Package Leaflet: Information for the User

fluoxetina cinfa 20 mg dispersible tablets EFG

Fluoxetine hydrochloride

Read 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. Do 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 leaflet. See section 4.

Fluoxetine belongs to a group of medications known as selective serotonin reuptake inhibitors (SSRIs).

This medication is indicated for the treatment of:

Adults:

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

Older children and adolescents (over 8 years):

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 psychotherapy.

How fluoxetine cinfa works

Every person has a substance called serotonin in their brain. People who are depressed or have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. The exact way fluoxetine and other SSRIs work is not fully understood, but they may help by increasing serotonin levels in the brain.

Treatment of these conditions is important to help improve. If not treated, your condition cannot disappear and may become more severe and harder to treat.

You may need to be treated for a few weeks or months to ensure you are free of symptoms.

Do not take fluoxetine cinfa

• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).
• If you experience an allergic reaction (such as hives, swelling of the face or lips, or difficulty breathing), stop taking the capsules immediately and contact your doctor as soon as possible.
• If you are taking other medicines, known as irreversible non-selective monoamine oxidase inhibitors (IMAOs), as this may cause a serious or fatal reaction (for example, iproniazid, which is used to treat depression).

Fluoxetine treatment can only be initiated after two weeks of completing a treatment with an irreversible non-selective MAO inhibitor.

Do not take any irreversible non-selective MAO inhibitor for at least five weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider setting a longer interval before taking an MAO inhibitor.

• If you are taking metoprolol (to treat heart failure) as this increases the risk of excessive slowing of the heart rate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluoxetine cinfa

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. This may increase when you start taking antidepressants, as all these medicines need 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. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with antidepressants.

If you ever have thoughts of self-harm or suicide, contact your doctor or go directly to the 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 has worsened, or if they are concerned about changes in your behavior.

Children and adolescents

Patients under 18 years have a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine.Fluoxetineshould 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 offluoxetinein relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. Despite this, and if you are a patient under 18 years, your doctor may prescribefluoxetinefor the treatment of moderate to severe depressive episodes in combination with psychological therapy when they decide it is in the best interest of the patient. If your doctor prescribes this medicineto a patient under 18 years and you wish to discuss this decision, please return to your doctor You must inform your doctor if any of the symptoms indicated above appear or worsen when patients under 18 years are takingfluoxetine.

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

Sexual dysfunction

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

Other medicines and fluoxetine cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not take fluoxetine with:

• Irreversible non-selective monoamine oxidase inhibitors (IMAOs)some of whichare used to treat depression. Do not use fluoxetine with irreversible non-selective MAO inhibitors as this may cause serious or fatal reactions (serotonin syndrome), (see section “Do not take fluoxetine cinfa”). Fluoxetine treatment can only be initiated at least 2 weeks after stopping a treatment with an irreversible non-selective MAO inhibitor (for example, tranilcipromina). Do not take any irreversible non-selective MAO inhibitor for at least 5 weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider setting a longer interval before taking an MAO inhibitor.
• Metoprololwhen used to treat heart failure; as this increases the risk of excessive slowing of the heart rate.

Fluoxetine may affect the action of other medicines (interaction):

Fluoxetine cinfa with food, drinks, and alcoholandalcohol

• Fluoxetinecan be taken with or without food, as you prefer.
• It is not recommended to take 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

Studies in babies whose mothers took fluoxetine during the first months of pregnancy have described an increased risk of congenital heart defects. 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.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like fluoxetine 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 within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take fluoxetine 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 so they can advise you.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, you and your doctor may decide to gradually stop taking fluoxetine during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to continue taking fluoxetine.

Caution should be exercised when using 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, and difficulty feeding or sleeping.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause adverse effects in the baby. 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 the impact on human fertility has not been observed so far.

Driving and operating machinery

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

Fluoxetine cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not take more tablets than indicated by your doctor.

Administration Form

Swallow the tablets with half a glass of water or dissolved in half a glass of water, which must be swallowed immediately and completely. Do not chew the tablets.

The tablet can be divided into equal doses.

Adults:

The recommended dose is:

Depression:The recommended dose is 1 tablet (20 mg) per day. Your doctor may review and adjust your dose as needed within 3 to 4 weeks after starting treatment. When necessary, the dose can be gradually increased up to a maximum of 3 tablets (60 mg) per day. 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 3 tablets (60 mg) per day.

Obsessive-Compulsive Disorder:The recommended dose is 1 tablet (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 3 tablets (60 mg) per day. If no improvement is observed within 10 weeks, your doctor will reconsider your treatment.

Use in 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. After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that you receive the minimum effective dose. Children with low weight may require lower doses. If there is a satisfactory response to treatment, your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved in 9 weeks, treatment should be reconsidered.

Use in elderly patients

The dose increases made by your doctor should be carried out more carefully, and the daily dose should not generally exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) per day.

Liver dysfunction

If you have a liver problem or are using another medication that may interact with fluoxetine, your doctor will decide to prescribe a lower dose or instruct you on how to use fluoxetine in alternate days.

