Properties
- Form
- kafsula
- Dosage mg
- 10
- Pack
- 28
What is it?
Fluoxetine Egis 10 mg hard capsules Fluoxetine Egis 20 mg hard capsules Fluoxetine Patient Information Leaflet Read this leaflet carefully and completely before you start taking this medicine, as it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist, or nurse. - This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they have the same symptoms as you. - If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. This leaflet contains the following information: 1. What Fluoxetine Egis is and what it is used for 2. What you need to know before you take Fluoxetine Egis 3. How to take Fluoxetine Egis 4. Possible side effects 5. How to store Fluoxetine Egis 6. Contents of the pack and other information 1. What Fluoxetine Egis is and what it is used for The active substance in Fluoxetine Egis is fluoxetine, which belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine Egis is used to treat the following conditions: Adults - Major depressive episodes - Obsessive-compulsive disorder (obsessive thoughts and behaviours) - Bulimia nervosa: In combination with psychotherapy, Fluoxetine Egis is used to reduce binge eating and purging behaviour. Children and adolescents aged 8 years and over - Moderate to severe major depressive episodes, if depression does not respond to psychotherapy after 4-6 sessions. For a child or adolescent with moderate to severe major depressive disorder, Fluoxetine Egis is indicated only in combination with psychotherapy. How Fluoxetine Egis works Everyone has a substance called serotonin in their brain. People with depression, obsessive-compulsive disorder, or bulimia nervosa have lower levels of serotonin compared to others. It is not fully understood how Fluoxetine Egis and other SSRIs work, but they can help by increasing serotonin levels in the brain. Treating these conditions is important to help you feel better. If left untreated, your condition may not improve, may become more serious, and treatment may become more difficult. You may need treatment for several weeks or months to ensure you are symptom-free. 2. What you need to know before you take Fluoxetine Egis Do not take Fluoxetine Egis - 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, swollen lips or face, or shortness of breath), stop taking this medicine immediately and consult your doctor. - if you are taking other medicines called irreversible, non-selective monoamine oxidase inhibitors (MAOIs) (e.g. iproniazid for depression) as serious or even fatal reactions may occur. Treatment with Fluoxetine Egis should only be started at least 2 weeks after stopping irreversible, non-selective MAOIs. Do not take irreversible, non-selective MAOIs for at least 5 weeks after stopping Fluoxetine Egis. If you have been taking Fluoxetine Egis for a long time/or at high doses, your doctor may consider a longer interval. - if you are being treated with metoprolol (for heart failure), as there is an increased risk of a significant slowing of your heart rate. Warnings and precautions Talk to your doctor or pharmacist before taking Fluoxetine Egis. Tell your doctor if any of the following apply to you: - Heart problems. - If you develop fever, muscle stiffness or tremors, changes in your mental state such as confusion, irritability and extreme agitation, you may be suffering from "serotonin syndrome" or "neuroleptic malignant syndrome". Although this syndrome is rare, it can lead to potentially life-threatening conditions. Seek immediate medical attention, as it may be necessary to stop taking Fluoxetine Egis. - If you have a history of mania or are currently experiencing mania. If you have a manic episode, consult your doctor immediately, as it may be necessary to stop treatment with fluoxetine. - If you have a bleeding disorder or have had bruises or unusual bleeding, or if you are pregnant (see "Pregnancy, breast-feeding and fertility"). - If you are currently being treated with medicines that can affect blood clotting (see "Other medicines and Fluoxetine Egis"). - If you have epilepsy or seizures (fits) or experience an increase in the frequency of seizures, consult your doctor immediately, as it may be necessary to stop treatment with fluoxetine. - If you are currently undergoing ECT (electroconvulsive therapy). - If you are currently being treated with tamoxifen (used to treat breast cancer) (see "Other medicines and Fluoxetine Egis"). - If you experience restlessness and are unable to sit or stand still (akathisia). Increasing the dose of Fluoxetine Egis may worsen this condition. - Diabetes (your doctor may consider it advisable to