ATOMOXETINE MACLEODS 80 mg HARD CAPSULES

Introduction

Leaflet:information for the user

Atomoxetine Macleods 10, 18, 25, 40, 60, 80 and 100 mg hard capsules EFG

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Atomoxetine Macleods and what is it used for
2. What you need to know before taking Atomoxetine Macleods
3. How to take Atomoxetine Macleods
4. Possible side effects
5. Storage of Atomoxetine Macleods
6. Package contents and additional information

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

What it is used for

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

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

It is used only as part of the complete treatment of the disease, which also requires non-drug treatments, such as counseling or behavioral therapy.

It is not used to treat ADHD in children under 6 years of age, as it is not known if the drug works or is safe in this population.

In adults, Atomoxetine Macleods is used to treat ADHD when symptoms are very problematic and affect work or social life, and when symptoms of the disease were present in childhood.

How it works

Atomoxetine Macleods increases the amount of noradrenaline in the brain. This is a naturally produced chemical 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 from the start of treatment with the medication until the symptoms improve completely.

About ADHD

Children and adolescents with ADHD find:

• difficulty sitting still
• difficulty concentrating

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

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

• work
• relationships
• low self-esteem
• education

2. What you need to know before taking Atomoxetine Macleods

Do not takeAtomoxetine Macleodsif you:

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

Do not take Atomoxetine Macleods if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Atomoxetine Macleods, as Atomoxetine Macleods may worsen these problems.

Warnings and precautions

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening situation that may occur when taking Atomoxetine Macleods in combination with other medications (see section 2 "Other medications and Atomoxetine Macleods"). The 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 emergency department of the nearest hospital if you think you are experiencing serotonin syndrome.

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

• thoughts or attempts of suicide.
• heart problems (including heart defects) or an increased heart rate. Atomoxetine Macleods may increase your heart rate (pulse). There have been reports of sudden death in patients with heart defects.
• high blood pressure. Atomoxetine Macleods may increase your blood pressure.
• low blood pressure. Atomoxetine Macleods may cause dizziness or fainting in people with low blood pressure.
• problems with sudden changes in 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 unreal things), believing things that are not true, or being suspicious.
• mania (feeling elated or overexcited, which causes unusual behavior) and agitation.
• feeling aggressive.
• feeling hostile or angry.

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

• mood changes or feeling unhappy.
• repeated spasms that are difficult to control in any part of the body or repetition of sounds and words.

Treatment with Atomoxetine Macleods 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 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, as Atomoxetine Macleods may worsen these problems. Your doctor will want to monitor how the medication affects you.

Tests that your doctor will perform before you start takingAtomoxetine Macleods

These tests are to decide if Atomoxetine Macleods is the right medication for you.

Your doctor will measure your

• blood pressure and heart rate (pulse) before and while you are taking Atomoxetine Macleods
• weight and height if you are a child or adolescent while taking Atomoxetine Macleods

Your doctor will ask you about:

• other medications 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 essential that you provide all the information you can. This will help your doctor decide if Atomoxetine Macleods is the right medication for you. Your doctor may decide to perform other medical tests before starting treatment with this medication.

TakingAtomoxetine Macleodswith other medications

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

Do not take Atomoxetine Macleods with medications called MAOIs (monoamine oxidase inhibitors) taken for depression. See section 2 "Do not take Atomoxetine Macleods".

If you are taking other medications, Atomoxetine Macleods may affect how they work or cause side effects. If you are taking any of the following medications, check with your doctor or pharmacist before taking Atomoxetine Macleods:

• medications that increase blood pressure or are used to control it.
• medications such as antidepressants, for example, imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine.
• some cough and cold remedies that contain medications that can affect blood pressure. When buying this type of product, it is essential to check with your pharmacist.
• some medications used to treat mental disorders.
• medications that are known to increase the risk of seizures.
• some medications that make Atomoxetine Macleods stay in the body longer than usual (such as quinidine and terbinafine).
• salbutamol (a medication for the treatment of asthma) when taken orally or injected, may cause a feeling that your heart is racing, but this will not worsen your asthma.

The medications described below may increase the risk of an abnormal heart rhythm when taking Atomoxetine Macleods:

• medications used to control heart rhythm
• medications that alter the salt content of the blood
• medications for the prevention and treatment of malaria
• some antibiotics (such as erythromycin and moxifloxacin)

If you are not sure if the medications you are taking are on the list of medications mentioned above, consult your doctor or pharmacist before taking Atomoxetine Macleods.

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

• Some antidepressants, opioids such as tramadol, and medications used to treat migraines called triptans. These medications may interact with Atomoxetine Macleods and cause serotonin syndrome, a potentially life-threatening situation. (See section 2, Warnings and precautions, Serotonin syndrome).

Pregnancy, breastfeeding, and fertility

It is not known if this medication can affect the fetus or pass into breast milk.

• This medication should not be taken during pregnancy unless your doctor tells you otherwise.
• You should avoid taking this medication if you are breastfeeding or stop breastfeeding.

