FLUOXETINE NORMON 20 mg/5 ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Fluoxetine Normon 20 mg/5 ml Oral Solution 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 is Fluoxetine Normon and what is it used for
2. What you need to know before you take Fluoxetine Normon
3. How to take Fluoxetine Normon
4. Possible side effects
5. Storing Fluoxetine Normon
6. Contents of the pack and other information

1. What is Fluoxetine Normon and what is it used for

Fluoxetine 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: Fluoxetine 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 psychological therapy.

2. What you need to know before you take Fluoxetine Normon

• Do not take Fluoxetine 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 non-selective monoamine oxidase inhibitor (MAOI) or reversible MAO-A inhibitor (e.g. moclobemide), as serious or life-threatening reactions may occur (serotonin syndrome), see section "Do not take Fluoxetine Normon". MAO-B inhibitors (e.g. selegiline) may be used with fluoxetine, provided that your doctor monitors your treatment carefully.

or reversible MAO-A inhibitors (e.g. moclobemide), as serious or life-threatening reactions may occur (serotonin syndrome), see section "Do not take Fluoxetine Normon".

Treatment with fluoxetine can only be started after two weeks after stopping treatment with an irreversible MAOI (e.g. tranylcypromine).

However, treatment with fluoxetine can be started the day after stopping treatment with certain reversible MAOIs, known as reversible MAO-A inhibitors (e.g. moclobemide).

Do not take any MAOI for at least five weeks after stopping treatment with fluoxetine. If you have been prescribed this medicine for a long time and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI. Examples of MAOIs are: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid, and toloxatone.

• Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine.

• If you develop skin rash 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 previously suffered from seizures, if you have seizures or experience an increase in the frequency of seizures, contact your doctor immediately, you may need to discontinue 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 bruising or unusual bleeding.
• If you are taking medicines that affect blood clotting (see "Taking other medicines").
• If you start to experience fever, stiffness or muscle tremors, changes in your mental state such as confusion, irritability or extreme agitation, you may be suffering from a condition called serotonin syndrome or neuroleptic malignant 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 Fluoxetine Normon in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Fluoxetine Normon so that they can advise you.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Some medicines in the same group as Fluoxetine Normon (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

• Children and adolescents from 8 to 18 years

Patients under 18 years have a higher risk of side effects such as suicidal attempts, suicidal thoughts and hostility (mainly aggression, confrontational behaviour and irritability) when taking this type of medicine. Fluoxetine Normon should only be used in children and adolescents from 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 on the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional and behavioural development in this age group. However, your doctor may prescribe this medicine to patients under 18 years 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 Fluoxetine Normon to a patient under 18 years and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the above symptoms appear or worsen when patients under 18 years are taking this medicine.

This medicine should not be used in the treatment of children under 8 years of age.

• Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may be 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 data have shown an increased risk of suicidal behaviour in young adults (less than 25 years) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behaviour.

• Other medicines and Fluoxetine Normon

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

• MAOIs (medicines used to treat depression). Non-selective MAOIs and MAO-A inhibitors (e.g. moclobemide) should not be used with fluoxetine, as serious or life-threatening reactions may occur (serotonin syndrome), see section "Do not take Fluoxetine Normon". MAO-B inhibitors (e.g. selegiline) may be used with fluoxetine, provided that your doctor monitors your treatment carefully.
• Lithium, tryptophan: there is an increased risk of serotonin syndrome if these medicines are administered with fluoxetine. When fluoxetine is administered in combination with lithium, your doctor should monitor you more frequently.
• Phenytoin (medicine used for epilepsy), fluoxetine may increase the blood levels of this medicine, so your doctor should adjust the dose of phenytoin with caution when administered with Fluoxetine Normon and should monitor you more frequently.
• Clozapine (used to treat some mental disorders), tramadol (for pain treatment) or triptans (for migraine treatment), there is an increased risk of hypertension.
• Flecainide or encainide (for heart problems), carbamazepine (for epilepsy treatment), tricyclic antidepressants (e.g. imipramine, desipramine and amitriptyline), because fluoxetine may change the blood levels of these medicines, so your doctor may need to reduce your dose when administered with Fluoxetine Normon.
• Warfarin or other medicines that affect blood clotting; fluoxetine may alter the effect of these medicines in the blood. Your doctor will need to perform certain tests if you start or stop treatment with Fluoxetine Normon while taking warfarin.
• Do not start taking herbal preparations containing St. John's Wort (Hypericum perforatum) while you are being treated with this medicine, as it may increase the risk of side effects. If you start treatment with Fluoxetine Normon while you are taking St. John's Wort, stop taking it and inform your doctor at your next visit.

