ATOMOXETINE TARBIS 60 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Atomoxetine Tarbis 10 mg hard capsules EFG

Atomoxetine Tarbis 18 mg hard capsules EFG

Atomoxetine Tarbis 25 mg hard capsules EFG

Atomoxetine Tarbis 40 mg hard capsules EFG

Atomoxetine Tarbis 60 mg hard capsules EFG

Atomoxetine Tarbis 80 mg hard capsules EFG

Atomoxetine 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is it used for

Atomoxetine Tarbis contains atomoxetine and is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is used

? in children from 6 years old

? in adolescents

? in adults

It is used only as part of a complete treatment program for ADHD which includes other treatments such as counseling or behavioral therapy.

It is not used to treat ADHD in children under 6 years old because it is not known if the medicine works or if it is safe in this age group.

In adults, atomoxetine is used to treat ADHD when the symptoms are very troublesome and affect work or social life and when symptoms of the disorder have been present since childhood.

How it works

Atomoxetine increases the amount of noradrenaline in the brain. This is a naturally occurring chemical that increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and therefore does not cause addiction.

It may take a few weeks from the start of treatment with this medicine before you start to feel better.

About ADHD

Children and adolescents with ADHD find it:

? difficult to sit still

? difficult to concentrate

This is not because they are naughty or disobedient but because they have ADHD. Many children and adolescents with ADHD find these things very difficult and it can cause problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They may have difficulty behaving well at home, in school or in other places. ADHD does not affect the intelligence of a child or adolescent.

Adults with ADHD find it difficult to do all the things that children find difficult, however this can mean that they have problems with:

? work

? relationships

? low self-esteem

? education

2. What you need to know before you take Atomoxetine Tarbis

Do not take Atomoxetine Tarbis:

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

Do not take atomoxetine if any of the above apply to you. If you are not sure, consult your doctor or pharmacist before taking atomoxetine because atomoxetine may make these problems worse.

Warnings and precautions

Both adults and children should be aware of the following warnings and precautions. Consult your doctor or pharmacist before starting to take atomoxetine if you have:

? thoughts or attempts of suicide.

? heart problems (including heart defects) or an increased heart rate. Atomoxetine Tarbis can increase your heart rate (pulse). There have been reports of sudden death in patients with heart defects.

? high blood pressure. Atomoxetine Tarbis can increase your blood pressure.

? low blood pressure. Atomoxetine Tarbis can cause dizziness or fainting in people who have low blood pressure.

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

? cardiovascular disease or a history of having a stroke.

? liver problems. You may need a lower dose.

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

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

? aggressive feelings.

? hostile or angry feelings.

? a history of epilepsy or having had seizures for any other reason. Atomoxetine may increase the risk of seizures.

? mood changes or feeling unhappy.

? repeated movements that you cannot control of any part of the body or repeating sounds and words.

Serotonin syndromeSerotonin syndrome is a potentially life-threatening condition that may occur when taking Atomoxetine Tarbis in combination with certain other medicines (see section 2 “Other medicines and Atomoxetine Tarbis”). The signs and symptoms of serotonin syndrome can 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 emergency room immediately if you think you are experiencing serotonin syndrome.

Treatment with Atomoxetine Tarbis may make you feel aggressive, hostile, or violent, or these symptoms may get worse if they are 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, talk to your doctor or pharmacist immediately.

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

Tests that your doctor will do before you start taking Atomoxetine Tarbis

These tests are to decide if atomoxetine is the right medicine for you.

Your doctor will measure your

? blood pressure and heart rate (pulse) before and while you are taking atomoxetine

? weight and height if you are a child or adolescent while you are taking atomoxetine

Your doctor will ask you about:

? other medicines you are taking

? if 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 if atomoxetine is the right medicine for you. Your doctor may decide to do other medical tests before starting treatment with this medicine.

Other medicines and Atomoxetine Tarbis

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

Atomoxetine Tarbis can affect or be affected by other medicines. These include:

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

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

If you are taking other medicines, atomoxetine may affect how they work or cause side 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 that contain medicines that can affect blood pressure. When buying these products, it is important to check with your pharmacist.

? some medicines used to treat mental health conditions.

? medicines that are known to increase the risk of seizures.

? some medicines that make atomoxetine stay in the body longer than usual (such as quinidine and terbinafine).

? salbutamol (a medicine for asthma) when taken by mouth or injected, may make you feel like your heart is racing, but this will not make your asthma worse.

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

? medicines used to control heart rhythm

? medicines that alter the levels of salts in the blood

? medicines for the prevention and treatment of malaria

? antibiotics (such as erythromycin and moxifloxacin)

If you are not sure if the medicines you are taking are included in the above list, consult your doctor or pharmacist before taking atomoxetine.

Pregnancy and breastfeeding

It is not known if this medicine can affect the unborn child or pass into breast milk.

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

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Atomoxetine may make you feel tired, sleepy, or dizzy. Be careful while driving or using machinery until you know how atomoxetine affects you. If you feel tired, sleepy, or dizzy, do not drive or use machinery.

Important information about the contents of the capsules

Do not open atomoxetine capsules because the contents of the capsules can irritate your eyes. If the contents of the capsules 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 contents of the capsule, wash the area with water as soon as possible.

