Fluoxetine Cinfa 20 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

fluoxetina cinfa 20 mg dispersible tablets EFG

Fluoxetine hydrochloride

Read the entire 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 you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Fluoxetine 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
• Bulimia nervosa: fluoxetine is indicated as an adjunct to psychotherapy for the reduction of binge eating and purging.

Children over 8 years of age and adolescents:

For 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 young people with moderate to severe depression only in combination with psychological therapy.

How fluoxetina cinfa works

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

Treating these conditions is important to help you get better. If left untreated, your condition may not resolve and could become more severe and more difficult to treat.

You may need to be treated for several weeks or months to ensure that your symptoms have resolved.

2. What you need to know before taking 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 develop a rash or any other allergic reaction (such as itching, swelling of the face or lips, or difficulty breathing), 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), because a serious or even fatal adverse reaction may occur (for example, iproniazid, used to treat depression).

Treatment with fluoxetine may only be started at least two weeks after stopping treatment with an irreversible non-selective MAO inhibitor.

Do not take any irreversible non-selective MAOI 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 the need for a longer interval before starting an MAOI.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking fluoxetine cinfa if:

• You have heart disease.
• You develop fever, muscle stiffness, or tremors, or changes in your mental state such as confusion, irritability, or extreme agitation. These may be symptoms of a condition called “serotonin syndrome” or “neuroleptic malignant syndrome.” Although rare, this condition can be life-threatening. Contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• You have experienced mania or have a history of mania; if you have a manic episode, contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• You have a history of bleeding disorders, or if you develop unusual bruising or bleeding, or if you are pregnant (see “Pregnancy”).
• You are taking medicines that affect blood clotting (see “Other medicines and fluoxetine cinfa”).
• You have epilepsy or seizures. If you experience seizures or an increase in their frequency, contact your doctor immediately; you may need to stop treatment with fluoxetine.
• You are receiving electroconvulsive therapy (ECT).
• You are being treated with tamoxifen (used to treat breast cancer) (see “Other medicines and fluoxetine cinfa”).
• You start feeling restless and unable to sit still or remain motionless (akathisia). Increasing your dose of fluoxetine may worsen this.
• You have diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment).
• You have liver problems (your doctor may need to adjust your dose).
• You have a slow resting heart rate and/or you know you may lose salt due to prolonged severe diarrhea, vomiting, or use of diuretics (water tablets).
• You are taking diuretics (water tablets), especially if you are elderly.
• Glaucoma (increased eye pressure).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These thoughts may increase when starting antidepressants, as these medicines take time to become effective—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 suicidal or self-harming thoughts.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

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

It may help to inform 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 notice your depression or anxiety worsening, or if they are concerned about changes in your behavior.

Children and adolescents

Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontation behavior, and irritability) when taking this type of medicine. Fluoxetine should 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.

Additionally, 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, if you are under 18, your doctor may prescribe fluoxetine for the treatment of moderate to severe depressive episodes in combination with psychological therapy if they consider it appropriate. If your doctor prescribes this medicine for a patient under 18 and you wish to discuss this decision, please consult your doctor again. Inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 are taking fluoxetine.

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

Sexual dysfunction

Some medicines in the same class as fluoxetine (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 need to 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 MAO inhibitors must not be used with fluoxetine, as this may cause serious or even fatal reactions (serotonin syndrome) (see section “Do not take fluoxetine cinfa”). Treatment with fluoxetine should only be started at least 2 weeks after stopping an irreversible MAOI (e.g., tranilcypramine). Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long time and/or at a high dose, your doctor may consider a longer interval before starting an MAOI.

• Metoprolol when used for heart failure, as this increases the risk of excessive slowing of the heartbeat.

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

• Tamoxifen (used to treat breast cancer); your doctor may consider an alternative antidepressant treatment because fluoxetine may alter blood levels of this medicine, and a reduced effect of tamoxifen cannot be ruled out.
• Monoamine oxidase A inhibitors (MAO-A) including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used to treat conjunctivitis, mild eye itching, and irritation): due to the risk of serious or even fatal adverse reactions (called serotonin syndrome). Fluoxetine treatment may be started the day after stopping reversible MAO inhibitors, but your doctor may monitor you closely and use a lower dose of the MAO-A inhibitor.
• Mequitazine (used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in the heart's electrical activity.
• Phenytoin (a medicine used for epilepsy): fluoxetine may increase blood levels of phenytoin, so your doctor will need to monitor and adjust your phenytoin dose more carefully when taken with fluoxetine and may need to check you more frequently.
• Lithium, selegiline, St. John’s wort, tramadol (for pain), triptans (for migraine), and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are taken with fluoxetine. Your doctor may monitor you more frequently.
• Medicines that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial treatments (particularly halofantrine), or certain antihistamines (astemizole, mizolastine); taking one or more of these with fluoxetine may increase the risk of changes in the heart's electrical activity.
• Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirin, and other medicines that affect blood clotting (including clozapine, used to treat certain mental disorders). Fluoxetine may alter the effect of these medicines on blood. Your doctor may need to perform certain tests, adjust your dose, and monitor you more frequently if you start or stop fluoxetine while taking warfarin.
• Cyproheptadine (used to treat allergies); as it may reduce the effect of fluoxetine.
• Medicines that lower sodium levels in the blood (including diuretics, desmopressin, carbamazepine, and oxcarbazepine); using fluoxetine with these medicines may increase the risk of excessively low blood sodium levels.
• Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (for strong pain), or antipsychotics such as phenothiazines or butyrophenones; using fluoxetine with these medicines may increase the risk of seizures.
• Flecainide, propafenone, nebivolol, or encainide (for heart conditions), carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline), or risperidone (for schizophrenia); since fluoxetine may alter blood levels of these medicines, your doctor may need to reduce their dose when taken together with fluoxetine.

