Label: information for the user

Strattera 4mg/ml oral solution

atomoxetine

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

What it is used for
Strattera contains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). It is used

• in children aged 6 years and above
• in young people
• in adults

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

It is not used for the treatment of ADHD in children under 6 years old because it is not known if the medication works or is safe in this population.

In adults, Strattera is used for the treatment of ADHD when symptoms are very problematic and affect work or social life and when symptoms of the disease were present when they were a child.

How it works
Strattera increases the amount of norepinephrine in the brain. This is a naturally produced substance 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 since starting treatment with the medication for symptoms to improve completely.

About ADHD
Children and young people with ADHD find:

• difficulty sitting still
• difficulty concentrating

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

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

• work
• relationships
• low self-esteem
• education

Do not take Strattera if you

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

Do not take Strattera if any of the above apply. If you are unsure, consult your doctor or pharmacist before taking Strattera because Strattera may worsen these problems.

Warnings and precautions

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

• ideas or attempts of suicide.
• heart problems (including heart defects) or an increased heart rate. Strattera may increase your heart rate (pulse). Cases of sudden death in patients with heart defects have been reported.
• high blood pressure. Strattera may increase your blood pressure.
• low blood pressure. Strattera may 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 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 feelings.
• history of epilepsy or has had seizures for any other reason. Strattera may increase the frequency of seizures.
• unusual mood (changes in mood) or feeling unhappy.
• repeated spasms of difficult control of any part of the body or repetition of sounds and words.

Consult your doctor or pharmacist if you have any of the symptoms mentioned above before starting treatment, as Strattera may worsen these problems. Your doctor will want to monitor how the medication affects you.

Strattera treatment 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 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 with your doctor or pharmacist immediately.

Serotonin syndrome

Serotonin syndrome is a potentially life-threatening situation that can occur when Strattera is taken in combination with other medications (see section 2 “Other medications and Strattera”). The signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, lack of coordination and stiffness, hallucinations, coma, rapid heart rate, increased body temperature, rapid changes in blood pressure, sweating, redness, 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 Strattera

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

Your doctor will measure your:

• blood pressure and heart rate (pulse) before and during the time you are taking Strattera
• weight and height if during the time you are taking Strattera, you are a child or adolescent

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 to provide as much information as possible. This will help your doctor decide if Strattera is the right medication for you. Your doctor may decide to perform other medical tests before starting treatment with this medication.

Other medications and Strattera

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

Do not take Strattera with medications called MAOIs (monoamine oxidase inhibitors) taken for depression. See section 2 “Do not take Strattera”.

If you are taking other medications, Strattera may affect the proper functioning of these or cause side effects. If you are taking any of the following medications, check with your doctor or pharmacist before taking Strattera:

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

The medications listed below may increase the risk of abnormal heart rhythm when taking Strattera:

• medications used to control heart rhythm,
• medications that alter the content of salts in the blood,
• medications for the prevention and treatment of malaria,
• antibiotics (such as erythromycin and moxifloxacino).

If you are unsure about whether the medications you are taking are on the list of medications mentioned above, consult your doctor or pharmacist before taking Strattera.

Strattera 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 Strattera and cause serotonin syndrome, a potentially life-threatening situation. (See section 2, Warnings and precautions, Serotonin syndrome).

Pregnancy and breastfeeding

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 in lactation period,
• think you might be pregnant or intend to become pregnant,
• intend to breastfeed,

consult your doctor or pharmacist before using this medication.

Driving and operating machines

Strattera may cause you to feel tired, drowsy, or dizzy. Be careful if you drive or operate machinery until you know how Strattera affects you. If you feel tired, drowsy, or dizzy, you should not drive or operate machinery.

Important information about the oral solution

This oral solution may irritate your eyes. If the oral solution comes 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 oral solution, you should also rinse them with water as quickly as possible.

Strattera oral solution contains sorbitol, sodium, sodium benzoate, and propylene glycol

This medication contains 32.97 mg of sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains 2.64 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 3.3% of the maximum daily sodium intake recommended for an adult.

This medication contains 0.8 mg of sodium benzoate in each ml.

This medication contains 9.8 mg of propylene glycol in each ml.

Important InstructionsFollow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. This medication is usually taken once or twice a day (morning and late afternoon or early evening).

