atomoxetina Tarbis 60 mg hard capsules EFG

Atomoxetina Tarbis 80 mg hard capsules EFG

Atomoxetina Tarbis 100 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

  1. What Atomoxetina Tarbis is and what it is used for
  2. What you need to know before taking Atomoxetina Tarbis
  3. How to take Atomoxetina Tarbis
  4. Possible adverse effects
  5. How to store Atomoxetina Tarbis
  6. Contents of the pack and other information

1. What Atomoxetina Tarbis is and what it is used for

What it is used for

Atomoxetina Tarbis contains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). It is used

  • in children from the age of 6 years

  • in adolescents

  • in adults

It is used only as part of a comprehensive treatment program for the disorder, which also includes non-pharmacological treatments such as counselling or behavioural therapy.

It is not used for the treatment of ADHD in children under 6 years of age, as it is not known whether the drug is effective or safe in this population.

In adults, atomoxetine is used for the treatment of ADHD when symptoms are highly problematic and affect work or social life, and when symptoms of the disorder were present during childhood.

How it works

Atomoxetine increases the amount of noradrenaline in the brain. Noradrenaline is a naturally produced chemical that enhances attention and reduces impulsivity and hyperactivity in patients with ADHD. This medicine has been prescribed to help control your ADHD symptoms. This medicine is not a stimulant and therefore does not cause addiction.

It may take several weeks after starting treatment with this medicine before symptoms improve fully.

About ADHD

Children and adolescents with ADHD find it difficult to:

  • sit still

  • concentrate

It is not their fault that they cannot do these things. Many children and adolescents find these things difficult. However, for patients with ADHD, these difficulties can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and completing homework. They may struggle to behave appropriately at home, at school, or in other settings. ADHD does not affect a child's or adolescent's intelligence.

Adults with ADHD find it difficult to manage the same things that children also find challenging, but this may lead to problems with:

  • work

  • relationships

  • low self-esteem

  • education

2. What you need to know before taking Atomoxetina Tarbis

Do not take Atomoxetina Tarbis:

  • if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
  • if you have taken a medicine called a monoamine oxidase inhibitor (MAOI) within the last two weeks, for example phenelzine. MAOIs are sometimes used for depression and other mental disorders; taking atomoxetine together with an MAOI could cause serious or life-threatening side effects. You must also wait at least 14 days after stopping treatment with atomoxetine before taking an MAOI.
  • if you have a type of eye disease called narrow-angle glaucoma (increased pressure in the eyes).
  • if you have serious heart problems that could worsen due to an increase in heart rate and/or blood pressure, which may occur with atomoxetine.
  • if you have serious blood vessel problems in your brain, such as stroke, part of a blood vessel being inflamed and weakened (aneurysm), or narrowed or blocked blood vessels.
  • if you have a tumor of your adrenal gland (pheochromocytoma).

Do not take atomoxetine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking atomoxetine, as atomoxetine may worsen these conditions.

Warnings and precautions

Both adults and children should consider the following warnings and precautions. Consult your doctor or pharmacist before starting atomoxetine if you have:

? suicidal thoughts or attempts.

? heart problems (including heart defects) or an increased heart rate. Atomoxetina Tarbis may increase your heart rate (pulse). Cases of sudden death have been reported in patients with heart defects.

? high blood pressure. Atomoxetina Tarbis may increase your blood pressure.

? low blood pressure. Atomoxetina Tarbis may cause dizziness or fainting in people with low blood pressure.

? problems with sudden changes in your blood pressure or heart rate.

? cardiovascular disease or a history of stroke.

? liver problems. You may need a lower dose.

? psychotic reactions including hallucinations (hearing voices or seeing unreal things), believing things that are not true, or being suspicious.

? mania (feeling elated or overexcited, leading to unusual behavior) and agitation.

? aggressive feelings.

? feelings of dislike and anger (hostility).

? a history of epilepsy or have had seizures for any other reason. Atomoxetine could increase the frequency of your seizures.

? mood different from usual (mood changes) or feeling unhappy.

? repeated, hard-to-control muscle spasms in any part of the body or repeated sounds and words.

Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition that may occur when taking Atomoxetina Tarbis in combination with certain other medicines (see section 2 “Other medicines and Atomoxetina Tarbis”). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, lack of coordination and stiffness, hallucinations, coma, rapid heart rate, increased body temperature, rapid changes in blood pressure, sweating, flushing, tremors, exaggerated reflexes, nausea, vomiting, and diarrhea. Contact a doctor or go to the nearest emergency department immediately if you think you are experiencing serotonin syndrome.

Treatment with Atomoxetina Tarbis may make you feel aggressive, hostile, or violent, or may worsen these symptoms if they were already present before treatment. It may also cause unusual changes in behavior or mood (including physical aggression, threatening behavior, and thoughts of harming others). If you or your family and/or friends notice any of these reactions, speak to your doctor or pharmacist immediately.

Consult your doctor or pharmacist if you have any of the symptoms listed above before starting treatment, as atomoxetine may worsen these problems. Your doctor will want to monitor how the medicine affects you.

Tests your doctor will perform before you start taking Atomoxetina Tarbis

These tests are to determine whether atomoxetine is the right medicine for you.

Your doctor will measure your

? blood pressure and heart rate (pulse) before and during your treatment with atomoxetine

? weight and height if you are a child or adolescent during treatment with atomoxetine

Your doctor will ask you about:

? other medicines you are taking

? whether you have a family history of sudden death

? any other medical problems (such as heart problems) that you or your family may have.

It is important that you provide all the information you can. This will help your doctor decide whether atomoxetine is the right medicine for you. Your doctor may decide to perform additional medical tests before starting treatment with this medicine.

Other medicines and Atomoxetina Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This includes medicines obtained without a prescription. Your doctor will decide whether you can take atomoxetine with other medicines, and in some cases, may need to adjust the dose or increase it more slowly.

Atomoxetina Tarbis may affect or be affected by other medicines. These include:

  • Some antidepressants, opioids such as tramadol, and migraine medicines called triptans. These medicines may interact with Atomoxetina Tarbis and cause serotonin syndrome, a potentially life-threatening condition. (See section 2, Warnings and Precautions, Serotonin Syndrome).

Do not take Atomoxetina with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 “Do not take Atomoxetina Tarbis”.

If you are taking other medicines, atomoxetine may affect their proper functioning or cause adverse effects. If you are taking any of the following medicines, check with your doctor or pharmacist before taking atomoxetine:

? medicines that increase blood pressure or are used to control it.

? medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine.

? some cough and cold remedies containing medicines that may affect blood pressure. When purchasing these products, it is important to check with your pharmacist.

? some medicines used to treat mental disorders.

? medicines known to increase the risk of seizures.

? some medicines that cause atomoxetine to remain in the body longer than usual (such as quinidine and terbinafine).

? salbutamol (a medicine for the treatment of asthma) when taken orally or injected, may make you feel that your heart races, but this will not worsen your asthma.

The following medicines may increase the risk of abnormal heart rhythm when taking atomoxetine:

? medicines used to control heart rhythm

? medicines that alter blood electrolyte levels

? medicines for prevention and treatment of malaria

? antibiotics (such as erythromycin and moxifloxacin)

If you are unsure whether the medicines you are taking are included in the list above, consult your doctor or pharmacist before taking atomoxetine.

Pregnancy and breastfeeding

It is not known whether this medicine may affect the fetus or pass into breast milk.

? This medicine should not be taken during pregnancy unless your doctor tells you otherwise.

? You should avoid taking this medicine if you are breastfeeding or stop breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, plan to become pregnant, or plan to breastfeed, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Atomoxetine may cause tiredness, drowsiness, or dizziness. Be cautious if driving or using machinery until you know how atomoxetine affects you. If you feel tired, drowsy, or dizzy, you should not drive or use machinery.

Important information about the capsule contents

Do not open the atomoxetine capsules, as the capsule contents may irritate your eyes. If the capsule contents come into contact with your eyes, rinse them immediately with plenty of water and consult your doctor. If your hands or any other part of your body come into contact with the capsule contents, wash with water as quickly as possible.

