PACKAGE LEAFLET: INFORMATION FOR THE USER. Fluoxetine 20mg Hard Capsules Fluoxetine

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER Fluoxetine 20mg Hard Capsules Fluoxetine Important things you need to know about Fluoxetine capsules Fluoxetine treats depression, obsessive-compulsive symptoms and eating disorders. Like all medicines, it can cause side effects. It is important that you and your doctor discuss the benefits and possible unwanted effects of fluoxetine before you start taking it. Fluoxetine won t work straight away. Some people taking antidepressants feel worse before feeling better. Tell your doctor if you haven t started feeling better after the first few weeks. Fluoxetine is not normally used in children and adolescents under 18. See Section 2, Use in children & adolescents aged 8 to 18 years of age. Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse or think of harming or killing yourself, see your doctor or go to a hospital straight away. See Section 2, Thoughts of suicide and worsening of your depression or anxiety disorder. Don t stop taking Fluoxetine without talking to your doctor. If you stop taking your medicine suddenly or miss a dose, you may get withdrawal effects. See Section 3, If you stop taking Fluoxetine. If you feel restless and feel like you can t sit or stand still, tell your doctor straight away. These symptoms may be more common in the first few weeks of treatment. See Section 4, Stop taking fluoxetine and see your doctor immediately. Taking some other medicines with Fluoxetine can cause problems. See Section 2, Using other medicines. If you are pregnant or planning to get pregnant, talk to your doctor. Read this leaflet. It includes a lot of information about this medicine. Keep this leaflet. You may need to read it again. In this leaflet: 1. What Fluoxetine capsules are and what they are used for 2. Before you use Fluoxetine capsules 3. How to use Fluoxetine capsules 4. Possible side effects 5. How to store Fluoxetine capsules 6. Further information 1. WHAT FLUOXETINE CAPSULES ARE AND WHAT THEY USED FOR Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) antidepressant that influences the central nervous system. Fluoxetine is used for the treatment of: Adults: Depression Obsessive thoughts and obsessive actions Bulimia Nervosa (compulsive eating/purging). 1

2 Children and adolescents aged 8 years and above: Moderate to severe major depressive disorder, if the depression does not respond to psychological therapy after 4-6 sessions. Fluoxetine capsules should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy. Note that the doctor may have prescribed this medicine for a different purpose and/or at a different dosage from that given in the package leaflet. You must always follow the doctor s prescription and the instructions given on the label of the pack. 2. BEFORE YOU USE FLUOXETINE CAPSULES Do not use Fluoxetine Capsules If you have had any allergic reaction to fluoxetine or to any of the other ingredients in the product. If you are taking (or have taken within the past two weeks) any medicine known as a monoamine oxidase inhibitor (MAOI) for the treatment of depression (e.g nialamide, iproniazide, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone) or for parkinsons disease (selegiline). These medicines should not be taken at the same time as Fluoxetine. Speak to your doctor for advice. Treatment with Fluoxetine Capsules should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide). None of the MAO inhibitors should be taken within the next 5 weeks after discontinuation of Fluoxetine capsules. If Fluoxetine has been prescribed for a long period and/or at a high dose, a long interval needs to be considered by your doctor. Take special care with Fluoxetine capsules If you have diabetes Fluoxetine capsules can raise or lower your blood sugar. The dose of your insulin or the antidiabetes medicines that you take by mouth may need to be adjusted. If you have had seizures, have epilepsy, reduced liver, kidney or heart function or have recently had a heart attack you must tell your doctor, because it may be necessary to prescribe a lower dose for you. If you have or have had mania If you have a tendency to bleed easily or you are taking medicines which thin the blood (anticoagulants) If you are taking other medicines or herbal preparations containing St. John s wort (Hypericum perforatum) (See Using other medicines) If you are receiving electric shock treatment. If you get an allergic reaction such as itching, nettle rash or swelling of the face, lips, tongue and/or throat (sometimes with breathlessness or difficulties in swallowing) the treatment with Fluoxetine capsules must be stopped. Contact your doctor if you develop symptoms such as high fever, muscle twitching, confusion and anxiety ( serotonergic syndrome ). The treatment with Fluoxetine capsules might need to be stopped. Weight loss may occur during the treatment with Fluoxetine capsules. 2