If you:

• are pregnant or breastfeeding,
• think you may be pregnant or plan to become pregnant,
• plan to breastfeed

consult your doctor or pharmacist before starting to take this medication.

Driving and using machines

Atomoxetine Macleods may cause fatigue, drowsiness, or dizziness. Be careful if you drive or use machinery until you know how Atomoxetine Macleods affects you. If you feel tired, drowsy, or dizzy, you should not drive or use machinery.

Important information about some of the components ofAtomoxetine Macleods

Do not open the capsules of Atomoxetine Macleods, as 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 soon as possible.

3. How to take Atomoxetine Macleods

• Follow the instructions for administration of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This will usually be once or twice a day (morning and late afternoon or early evening).
• Children should not take this medication without the help of an adult.
• If you feel drowsy or nauseous when taking Atomoxetine Macleods once a day, your doctor may change the medication 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 medication at the same time every day can help you remember to take it.

How much to take

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

Your doctor will tell you the dose of Atomoxetine Macleods you should take based on your weight. You will usually 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 at least 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.
• Over 70 kg of weight: Starting with a total daily dose of 40 mg for at least 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 Macleods should be started with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide if it should be increased to the usual maintenance dose of 80 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 moreAtomoxetine Macleodsthan 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, serotonin syndrome, a potentially life-threatening situation, has also been reported. (See section 2, Warnings and precautions, Serotonin syndrome).

If you forget to takeAtomoxetine Macleods

If you forget a dose, take another as soon as possible, but do not take an amount that exceeds the total daily dose in a 24-hour period. Do not take a double dose to make up for forgotten doses.

If you stop takingAtomoxetine Macleods

If you stop taking Atomoxetine Macleods, you will not usually experience side effects, but the symptoms of ADHD may return. You should talk to your doctor before stopping treatment.

What your doctor will do while you are being treated:

Your doctor will perform some tests

• Before starting, your doctor will make sure that Atomoxetine Macleods is safe and will benefit you.
• After starting, tests will be performed at least every 6 months, although they may be more frequent.

Tests will also be performed when the dose is changed. These tests will include:

• Measurement of height and weight in children and adolescents.
• Measurement of blood pressure and heart rate.
• Checking if you have any problems or if side effects have worsened while taking Atomoxetine Macleods.

Long-term treatment

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

If you have any doubts about the use of this medication, 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 Atomoxetina Macleods 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 changes
• 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 young people 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 changes (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 Atomoxetina Macleods 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 nausea
• fatigue
• itching
• feeling of starting with a cold

Other reported adverse effects are as follows. If any of them worsen, consult your doctor or pharmacist.

Only in pediatric patients:

Involuntary grinding of the teeth (bruxism). (Frequency not known).

Effects on Growth

When some children start taking Atomoxetina Macleods, 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 or temporarily suspend treatment with Atomoxetina Macleods.

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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Atomoxetina Macleods

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 blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of the hard capsules of Atomoxetina Macleods 10, 18, 25, 40, 60, 80, and 100 mg.

• The active ingredient is atomoxetine hydrochloride. Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine.
• The other ingredients are: pregelatinized starch and colloidal silicon dioxide.
• The capsule ingredients are: sodium lauryl sulfate and gelatin. The capsule colorants are:

Yellow iron oxide (E172) (18 mg, 60 mg, 80 mg, and 100 mg)

Titanium dioxide (E171) (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg)

FD&C blue 2 (carmine indigo) (E132) (25 mg, 40 mg, and 60 mg)

Red iron oxide (E172) (80 mg and 100 mg)

Printing ink

Shellac (E904), Dehydrated alcohol (E1510), Isopropyl alcohol, Butanol, Propylene glycol (E1520), Ammonium hydroxide (E527), Black iron oxide (E172), Potassium hydroxide (E525)

Appearance of the Product and Content of the Packaging

10 mg: Size "3" capsule with white opaque cap/white opaque body, contains a white to off-white powder, with "I 23" printed in black ink on the body.

18 mg: Size "3" capsule with golden cap/white opaque body, contains a white to off-white powder, with "I 24" printed in black ink on the body.

25 mg: Size "3" capsule with blue opaque cap/white opaque body, contains a white to off-white powder, with "I 25" printed in black ink on the body.

40 mg: Size "3" capsule with blue opaque cap/blue opaque body, contains a white to off-white powder, with "I 26" printed in black ink on the body.

60 mg: Size "2" capsule with blue opaque cap/golden body, contains a white to off-white powder, with "I 27" printed in black ink on the body.

80 mg: Size "2" capsule with brown opaque cap/white opaque body, contains a white to off-white powder, with "I 28" printed in black ink on the body.

100 mg: Size "1" capsule with brown opaque cap/brown opaque body, contains a white to off-white powder, with "I 29" printed in black ink on the body.

The capsules are packaged in clear PVC/PVdC blister packs - Aluminum

Packaging sizes: 7, 28, and 56 capsules.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

Avenida Diagonal, 468, 6º, puerta A

08006 Barcelona

Spain

Manufacturer

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

Date of the Last Revision of this Prospectus:November 2024

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