adjust the dose of insulin or other antidiabetic medicines). - Liver problems (your doctor may consider it advisable to adjust your dose). - If you have a slow heart rate and/or if you know that you may have low salt levels as a result of prolonged severe diarrhoea and vomiting (feeling sick) or the use of diuretics (water tablets). - If you are currently being treated with diuretics, especially if you are elderly. - Glaucoma (increased pressure in the eye). - Weight loss may occur in patients taking this medicine, but it is usually proportional to the initial body weight. Medicines like Fluoxetine Egis (so-called SSRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment has stopped. Suicidal thoughts and worsening of depression or anxiety disorder If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. The likelihood of developing these symptoms may be increased at the beginning of antidepressant treatment, as these medicines take time to start working, usually 2 weeks, but sometimes longer. You are more likely to have such thoughts if: - you have had thoughts of harming yourself or committing suicide in the past. - you are young. Clinical trial data have shown an increased risk of suicidal behaviour in young people under 25 years of age with mental disorders who are treated with antidepressants. If you have thoughts of suicide or self-harm at any time, seek immediate medical attention or go to hospital. It is helpful if you tell a relative or close friend that you have depression or an anxiety disorder and ask them to read this leaflet. Ask them to tell you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour. Children and adolescents aged 8 to 18 years In patients under 18 years of age, there is an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking medicines of this class. Fluoxetine Egis should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used for other conditions. There is only limited information on the long-term safety of fluoxetine in this age group regarding growth, puberty, mental, emotional, and behavioural development. Nevertheless, your doctor may prescribe Fluoxetine Egis to patients under 18 years of age for the treatment of moderate to severe depressive episodes in combination with psychotherapy if they believe it is in the patient's best interest. If your doctor has prescribed fluoxetine to a patient under 18 years of age and you wish to discuss this, please contact your doctor. Tell your doctor if any of the above symptoms develop or worsen when patients under 18 years of age are taking this medicine. Fluoxetine Egis should not be used to treat children under 8 years of age. Other medicines and Fluoxetine Egis Tell your doctor or pharmacist if you are taking, have recently taken (within 2 weeks), or might take any other medicines. Do not take Fluoxetine Egis with the following medicines: - Irreversible, non-selective monoamine oxidase inhibitors (MAOIs). Some of these are used to treat depression. Serious or even fatal reactions (serotonin syndrome) may occur when taking irreversible, non-selective MAOIs (see section "Do not take Fluoxetine Egis"). Treatment with Fluoxetine Egis should only be started at least 2 weeks after stopping irreversible MAOIs (e.g. tranylcypromine). Do not take irreversible, non-selective MAOIs for at least 5 weeks after stopping Fluoxetine Egis. If Fluoxetine Egis has been prescribed to you for a long period and/or at high doses, your doctor may consider an interval longer than 5 weeks. - Metoprolol used for heart failure, as there is an increased risk of a significant slowing of your heart rate. Fluoxetine Egis may affect other medicines, and other medicines may affect Fluoxetine Egis (drug interactions): - Tamoxifen (used to treat malignant breast cancer). Fluoxetine may reduce the effect of tamoxifen. Your doctor may consider alternative antidepressant treatment. - (MAO-A inhibitors) including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also known as methylene blue, used to treat methaemoglobinaemia caused by drugs or chemicals). There is an increased risk of serious or even fatal reactions (serotonin syndrome). Treatment with fluoxetine can be started the day after stopping treatment with reversible MAO-A inhibitors, but your doctor may want to monitor you closely and use a lower dose of the MAO-A inhibitor medicine. - Mequitazine (for allergies): as taking this medicine with Fluoxetine Egis may increase the risk of changes in the electrical activity of the heart. - Phenytoin (for epilepsy): as fluoxetine may affect the level of the active substance in the blood, your doctor may need to start treatment with