Fluoxetine Normon 20 mg/5 ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluoxetina 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 as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fluoxetina Normon is and what it is used for
2. What you need to know before taking Fluoxetina Normon
3. How to take Fluoxetina Normon
4. Possible side effects
5. How to store Fluoxetina Normon
6. Contents of the pack and other information

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

Fluoxetina Normon belongs to a group of medicines known as 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 an adjunct to psychotherapy for the reduction of binge eating and purging.

Children over 8 years of age and adolescents:

• Moderate to severe depressive episodes, when there is no response to psychological therapy after 4 to 6 sessions. Fluoxetine should be offered to children or adolescents with moderate to severe depression only in combination with psychological therapy.

2. What you need to know before taking Fluoxetina Normon

• Do not take Fluoxetina Normon

• If you are allergic (hypersensitive) to fluoxetine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of the face or lips, or difficulty breathing.

• If you are taking any medicine belonging to another group of medicines also used to treat depression, known as non-selective monoamine oxidase inhibitors (MAOIs),
  or reversible inhibitors of monoamine oxidase type A (also called MAO-A inhibitors), a serious or even fatal adverse reaction may occur.

Treatment with fluoxetine may only be started two weeks after stopping treatment with an irreversible MAO inhibitor (e.g. tranylcypromine).

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

Do not take any MAO inhibitors for at least five weeks after stopping treatment with fluoxetine. 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 starting an MAO inhibitor. Examples of MAO inhibitors are: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid, and toloxatone.

• Warnings and precautions

Talk to your doctor or pharmacist before taking 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 previously had seizures, or if you experience seizures or an increase in their frequency, contact your doctor immediately; you may need to discontinue treatment with fluoxetine.
• If you have previously experienced mania, and you have a manic episode, contact your doctor immediately; you may need to discontinue fluoxetine.
• If you have diabetes, your doctor may need to adjust your insulin dose 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 elderly.
• If you are receiving electroconvulsive therapy (ECT).
• If you have a history of bleeding disorders or if you develop unusual bruising or bleeding.
• If you are taking medicines that affect blood clotting (see "Taking other medicines").
• If you start experiencing fever, muscle stiffness or twitching, changes in mental status such as confusion, irritability, or extreme agitation, you may be experiencing a condition called serotonin syndrome or neuroleptic malignant syndrome. Although rare, this condition can be life-threatening, so contact your doctor immediately; fluoxetine treatment may need to be discontinued.
• If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
• If you are pregnant (see **"Pregnancy"**1).

Pregnancy1

If you take Fluoxetina Normon in the late stages of pregnancy, there is an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Fluoxetina Normon so they can advise you appropriately.

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

Some medicines in the group to which Fluoxetina Normon belongs (called SSRIs/SNRIs) 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

Patients under 18 years of age have a higher risk of adverse effects such as suicide 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 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 regarding the long-term safety of fluoxetine with respect to growth, puberty, and cognitive, emotional, and behavioral development in this age group. Nevertheless, 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 consider it appropriate. If your doctor prescribes Fluoxetina Normon to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms mentioned above appear or worsen while patients under 18 years of age are taking this medicine.

This medicine should not be used in 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 occasionally have thoughts of self-harm or suicide. These may increase when first starting antidepressants, as all these medicines require time to take effect—usually about two weeks, although in some cases it may take longer.

You are more likely to have such 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 behavior in young adults (under 25 years) with psychiatric disorders 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 close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether 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, have recently taken (within the last 5 weeks), or might need to take any other medicines. This medicine may affect the action of other medicines (interaction). Interactions may occur with:

• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression). Non-selective MAO inhibitors and MAO inhibitors known as MAO-A inhibitors (e.g. moclobemide) must not be used with fluoxetine, as serious or even fatal reactions (serotonin syndrome) may occur (see section "Do not take Fluoxetina Normon"). MAO inhibitors known as MAO-B inhibitors (selegiline) may be used with fluoxetine provided your doctor carefully monitors your treatment.

• Lithium, tryptophan: there is an increased risk of serotonin syndrome if these medicines are taken with fluoxetine. When fluoxetine is administered with lithium, your doctor should monitor you more frequently.

• Phenytoin (a medicine used for epilepsy): fluoxetine may increase blood levels of this medicine, so your doctor should carefully adjust your phenytoin dose when administered with Fluoxetina Normon and monitor you more frequently.

• Clozapine (used to treat certain 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), tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline), because fluoxetine may alter blood levels of these medicines; thus, your doctor may need to reduce their dose when co-administered with Fluoxetina Normon.

• Warfarin or other medicines that affect blood clotting: fluoxetine may alter the effect of these medicines on blood. Your doctor will need to perform certain blood tests if you start or stop treatment with Fluoxetina Normon while taking warfarin.