3 Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: - If you have previously had thoughts about killing or harming yourself. - If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Use in children and adolescents aged 8 to 18 years of age Fluoxetine capsules should normally not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Fluoxetine capsules for patients under 18 because he/she decides that this in their interests. If your doctor has prescribed Fluoxetine capsules for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Fluoxetine capsules. Also, only limited information concerning the long-term safety of Fluoxetine capsules on growth, puberty, mental, emotional and behavioural development in this age group is available. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (up to 5 weeks ago), including medicines obtained without a prescription. Fluoxetine capsules may affect the way some other medicines work (interaction), especially the following: Monoamine oxidase inhibitors (MAOI s), used to treat depression. Non-selective Monoamine oxidase MAOI s and MAOI s type A.- these should not be taken at the same time as fluoxetine (See Section 2, Do not use fluoxetine capsules). MAOI s type B (selegeline) can be used with fluoxetine capsules provided that your doctor monitors you closely. Blood-thinning medicine (warfarin) Other medicine for depression (e.g. tricyclic antidepressants), or medicines containing tryptophan or lithium Medicine for epilepsy (e.g. phenytoin or carbamazepine) Medicine of the tryptan type for migraine (e.g. sumatriptan or zolmitriptan) Pain-relieving medicine containing tramadol Medicine used to treat certain mental disorders (clozapine), A natural remedy containing St. John s wort (Hypericum perforatum) Medicine containing flecainide or encainide (for irregular heart rhythm). 3

4 Taking Fluoxetine Capsules with food and drink Food: The capsules may be taken with or between meals. Alcohol: The combination of Fluoxetine capsules and alcohol is not recommended. Pregnancy, breast-feeding and fertility Both intake of Fluoxetine capsules during pregnancy and breast feeding may affect the inborn child/breastfed infant. Pregnancy Talk to your doctor as soon as possible if you re pregnant, if you might be pregnant, or if you re planning to become pregnant. In babies whose mothers took Fluoxetine capsules during the first few months of pregnancy, there have been some reports suggesting an increased risk of birth defects affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about 2 in 100 babies in mothers who took Fluoxetine capsules. You and your doctor may decide that it is better for you to gradually stop taking Fluoxetine capsules while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine capsules. Make sure your midwife and/or doctor know you are on Fluoxetine capsules.when taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetine capsules may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Information collected to date does not indicate an increased risk when used during pregnancy. However caution should be exercised when used during pregnancy, especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistent crying, and difficulty in sucking or in sleeping. Please tell your doctor if you are pregnant or think that you are pregnant. Breast-feeding Fluoxetine is excreted in breast milk and can cause side effects in babies. You should only breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower dose of fluoxetine. Please tell your doctor if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Fertility Fluoxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet. 4

5 Driving and using machines Fluoxetine capsules can impair judgement, thinking capacity and motor skills. This should be taken into account in situations where increased alertness is necessary, e.g. when driving or operating hazardous machinery. 3. HOW TO USE FLUOXETINE CAPSULES Always take Fluoxetine capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Fluoxetine can be taken as a single dose or divided into several doses. Adults: The usual dose is: Depression: The recommended dose is 1 capsule (20 mg) daily. Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment. If required, the dosage can be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be increased carefully to ensure that you receive the lowest effective dose. Bulimia nervosa: The recommended dose is 3 capsules (60 mg) daily. Your doctor will review the need for continuing treatment beyond 6 months (3 months for bulimia), and treatment will be reassessed if no improvement is seen. OCD: The recommended dose is 1 capsule (20 mg) daily. Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment. If required, the dosage can be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment. Children and adolescents aged 8 to 18 years with depression: Treatment should be started and be supervised by a specialist. The starting dose is 10mg/day. After 1 to 2 weeks, your doctor may increase the dose to 20mg/day. The dose should be increased carefully to ensure that you receive the lowest effective dose. Lower weight children may need lower doses. Elderly: Your doctor will increase the dose with more caution and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily. Liver impairment: If you have a liver problem or are using other medication that might affect Fluoxetine, your doctor may decide to prescribe a lower dose or tell you to use Fluoxetine every other day. 5

