Atomoxetine CINFA 100 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

atomoxetina cinfa 100 mg hard capsules EFG

atomoxetine hydrochloride

Read the entire 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 only, and you must not give it 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What atomoxetine cinfa is and what it is used for

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 from the age of 6 years
• in adolescents
• in adults

It is used only as part of a comprehensive treatment programme for the condition, which also requires 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 medicine is effective or safe in this population.

In adults, atomoxetine cinfa 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 cinfa increases the amount of noradrenaline in the brain. Noradrenaline is a naturally occurring chemical that enhances attention and reduces impulsivity 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 several weeks from the start of treatment with this medicine before symptoms are fully improved.

About ADHD

Children and adolescents with ADHD find it:

• difficult to sit still
• difficult to 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 may 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 tasks that children also find challenging, but this may lead to problems with:

• work
• relationships
• self-esteem
• education.

2. What you need to know before starting to take atomoxetine cinfa

Do not take atomoxetine cinfa:

• if you are allergic to atomoxetine or to 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 adverse effects or be life-threatening. 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, a weakened and inflamed blood vessel (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:

• thoughts 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. Atomoxetine may increase your blood pressure.
• low blood pressure. Atomoxetine may cause dizziness or fainting in people who have 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 feeling 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 seizures from any other cause. Atomoxetine may increase the frequency of your seizures.
• mood different from usual (mood changes) or feelings of unhappiness.
• repeated, difficult-to-control spasms in any part of your body or repetition of sounds and words.

Treatment with atomoxetine may make you feel aggressive, hostile, or violent, or may worsen these symptoms if they were already present. 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 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.

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening condition that may occur when atomoxetine is taken together with other medicines (see section 2 “Taking atomoxetine cinfa with other medicines”). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, lack of coordination and stiffness, hallucinations, coma, rapid heartbeat, 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 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 taking atomoxetine cinfa.

Your doctor will ask you about:

• other medicines you are taking.
• any 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.

Taking atomoxetine cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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.

Do not take atomoxetine with medicines called MAOIs (monoamine oxidase inhibitors) used to treat depression. See section 2 “Do not take atomoxetine cinfa”.

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

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

If you are taking other medicines, atomoxetine may interfere with their proper function 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 normal (such as quinidine and terbinafine).
• salbutamol (a medicine used to treat asthma) when taken orally or injected, may make you feel that your heart is racing, but this will not worsen your asthma.

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

• medicines used to control heart rhythm.
• medicines that alter blood salt levels.
• medicines used 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 can affect the fetus or pass into breast milk.

• This medicine should not be taken during pregnancy unless your doctor specifically instructs you to do so.
• 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Atomoxetine cinfa may cause tiredness or drowsiness. Be cautious if driving or operating 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 ingredients of atomoxetine cinfa

Do not open the atomoxetine capsules, as the 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 the area with water as quickly as possible.

Atomoxetine cinfa contains sodium

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

3. How to take atomoxetine cinfa

• Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual dosing schedule is once or twice daily (in the 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 change your dosing schedule to twice daily.
• Capsules should be swallowed whole, with or without food.
• 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. Usually, treatment starts with a low dose before increasing it, 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 atomoxetine 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 per day. The maximum daily dose is 100 mg.

Adults

• Treatment with atomoxetine should start 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 cinfa 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 cinfa

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 cinfa

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 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 when the dose is adjusted. These tests include:
  • Measurement of height and weight in children and adolescents.
  • Measurement of blood pressure and heart rate.
  • Checking whether you have any problems or whether adverse 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 one year, your doctor must review your treatment to determine whether the medicine is still necessary.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets 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 about suicide
• feeling aggressive
• feeling 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 there), believing things that are not true, or becoming suspicious.

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

• thoughts or feelings about 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 there), 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 side of the abdomen, just below the ribs
• unexplained feeling of discomfort (nausea)
• tiredness
• itching
• feeling of having a cold coming on.

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

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of atomoxetine cinfa

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 "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. Instead, return unused medicines and their packaging to a pharmacy’s SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of atomoxetine cinfa

• The active substance is atomoxetine hydrochloride. Each hard capsule contains 100 mg of atomoxetine (as hydrochloride).
• The components of the capsule contents are: pregelatinized maize starch, dimethicone, anhydrous colloidal silica.
• The composition of the capsule coating is: gelatin, sodium lauryl sulfate (E-487), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), purified water, and black ink (Shellac Glaze-45% in ethanol, black iron oxide, and propylene glycol).

Appearance of the product and contents of the pack

Hard capsule, opaque brown in colour, printed in black ink with the markings “100” and “mg”.

atomoxetina cinfa 100 mg hard capsules EFG is available in packs of 7, 14, 28 and 56 capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Pharmathen, S.A.

Dervenakion 6

Pallini Attiki 15351

Greece

Or

Pharmathen International, S.A.

Industrial Park Sapes Rodopi Perfecture

Block No. 5

Rodopy 69300

Greece

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this Patient Information Leaflet: November 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82440/P_82440.html

QR code to: https://cima.aemps.es/cima/dochtml/p/82440/P_82440.html