Package Insert: Information for the User

Fluoxetina Normon 20 mg/5 ml Oral Solution EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

Fluoxetina Normon belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

This medicine is indicated for the treatment of:

Adults:

• Major depressive episodes.
• Obsessive-compulsive disorder (OCD).
• Bulimia nervosa: Fluoxetina Normon is indicated as a complement to psychotherapy for the reduction of binge eating and purging.

Children over 8 years and adolescents:

• For moderate to severe depressive episodes, if there is no response to psychological therapy after 4 to 6 sessions. Fluoxetine should be offered to children or young people with moderate to severe depression only in combination with a psychological therapy.

• Do not take Fluoxetina Normon

• If you are allergic (hypersensitive) to fluoxetine or any of the other ingredients of this medicine (listed in section 6). An allergy may include rash, itching, swelling of the face or lips or difficulty breathing.
• If you are taking any other type of medicine that is also used to treat depression and are known as non-selective monoamine oxidase inhibitors

or reversible inhibitors of monoamine oxidase type A (also called IMAO-A), there may be a serious or even fatal reaction.

Fluoxetine treatment can only be started after two weeks of finishing a treatment with an irreversible MAO inhibitor (for example, tranilcipromina).

However, treatment with fluoxetine can be started the day after finishing a treatment with certain reversible MAO inhibitors, known as IMAO-A (for example, moclobemida).

Do not take any IMAO for at least five weeks after stopping fluoxetine treatment. If you have been prescribed this medicine for a long period of time and/or at a high dose,your doctor may consider the need for a longer interval before taking an IMAO. Examples of IMAOs are: nialamida, iproniazida, selegelina, moclobemida, fenelcina, tranilcipromina, isocarboxacida, and toloxatona.

• Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• If you develop skin rashes or other allergic reactions (such as itching, swelling of the face or lips or difficulty breathing), stop taking this medicine and contact your doctor immediately.
• If you have epilepsy or have had seizures in the past, if you have seizures or experience an increase in their frequency, contact your doctor immediately, you may need to interrupt the treatment with fluoxetine.
• If you have had mania in the past, if you have a manic episode, contact your doctor immediately, you may need to discontinue the use of fluoxetine.
• If you have diabetes, your doctor may need to adjust your insulin or other antidiabetic treatment.
• If you have liver problems (your doctor may need to adjust your dose).
• If you have heart disease.
• If you are taking diuretics, especially if you are an elderly patient.
• If you are receiving electroconvulsive therapy (ECT).
• If you have a history of bleeding disorders or if you develop unusual bleeding or bruising.
• If you are taking medications that affect blood clotting (see “Taking other medicines”).
• If you start to experience fever, stiffness, or muscle spasms, changes in your mental state such as confusion, irritability, or extreme agitation, you may be experiencing a condition called serotonin syndrome or malignant neuroleptic syndrome. Although this syndrome is rare, it can be life-threatening, so contact your doctor immediately, the use of fluoxetine may be discontinued.
• If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• If you are pregnant (see“Pregnancy”1).

Pregnancy1

If you take Fluoxetina Normon in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Fluoxetina Normon so that they can advise you.

There has been an observed increase in the risk of bone fractures in patients treated with this type of medicine.

Some medicines in the group to which Fluoxetina Normon belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

• Children and adolescents aged 8 to 18 years

Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Fluoxetina Normon should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe depressive episodes in combination with psychological therapy, and should not be used for other indications in this age group.

Furthermore, there is only limited information available regarding the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, your doctor may prescribe this medicine to patients under 18 years of age for the treatment of moderate to severe depressive episodes in combination with psychological therapy when they decide that it is in the best interest of the patient. If your doctor prescribes Fluoxetina Normon to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age taking this medicine.

This medicine should not be used to treat children under 8 years of age.

• Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when you first start taking antidepressants, as they take time to start working, usually around two weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If you ever have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

Telling a family member or close friend that you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

• Other medicines and Fluoxetina Normon

Inform your doctor or pharmacist if you are taking or have taken recently (in the last 5 weeks) or may need to take any other medicine. This medicine may affect the action of other medicines (interaction). Interactions may occur with:

• MAO inhibitors (medicines used to treat depression). Non-selective MAO inhibitors and MAO inhibitors known as IMAO type A (such as moclobemida) should not be used with fluoxetine, as they may cause serious or even fatal reactions (serotonin syndrome), see section “Do not take Fluoxetina Normon”. MAO inhibitors known as IMAO-B (selegilina) may be used with fluoxetine, provided your doctor closely monitors your treatment.
• Lithium, tryptophan: there is an increased risk of serotonin syndrome if these medicines are administered with fluoxetine. When fluoxetine is administered with lithium, your doctor should perform more frequent checks.
• Phenytoin (medicine used to treat epilepsy), fluoxetine may increase the levels of this medicine in the blood, so your doctor should dose you more carefully when taking Fluoxetina Normon and should perform more frequent checks.
• Clozapine (used to treat certain mental disorders), tramadol (for pain relief), or triptans (for migraine treatment), there is an increased risk of hypertension.
• Flecainide or encainide (for heart problems), carbamazepine (for epilepsy treatment), tricyclic antidepressants (such as imipramine, desipramine, and amitriptyline), because fluoxetine may change the levels of these medicines in the blood, so your doctor may need to reduce your dose when taking Fluoxetina Normon.
• Warfarin or other medicines that affect blood clotting; fluoxetine may alter the effect of these medicines on the blood. Your doctor will need to perform certain tests if you start or stop taking Fluoxetina Normon while taking warfarin.
• You should not start taking herbal preparations containing St. John's Wort (Hypericum perforatum) while taking this medicine, as it may cause an increase in adverse effects. If you start taking Fluoxetina Normon and are already taking St. John's Wort, stop taking it and inform your doctor at your next visit.

• Taking Fluoxetina Normon with food, drinks, and alcohol

Fluoxetina Normon can be taken with or without food, as you prefer.

It is not recommended to consume alcohol while taking this medicine.

• Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The information available to date does not indicate an increased risk when using this medicine during pregnancy. However, caution should be exercised when using it during pregnancy, especially in the final stages of pregnancy or just before delivery, as there have been reports of the following effects in newborn babies: irritability, tremors, muscle weakness, persistent crying, difficulty feeding or sleeping.

There have been reports of an increased risk of congenital heart defects in babies whose mothers took fluoxetine during the first months of pregnancy. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to around 2 in 100 in those babies whose mothers took fluoxetine. You and your doctor can decide whether it is best to stop taking fluoxetine while pregnant, or whether you should continue taking it. However, depending on your circumstances, your doctor may suggest that you continue taking fluoxetine.

Make sure your midwife and/or doctor know that you are taking Fluoxetina Normon. When taken during pregnancy, especially in the last 3 months of pregnancy, medicines like Fluoxetina Normon may increase the risk of a serious condition in newborn babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause adverse effects in babies. You should only continue breastfeeding if absolutely necessary. If you continue breastfeeding, your doctor may prescribe a lower dose of fluoxetine.

Fertility

Studies in animals have shown that fluoxetine reduces the quality of sperm. Theoretically, this could affect fertility, but there is no observed impact on human fertility yet.

• Driving and operating machinery

During treatment with Fluoxetina Normon, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how the treatment affects you.

• Fluoxetina Normon contains saccharose and benzoic acid (E-210)

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may harm your teeth.

This medicine contains 2.4 mg of benzoic acid in each 5 ml.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The normal dose is:

• Depression: the recommended initial dose is 20 mg. Your doctor may review and adjust your dose as needed in the 3 to 4 weeks following the start of treatment. When necessary, the dose can be increased gradually up to a maximum of 60 mg. The dose should be increased carefully to ensure that you receive the minimum effective dose. You may not feel better immediately when starting to take your medication for depression. This is common since there is no improvement in depressive symptoms until after the first few weeks of treatment. Patients with depression should be treated for a period of at least 6 months.
• Bulimia nervosa: the recommended dose is 60 mg per day.
• Obsessive-compulsive disorder: the recommended dose is 20 mg per day. Your doctor may review and adjust the dose after two weeks of treatment. When necessary, the dose can be increased gradually up to a maximum of 60 mg. If no improvement is observed within 10 weeks, the treatment with this medication should be reconsidered.
• Children and adolescents aged 8 to 18 with depression: Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day (administered as 2.5 ml of the Fluoxetina Normon oral solution presentation). After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that the patient remains on the minimum effective dose. Children with low weight may require lower doses. Your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved, treatment should be reconsidered.
• If you are an elderly patient, the dose increases made by your doctor should be carried out more carefully, and the daily dose should not generally exceed 40 mg. The maximum dose is 60 mg per day.
• If you have a liver problem or are using another medication that may affect fluoxetine, your doctor will decide to prescribe a lower dose or instruct you on how to use this medication on alternate days.