6 If you take more Fluoxetine capsules than you should If you have taken too much Fluoxetine capsules you should contact your doctor or a hospital. Symptoms of overdose: nausea, vomiting, seizures, anxiety, restlessness, excessive cheerfulness, impaired heart function (e.g. irregular heartbeats) and impaired breathing. If you forget to take Fluoxetine capsules Do not take a double dose to make up for a forgotten dose. If you stop taking Fluoxetine capsules Do not stop taking Fluoxetine capsules until your doctor tells you to. Usually your doctor will help you to reduce your dose slowly over a number of weeks. When treatment with Fluoxetine capsules is stopped, especially if it is done abruptly, there is a risk of so-called withdrawal effects. The risk is higher, when Fluoxetine capsules has been used for a long time or in high doses or when the dose is reduced too quickly. Withdrawal effects include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). Most people find that the symptoms are mild and go away on their own within two weeks. If you get severe withdrawal effects when you stop taking Fluoxetine capsules, please contact your doctor. He or she may ask you to start taking your capsules again and come off them more slowly. Please see your doctor if you are worried about withdrawal effects when stopping Fluoxetine capsules. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Fluoxetine capsules can cause side effects, although not everybody gets them. You should stop taking Fluoxetine capsules and see your doctor immediately if you experience symptoms such as: - swollen face, tongue and/or throat and/or difficulty to swallowing or hives together with difficulties breathing. These symptoms could be a sign of a severe allergic reaction. - feeling restless and you cannot sit or stand still. You may have akathisia - your skin starts to turn red or you develop a varied skin reaction or your skin starts to blister or peel. - high fever, muscle twitching, confusion and anxiety since these symptoms could be a sign of so called serotonin syndrome Whole body - Shivers, skin irritation in strong sunlight, weight loss. Digestive system - Gastrointestinal symptoms such as e.g. diarrhoea, nausea, vomiting, digestive disorders, difficulties in swallowing, changes in taste perception - Dry mouth - Rare cases of abnormal liver function values and very rare cases of hepatitis. Nervous system - Headache, sleeping problems (e.g. abnormal dreams, insomnia), dizziness, poor appetite, fatigue, somnolence and drowsiness, elation 6

7 - Abnormal movements of short duration such as muscle twitching, disturbances in co-ordination of muscle movements, tremors, muscle cramps, seizures. - Hallucinations, manic reaction, confusion, agitation, anxiety and nervousness, impaired ability to concentrate and impaired thought processes, and panic attacks have been reported, but may be due to the underlying disorder. Thoughts of suicide or harming yourself. Bone fractures - An increased risk of bone fractures has been observed in patients taking this type of medicines. Urogenital system & reproductive disorder - Difficulty in urinating or frequent urination, delayed orgasm or lack of orgasm, persistent erection, breast discharge. Respiratory systems - Throat inflammation and breathlessness - Rarely, tissue inflammations in the lungs have been reported. Other - Hair loss, yawning, visual disturbances such as blurred vision and dilated pupils, sweating, widening of blood vessels, joint pain, muscle pain, fall in blood pressure, bruises - Gynaecological bleeds, bleeding from the digestive tract and other skin or mucous membrane bleeds have been reported in rare cases. - Reduced sodium level in the blood can occur, especially in elderly patients taking diuretic medicine or who have a fluid deficiency for some other reason. Children and Adolescents (8-18 years) - Fluoxetine may slow growth or possibly delay sexual maturity. Also, patients under 18 have an increased risk of side effects such as suicidal thoughts and harming themselvelves when they take Fluoxetine capsules (see section 2 Thoughts of suicide and worsening of your depression or anxiety disorder). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE FLUOXETINE CAPSULES Keep out of the reach and sight of children. Do not store above 25º C. Store in the original package in order to protect from moisture. Do not use Fluoxetine capsules after the expiry date which is stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Fluoxetine capsules 20mg contains The active substance is fluoxetine hydrochloride equivalent to 20 mg fluoxetine. The other ingredient is pre-gelatinised maize starch. The capsule shell contains gelatine, brilliant blue (E133), titanium dioxide (E171), yellow iron oxide (E172). Printing ink components are activated charcoal and shellac (E904). 7

8 What Fluoxetine capsules 20mg look like and contents of the pack Fluoxetine 20 mg capsules are green/off white gelatine capsules with FLX/MIL marked on it and available in blister packs of 10,14,20, 30,50,70 or 100 capsules. Not all pack sizes may be marketed Marketing Authorisation Holder Brown & Burk UK Ltd 5, Marryat Close, Hounslow west, Middlesex TW4 5DQ, UK Site responsible for batch release Brown & Burk UK Ltd 5, Marryat Close, Hounslow west, Middlesex TW4 5DQ, UK This leaflet was last approved in 12/2012 8