• Taking Fluoxetine Normon with food, drinks and alcohol

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

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

• Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Information obtained to date does not indicate an increased risk when this medicine is used during pregnancy. However, caution should be exercised when used during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty feeding or sleeping.

In babies whose mothers took fluoxetine during the first months of pregnancy, there are reports suggesting a higher risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to approximately 2 in 100 in babies whose mothers took fluoxetine. You and your doctor can decide that while you are pregnant it is better to stop taking fluoxetine gradually. However, depending on your circumstances, your doctor may suggest that you continue taking fluoxetine.

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

Breast-feeding

Fluoxetine is excreted in breast milk and may cause side effects in the child. You should only continue breast-feeding if it is absolutely necessary. If you continue breast-feeding, your doctor may prescribe a lower dose of fluoxetine.

Fertility

Animal studies have shown that fluoxetine reduces sperm quality. This could theoretically affect fertility, but the impact on human fertility has not been observed to date.

• Driving and using machines

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

• Fluoxetine Normon contains sucrose and benzoic acid (E-210)

This medicine contains sucrose. 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.

3. How to take Fluoxetina Normon

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 if necessary within 3 to 4 weeks after starting treatment. When necessary, the dose can be gradually increased up to a maximum of 60 mg. The dose should be carefully increased to ensure that you receive the lowest effective dose. You may not feel better immediately after starting to take your medication for depression. This is common since there is no improvement in depressive symptoms until after the first few weeks after starting 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 gradually increased up to a maximum of 60 mg. If no improvement is observed within 10 weeks, treatment with this medication should be reconsidered.
• Children and adolescents from 8 to 18 years 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 up to 20 mg/day. The dose should be carefully increased to ensure that the patient maintains the lowest effective dose. Children with low weight may need 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 other medication that may affect fluoxetine, your doctor will decide whether 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 swallow 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose include: nausea, vomiting, seizures, heart problems (such as irregular heartbeat or cardiac arrest), lung 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 make up for the missed doses.
• Taking your medicine at the same time every day can help you remember to take it regularly.

• If you interrupt treatment with Fluoxetina Normon

Do not stop taking this medication unless your doctor has indicated it. It is important that you continue taking your medication.

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

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

Most people find that the symptoms that occur when interrupting treatment with fluoxetine are moderate and disappear spontaneously in 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 possibility of withdrawal effects.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people experience them.

• -If you have a skin rash or allergic reactions such as itching, swelling of the face or lips, or shortness of breath, stop taking Fluoxetina Normon and tell your doctor immediately.
• If you feel restless and feel like you cannot sit still or remain quiet, you may be suffering from something called akathisia, and increasing your dose of Fluoxetina Normon could make you feel worse. If you feel this way, consult your doctor.
• Talk to 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 include unexplained fever with increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or drowsiness (only rarely).
• Feeling of weakness, drowsiness, or confusion mainly in the elderly and in people treated with diuretics (elderly).
• Prolonged and painful erection.
• Irritability and extreme agitation.

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

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

General disorders: Cooling, sensitivity to light, weight loss.

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

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

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

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

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

Others: Hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flashes, feeling of dizziness when standing up, muscle or joint pain, low sodium levels in the blood.

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

In addition, in children and adolescents (8 to 18 years), fluoxetine may decrease growth or delay sexual maturation.

If you notice adverse effects not mentioned in this prospectus or if you suffer from one of the adverse effects described in a severe form, inform your doctor or pharmacist.

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 does not appear in this prospectus. You can also report them directly through the Spanish Medication Pharmacovigilance System www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fluoxetina Normon

Keep this medication out of 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 storage conditions are required.
• Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Fluoxetina Normon 20 mg/5 ml oral solution

The active principle 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 package contents

Fluoxetina Normon 20 mg/5 ml oral solution is presented in packages with 70 and 140 ml of oral solution. Each package has a dosing cup with measures from 2.5 to 15 ml.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this prospectus:January 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.