If you take more fluoxetine cinfa than you should

If you take too many tablets, go to the nearest hospital emergency service or consult your doctor immediately.

Bring the packaging of fluoxetine with you.

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

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.

If you forget to take fluoxetine cinfa

Do not worry if you forget to take a dose. Take the next dose the next 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 fluoxetine cinfa

Do not stop taking fluoxetine unless your doctor has told you to, even if you start feeling better. It is essential that you continue taking your medication.

Make sure you do not run out of medication.

You may experience the following effects (withdrawal effects) when stopping treatment with fluoxetine: 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 (feeling sick or being sick), tremors (unsteadiness), and headaches.

Most people find that the symptoms that occur when stopping treatment with fluoxetine are moderate and disappear within a few weeks. If you experience these symptoms when stopping your treatment, consult your doctor.

When stopping treatment with fluoxetine, your doctor will help you gradually reduce the dose over one to two weeks. This 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 causeside effects, although not everyone will experience them.

The most common side effects (very common side effects that can affect more than 1 in 10 people) are insomnia, headache, diarrhea, nausea and fatigue.

Some patients have experienced:

• A combination of symptoms (known as "serotonin syndrome") that includes fever of unknown cause with an increase in breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or somnolence (only in rare cases).
• Feeling weak, drowsiness or confusion, mainly in elderly patients and in people treated with diuretics.
• Prolonged and painful erection.
• Irritability and extreme agitation.
• Heart problems, such as rapid or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rhythm.

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

The following side effects have also been reported in patients taking fluoxetine.

Common (can affect up to 1 in 10 people)

• Loss of appetite, weight loss.
• Nervousness, anxiety.
• Restlessness, lack of concentration.
• Sensation of nervous tension.
• Decreased libido or sexual problems (including difficulty maintaining an erection during sexual activity).
• Changes in sleep, abnormal dreams, fatigue or somnolence.
• Dizziness.
• Alteration of taste.
• Uncontrollable tremors.
• Blurred vision.
• Sensation of rapid and irregular heartbeats.
• Flushing.
• Yawning.
• Indigestion, vomiting.
• Dry mouth.
• Skin rash, urticaria, itching.
• Excessive sweating.
• Joint pain.
• Increased frequency of urination.
• Unexplained vaginal bleeding.
• Sensation of weakness or chills.

Uncommon (can affect up to 1 in 100 people)

• Feeling detached, distant from oneself.
• Strange thoughts.
• Euphoria.
• Sexual problems, including orgasm problems, persisting occasionally after treatment is stopped.
• Thoughts of suicide or self-harm.
• Teeth grinding.
• Muscle spasms, involuntary movements or problems with balance or coordination.
• Memory changes.
• Dilated pupils.
• Noise in the ears.
• Low blood pressure.
• Difficulty breathing.
• Nasal bleeding.
• Difficulty swallowing.
• Hair loss.
• Increased tendency to bruise.
• Unexplained bruises or bleeding.
• Cold sweat.
• Difficulty urinating.
• Sensation of cold or heat.
• Abnormal liver test results.

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

• Low sodium levels in the blood.
• Reduction in platelet count in the blood, which increases the risk of bleeding or bruising.
• Reduction in white blood cell count.
• Atypical behavior.
• Hallucinations.
• Agitation.
• Panic attacks.
• Confusion.
• Stuttering.
• Aggression.
• Seizures.
• Vasculitis (inflammation of a blood vessel).
• Quick swelling of tissues around the neck, face, mouth and/or throat.
• Esophageal pain (the tube that connects the mouth to the stomach).
• Hepatitis.
• Lung problems.
• Sensitivity to sunlight.
• Muscle pain.
• Urination problems.
• Milk production.

Frequency not known(cannot be estimated from available data)

• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Fractures:In patients taking this type of medication, an increased risk of bone fractures has been observed.

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

Other side effects in children and adolescents (8 to 18 years)

In addition to the possible side effects mentioned above, fluoxetine may reduce growth or delay sexual maturation.

Self-destructive behaviors (suicide attempts and suicidal thoughts), hostility, mania, and nasal bleeding have also been reported frequently in children.

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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.esBy 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.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of fluoxetine cinfa

• The active ingredient is fluoxetine. Each dispersible tablet contains 20 mg of fluoxetine (in the form of fluoxetine hydrochloride).

• The other components are: Tablet core: colloidal anhydrous silica, pregelatinized starch, microcrystalline cellulose, sodium crospovidone, xylitol, sodium stearate fumarate, sodium saccharin, and peppermint aroma. Tablet coating: hypromellose, macrogol 6000.

Appearance of the product and content of the packaging

White, biconvex, coated, cylindrical, dispersible tablets with a notch on one side and marked with the code “F20C” on the other side.

Presented in ALU/ALU blisters. Each package contains blisters of 14, 28, or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: May 2021

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62722/P_62722.html

QR code to: https://cima.aemps.es/cima/dochtml/p/62722/P_62722.html