ATOMOXETINE CINFA 80 mg HARD CAPSULES

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

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 for depression and other mental health conditions; taking atomoxetine with an MAOI could cause serious side effects or be life-threatening. Also, you should wait at least 14 days after you stop taking atomoxetine before taking an MAOI.
• if you have an eye condition called narrow-angle glaucoma (increased pressure in the eye)
• if you have serious heart problems that may get worse due to an increase in heart rate and/or blood pressure, which may occur with atomoxetine
• if you have serious blood vessel problems in the brain, such as stroke, an aneurysm (a bulge in a blood vessel that can burst), or narrowed or blocked blood vessels
• if you have a tumor of the adrenal gland (pheochromocytoma)

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

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 atomoxetine if you have:

• thoughts of suicide or attempted suicide
• heart problems (including heart defects) or an increased heart rate. Atomoxetine may increase your heart rate (pulse). There have been reports of sudden death 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 with low blood pressure.
• problems with sudden changes in blood pressure or heart rate.
• heart 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 or angry feelings.
• a history of epilepsy or having had seizures for any other reason. Atomoxetine may increase the frequency of seizures.
• unusual changes in mood or feelings of sadness.
• repetitive behaviors or sounds or words.

Treatment with atomoxetine 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 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, because atomoxetine may make these problems worse. 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 taking atomoxetine in combination with other medicines (see section 2 "Taking atomoxetine cinfa with other medicines"). The signs and symptoms of serotonin syndrome can 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.

Tests your doctor will do 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 while you are taking atomoxetine
• weight and height if you are a child or adolescent while taking atomoxetine cinfa

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 important that you provide all the information you can. This will help your doctor decide if atomoxetine is 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 take atomoxetine with 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:

• certain antidepressants, opioids such as tramadol, and medicines used to treat migraine called triptans. These medicines can 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 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:

• medicines that increase blood pressure or are used to control it
• medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine
• certain cough and cold remedies that contain medicines that can affect blood pressure. When buying these products, it is important to 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 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 medicines described below may increase the risk of an abnormal heart rhythm when taking atomoxetine:

• medicines used to control heart rhythm
• medicines that alter the levels of salts in the blood
• medicines for the prevention and treatment of malaria
• antibiotics (such as erythromycin and moxifloxacin)

If you are not sure if 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 unborn child 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 may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

atomoxetine cinfa may make you feel tired or sleepy. Be careful while driving or using heavy machinery until you know how atomoxetine cinfa affects you. If you feel tired or sleepy, do not drive or use heavy machinery.

Important information about some of the ingredients of atomoxetine cinfa

Do not open the capsules of atomoxetine 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, wash them as soon as possible with water.

atomoxetine cinfa contains sodium

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

3. How to take atomoxetine cinfa

• Always 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 normally 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 sleepy or nauseous when taking atomoxetine once a day, your doctor may change the medicine 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 other 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 (from 6 years old) or an adolescent:

Your doctor will tell you what dose of atomoxetine to take based on your weight. You will normally start with a low dose before increasing it, based on your weight.

• Up to 70 kg in weight: Starting with a total daily dose of 0.5 mg per kg of body weight for a minimum of 7 days. Your doctor will then decide if it should be increased to the usual maintenance dose of 1.2 mg per kg of body weight per day.
• Over 70 kg in weight: Starting with a total daily dose of atomoxetine of 40 mg for a minimum of 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

• You should start atomoxetine with a total daily dose of 40 mg for a minimum of 7 days. Your doctor will then decide if it 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 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, telephone: 91 562 04 20, stating the medicine and the amount taken.

The most commonly reported symptoms after an overdose are gastrointestinal symptoms, sleepiness, dizziness, tremors, 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 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 missed doses.

If you stop taking atomoxetine cinfa

If you stop taking atomoxetine, you will not normally get any 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 taking atomoxetine cinfa: Your doctor will do some tests

• Before you start, your doctor will make sure that atomoxetine is safe for you and will benefit you.
• After you start, 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:

• Measuring height and weight in children and adolescents.
• Measuring blood pressure and heart rate.
• Checking if you have any problems or if side effects have gotten worse 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 see if the medicine is still needed.

If you have any other questions about 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 atomoxetine 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 rashes 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 have a higher 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 atomoxetine and contact your doctor immediately if you experience any of the following adverse effects:

• dark urine
• yellowish skin and eyes
• pain when pressing 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 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 recover the expected weight and height 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 of atomoxetine or temporarily suspend treatment with atomoxetine.

Reporting 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 Atomoxetine Cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAtomoxetine Cinfa

• The active ingredient is atomoxetine hydrochloride. Each hard capsule contains 80 mg of atomoxetine (as hydrochloride).
• The ingredients of the capsule content are: pregelatinized cornstarch, dimethicone, anhydrous colloidal silica.
• The composition of the capsule shell is: gelatin, sodium lauryl sulfate (E487), titanium dioxide (E 171), yellow iron oxide (E172), red iron oxide (E172), purified water, and black ink (ShellacGlaze-45% in ethanol, black iron oxide, and propylene glycol).

Appearance of the Product and Package Contents

Hard capsule, with a brown opaque cap and a white opaque body, and has printed in black ink the legend "80" and "mg".

Atomoxetine Cinfa 80 mg hard capsules EFG are available in packs of 7, 14, 28, and 56 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 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/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82446/P_82446.html

QR code to: https://cima.aemps.es/cima/dochtml/p/82446/P_82446.html