• Children should not take this medication without adult supervision.
• If you feel drowsiness or nausea when taking Strattera once a day, your doctor may change the medication dosage to twice a day.
• The medication can be taken with or without food.
• The oral solution should not be mixed with food or water as it may reduce the amount ingested or make the taste less pleasant.
• Taking the medication at the same time every day may help you remember to take it.

Strattera oral solution is available in a bottle. This is part of a package that also includes a dosing device consisting of a 10 ml oral dosing syringe graduated in fractions of 1 ml and a bottle adapter. To see the instructions on how to use the adapter and the dosing syringe, read the user manual instructions included in the package.

How Much to Take
If You Are a Child (6 Years or Older) or an Adolescent:
Your doctor will tell you the dose of Strattera 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: start with a total daily dose of 0.5 mg per kg of weight for a minimum of 7 days. Your doctor will then decide if you should increase to the usual maintenance dose of 1.2 mg per kg of weight and per day.
• More than 70 kg of weight: start with a total daily dose of Strattera 40 mg for a minimum of 7 days. Your doctor will then decide if you should increase to the usual maintenance dose of 80 mg per day. The maximum daily dose is 100 mg.

Adults

• You should start Strattera with a total daily dose of 40 mg for a minimum of 7 days. Your doctor will then decide if you should increase 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.

What to Do If You Take Too Much Strattera
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, the serotonin syndrome, a potentially life-threatening situation, has also been reported. (See section 2, Warnings and Precautions, Serotonin Syndrome).

What to Do If You Miss a Dose
If you forget a dose, take another as soon as possible, but do not take a dose that exceeds the total daily dose in a 24-hour period. Do not take a double dose to compensate for missed doses.

What to Do If You Stop Taking Strattera
If you stop taking Strattera, you usually will not experience any side effects, but the ADHD symptoms may return. You should talk to your doctor before stopping treatment.

What Your Doctor Will Do While You Are on Treatment

Your Doctor Will Perform Some Tests

• before starting - they will ensure that Strattera is safe and will benefit you.
• after starting - 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:

• height and weight measurement in children and young people
• blood pressure and heart rate measurement
• checking if you have any problems or if the side effects have worsened while taking Strattera

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Although some people experience side effects, most consider that Strattera helps them. Your doctor will talk to you about these side effects.

Some side effects could be serious.If you experience any of the following side effects, contact your doctor immediately.

Rare(may affect up to 1 in 100 people)

• feeling or having a very fast or abnormal heartbeat
• thought or feeling of suicide
• aggressive feeling
• 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 spots 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 being suspicious.

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

• thought or feeling 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 experiencing side 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 being suspicious

Rare(may affect up to 1 in 1,000 people)

• liver damage

Stop taking Strattera and contact your doctor immediately if you experience any of the following side effects:

• dark urine
• yellowing of the skin and eyes
• pain in the upper right abdomen, just below the ribs
• unexplained nausea
• fatigue
• itching
• feeling of starting a cold

Other side effects reported have been the following. If any of them worsen, consult with your doctor or pharmacist.

Effects on growth
When some children start taking Strattera, their growth (weight and height) is reduced. However, with long-term treatment, children recover their weight and height appropriate 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, your doctor may change the dose of Strattera or temporarily suspend treatment with Strattera.

Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the bottle after “CAD”. The expiration date is the last day of the month indicated.

Do not use the oral solution more than 45 days after the first opening of the bottle.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Strattera 4mg/ml

• The active ingredient is atomoxetine hydrochloride. Each milliliter of oral solution contains atomoxetine hydrochloride in an amount equivalent to 4mg of atomoxetine.
• The other components are sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, phosphoric acid, sorbitol liquid (crystallizable) E420, xylitol, artificial strawberry flavor (which contains propylene glycol E1520), sucralose, sodium hydroxide, purified water.

Appearance of the product and contents of the package
Oral solution, 4mg/ml (transparent and colorless)

Strattera oral solution is available in a bottle containing 100 ml of solution, with a child-resistant cap. The package also includes a dosing device consisting of a 10 ml oral dosing syringe graduated in fractions of 1 ml and a bottle adapter.

Strattera oral solution is available in a single-bottle package and a multiple-bottle package with three bottles.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
Lilly S.A. Avda de la Industria 30, 28108 Alcobendas, Madrid, Spain.