Atomoxetina Tarbis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Atomoxetine Tarbis

  • Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. The usual dosing schedule is once or twice daily (morning and late afternoon or early evening).
  • Children must not take this medicine without adult assistance.
  • If you experience drowsiness or nausea while taking atomoxetine once daily, your doctor may switch your dosing schedule to twice daily.
  • The capsules must be swallowed whole, with or without food.
  • The capsules must not be opened, and the contents must not be removed in any way.
  • Taking the medicine at the same time each day may help you remember to take it.

Dosage

If you are a child (6 years of age or older) or adolescent:

Your doctor will determine the dose of atomoxetine based on your body weight. You will usually start with a low dose, which may be increased later depending on your weight.

  • Weighing up to 70 kg: Start with a total daily dose of 0.5 mg per kg of body weight for at least 7 days. Your doctor will then decide whether to increase the dose to the usual maintenance dose of 1.2 mg per kg of body weight per day.
  • Weighing over 70 kg: Start with a total daily dose of 40 mg of atomoxetine for at least 7 days. Your doctor will then decide whether to increase the dose to the usual maintenance dose of 80 mg per day. The maximum daily dose is 100 mg.

Adults

  • Treatment should begin with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide whether to increase the dose to the usual maintenance dose of 80 mg to 100 mg per day. The maximum daily dose is 100 mg.

If you have liver problems, your doctor may recommend a lower dose.

If you take more Atomoxetine Tarbis than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. The most commonly reported symptoms following overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor, and abnormal behavior. Very rarely, serotonin syndrome, a potentially life-threatening condition, has also been reported. (See section 2, Warnings and precautions, Serotonin Syndrome).

If you forget to take Atomoxetine Tarbis

If you miss a dose, take it as soon as possible, but do not exceed the total daily dose within a 24-hour period. Do not take a double dose to make up for a missed dose.

If you stop taking Atomoxetine Tarbis

If you stop taking atomoxetine, adverse effects usually do not occur, but symptoms of ADHD may return. You should speak with your doctor before stopping treatment.

What your doctor will do during your treatment:

Your doctor will perform certain tests

  • Before starting treatment, your doctor will ensure that atomoxetine is safe and will benefit you.

  • After starting treatment, these tests will be performed at least every 6 months, although they may be more frequent.

  • Tests will also be performed whenever the dose is adjusted. These tests include:

    • Measurement of height and weight in children and adolescents.
    • Measurement of blood pressure and heart rate.
    • Checking for any problems or worsening of adverse effects while taking atomoxetine.

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 can cause adverse effects, although not everyone experiences them. Although some people experience adverse effects, most find that atomoxetine helps them. Your doctor will discuss these adverse effects with you.

Some adverse effects could be serious. If you experience any of the effects described below, contact your doctor immediately.

Uncommon (may affect up to 1 in 100 people)

  • feeling or having a very fast heartbeat, irregular heartbeat

  • thoughts or feelings of suicide

  • aggressive feelings

  • feelings of dislike and anger (hostility)

  • mood changes

  • severe allergic reaction with symptoms such as:

  • swelling of the face and throat

  • difficulty breathing

  • hives (small red, itchy rashes on the skin)

  • seizures

  • psychotic symptoms including hallucinations (such as hearing voices or seeing things that are not real), believing things that are not true, or becoming suspicious.

Children and young people under 18 years of age are at higher risk of experiencing adverse effects such as:

  • thoughts or feelings of suicide (may affect up to 1 in 100 people)
  • mood changes (may affect up to 1 in 10 people)

Adults have a lower risk (may affect up to 1 in 1,000 people) of experiencing adverse effects such as:

  • seizures
  • psychotic symptoms including hallucinations (such as hearing voices or seeing things that are not real), believing things that are not true, or becoming suspicious.