phenytoin more carefully and perform regular blood tests while you are taking fluoxetine. - Lithium (used to treat manic depression), tryptophan (used to treat insomnia or depression), tramadol (a strong painkiller) or triptans (used to treat migraine), selegiline, St. John's Wort: taking these active substances with Fluoxetine Egis increases the risk of mild serotonin syndrome. Your doctor will schedule more frequent check-ups. - Medicines that can affect heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials, particularly halofantrine, or certain antihistamines (astemizole, mizolastine), as taking these medicines with Fluoxetine Egis may increase the risk of changes in the electrical activity of the heart. - Anticoagulants (such as warfarin), non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen, diclofenac), acetylsalicylic acid or other medicines that can thin the blood (including clozapine, used to treat certain mental disorders). Fluoxetine Egis may alter the action of these medicines in the blood. If treatment with fluoxetine is started or stopped while taking warfarin, your doctor will schedule certain tests, adjust your dose, and check you more frequently. - Cyproheptadine (for allergies), as it can reduce the effect of Fluoxetine Egis. - Medicines that lower sodium levels in the blood (including: diuretics, desmopressin /used to treat diabetes insipidus/, carbamazepine and oxcarbazepine /used to treat epilepsy/). - Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain) or antipsychotics such as phenothiazines or butyrophenones, as taking these medicines together with fluoxetine may increase the risk of seizures. - Flecainide, propafenone and nebivolol or encainide (used to treat heart problems), atomoxetine or tricyclic antidepressants (e.g. imipramine, desipramine and amitriptyline), or risperidone (used to treat certain mental health disorders) - as fluoxetine may alter the concentration of these medicines in the blood, your doctor may need to reduce their dose when taken with fluoxetine. Fluoxetine Egis with food, drink and alcohol You can take Fluoxetine Egis with or without food, as you prefer. You should avoid alcohol while taking this medicine. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, 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 infants whose mothers took this medicine in the first months of pregnancy, there have been reports of an increased risk of congenital heart defects. In the general population, about 1 in 100 babies are born with a heart defect, which increases to 2 in 100 babies born to mothers taking fluoxetine. During pregnancy, especially in the last 3 months, medicines like fluoxetine may increase the risk of a serious condition in infants called persistent pulmonary hypertension of the newborn (PPHN), which manifests as rapid breathing and bluish skin in the baby. These symptoms usually start within the first 24 hours after the baby is born. If your baby develops these symptoms, contact your doctor and/or midwife immediately. It is best not to use this medicine during pregnancy unless the potential benefit outweighs the potential risk. Therefore, you and your doctor may decide to gradually stop taking Fluoxetine Egis during pregnancy or before pregnancy. However, depending on your circumstances, your doctor may advise that it is better to continue taking Fluoxetine Egis. Caution is advised during pregnancy, especially in the late stages or before labour, as the following effects have been observed in newborns: irritability, tremors, muscle weakness, persistent crying, and difficulty sucking or sleeping. If you take Fluoxetine Egis late in pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Fluoxetine Egis so that they can advise you. Breast-feeding This medicine is excreted in breast milk and may cause side effects in infants. You should only breast-feed if it is clearly necessary. If breast-feeding continues, your doctor may prescribe a lower dose of this medicine. Fertility Studies in animals have shown that fluoxetine reduces sperm quality. Theoretically, this could affect fertility, but no effect on human fertility has been observed yet. Driving and using machines Fluoxetine may affect your judgment or coordination. Do not drive or operate machinery until you know how Fluoxetine Egis affects you. Fluoxetine Egis contains lactose If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Fluoxetine Egis Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Do not take more medicine than your doctor has prescribed. Swallow the capsules with water. Do not chew the capsules. Adults The recommended dose is: Depression: The