FLUOXETINE CINFA 20 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

fluoxetine cinfa 20 mg dispersible tablets EFG

Fluoxetine hydrochloride

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is fluoxetine cinfa and what is it used for
2. What you need to know before you take fluoxetine cinfa
3. How to take fluoxetine cinfa
4. Possible side effects
5. Storing fluoxetine cinfa
6. Package contents and further information

1. What is fluoxetine cinfa and what is it used for

Fluoxetine 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
• Bulimia nervosa: fluoxetine 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 only be offered to children or young people with moderate to severe depression in combination with psychological therapy.

How fluoxetine cinfa works

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

Treating these conditions is important to help you improve. If left untreated, your illness may not disappear and may become more severe and more difficult to treat.

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

2. What you need to know before you take fluoxetine cinfa

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 have a rash or other type of allergic reaction (such as itching, swelling of the face or lips or shortness of breath), stop taking the tablets immediately and contact your doctor as soon as possible.
• If you are taking other medicines, known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as a severe or life-threatening reaction may occur (e.g. iproniazid, which is used to treat depression).

Treatment with fluoxetine can only be started after 2 weeks after finishing a treatment with an irreversible non-selective MAOI.

Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine medication. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider the need to set a longer interval before taking an MAOI.

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking fluoxetine cinfa

• If you have heart disease.
• If you start to experience fever, muscle stiffness or tremors, changes in your mental state such as confusion, irritability and 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, contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• If you suffer from mania or have suffered from mania in the past; if you have a manic episode, contact your doctor immediately, as you may need to stop treatment with fluoxetine;
• If you have a history of bleeding disorders or if you develop bruising or unusual bleeding, or if you are pregnant (see "Pregnancy").
• If you are taking medicines that affect blood clotting (see "Other medicines and fluoxetine cinfa").
• If you have epilepsy or seizures. If you have had seizures or experience an increase in the frequency of seizures, contact your doctor immediately; you may need to stop treatment with fluoxetine.
• If you are receiving electroconvulsive therapy (ECT).
• If you are being treated with tamoxifen (used to treat breast cancer) (see "Other medicines and fluoxetine cinfa").
• If you start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of fluoxetine may worsen it.
• 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 a low resting heart rate and/or if you know you may have salt loss as a result of severe prolonged diarrhea and vomiting or the use of diuretics (water pills).
• If you are taking diuretics (water pills), especially if you are an elderly patient.
• Glaucoma (increased eye pressure).

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. This may increase when you first start taking antidepressants, as all these medicines need time to start working, usually around 2 weeks, although in some cases it may be longer.

You will be more likely to have these thoughts:

• If you have had suicidal thoughts or self-harm before.
• 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 have suicidal thoughts or self-harm at any time, contact your doctor or go to the hospital immediately.

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 package leaflet. You can ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and adolescents

Patients under 18 years have a higher risk of side effects such as suicidal attempts, suicidal thoughts and hostility (mainly aggression, confrontational behavior and irritability) when taking this type of medicine. Fluoxetine 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.

Additionally, there is only limited information regarding the long-term safety of fluoxetine in relation to growth, puberty and cognitive, emotional and behavioral development in this age group. Nevertheless, and if you are a patient under 18 years, your doctor may prescribe fluoxetine for the treatment of moderate to severe depressive episodes in combination with psychological therapy when they decide it is the most convenient for the patient. If your doctor prescribes this medicine to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when patients under 18 years are taking fluoxetine.

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

Sexual dysfunction

Some medicines of 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take fluoxetine with:

• Irreversible non-selective monoamine oxidase inhibitors (MAOIs,some of which are used to treat depression. Irreversible non-selective MAOIs should not be used with fluoxetine as they may cause serious or life-threatening reactions (serotonin syndrome), (see section "Do not take fluoxetine cinfa"). Treatment with fluoxetine should only be started at least 2 weeks after stopping a treatment with an irreversible MAOI (e.g. tranilcipromine). Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine medication. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider the need to set a longer interval before taking an MAOI.
• Metoprololwhen used for heart failure; as it increases the risk of excessive slowing of heartbeats.

