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 this leaflet carefully before you start taking this medicine, because 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 you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Atomoxetina Tarbis

3. How to take Atomoxetina Tarbis

4. Possible side effects

5. Storage of Atomoxetina Tarbis

6. Contents of the pack and additional information

For what it is used

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

?in children aged 6 years and above

?in young people

?in adults

It is used solely as part of the complete treatment of the disease, which also requires treatments that do not include medications, such as counseling or behavioral therapy.

It is not used for the treatment of ADHD in children under 6 years old because it is not known if the medication works or is safe in this population.

In adults, atomoxetine is used for the treatment of ADHD when symptoms are very problematic and affect work or social life and when symptoms of the disease have been present since childhood.

How it works

Atomoxetine increases the amount of norepinephrine in the brain. This is a naturally produced substance that increases attention and decreases impulsivity and hyperactivity in ADHD patients. This medication has been prescribed to help control ADHD symptoms. This medication is not a stimulant and therefore does not cause addiction.

It may take several weeks since starting treatment with the medication for symptoms to improve completely.

About ADHD

Children and young people with ADHD find:

?difficulty sitting still

?difficulty concentrating

It is not their fault that they cannot do these things. Many children and young people find this difficult. However, for patients with ADHD, this can cause problems in daily life. Children and young people with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, school, or other places. ADHD does not affect a child's or young person's intelligence.

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

?work

?relationships

?low self-esteem

?education

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 to treat depression and other mental disorders; taking atomoxetine with an MAOI could cause serious side effects or be life-threatening. Also, you should wait at least 14 days after stopping your treatment with atomoxetine before taking an MAOI.

-if you have a condition called narrow-angle glaucoma (increased pressure in the eyes).

-if you have serious heart problems that could get worse with an increase in heart rate and/or blood pressure, which can occur with atomoxetine.

-if you have serious problems with the blood vessels in your brain, such as a stroke, a part of a blood vessel that is inflamed and weakened (aneurysm), or blood vessels that are narrow or blocked.

-if you have a tumor of your adrenal gland (pheochromocytoma).

Do not take atomoxetine if any of the above applies to you. If you are unsure, 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:

?ideas or attempts at suicide.

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

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

?low blood pressure. Atomoxetine 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 having had 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, which causes unusual behavior) and agitation.

?aggressive feelings.

?hostile feelings.

?history of epilepsy or has had seizures for any other reason. Atomoxetine may cause an increase in the frequency of seizures.

?unusual mood changes or feelings of unhappiness.

?repeated spasms of difficult control of any part of the body or repetition of sounds and words.

Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition that can occur when taking Atomoxetine Tarbis in combination with some other medicines (see section 2 “Other medicines and Atomoxetine Tarbis”). The 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.

The treatment with Atomoxetine Tarbis may make you feel aggressive, hostile, or violent, or that these symptoms worsen 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 with your doctor or pharmacist immediately.

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

Tests that your doctor will perform 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 during the time you are taking atomoxetine

?weight and height if during the time you are taking atomoxetine, you are a child or an adolescent

Your doctor will ask you about:

?other medicines you are taking

?if you have a family history of sudden death

?any other medical problem (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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes those 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 may affect or be affected by other medicines. These include:

• Some antidepressants, opioids such as tramadol, and medicines used to treat migraines called triptans. These medicines may 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 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 the correct functioning of these 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 may affect blood pressure. When buying this type of product, it is important to check with your pharmacist.

?some medicines used to treat mental disorders.

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

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

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

The medicines listed below may increase the risk of an abnormal heart rate when taking atomoxetine:

?medicines used to control heart rate

?medicines that alter the content of salts in the blood

?medicines for the prevention and treatment of malaria

?antibiotics (such as erythromycin and moxifloxacin)

If you are unsure about 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 if this medicine can affect the fetus 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 in the lactation period, think you might be pregnant, or intend to become pregnant orintend to breastfeed your baby,consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Atomoxetine may make you feel tired, drowsy, or dizzy. Be careful if you drive or operate machinery until you know how atomoxetine affects you. If you feel tired, drowsy, or dizzy, you should not drive or operate machinery.

Important information about the contents of the capsules

Do not open the atomoxetine capsules as the contents of the capsules may 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, you should rinse them with water as quickly as possible.

Atomoxetine Tarbis contains sodium

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

• Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This will be normally once or twice a day (morning and last hour of the afternoon or first of the night).
• Children should not take this medication without the help of an adult.
• If you feel drowsiness or nausea when taking atomoxetine once a day, your doctor may change the medication intake to twice a day.
• The capsules should be swallowed whole with or without food.
• The capsules should not be opened and the content inside the capsules should not be taken out in any other way.
• Taking the medication always at the same time each day may 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 indicate the atomoxetine dose you should take based on your weight. Normally, you should start with a low dose before increasing it, based on your weight.