Taking fluoxetine cinfa with food, drinks, and alcohol

• Fluoxetine can 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

Studies have reported an increased risk of congenital heart defects in babies whose mothers took fluoxetine during the first months of pregnancy. In the general population, about 1 in 100 babies is born with a heart defect. This risk increases to about 2 in 100 in babies whose mothers took fluoxetine.

Medicines like fluoxetine, when taken during pregnancy—particularly during the last three 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 occurs with your baby, contact your midwife and/or doctor immediately.

If you take fluoxetine late in 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 be aware that you are taking fluoxetine so they can advise you appropriately.

It is generally 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 discontinue fluoxetine during pregnancy or before becoming pregnant. However, depending on your individual circumstances, your doctor may advise that it is better for you to continue taking fluoxetine.

Caution should be exercised when using fluoxetine during pregnancy, especially during the last stage or just before delivery, as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, and difficulty feeding or sleeping.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause adverse effects in infants. Breastfeeding should only continue 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 fluoxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

fluoxetine cinfa contains sodium

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

3. How to take fluoxetine cinfa

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in 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 must be swallowed immediately and completely. Do not chew the tablets.

The tablet may be divided into equal doses.

Adults:

The recommended dose is:

Depression: the recommended dose is 1 tablet (20 mg) daily. Your doctor may review and adjust your dose if necessary within the first 3 to 4 weeks of starting treatment. When required, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) daily. 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 usually 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 3 tablets (60 mg) daily.

Obsessive-compulsive disorder: the recommended dose is 1 tablet (20 mg) daily. 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 3 tablets (60 mg) daily. If no improvement is observed within the following 10 weeks, your doctor will reconsider your treatment.

Use in children and adolescents aged 8 to 18 years with depression

Treatment must 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 you receive the lowest effective dose. Children with low body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor should re-evaluate 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 cautiously, and the daily dose generally should not exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) daily.

Hepatic impairment

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 fluoxetine on alternate days.

If you take more fluoxetine cinfa than you should

If you take too many tablets, go immediately to the nearest hospital emergency department or contact your doctor right away.

If possible, bring the fluoxetine packaging with you.

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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

If you forget to take fluoxetine cinfa

Do not worry if you forget to take 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 fluoxetine cinfa

Do not stop taking fluoxetine unless your doctor tells you to, even if you start to feel better. It is important that you continue taking your medication.

Make sure you do not run out of medication.

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

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

When discontinuing 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 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 at any time you have suicidal thoughts or thoughts of self-harm, contact your doctor or go directly to the hospital (see section 2).
• If you develop 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 as though you cannot sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your fluoxetine dose could make you feel worse. If you feel this way, consult your doctor.
• Speak to your doctor immediately if your skin starts to redden or shows any reaction, blisters appear, or your skin begins to peel. This occurs very rarely.

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

Some patients have experienced:

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

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

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

Common (may affect up to 1 in 10 people)

• Loss of appetite, weight loss.
• Nervousness, anxiety.
• Restlessness, difficulty concentrating.
• Feeling tense.
• Decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity).
• Sleep disturbances, abnormal dreams, tiredness or drowsiness.
• Dizziness.
• Altered sense of taste.
• Uncontrollable trembling movements.
• Blurred vision.
• Sensation of rapid or irregular heartbeat.
• Flushing.
• Yawning.
• Indigestion, vomiting.
• Dry mouth.
• Skin rash, hives, itching.
• Excessive sweating.
• Joint pain.
• Increased frequency of urination.
• Unexplained vaginal bleeding.
• Feeling weak or chills.

Uncommon (may affect up to 1 in 100 people)

• Feeling detached or 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 problems with balance or coordination.
• Memory disturbances.
• Dilated pupils.
• Ringing in the ears.
• Low blood pressure.
• Difficulty breathing.
• Nosebleeds.
• Difficulty swallowing.
• Hair loss.
• Increased tendency to bruise.
• Unexplained bruising or bleeding.
• Cold sweats.
• Difficulty urinating.
• Sensation of feeling cold or hot.
• Abnormal liver function tests.

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

• Low sodium levels in the blood.
• Reduction in platelets in the blood, increasing the risk of bleeding or bruising.
• Reduction in white blood cell count.
• Unusually uninhibited behaviour.
• 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 oesophagus (the tube connecting 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 childbirth (postpartum haemorrhage); see "Pregnancy" in section 2 for more information.

Bone fractures: An increased risk of bone fractures has been observed in patients taking this type of medicine.

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

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

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

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

Reporting of adverse effects

If you experience any 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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of fluoxetine cinfa

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 refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of fluoxetine cinfa

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

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

Appearance of the product and contents of the container

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

Presented in ALU/ALU blisters. Each pack contains blister packs 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 the most recent review of this leaflet: May 2021

Detailed 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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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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