Rare (may affect up to 1 in 1,000 people)

  • liver problems

Stop treatment with atomoxetine and contact your doctor immediately if you experience any of the following adverse effects:

  • dark urine
  • yellowing of the skin and eyes
  • pain when pressing the upper right part of the abdomen, just below the ribs
  • unexplained nausea or feeling unwell
  • tiredness
  • itching
  • feeling as if you are developing a cold

Other reported adverse effects include the following. If any of these worsen, consult your doctor or pharmacist.

Adverse reactions very common (may affect more than 1 in 10 people)

CHILDREN over 6 years and ADOLESCENTS

ADULTS

  • headache
  • stomach (abdominal) pain
  • decreased appetite (loss of hunger)
  • feeling unwell (nausea) or vomiting
  • drowsiness
  • increased blood pressure
  • increased heart rate (pulse)

These effects may disappear over time in most patients

  • feeling unwell (nausea)
  • dry mouth
  • headache
  • decreased appetite (loss of hunger)
  • difficulty falling asleep, staying asleep, or waking up early.
  • increased blood pressure
  • increased heart rate (pulse)

Adverse reactions common (may affect up to 1 in 10 people)

CHILDREN over 6 years and ADOLESCENTS

ADULTS

  • irritability and restlessness
  • sleep disturbances, including early waking
  • depression
  • feelings of sadness or hopelessness
  • feelings of anxiety
  • tics
  • dilated pupils (the black center of the eye)
  • dizziness
  • constipation
  • loss of appetite
  • stomach pain, indigestion
  • skin rash, redness, itching
  • skin rash
  • feeling sluggish (lethargy)
  • chest pain
  • fatigue
  • weight loss
  • feeling restless
  • decreased sexual desire
  • sleep disturbance
  • depression
  • feelings of sadness or hopelessness
  • feelings of anxiety
  • dizziness
  • unusual or persistent altered taste
  • tremors
  • numbness or tingling sensation in hands and feet
  • numbness, drowsiness, feeling of fatigue
  • constipation
  • stomach pain
  • indigestion
  • gas (flatulence)
  • vomiting
  • hot flushes
  • feeling or having a fast heartbeat
  • skin rash, redness, itching
  • increased sweating
  • skin rash
  • urinary problems such as inability to urinate, frequency, difficulty starting to urinate, pain during urination
  • inflammation of the prostate gland (prostatitis)
  • groin pain in men
  • problems achieving an erection
  • delayed orgasm
  • difficulty maintaining an erection
  • menstrual cramps
  • lack of strength or energy
  • fatigue
  • feeling sluggish (lethargy)
  • chills
  • feeling irritable, nervous
  • feeling thirsty
  • weight loss

Uncommon adverse effects (may affect up to 1 in 100 people)

CHILDREN over 6 years and ADOLESCENTS

ADULTS

  • fainting
  • tremors
  • migraine
  • blurred vision
  • abnormal skin sensations such as burning, prickling, itching, or tingling
  • tingling or numbness in the hands and feet
  • seizures (fits)
  • feeling or having a very fast heartbeat (QT interval prolongation)
  • shortness of breath
  • increased sweating
  • itching of the skin
  • lack of strength or energy
  • agitation
  • tics
  • fainting
  • migraines
  • blurred vision
  • unusual heartbeat (QT interval prolongation)
  • sensation of cold in fingers and toes
  • chest pain
  • shortness of breath
  • itchy, red, raised rash (hives)
  • muscle cramps
  • urgent need to urinate
  • absence or abnormality of orgasms
  • irregular menstruation
  • absence of ejaculation

Adverse reactions rare (may affect up to 1 in 1,000 people)

CHILDREN over 6 years and ADOLESCENTS

ADULTS

  • numb and pale fingers and toes due to poor blood circulation (Raynaud's phenomenon)
  • problems with urination such as inability to urinate, frequency or difficulty starting to urinate, pain during urination
  • prolonged and painful erections
  • groin pain in men
  • numb and pale fingers and toes due to poor blood circulation (Raynaud's phenomenon)
  • prolonged and painful erections

Frequency unknown (cannot be estimated from the available data)

CHILDREN and ADOLESCENTS over 6 years

? Involuntary grinding of teeth (bruxism)

Effects on growth

When some children start taking atomoxetine, their growth (weight and height) may be reduced. However, with long-term treatment, children regain appropriate weight and height for their age range. Your doctor will monitor your child's height and weight. If your child does not grow or gain weight as expected, the doctor may adjust the dose of atomoxetine or temporarily discontinue treatment with atomoxetine.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Atomoxetina Tarbis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after the abbreviation “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Atomoxetina Tarbis

The active substance is atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 18 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 25 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 40 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 60 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 80 mg of atomoxetine.

