ATOMOXETINE MACLEODS 18 mg HARD CAPSULES

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 stopping MAOI treatment before starting treatment with Atomoxetine Macleods.
• have an eye condition 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 blood pressure or heart rate to increase.
• have serious blood vessel problems that may cause your blood pressure or heart rate to increase.
• 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, consult your doctor or pharmacist before taking Atomoxetine Macleods, as it may worsen these conditions.

Warnings and precautions

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening condition that may occur when taking Atomoxetine Macleods with other medicines (see section 2 "Other medicines and Atomoxetine Macleods"). The signs and symptoms of serotonin syndrome can include a combination of the following: confusion, restlessness, lack of coordination, and rigidity, hallucinations, coma, rapid heartbeat, increased body temperature, changes in blood pressure, sweating, flushing, tremors, hyperactive reflexes, nausea, vomiting, and diarrhea. Contact a doctor or go to the emergency department of the nearest hospital immediately 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 treatment with 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 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 behaviour) and agitation.
• aggressive feelings.
• hostile or angry feelings.

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

• mood changes or feelings of unhappiness.
• repetitive movements or sounds.

Treatment with Atomoxetine Macleods may make you feel aggressive, hostile, or violent, or make these symptoms worse if they were already present before treatment. It may also cause unusual changes in your behaviour or mood (including physical aggression, threatening behaviour, 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 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 decide if 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 weight and height 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 a family history of sudden death
• any other medical problems (such as heart problems) that you or your family may have.

It is very important that you provide all the information you can. This will help your doctor decide if Atomoxetine Macleods is the right medicine for you. Your doctor may decide to do other medical tests before starting treatment with 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 and may need to adjust the dose or increase it more slowly.

Do not take Atomoxetine Macleods with medicines called 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 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 it.
• medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine.
• some cough and cold remedies that contain medicines that can affect blood pressure. When buying these products, it is important to check with your pharmacist.
• some medicines used to treat mental health conditions.
• medicines that are known to increase the risk of seizures.
• some medicines that make Atomoxetine Macleods stay in the body longer than usual (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 heart rhythm
• medicines that alter the levels of salts in the blood
• medicines for the prevention and treatment of malaria
• some antibiotics (such as erythromycin and moxifloxacin)

If you are not sure if the medicines you are taking are listed above, consult your doctor or pharmacist before taking Atomoxetine Macleods.

Atomoxetine Macleods 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 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 unborn baby or pass into breast milk.

• This medicine should not be taken during pregnancy unless your doctor advises you to do so.
• You should avoid taking 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

consult your doctor or pharmacist 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 consult 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

• Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. This will usually be once or twice a day (in the morning and late afternoon or early evening).
• Children should not take this medicine without the help of an adult.
• If you feel drowsy or nauseous when taking Atomoxetine Macleods once a day, your doctor may change the 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 in any way.
• Taking the medicine at the same time each day can help you remember to take it.

How much to take

If you are a child (over 6 years) or 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

• Atomoxetine Macleods should be started 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 have taken too much Atomoxetine Macleods, contact your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. The most commonly reported symptoms of overdose are gastrointestinal symptoms, drowsiness, dizziness, tremors, and abnormal behaviour. 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 takeAtomoxetine Macleods

If you forget to take a dose, take another as soon as you remember, but do not take more than the total 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, you may not experience any side effects, but your ADHD symptoms may return. You should talk to your doctor before stopping treatment.

What your doctor will do while you are takingAtomoxetine Macleods

Your doctor will do some tests

• Before you start, to make sure Atomoxetine Macleods is safe and will be of benefit.
• After you start, at least every 6 months, although this may be more often.

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

• Checking your height and weight (for children and adolescents).
• Checking your blood pressure and heart rate.
• Checking if you have any problems or if 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 product, 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 group.

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 wastewater or household waste. 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. Package contents and additional information

Composition of Atomoxetina Macleods hard capsules 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 package contents

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.

Only some 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/)