Package Leaflet: Information for the User

fluoxetina cinfa 20 mg hard capsules 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 similar symptoms to 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 a psychological therapy.

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

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 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.

• Glaucoma (increased eye pressure).

Thoughts of suicide and worsening of 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 starting to take 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 ever have thoughts of self-harm or suicide, contact your doctor or go directly to the hospital.

It may be helpful to tell a family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. 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 attempts, 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 prescribe fluoxetine for the treatment of moderate to severe depressive episodes in combination with psychological therapy when they decide it is the best option for the patient. If your doctor prescribes fluoxetine 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 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 IMAOs with fluoxetine as this may cause severe 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 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.

Fluoxetinemay affect the action of other medicines (interaction):

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment as fluoxetine may change the levels of this medicine in the blood and it cannot be ruled out that the effect of tamoxifen is reduced.

• Irreversible monoamine oxidase A inhibitors (IMAO-A)including moclobemida, linezolid (an antibiotic) and chlorpromazine (also known as methylene blue indicated for the treatment of conjunctivitis, itching, and mild eye irritation): due to the risk of severe or fatal reactions (serotonin syndrome). Fluoxetine treatment can be initiated the day after stopping a treatment with reversible MAO inhibitors, but your doctor may monitor you closely and use a lower dose of the MAO-A inhibitor.
• Mequitazina(used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in heart activity.
• Fenitoína(medicine used to treat epilepsy):fluoxetinemay increase the levels of this medicine in the blood, so your doctor will need to dose you more carefully when taking fluoxetine and fenitoína together and will need to monitor you more frequently.
• Litio, selegilina, St. John's Wort, tramadol(for pain relief),triptanos(for migraine treatment)andtriptófano: there is an increased risk of mild serotonin syndrome if these medicines are taken with fluoxetine. Your doctor will monitor you more frequently.
• Medicines that can affect heart rhythm, for example,antiarrhythmic Class IAandIII, antipsychotics(for example, phenothiazine derivatives, pimozide, haloperidol),tricyclic antidepressants, someantimicrobial agents(for example, esparfloxacino, moxifloxacino, eritromicina intravenosa, pentamidina), treatment for malaria in particular halofantrina or someantihistamines(astemizol, mizolastina), as taking one or more of these medicines with fluoxetine may increase the risk of changes in heart activity.
• Anticoagulants(such as warfarina),AINEs(such as ibuprofeno, diclofenaco),aspirinaandother medicines that affect blood clotting(including clozapina, used to treat some mental disorders). Fluoxetine may alter the effect of these medicines on the blood. Your doctor will need to do some tests, adjust your dose, and monitor you more frequently if you start or stop taking fluoxetine while taking warfarina.
• Ciproheptadinas(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, desmopressina, carbamazepina, and oxcarbazepina); as taking fluoxetine with these medicines may increase the risk of excessive decrease in sodium levels in the blood.
• Antidepressantssuch astricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropión, mefloquina or cloroquina(used to treat malaria),tramadol(for strong pain relief) orantipsychoticssuch as phenothiazines or butyrophenones; as taking fluoxetine with these medicines may increase the risk of seizures.
• Flecainida, propafenona, nebivolol or encainida(for heart problems),carbamazepina(for epilepsy treatment),atomoxetina or tricyclic antidepressants(for exampleimipramina, desipramina, and amitriptilina)orrisperidona(for schizophrenia treatment); as fluoxetine may change the levels of these medicines in the blood, your doctor may need to reduce your dose when taking them with fluoxetine.

Fluoxetine cinfa and food, drinks, and alcohol

• Fluoxetinecan be taken with or without food, as you prefer.
• It is not recommended to drink 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 have shown that babies whose mothers took fluoxetine during the first months of pregnancy have a higher risk of being born with 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 newborns, 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.

Fluoxetine taken in the final stages of pregnancy may increase the risk of heavy vaginal bleeding 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 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, tremors, muscle weakness, persistent crying, and difficulty breastfeeding or sleeping.

Breastfeeding

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

Driving and operating machinery

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

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

Do not take more capsules than those indicated by your doctor.

Administration Form

Swallow the capsules with water. Do not chew the capsules.

Adults

The recommended dose is:

• Depression:The recommended dose is 1 capsule (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 may be increased gradually to a maximum of 3 capsules (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 capsules (60 mg) per day.
• Obsessive-Compulsive Disorder:The recommended dose is 1 capsule (20 mg) per day. Your doctor may review and adjust the dose after two weeks of treatment. When necessary, the dose may be increased gradually to a maximum of 3 capsules (60 mg) per day. If no improvement is observed within ten weeks, your doctor will reconsider your treatment.

Use in Children and Adolescents

Treatment in children and adolescents aged 8 to 18 years with depression should be initiated and supervised by a specialist. The initial dose is 10 mg per day. After one or two weeks, your doctor may increase the dose to 20 mg per 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. If there is a satisfactory response to treatment, your doctor should reevaluate the need to continue treatment after 6 months. If no improvement is observed within 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 capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Liver Impairment

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 capsules, go to the nearest hospital emergency department or consult your doctor immediately. If possible, bring the packaging of fluoxetine with you.

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.

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 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), 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 medicinecan cause side effects, although not everyone will experience them.

• If you have thoughts of suicide 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 face/hives/lack of breathing,stop taking the capsules and inform 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 fluoxetine dose may make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediatelyif your skin starts to redden or presents any type of reaction or blisters appear or if your skin starts to peel. This happens very rarely.

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 tremors, confusion, extreme agitation or drowsiness (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 heart rate, 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).
• Sleep disturbances, abnormal dreams, fatigue, drowsiness.
• Dizziness.
• Alteration of taste.
• Uncontrollable tremors.
• Blurred vision.
• Sensation of rapid and irregular heartbeats.
• Flush.
• Yawns.
• 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.
• Grinding of teeth.
• Muscle spasms, involuntary movements or balance or coordination problems.
• Memory alterations.
• Dilated pupils.
• Noise in the ears.
• Low blood pressure.
• Difficulty breathing.
• Nasal bleeding.
• Difficulty swallowing.
• Hair loss.
• Increase in 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, uncontrolled behavior.
• Hallucinations.
• Agitation.
• Panic attacks.
• Confusion.
• Stammering.
• Aggression.
• Seizures.
• Vasculitis (inflammation of a blood vessel).
• Fast 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 decrease growth or delay sexual maturation. Suicidal 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 Medicinal Products for Human Use: https://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.

This medication does not require special conditions for conservation.

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof 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 capsule contains 20 mg of fluoxetine (in the form of fluoxetine hydrochloride).
• The other components are:

Contents of the capsule: pregelatinized cornstarch.

Components of the capsule: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), and erythrosine (E-127).

Appearance of the product and contents of the packaging

Hard gelatin capsules with orange-colored cap and white body.

Presented in PVC/ALU blisters. Each package contains blisters of 14, 28, or 60 hard capsules.

Holder of the marketing authorization and responsible manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:May 2021

Detailed information about this medication 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 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/63499/P_63499.html

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