Each hard capsule contains atomoxetine hydrochloride equivalent to 100 mg of atomoxetine.

The other components are: pregelatinized maize starch, dimethicone.

Capsule shell

Atomoxetina Tarbis 10 mg hard capsules EFG

Cap: Titanium dioxide, gelatin, sodium lauryl sulfate

Body: Titanium dioxide, gelatin, sodium lauryl sulfate

Atomoxetina Tarbis 18 mg hard capsules EFG

Cap: Yellow iron oxide, gelatin, sodium lauryl sulfate

Body: Titanium dioxide, gelatin, sodium lauryl sulfate

Atomoxetina Tarbis 25 mg hard capsules EFG

Cap: Titanium dioxide, indigo carmine, gelatin, sodium lauryl sulfate

Body: Titanium dioxide, gelatin, sodium lauryl sulfate

Atomoxetina Tarbis 40 mg hard capsules EFG

Cap: Yellow iron oxide, indigo carmine, gelatin, sodium lauryl sulfate

Body: Titanium dioxide, indigo carmine, gelatin, sodium lauryl sulfate

Atomoxetina Tarbis 60 mg hard capsules EFG

Cap: Titanium dioxide, indigo carmine, gelatin, sodium lauryl sulfate

Body: Yellow iron oxide, gelatin, sodium lauryl sulfate

Atomoxetina Tarbis 80 mg hard capsules EFG

Cap: Yellow iron oxide, red iron oxide, titanium dioxide, gelatin, sodium lauryl sulfate

Body: Titanium dioxide, gelatin, sodium lauryl sulfate

Atomoxetina Tarbis 100 mg hard capsules EFG

Cap: Yellow iron oxide, red iron oxide, titanium dioxide, gelatin, sodium lauryl sulfate

Body: Yellow iron oxide, red iron oxide, titanium dioxide, gelatin, sodium lauryl sulfate

Printing ink (black)

Shellac, black iron oxide, potassium hydroxide

Appearance of Atomoxetina Tarbis and contents of the pack

Atomoxetina Tarbis 10 mg hard capsules EFG

White opaque/white opaque hard gelatin capsules, size "5", printed with "I" on the cap and "105" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis 18 mg hard capsules EFG

Yellow/white, opaque hard gelatin capsules, size "4", printed with "I" on the cap and "106" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis 25 mg hard capsules EFG

Opaque blue/opaque white hard gelatin capsules, size "3", printed with "I" on the cap and "107" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis 40 mg hard capsules EFG

Opaque blue/opaque blue hard gelatin capsules, size "2", printed with "I" on the cap and "108" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis 60 mg hard capsules EFG

Opaque blue/yellow hard gelatin capsules, size "2", printed with "I" on the cap and "109" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis 80 mg hard capsules EFG

Opaque brown/opaque white hard gelatin capsules, size "2", printed with "I" on the cap and "110" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis 100 mg hard capsules EFG

Opaque brown/opaque brown hard gelatin capsules, size "1", printed with "I" on the cap and "111" on the body, filled with white to off-white granular powder.

Atomoxetina Tarbis capsules are available in blister packs containing 7, 28, 30, 56 and 98 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Atomoxetin Amarox 10 mg/18 mg/25 mg/40 mg/60 mg/80 mg/100 mg Hartkapseln

Netherlands: Atomoxetine Amarox 10 mg/18 mg/25 mg/40 mg/60 mg/80 mg/100 mg harde capsules

Spain: Atomoxetina Tarbis 10 mg/18 mg/25 mg/40 mg/60 mg/80 mg/100 mg hard capsules EFG

Date of the most recent review of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es