recommended dose is 20 mg per day (i.e. two 10 mg capsules or one 20 mg capsule). Your doctor will adjust the dose if necessary within 3-4 weeks of starting treatment. If necessary, the dose can be gradually increased to a maximum of 60 mg per day (i.e. three 20 mg capsules). Dose increases should be made cautiously to ensure you are taking the lowest effective dose. You may not feel better immediately when you start taking medicines for depression. This is normal, as improvement in depressive symptoms may occur after the first few weeks. Patients with depression should be treated for at least 6 months. Bulimia nervosa: The recommended dose is 60 mg per day (three 20 mg capsules). OCD (obsessive-compulsive disorder): The recommended dose is 20 mg per day (two 10 mg capsules or one 20 mg capsule). Your doctor will review and adjust your dose if necessary 2 weeks after starting treatment. If necessary, the dose can be gradually increased to a maximum of 60 mg per day (three 20 mg capsules). If there is no improvement after 10 weeks, your doctor will review your treatment. Use in children and adolescents Children and adolescents aged 8 to 18 years with depression should start treatment and be supervised by a specialist. The initial dose is 10 mg (one 10 mg capsule) per day. After 1-2 weeks, your doctor may increase your dose to 20 mg per day (two 10 mg capsules or one 20 mg capsule). Dose increases should be made cautiously to ensure you are taking the lowest effective dose. Children with low body weight may require lower doses. If there is a satisfactory response to treatment, your doctor will consider the need for continued treatment for more than 6 months. If there is no improvement after 9 weeks, your doctor will re-evaluate your treatment. Elderly patients Your doctor will increase the dose more cautiously and the daily dose should not exceed 40 mg (two 20 mg capsules). The maximum dose is 60 mg per day (three 20 mg capsules). Liver impairment If you have liver problems or are taking other medicines that may affect fluoxetine, your doctor may decide to prescribe a lower dose or recommend taking fluoxetine every other day. If you take more Fluoxetine Egis than you should If you take more capsules than prescribed, seek immediate medical attention at the nearest hospital emergency department (or accident and emergency department) or inform your doctor. If possible, take the Fluoxetine Egis packaging with you. Symptoms of overdose include: nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), lung problems, and changes in mental state from agitation to coma. If you forget to take Fluoxetine Egis Do not worry if you miss a dose. Take the next dose the following day at the usual time. Do not take a double dose to make up for a missed dose. Taking the medicine at the same time each day will help you remember to take it regularly. If you stop taking Fluoxetine Egis Do not stop taking Fluoxetine Egis without consulting your doctor, even when you feel better. It is important to continue taking your medicine. Make sure you do not run out of capsules. When you stop taking Fluoxetine Egis, you may notice the following symptoms (withdrawal effect): dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, insomnia), feeling restless or agitated, unusual tiredness or weakness, feeling anxious, nausea/vomiting (feeling sick or being sick), tremors (shaking), headache. Most people find that any symptoms when stopping Fluoxetine Egis are mild and disappear within a few weeks. If you experience symptoms when stopping treatment, consult your doctor. When stopping Fluoxetine Egis, your doctor will help you reduce the dose slowly over one or two weeks – this will help reduce the likelihood of withdrawal effects occurring. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have thoughts of harming yourself or committing suicide at any time, seek immediate medical attention or go to hospital (see section 2). If you develop a rash or an allergic reaction, such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking the capsules immediately and consult your doctor. If you feel restless and unable to sit or stand still, you may have akathisia; increasing the dose of Fluoxetine Egis may worsen your condition. If you experience this, consult your doctor. Tell your doctor immediately if your skin starts to redden or you develop blisters or peeling on your skin. This is very rare. The most frequent side effects (very common side effects, which may affect more than 1 in 10 people) are: insomnia, headache, diarrhoea, feeling sick (nausea) and fatigue. Some patients have experienced: a combination of symptoms (known as "serotonin syndrome"), including: unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (only rarely); feeling weak, drowsy or confused, mostly in elderly patients taking diuretics (water tablets), prolonged and painful erection, irritability and extreme agitation, heart problems such as fast or irregular heartbeat, weakness, collapse or dizziness when standing up, which may indicate an abnormal heart rhythm. If you experience any of the above side effects, tell your doctor immediately. The following side effects have also been reported in patients taking Fluoxetine Egis: Common (may affect up to 1 in 10 people) Poor appetite, weight loss, nervousness, anxiety, restlessness, difficulty concentrating, feeling tense, decreased libido or sexual problems (including difficulty maintaining an erection for sexual activity and ejaculation problems), sleep problems, unusual dreams, or drowsiness, dizziness, altered taste, uncontrollable shaking movements, blurred vision, feeling of fast or irregular heartbeat, hot flushes, yawning, indigestion, vomiting, dry mouth, rash, nettle rash, itching, excessive sweating, joint pain, more frequent urination, unexplained vaginal bleeding, feeling shivery or cold. Uncommon (may affect up to 1 in 100 people) Feeling detached from oneself, strange thoughts, abnormally elevated mood, orgasm problems, thoughts of suicide or self-harm, grinding of teeth, muscle cramps, involuntary movements or problems with balance or coordination, memory impairment, enlarged (dilated) pupils, ringing in the ears, low blood pressure, shortness of breath, nosebleeds, difficulty swallowing, bleeding in the abdomen, abnormal hair loss, increased tendency to bruising; unexplained bruising or bleeding, cold sweats, difficulty urinating, sexual dysfunction, generally feeling unwell/unusual, feeling hot or cold, abnormal results of liver function tests in blood tests. Rare (may affect up to 1 in 1,000 people) Low salt levels in the blood, low platelet count in the blood, which increases the risk of bleeding or bruising, low white blood cell count, atypical wild behaviour, seeing, feeling or hearing things that are not there (hallucinations), agitation, panic attacks, confusion, tongue-tie, aggression, seizures, irregular heartbeat, vasculitis (inflammation of blood vessels), widening of blood vessels (vasodilation), rapid swelling of tissues around the neck, face, mouth and/or throat, pain in the gullet (the tube through which food and water pass to the stomach), sore throat and discomfort when swallowing, hepatitis, lung problems, sensitivity to the sun, muscle pain, urinary problems, milk production, increased levels of prolactin (a hormone) in the blood, bleeding from mucous membranes, such as the nose or mouth. Unknown (frequency cannot be estimated from the available data) Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2 - Pregnancy, breast-feeding and fertility for more information. An increased risk of bone fractures has been observed in patients taking this type of medicine. Most of these side effects are likely to disappear with continued treatment. Additional side effects in children and adolescents (8-18 years) Fluoxetine Egis may slow growth or may inhibit puberty. Suicidal behaviour (suicide attempts and suicidal thoughts), hostile attitude, mania and nosebleeds have also been frequently reported in children. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 5. How to store Fluoxetine Egis Store below 30°C, in the original packaging to protect from light. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Fluoxetine Egis contains The active substance is: 10 mg or 20 mg fluoxetine (as fluoxetine hydrochloride) in each hard capsule, respectively. Other ingredients are: 10 mg hard capsules: magnesium stearate, pregelatinised starch, lactose monohydrate (56.8 mg) Hard gelatin capsule shell: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin. 20 mg hard capsules: magnesium stearate, pregelatinised starch, lactose monohydrate (56.8 mg) Capsule shell: indigo carmine (E 132), yellow iron oxide (E 172), titanium dioxide (E17), gelatin. What Fluoxetine Egis looks like and contents of the pack Fluoxetine Egis 10 mg hard capsules: A size 3, hard gelatin capsule, yellow in colour, with the inscription EGIS 412 on the cap, filled with white or almost white powder. Fluoxetine Egis 20 mg hard capsules: A size 3, hard gelatin capsule, green in colour, filled with white or almost white powder. 14 or 28 capsules in a PVC/PVDC/aluminium foil blister and in a cardboard box. Dispensing category: Pharmaceutical product group - II, dispensed with prescription form No. 3
