ATOMOXETINE MACLEODS 40 mg HARD CAPSULES

Introduction

Package Leaflet:information for the user

Atomoxetine Macleods 10, 18, 25, 40, 60, 80 and 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 Atomoxetine Macleods is and what it is used for
2. What you need to know before you take Atomoxetine Macleods
3. How to take Atomoxetine Macleods
4. Possible side effects
5. Storing Atomoxetine Macleods
6. Contents of the pack and other information

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

What it is used for

Atomoxetine Macleods contains atomoxetine and is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in:

• children over 6 years
• adolescents
• adults

It is used as part of a comprehensive treatment programme which includes psychological, educational, and social measures.

Atomoxetine Macleods is not for use as a treatment for ADHD in children under 6 years of age, as the safety and efficacy in this age group have not been established.

In adults, Atomoxetine Macleods is used to treat ADHD when the symptoms are very troublesome and affect your work or social life and when you have had symptoms of the disorder as a child.

How it works

Atomoxetine Macleods increases the levels of noradrenaline in the brain. Noradrenaline is a chemical that is produced naturally in the brain and helps to increase attention and decrease 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 it is not addictive.

It may take a few weeks before you start to feel the benefits of Atomoxetine Macleods. You should not stop taking your medicine without first talking to your doctor.

About ADHD

Children and adolescents with ADHD find it:

• difficult to sit still
• difficult to concentrate

This is not because they are not trying, but because their brains are not able to control their behaviour. In addition to these symptoms, children and adolescents with ADHD may also have difficulties with:

• learning and doing homework
• behaving 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 and adolescents with ADHD find difficult. This may mean that they have difficulties with:

• work
• relationships
• low self-esteem
• education

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

Do not takeAtomoxetine Macleodsif you:

• are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6)
• have taken a medicine called a monoamine oxidase inhibitor (MAOI) in the last two weeks. MAOIs are sometimes used for depression and other mental health conditions; taking Atomoxetine Macleods with an MAOI could cause serious side effects or be life-threatening. You should also wait at least 14 days after you stop taking Atomoxetine Macleods before you take an MAOI.
• have an eye problem called narrow-angle glaucoma (increased pressure in the eye)
• have serious heart problems that may get worse if you take Atomoxetine Macleods. These include problems that may cause your heart to suddenly lose its normal rhythm, which could be life-threatening.
• have serious blood vessel problems, including those that affect blood flow to your brain or heart, which could lead to a stroke or heart attack
• have a tumour of your adrenal gland (phaeochromocytoma)

Do not take Atomoxetine Macleods if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atomoxetine Macleods, as it may not be suitable for you.

Warnings and precautions

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening condition that may happen when you take Atomoxetine Macleods with certain other medicines (see section 2, “Other medicines and Atomoxetine Macleods”). Symptoms of serotonin syndrome may include:

• confusion
• restlessness
• loss of coordination
• stiffness
• hallucinations
• coma
• fast heart beat
• changes in blood pressure
• increased body temperature
• sweating
• flushing
• tremors
• overactive reflexes
• nausea
• vomiting
• diarrhoea

Contact your doctor or go to the hospital immediately if you get any of these symptoms.

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

• thoughts of suicide or have tried to harm yourself
• heart problems (including heart defects) or an increased heart rate. Atomoxetine Macleods can increase your heart rate (pulse). There have been reports of sudden death in patients with heart defects.
• high blood pressure. Atomoxetine Macleods can increase your blood pressure.
• low blood pressure. Atomoxetine Macleods can 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 symptoms including hallucinations (hearing voices or seeing things that are not there), believing things that are not true, or being suspicious.
• mania (feeling elated or overexcited, which can lead to abnormal behaviour) and agitation.
• aggressive behaviour.
• hostility.

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

• mood changes or feeling unhappy.
• repetitive movements or sounds.

Treatment with Atomoxetine Macleods may cause you to feel agitated, hostile, or violent, or cause changes in your behaviour or mood (including aggression, being threatening or unusual changes in behaviour). If you or your family/carer notice any of these symptoms, talk to your doctor or pharmacist immediately.