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

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment because fluoxetine may change the blood levels of this medicine and it cannot be ruled out that the effect of tamoxifen may be reduced.
• Monoamine oxidase A inhibitors (MAO-A)including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also known as methylthionine, used to treat mild eye irritation): due to the risk of serious or life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine can be started the day after finishing a treatment with reversible MAOIs, but your doctor may monitor you closely and use a lower dose of the MAOI medicine.
• Mequitazine(used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in heart electrical activity.
• Phenytoin(a medicine used for epilepsy): fluoxetine may increase the blood levels of this medicine, so your doctor will need to monitor you more closely when administering phenytoin with fluoxetine and will need to review you more frequently.
• Lithium, selegiline, St. John's Wort, tramadol(for pain treatment), triptans(for migraine treatment) andtryptophan: there is an increased risk of mild serotonin syndrome if these medicines are administered with fluoxetine. Your doctor will monitor you more closely.
• Medicines that may affect heart rhythm, such as Class IA and III antiarrhythmicsand antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents(e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), malaria treatment, particularly halofantrine, or some antihistamines(astemizole, mizolastine), as taking one or more of these medicines with fluoxetine may increase the risk of changes in heart electrical activity.
• Anticoagulants(such as warfarin), NSAIDs(such as ibuprofen, diclofenac), aspirinand other medicines that have an effect on blood clotting(including clozapine, used to treat some mental disorders). Fluoxetine may alter the effect of these medicines in the blood. Your doctor will need to perform certain tests, adjust your dose and monitor you more closely if you start or stop treatment with fluoxetine while taking warfarin.
• Cyproheptadine(used to treat allergies); as it may reduce the effect of fluoxetine.
• Medicines that decrease sodium levels in the blood(including, medicines that increase urine production, desmopressin, carbamazepine and oxcarbazepine); as the use of fluoxetine with these medicines may increase the risk of excessive decrease in sodium levels in the blood.
• Antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine(used to treat malaria), tramadol(for pain treatment) or antipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine with these medicines may increase the risk of seizures.
• Flecainide, propafenone, nebivolol or encainide(for heart problems), carbamazepine(for epilepsy treatment), atomoxetine or tricyclic antidepressants(e.g. imipramine, desipramine and amitriptyline)or risperidone(for schizophrenia treatment); as fluoxetine may change the blood levels of these medicines, it is possible that your doctor will need to reduce your dose when administered with fluoxetine.

Taking fluoxetine cinfa with food, drinks and alcohol

• Fluoxetine can be taken with or without food, as you prefer.
• It is not advisable to drink alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility

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

Pregnancy

In babies whose mothers took fluoxetine during the first months of pregnancy, there are studies that describe a higher risk of suffering from congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to about 2 in 100 in 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 disease in 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.

If you take fluoxetine in the final stage of pregnancy, it may cause a higher 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 to be able to 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 stop taking fluoxetine gradually 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 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 and difficulty sleeping or feeding.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause side effects in children. Breastfeeding should only be continued if it is absolutely necessary. If breastfeeding continues, 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 the impact on human fertility has not been observed yet.

Driving and using machines

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

fluoxetine cinfa contains sodium

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

3. How to take fluoxetine cinfa

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

Method of administration

Swallow the tablets with half a glass of water or dissolved in half a glass of water, which should 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 if necessary 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 lowest effective dose. You may not feel better immediately after starting to take your medication for depression. This is common, as improvement in depressive symptoms does not occur until after the first few weeks of treatment.

Patient 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 from 8 to 18 years 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 up to 20 mg/day. The dose should be increased carefully to ensure that you receive the lowest effective dose. Children with low weight may require lower doses. If there is a satisfactory response to treatment, your doctor should reassess the need to continue treatment after 6 months. If you have not improved within 9 weeks, treatment should be reconsidered.

Use in elderly patients

Dose increases 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.