• Up to 70 kg of weight: starting with a total daily dose of 0.5 mg per kg of weight for a minimum of 7 days. Your doctor will then decide if it should be increased to the usual maintenance dose of 1.2 mg per kg of weight and per day.
• More than 70 kg of weight: starting with a total daily dose of atomoxetine of 40 mg for a minimum of 7 days. Your doctor will then decide if it 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 it 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 Atomoxetina Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.The most commonly reported symptoms after an overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behavior.Very rarely, a serotonin syndrome, a potentially fatal condition, has also been reported. (See section 2, Warnings and precautions, Serotonin Syndrome).

If you forgot to take Atomoxetina Tarbis

If you forget a dose, take another as soon as possible, but do not take a quantity that exceeds the total daily dose in a 24-hour period. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Atomoxetina Tarbis

If you stop taking atomoxetine, normally there are no side effects, but the ADHD symptoms may reappear. You should talk to your doctor before stopping treatment.

What your doctor will do while you are on treatment:

Your doctor will perform some tests

• Before starting, they will ensure that atomoxetine is safe and beneficial for 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:

• Measurement of height and weight in children and young people.
• Measurement of blood pressure and heart rate.
• Checking if you have any problems or if the side effects have worsened while taking atomoxetine.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Although some people experience side effects, most consider that atomoxetine helps them. Your doctor will talk to you about these side effects.

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

Rare(may affect up to 1 in 100 people)

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

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

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

Children and young people under 18 years have a higher risk of experiencing side effects such as:

• thought or feeling 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 side effects such as:

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

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

• liver damage

Stop taking atomoxetine and contact your doctor immediately if you experience any of the following side 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 nausea
• fatigue
• itching
• feeling of starting a cold

Other reported side effects have been the following. If any of them worsen, consult with 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 their weight and height appropriate 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, your doctor may change the dose of atomoxetine or temporarily suspend treatment with atomoxetine.

Reporting of side effects

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

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

Do not use this medication 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 medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atomoxetina Tarbis

The active ingredient of atomoxetine.

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

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

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

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

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

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

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

The other components are: pregelatinized cornstarch, dimethicone

Capsule coating

Atomoxetina Tarbis 10 mg hard capsules EFG

Cap:Titanium dioxide, Gelatin, Lauril sulfate of sodium

Body:Titanium dioxide, Gelatin, Lauril sulfate of sodium

Atomoxetina Tarbis 18 mg hard capsules EFG

Cap:Yellow iron oxide, Gelatin, Lauril sulfate of sodium

Body:Titanium dioxide, Gelatin, Lauril sulfate of sodium

Atomoxetina Tarbis 25 mg hard capsules EFG

Cap:Titanium dioxide, Indigo carmine, Gelatin, Lauril sulfate of sodium

Body:Titanium dioxide, Gelatin, Lauril sulfate of sodium

Atomoxetina Tarbis 40 mg hard capsules EFG

Cap:Yellow iron oxide, Indigo carmine, Gelatin, Lauril sulfate of sodium

Body:Titanium dioxide, Indigo carmine, Gelatin, Lauril sulfate of sodium

Atomoxetina Tarbis 60 mg hard capsules EFG

Cap:Titanium dioxide, Indigo carmine, Gelatin, Lauril sulfate of sodium

Body:Yellow iron oxide, Gelatin, Lauril sulfate of sodium

Atomoxetina Tarbis 80 mg hard capsules EFG

Cap:Yellow iron oxide, Red iron oxide, Titanium dioxide, Gelatin, Lauril sulfate of sodium

Body:Titanium dioxide, Gelatin, Lauril sulfate of sodium.

Atomoxetina Tarbis 100 mg hard capsules EFG

Cap:Yellow iron oxide, Red iron oxide, Titanium dioxide, Gelatin, Lauril sulfate of sodium

Body:Yellow iron oxide, Red iron oxide, Titanium dioxide, Gelatin, Lauril sulfate of sodium.

Printing ink (black)

Shellac, Iron oxide black, Potassium hydroxide

Appearance of Atomoxetina Tarbis and contents of the package

Atomoxetina Tarbis10 mghard capsules EFG

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

Atomoxetina Tarbis18 mghard capsules EFG

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

Atomoxetina Tarbis25 mghard capsules EFG

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

Atomoxetina Tarbis 40mghard capsules EFG

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

Atomoxetina Tarbis60 mghard capsules EFG

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

Atomoxetina Tarbis80 mghard capsules EFG

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

Atomoxetina Tarbis 100mghard capsules EFG

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

Atomoxetina Tarbis capsules 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

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany: Atomoxetin Amarox10 mg/18 mg/25 mg/40 mg/60 mg/80 mg/100 mgHard capsules

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

Spain: Atomoxetina Tarbis10 mg/18 mg/25 mg/40 mg/60 mg/80 mg/100hard capsules EFG

Last review date of this leaflet:November 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es