Responsible manufacturer:
Patheon France, 40 Boulevard de Champaret, 38300 Bourgoin-Jallieu, France.

Strattera is a registered trademark of Eli Lilly and Company Limited.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Irisfarma S.A. Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

This medication is authorized in the member states of the European Economic Area with the following names:
Austria, Denmark, Germany, Hungary, , Ireland, Italy, Malta, Norway, Portugal, Romania, Slovenia, Spain, Sweden: Strattera.

Last review date of this leaflet: November 2024

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

Strattera
atomoxetine
oral solution

Instructions for Use

Your step-by-step guide to using STRATTERA

WHEN YOU USE STRATTERA, read and carefully follow the step-by-step instructions.

WARNING:The adapter poses a RISK OF ASPHYXIATION due to being a small component. Do not attach the syringe to the adapter until the adapter is completely inserted into the bottle. For safe use, the adapter must be completely inserted into the bottle. Use only under adult supervision..

IMPORTANT

DO NOTlet your child take the medication without your help.

DO NOTuse the medication if it has expired (check the expiration date on the label).

DO NOTuse the medication if more than 45 days have passed since the first time you opened the bottle. See the section on DISPOSAL for more information on what to do with unused medication.

DO NOTwash the oral dosing syringe with soap or detergent.DO NOTput the syringe in the dishwasher. If you do, the syringe may not work as well as it should. Please see the cleaning instructions from step N to P.
Do not recommend mixing STRATTERA oral solution with food or water because it may affect the taste or prevent a complete dose from being taken.

STRATTERA causes eye irritation..Avoid contact with the eyes.If the medication comes into contact with the eyes, wash them immediately with water and consult your doctor. Wash your hands and any surfaces that may have come into contact with the medication as soon as possible.

STEP 1 INITIAL BOTTLE PREPARATION

STEP 2 PREPARATION

Write the dose of your child here:

______ ml

Make sure it is the exact dose prescribed by your child's doctor.

If your child's dose is10 ml OR LESS,you will use the syringe once

If your child's dose isMORE THAN 10 mlbut NOT more than 20 ml, you will use the same syringe twice.

If your child's dose isMORE THAN 20 ml,you will use the same syringe three times.

STEP 3 DOSING

STEP 4 ADMINISTRATION OF THE MEDICATION

STEP5CLEANINGCARA 1

Seetheothersideofthisdocumentforanswerstothemostfrequentlyaskedquestions,
checkthedosagechartandotherimportantinformation.

CARA 2

DOSE CHARTFORDOSAGESOFMORETHAN10ml

Usethischarttocalculatethedosetobeadministeredtoyourchild.Lookforthecorrectdoseinthefirstcolumn.
Consultwithyourdoctororpharmacistonhowtoadministerthecorrectdosetoyourchild.

Frequently Asked Questions

Q.What happens if there is an air bubble in the oral dosing syringe?

A.DO NOTadminister the medication to your child. Bubbles can make the dose incorrect.
Empty the medication back into the bottle and repeat from step D to H.

Q.What happens if there is too much medication in the syringe?

A.Hold the syringe in the bottle. Turn the bottle upwards.
Pull the plunger down until the correct dose is in the syringe.

Q.What happens if there is not enough medication in the syringe?

A.Hold the syringe in the bottle. Turn the bottle downwards. Pull the plunger down until the correct dose is in the syringe.

Q.What do I do if the medication comes into contact with my eyes or my child's eyes?

A.Wash your eyes immediately with water and consult your doctor. As soon as possible, wash your hands and any surface that may have come into contact with the medication.

Q.How do I travel with this medication?

A.Make sure you have enough STRATTERA for the entire trip. Keep the medication in a safe place, upright at room temperature.

Q.Can I mix STRATTERA with food or water before giving it to my child?

A.No, it is not recommended to mix STRATTERA oral solution with food or water. It may affect the taste or prevent a complete dose from being taken.
Your child can drink a glass of water after taking the entire dose of medication.

Storage

This medication does not require special storage conditions.
Keep the bottle and syringe out of the sight and reach of children.

Disposal
Do not throw the medication directly into the sink or trash.
Consult your pharmacist on how to dispose of unused medication.
These measures will help protect the environment.