Talk to your doctor or pharmacist before taking Atomoxetine Macleods if you have any of the symptoms mentioned above, as Atomoxetine Macleods may make these problems worse. Your doctor will want to monitor how the medicine affects you.

Tests your doctor will do before you start takingAtomoxetine Macleods

These tests are to make sure that Atomoxetine Macleods is the right medicine for you.

Your doctor will:

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

Your doctor will ask you:

• about other medicines you are taking
• if you have any family history of sudden death
• about any other medical conditions (such as heart problems) that you or your family may have.

It is important that you provide as much information as you can. This will help your doctor decide if Atomoxetine Macleods is the right medicine for you. Your doctor may decide to do other tests before you start taking this medicine.

TakingAtomoxetine Macleodswith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. Your doctor will decide if you can take Atomoxetine Macleods with other medicines.

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

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

• medicines that increase blood pressure or are used to control blood pressure.
• certain medicines used to treat depression, such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine.
• some cough and cold remedies that contain medicines that can affect blood pressure. When you buy these products, check with your pharmacist.
• certain medicines used to treat mental health conditions.
• medicines that are known to increase the risk of seizures.
• certain medicines that make Atomoxetine Macleods stay in the body longer than it normally would, 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 taken with Atomoxetine Macleods:

• medicines used to control the heart rhythm
• medicines that alter the amount of salts in the blood
• medicines for preventing and treating malaria
• certain antibiotics (such as erythromycin and moxifloxacin)

If you are not sure if any of the medicines you are taking are in the list above, talk to your doctor or pharmacist before taking Atomoxetine Macleods.

Atomoxetine Macleods may affect how well other medicines work or vice versa. These include:

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

Pregnancy, breast-feeding and fertility

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

• This medicine should not be taken during pregnancy unless your doctor advises you to do so.
• You should not take this medicine if you are breast-feeding.

If you:

• are pregnant or breast-feeding
• think you may be pregnant or are planning to have a baby
• are planning to breast-feed

ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Atomoxetine Macleods may cause drowsiness, dizziness, or affect your ability to concentrate and make decisions. Be careful while driving or operating machinery until you know how Atomoxetine Macleods affects you. If you feel drowsy, dizzy, or have difficulty concentrating, you should not drive or operate machinery.

Important information about some of the ingredients ofAtomoxetine Macleods

Do not open Atomoxetine Macleods capsules 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 talk to 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.

3. How to take Atomoxetine Macleods

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This will usually 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 dizzy or sick when taking Atomoxetine Macleods once a day, your doctor may change your dose to twice a day.
• The capsules should be swallowed whole with or without food.
• The capsules should not be opened and the contents should not be removed.
• Taking the medicine at the same time each day may help you remember to take it.

How much to take

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

Your doctor will tell you how much Atomoxetine Macleods to take, based on your weight. You will usually 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 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

• Start 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 moreAtomoxetine Macleodsthan you should

If you or someone else takes too much Atomoxetine Macleods, talk to a doctor or go to the hospital immediately. Take the medicine pack with you. The most common symptoms reported in cases of overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behaviour. Rarely, seizures and serotonin syndrome have been reported (see section 2, Warnings and precautions, Serotonin syndrome).

If you forget to takeAtomoxetine Macleods

If you miss a dose, take it as soon as you remember. Do not take more than your daily dose in a 24-hour period. Do not take a double dose to make up for a forgotten dose.

If you stop takingAtomoxetine Macleods

If you stop taking Atomoxetine Macleods, your ADHD symptoms may return. You should talk to your doctor before you stop taking this medicine.

What your doctor will do while you are takingAtomoxetine Macleods

Your doctor will do some tests

• Before you start, to make sure that Atomoxetine Macleods is safe for you and will be of benefit.
• After you start, at least every 6 months, but possibly more often.

These tests will include:

• Checking your height and weight if you are a child or adolescent.
• Checking your blood pressure and heart rate.
• Checking if you have any problems or if the side effects have got worse while you are 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 will review your treatment to see if the medicine is still needed.

If you have any further questions on 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 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 part 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 expected weight and height for their age group.

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 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 components are: pregelatinized starch and colloidal silicon dioxide.
• The components of the capsule 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 (indigo carmine) (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

Package sizes: 7, 28, and 56 capsules.

Not all package 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/)