• Do not start taking herbal preparations containing St. John’s wort (Hypericum perforatum) while being treated with this medicine, as this may lead to an increase in adverse effects. If you are taking St. John’s wort when starting treatment with Fluoxetina Normon, stop taking it and inform your doctor at your next visit.

• Taking Fluoxetina Normon with food, drinks, and alcohol

Fluoxetina Normon may be taken with or without food, as preferred.

Alcohol consumption is not recommended while taking this medicine.

• Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

In infants whose mothers took fluoxetine during the first months of pregnancy, reports suggest an increased risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This risk increased to about 2 in 100 in babies whose mothers took fluoxetine. You and your doctor may decide it is better to gradually discontinue fluoxetine during pregnancy. However, depending on your circumstances, your doctor may recommend continuing fluoxetine.

Ensure that your midwife and/or doctor knows you are taking Fluoxetina Normon. Medicines like Fluoxetina Normon, when taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. 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 infants. You should continue breastfeeding only if absolutely necessary. If breastfeeding is continued, your doctor may prescribe a lower dose of fluoxetine.

Fertility

Animal studies have shown that fluoxetine reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

• Driving and using machines

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

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

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

May be harmful to teeth.

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

3. How to take Fluoxetina Normon

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is:

• Depression: The recommended initial dose is 20 mg. Your doctor may review and adjust your dose as necessary within the first 3 to 4 weeks of starting treatment. When necessary, the dose may be gradually increased up to a maximum of 60 mg. The dose should be increased carefully to ensure you receive the lowest effective dose. You may not feel better immediately when starting your antidepressant medication. This is common, as improvement in depressive symptoms typically does not occur 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 may be gradually increased up to a maximum of 60 mg. If no improvement is observed within 10 weeks, treatment with this medicine should be reconsidered.
• Children and adolescents aged 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 Fluoxetina Normon oral solution). After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure the patient remains on the lowest effective dose. Children with low body 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, dose increases should be made more cautiously, and the daily dose generally should not exceed 40 mg. The maximum dose is 60 mg per day.
• If you have liver problems or are taking other medications that may interact with fluoxetine, your doctor will decide whether to prescribe a lower dose or instruct you to take this medicine 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 at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeat or cardiac arrest), respiratory problems, and changes in mental status ranging from agitation to coma.

• If you forget to take Fluoxetina Normon

• Do not worry if you forget a dose. Take your next dose the following day at the usual time. Do not take a double dose to make up for missed doses.

• Taking your medicine at the same time each day may help you remember to take it regularly.

• If you stop taking Fluoxetina Normon

Do not stop taking this medicine unless your doctor has instructed you to do so. It is important that you continue taking your medicine.

• Do not stop taking your medicine without first consulting 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 stopping treatment with Fluoxetina Normon: dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of restlessness or agitation, unusual tiredness or weakness, anxiety, nausea and/or vomiting, tremors (shakiness), and headache.

Most people find that symptoms occurring when stopping fluoxetine are mild and resolve spontaneously within a few weeks. If you experience these symptoms when stopping treatment, consult your doctor.

When discontinuing 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 further 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 everyone experiences them.

• -If you develop a skin rash or allergic reactions such as itching, swelling of the face or lips, or difficulty breathing, stop taking Fluoxetine Normon and tell your doctor immediately.
• If you feel restless and have an urge to keep moving or an inability to sit still, you may be experiencing a condition called akathisia; increasing your dose of Fluoxetine Normon could worsen this. If you feel this way, consult your doctor.
• Contact your doctor immediately if your skin becomes red and then blisters or starts to peel. This is very rare.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) including unexplained fever with increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only very rarely).
• Weakness, drowsiness, or confusion, mainly in elderly patients and in patients treated with diuretics (elderly).
• Prolonged and painful erection.
• Irritability and extreme agitation.

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

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

General disorders: Chills, light sensitivity, weight loss.

Gastrointestinal system: Diarrhea and stomach discomfort, vomiting, indigestion, difficulty swallowing, altered sense 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, uncontrollable movements, seizures, extreme restlessness, hallucinations, unusually reckless behavior, confusion, agitation, anxiety, nervousness, difficulty concentrating and thinking clearly, panic attacks, or thoughts of suicide or self-harm.

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

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

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

Other: Hair loss, yawning, blurred vision, bruising or unexplained bleeding, sweating, hot flushes, dizziness upon standing, muscle or joint pain, low sodium levels in blood.

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

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

If you notice any adverse effects not listed in this leaflet, or if you experience any of the listed adverse effects severely, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluoxetine Normon

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

• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

• No special storage conditions are required.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluoxetine Normon 20 mg/5 ml oral solution

The active substance is fluoxetine in the form of hydrochloride.

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

Appearance of the product and contents of the pack

Fluoxetine Normon 20 mg/5 ml oral solution is available in containers with 70 ml and 140 ml of oral solution. Each container includes a dosing cup with markings 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 most recent revision of this summary: January 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.