Method of administration:

Measure the appropriate amount of medication using the dosing cup, then take it.

• If you take more Fluoxetina Normon than you should

In case of overdose or accidental ingestion, go to a medical center, consult your doctor or pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeats or cardiac arrest), respiratory problems, and changes in mental state ranging from excitement to coma.

• If you forgot to take Fluoxetina Normon

• Do not worry if you forgot to take a dose. Take the next dose the following day at the usual time. Do not take a double dose to compensate for the missed doses.
• Taking your medicine at the same time every day may help you remember to take it regularly.

• If you interrupt treatment with Fluoxetina Normon

Do not stop taking this medication unless your doctor has told you to.It is essential that you continue taking your medication.

• Do not stop taking your medication without first asking your doctor, even if you start feeling better.
• Make sure you do not run out of medication.

You may experience the following effects when interrupting treatment with Fluoxetina Normon: dizziness, a sensation of pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), a feeling of restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting, tremors (instability), and headaches.

Most people find that the symptoms that occur when interrupting treatment with fluoxetine are moderate and resolve on their own within a few weeks. If you experience these symptoms when interrupting your treatment, consult your doctor.

When interrupting treatment with Fluoxetina Normon, your doctor will help you gradually reduce the dose over one to two weeks, which will help reduce the likelihood of withdrawal effects.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

• -If you have a skin rash or allergic reactions such as itching, swelling of the face or lips, or difficulty breathing, stop taking Fluoxetina Normon and tell your doctor immediately.
• If you feel restless and feel like you cannot sit or stay still, you may be experiencing something called akathisia, so increasing your dose of Fluoxetina Normon may make you feel worse. If you feel this way,consult your doctor.
• Tell your doctor immediatelyif your skin starts to redden and then blisters or peels. This happens very rarely.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) that includes fever of unknown cause with increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (only rarely).
• Feeling weak, drowsy, or confused mainly in the elderly and in people treated with diuretics (the elderly).
• Prolonged and painful erection.
• Irritability and extreme agitation.

If you experience any of the side effects described above, contact your doctor immediately.

If you experience any of the symptoms described below and they bother you or persist over time, inform your doctor:

Generalized disorders: Chills, sensitivity to light, weight loss.

Digestive system: Diarrhea and stomach discomfort, vomiting, indigestion, difficulty swallowing, or alteration of taste or dry mouth. Rarely, abnormalities in liver function tests have been reported, with very rare cases of hepatitis.

Nervous system: Headache, sleep disturbances, or abnormal dreams, dizziness, loss of appetite, fatigue, euphoria, involuntary movements, convulsions, extreme restlessness, hallucinations, abnormal behavior, confusion, agitation, anxiety, nervousness, inability to concentrate and think clearly, panic attacks, or thoughts of suicide or self-harm.

Urinary and reproductive system disorders and breast disorders: Difficulty urinating, increased frequency of urination, sexual dysfunction, prolonged erections, and milk production.

Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see««Pregnancy»1in section 2 for more information (frequency not known).

Respiratory system: Sore throat, difficulty breathing. Rarely, pulmonary changes (including inflammatory processes and various histopathological processes and/or fibrosis) have been reported.

Other: Hair loss, yawning, blurred vision, unexplained bruises or bleeding, sweating, hot flashes, feeling dizzy when standing up, muscle or joint pain, low sodium levels in the blood.

Most of these side effects tend to disappear with continued treatment.

Additionally, in children and adolescents (8 to 18 years)fluoxetine may slow growth or delay sexual maturation.

If you notice side effects not mentioned in this leaflet or if you experience one of the side effects described in a severe manner, inform your doctor or pharmacist.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use 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 after CAD. The expiration date is the last day of the month indicated.

• No special conditions for conservation are required.
• Medications should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Fluoxetina Normon 20 mg/5 ml oral solution

The active ingredient is fluoxetine in the form of hydrochloride.

The other components are: Benzoic acid (E-210), sucrose, glycerol (E-422), peppermint essence, and purified water.

Appearance of the product and contents of the packaging

Fluoxetina Normon 20 mg/5 ml oral solution is presented in containers with 70 and 140 ml of oral solution for use. Each container has a dosing cup with measurements of 2.5 to 15 ml.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid (SPAIN)

Date of the last review of this leaflet:January 2021

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