Hepatic impairment

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

If you take more fluoxetine cinfa than you should

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

If possible, bring the fluoxetine packaging with you.

Symptoms of overdose include nausea, vomiting, seizures, heart problems (such as irregular heartbeat or cardiac arrest), lung problems, and changes in mental status 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 following day at the usual time. Do not take a double dose to make up for the missed doses.

Taking your medication at the same time every day can help you remember to take it regularly.

If you stop treatment with fluoxetine cinfa

Do not stop taking fluoxetine unless your doctor has indicated it, even if you start to feel 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, sensation of tingling similar to pinpricks or needles, sleep disturbances (intense dreams, nightmares, insomnia), feeling of restlessness or agitation, unusual fatigue or weakness, anxiety, nausea and/or vomiting (feeling sick or being sick), tremors (instability), and headache.

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 possibility of withdrawal effects.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

• If you have suicidal thoughts or self-harm at any time, contact your doctor or go directly to the hospital (see section 2).
• If you have a skin rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, stop taking the tablets and inform your doctor immediately.
• If you feel restless and feel like you cannot sit still or stay quiet, you may have something called akathisia, and increasing your fluoxetine dose could make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediately if your skin starts to redden or shows any type of reaction or blisters, or if your skin begins to peel. This happens very rarely.

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

Some patients have experienced:

• A combination of symptoms (known as "serotonin syndrome") that include unknown cause fever with increased breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (only in rare cases).
• Feeling of weakness, 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 above side effects, inform your doctor immediately.

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

Frequent (may affect up to 1 in 10 people)

• Lack of appetite, weight loss.
• Nervousness, anxiety.
• Restlessness, lack of concentration.
• Feeling of nervous tension.
• Decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity).
• Sleep disturbances, abnormal dreams, fatigue, or drowsiness.
• Dizziness.
• Alteration of taste.
• Uncontrollable tremors.
• Blurred vision.
• Feeling of rapid and irregular heartbeats.
• Flushing.
• Indigestion, vomiting.
• Dry mouth.
• Skin rash, hives, itching.
• Excessive sweating.
• Joint pain.
• Increased frequency of urination.
• Unexplained vaginal bleeding.
• Feeling of weakness or chills.

Infrequent (may affect up to 1 in 100 people)

• Feeling separated, distant from oneself.
• Strange thoughts.
• Euphoria.
• Sexual problems, including orgasm problems, occasionally persisting after treatment discontinuation.
• Suicidal thoughts or self-harm.
• Teeth grinding.
• Muscle spasms, involuntary movements, or balance and coordination problems.
• Memory disturbances.
• Dilated pupils.
• Noise in the ears.
• Low blood pressure.
• Breathing difficulties.
• Nosebleeds.
• Difficulty swallowing.
• Hair loss.
• Increased tendency to bruising.
• Unexplained bruising or bleeding.
• Cold sweats.
• Difficulty urinating.
• Feeling of cold or heat.
• Liver test abnormalities.

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

• Low sodium levels in the blood.
• Reduced platelet count in the blood, which increases the risk of bleeding or bruising.
• Reduced white blood cell count.
• Atypically unrestrained behavior.
• Hallucinations.
• Agitation.
• Panic attacks.
• Confusion.
• Stuttering.
• Aggressiveness.
• Seizures.
• Vasculitis (inflammation of a blood vessel).
• Rapid swelling of tissues around the neck, face, mouth, and/or throat.
• Pain in the esophagus (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)

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

Bone 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 decrease growth or delay sexual maturation.

Suicidal behavior (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have also been frequently reported in children.

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online system: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of fluoxetine cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of fluoxetine cinfa

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

• The other ingredients are: Tablet core:anhydrous colloidal silica, pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, xylitol, sodium stearyl fumarate, sodium saccharin, and peppermint flavor. Tablet coating:hypromellose, macrogol 6000.

Appearance of the product and package contents

Dispersible, cylindrical, biconvex, coated tablets, white in color, scored on one side, and marked with the code "F20C" on the other side.

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

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:May 2021

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

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

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