Atomoxetine Tarbis contains sodium

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

3. How to take Atomoxetine Tarbis

• Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again. This will normally be once or twice a day (morning and late afternoon or early evening).
• Children should not take this medicine without the help of an adult.
• If you feel sleepy or nauseous when taking atomoxetine once a day, your doctor may change the timing of your medicine to twice a day.
• The capsules should be swallowed whole with or without food.
• The capsules should not be opened and the contents of the capsules should not be removed in any way.
• Taking the medicine at the same time each day can help you remember to take it.

How much to take

If you are a child (from 6 years old) or an adolescent:

Your doctor will tell you what dose of atomoxetine to take based on your weight. You will normally start with a low dose before increasing it, based on your weight.

• Up to 70 kg body weight: starting with a total daily dose of 0.5 mg per kg body weight for a minimum of 7 days. Your doctor will then decide if the dose should be increased to the usual maintenance dose of 1.2 mg per kg body weight per day.
• Over 70 kg body weight: starting with a total daily dose of atomoxetine of 40 mg for a minimum of 7 days. Your doctor will then decide if the dose should be increased to the usual maintenance dose of 80 mg per day. The maximum daily dose is 100 mg.

Adults

• Atomoxetine should be started with a total daily dose of 40 mg for a minimum of 7 days. Your doctor will then decide if the dose should be increased 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken. The most commonly reported symptoms after an overdose are gastrointestinal symptoms, sleepiness, dizziness, tremors, 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 another as soon as you remember, but do not take more than the total daily dose in a 24-hour period. Do not take a double dose to make up for missed doses.

If you stop taking Atomoxetine Tarbis

If you stop taking atomoxetine, you will normally not get any side effects but the symptoms of ADHD may come back. You should talk to your doctor before stopping treatment.

What your doctor will do while you are taking Atomoxetine Tarbis

Your doctor will do some tests

• Before starting to make sure that atomoxetine is safe for you and will benefit you.
• After starting, the tests will be done at least every 6 months, although they may be more frequent.

The tests will also be done when the dose is changed. These tests will include:

• Measuring height and weight in children and adolescents.
• Measuring blood pressure and heart rate.
• Checking if you have any problems or if side effects have gotten worse while taking atomoxetine.

If you have any other 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 all people suffer from them. Although some people suffer from adverse effects, most people consider that atomoxetine helps them. Your doctor will talk to you about these adverse effects.

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

Uncommon(may affect up to 1 in 100 people)

• feeling or having a very fast heart rate, abnormal heart rhythm
• thoughts or feelings of suicide
• feeling aggressive
• feeling of hostility and anger
• mood swings
• severe allergic reaction with symptoms of:

• swelling of the face and throat
• difficulty breathing
• hives (small, itchy, red bumps on the skin)

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

Children and adolescents under 18 years of age are at greater risk of suffering from adverse effects such as:

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

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

• seizures
• psychotic symptoms including hallucinations (such as hearing voices or seeing things that do not exist), believing things that are not true, or being 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 on the upper right side of the abdomen, just below the ribs
• unexplained feeling of discomfort (nausea)
• fatigue
• itching
• feeling of starting a cold

Other reported adverse effects

If any of these effects worsen, consult your doctor or pharmacist.

Effects on Growth

When some children start taking atomoxetine, their growth (weight and height) is reduced. However, with long-term treatment, children recover the weight and height appropriate for their age range. Your doctor will monitor your child's height and weight. If your child is not growing or gaining weight as expected, your doctor may change the dose of atomoxetine or temporarily suspend treatment with atomoxetine.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Atomoxetina Tarbis

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister after the abbreviation "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Atomoxetina Tarbis

The active ingredient of 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 cornstarch, 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, Carmine indigo, Gelatin, Sodium lauryl sulfate

Body: Titanium dioxide, Gelatin, Sodium lauryl sulfate

Atomoxetina Tarbis 40 mg hard capsules EFG

Cap: Yellow iron oxide, Carmine indigo, Gelatin, Sodium lauryl sulfate

Body: Titanium dioxide, Carmine indigo, Gelatin, Sodium lauryl sulfate

Atomoxetina Tarbis 60 mg hard capsules EFG

Cap: Titanium dioxide, Carmine indigo, 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)

Lacquer, Black iron oxide, Potassium hydroxide

Appearance of Atomoxetina Tarbis and Package Contents

Atomoxetina Tarbis 10 mg hard capsules EFG

Hard gelatin capsules, white opaque/white opaque, 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

Hard gelatin capsules, yellow/white, opaque, 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

Hard gelatin capsules, blue opaque/white opaque, 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

Hard gelatin capsules, blue opaque/blue opaque, 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

Hard gelatin capsules, blue opaque/yellow, 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

Hard gelatin capsules, brown opaque/white opaque, 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

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

The capsules of Atomoxetina Tarbis are available in blisters containing 7, 28, 30, 56, and 98 hard capsules.

Only some package 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

Netherlands

This medicine is authorized in the Member States of the European Economic Area with 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 last revision of this prospectus:November 2024

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