Leaflet: information for the user

atomoxetine cinfa 40 mg hard capsules EFG

atomoxetine hydrochloride

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 or your child alone. Do 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 atomoxetine cinfa and what it is used for

2. What you need to know before taking atomoxetine cinfa

3. How to take atomoxetine cinfa

4. Possible side effects

5. Storage of atomoxetine cinfa

6. Contents of the pack and additional information

What it is used for

atomoxetine cinfa 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 cinfa is used for the treatment of ADHD when symptoms are very problematic and affect work or social life and when symptoms of the disease were present when they were a child.

How it works

atomoxetine cinfa increases the amount of norepinephrine in the brain. This is a naturally produced substance that increases attention and decreases impulsivity and hyperactivity in patients with ADHD. This medication has been prescribed to help control the symptoms of ADHD. 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 everyday 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 cinfa:

• 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. You should also 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 severe heart problems that may worsen with an increase in heart rate and/or blood pressure, which can occur with atomoxetine.
• if you have severe blood vessel problems in your brain, such as a stroke, a weakened and inflamed blood vessel (aneurysm), or narrow or blocked blood vessels.
• if you have a tumor of your adrenal gland (pheochromocytoma).

Do not take atomoxetine if any of the above applies. If you are unsure, consult your doctor or pharmacist before taking atomoxetine because atomoxetine may worsen these problems.

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 atomoxetineif you have:

• ideas or attempts of suicide.
• heart problems (including heart defects) or an increased heart rate. Atomoxetine may increase your heart rate (pulse). Cases of sudden death have been reported in patients with heart defects.
• high blood pressure. Atomoxetinemay increase your blood pressure
• low blood pressure. Atomoxetinemay 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 increase the frequency of seizures.
• unusual mood changes (mood swings) or feelings of unhappiness.
• repeated spasms of difficult control of any part of the body or repetition of sounds and words.

Atomoxetine treatment may make you feel aggressive, hostile, or violent; or worsen these symptoms if they were present before treatment. It may also cause unusual changes in your 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, becauseatomoxetinemay worsen these problems. Your doctor will want to monitor how the medicine affects you.

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening situation that can occur when atomoxetine is taken in combination with other medicines (see section 2 “Taking atomoxetine cinfa with other medicines”). 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, hyperactive reflexes, nausea, vomiting, and diarrhea. Contact a doctor or go immediately to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.

Tests your doctor will perform before you start taking atomoxetine cinfa

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 cinfa, 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 to provide all the information you can. This will help your doctor decide ifatomoxetineis the right medicine for you. Your doctor may decide to do other medical tests before starting treatment with this medicine.

Taking atomoxetine cinfa with other medicines

Inform your doctor or pharmacist if you aretaking, have taken recentlyor may need to take any other medicine.

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.

Do not takeatomoxetinewith medicines called MAOIs (monoamine oxidase inhibitors) taken for depression. See section 2 “Do not take atomoxetine cinfa”.

Atomoxetine may 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 may interact with atomoxetine and cause serotonin syndrome, a potentially life-threatening situation. (See section 2, Warnings and precautions, Serotonin syndrome).

If you are taking other medicines,atomoxetinemay 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 takingatomoxetine:

• 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 you buy this type of product, it is essential 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 makeatomoxetinestay in the body longer than normal (such as quinidine and terbinafine).
• salbutamol (a medicine for treating 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 presenting an abnormal heart rhythm when taking atomoxetine:

• medicines used to control heart rhythm
• 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 on the list of medicines mentioned 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 breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Important information about some of the components of atomoxetine cinfa

Do not open the atomoxetine capsules because the contents 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 cinfa contains sodium

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

• Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken normally one or two times 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 dosage to two times a day.
• The capsules should be swallowed whole with or without food.
• The capsules should not be opened and the content of the capsules should not be removed in any other way. Taking the medication at the same time every 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 tell you the atomoxetine dosage 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 you should increase 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 you should increase to the usual maintenance dose of 80 mg per day. The maximum daily dose is 100 mg.

Adults

• You should start atomoxetine with a total daily dose of 40 mg for a minimum of 7 days. Your doctor will then decide if you should increase 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 cinfa 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, 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, the serotonin syndrome has also been reported, a situation that potentially threatens life. (See section 2, Warnings and precautions, Serotonin syndrome).

If you forgot to take atomoxetine cinfa

If you forget a dose, take another as soon as possible, but do not take a dose 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 atomoxetine cinfa

If you stop taking atomoxetine, you will normally not experience any 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:

• Height and weight measurement in children and young people.
• Blood pressure and heart rate measurement.
• Checking if you have any problems or if the side effects have worsened while taking atomoxetine.

Long-term treatment

Atomoxetine does not need to be taken indefinitely. If you take atomoxetine cinfa for more than a year, your doctor should review your treatment to check if the medication is still necessary.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.Although some people experience side effects, most people find 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 or abnormal heartbeat
• thought or feeling of suicide
• aggressive feelings
• 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 spots 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 old are at 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 in the upper right abdomen, just below the ribs
• unexplained nausea
• fatigue
• itching
• feeling like you're coming down with a cold.

Other side effects reported have been the following. If any of them 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 regain their weight and height to 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 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: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appearson the packaging and in the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions..

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacisthow to dispose ofthepackaging and unusedmedications. By doing so, you will help protect the environment.

Composition ofatomoxetine cinfa

• The active ingredient is atomoxetine hydrochloride. Each hard capsule contains 40 mg of atomoxetine (as hydrochloride).
• The components of the capsule content are: pregelatinized maize starch, dimethicone, anhydrous colloidal silica.
• The composition of the capsule coating is: gelatin, sodium lauryl sulfate (E487), titanium dioxide (E 171), indigo carmine (E132), purified water and black ink (ShellacGlaze-45% in ethanol, iron oxide black and propylene glycol).

Appearance of the product and contents of the package

Hard capsule, blue opaque, and has printed in black ink the legend “40” and “mg”.

atomoxetine cinfa 40 mg hard capsules EFG is available in packs of 7, 14, 28 and 56 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer:

Pharmathen, S.A.

Dervenakion 6

Pallini Attiki 15351

Greece

O

Pharmathen International, S.A.

Industrial Park Sapes Rodopi Perfecture

Block No. 5

Rodopy 69300

Greece

O

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2024

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/82444/P_82444.html

QR code to:https://cima.aemps.es/cima/dochtml/p/82444/P_82444.html