FLUOXETINE 20MG CAPSULES.

develop bruises or unusual bleeding are using medicinal products that affect the coagulation of blood (see 'Taking other medicines') start to experience fever, muscle stiffness or tremor, changes in your mental state like PATIENT INFORMATION LEAFLET confusion, irritability and extreme agitation; you may suffer from the so-called serotonin syndrome or neuroleptic malignant syndrome. Although this syndrome occurs rarely it may result in potentially life-threatening conditions, Please read this leaflet carefully before you take contact your doctor immediately, the use of these capsules. It briefly outlines the most fluoxetine might need to be discontinued important things you need to know. If you want to have suicidal thoughts or want to harm know more about this medicine, or you are not sure yourself. Depression is associated with an about anything, ask your doctor or your pharmacist. increased risk of suicidal thoughts, self harm The name of your medicine is Fluoxetine Capsules and suicide (suicide-related events). This risk 20 mg. persists until improvements of your illness occur. Since it can take 3 to 4 weeks before your WHAT IS FLUOXETINE ? illness improves following treatment with fluoxetine, your doctor will monitor you closely Each hard capsule contains 22.36 mg at the start of the treatment. Other psychiatric of of the active ingredient Fluoxetine conditions for which Fluoxetine is prescribed Hydrochloride Ph. Eur. which is can also be associated with an increased risk of equivalent to 20 mg of Fluoxetine. The suicide-related events. The same precautions other ingredients are colloidal anhydrous silica, should therefore be observed when treating pregelatinised starch and simethicone emulsion. The patients with other psychiatric disorders. capsule shell contains gelatin and the colours indigo Use in children and adolescents aged 8 to 18 years: carmine (E132) and titanium dioxide (E171). The Patients under 18 have an increased risk of side printing ink contains shellac, iron oxide (E172) and effects such as suicide attempt, suicidal thoughts Propylene Glycol (E1520). and hostility (predominantly aggression, oppositional behaviour and anger) when they take The product is available in pack sizes of 12, 14, 20, this class of medicines. Fluoxetine should only be 28, 30, 50, 60, 70, 90, 98, 100 or 500 capsules. used in children and adolescents aged 8 to 18 years See outer packaging or the pharmacy label for for the treatment of moderate to severe major contents i.e. the number of capsules. depressive episodes (in combination with psychological therapy) and it should not be used in Fluoxetine is an antidepressant. other indications. Additionally, only limited information concerning the long-term safety of Fluoxetine Capsules are manufactured by Teva fluoxetine on growth, puberty, mental, emotional Pharmaceuticals, Kfar Saba, Israel on behalf of the and behavioural development in this age group is Marketing Authorisation holder Teva Pharma BV, available. Despite this, your doctor may prescribe 3542 DR Utrecht, The Netherlands. They are Fluoxetine for patients under 18 for moderate to distributed in the UK by Approved Prescription severe major depressive episodes in combination Services Limited, Leeds, LS27 0JG England. with psychological therapy because he/she decides WHAT IS FLUOXETINE USED FOR ? that this is in their best interests. If your doctor has prescribed Fluoxetine for a patient under 18 and you want to discuss this, please go back to your Fluoxetine capsules are used to treat doctor. You should inform your doctor if any of the the following conditions: symptoms listed above develop or worsen when In adults: patients under 18 are taking Fluoxetine. major depressive episodes Fluoxetine should not be used in the treatment of obsessive-compulsive disorder (OCD) children under the age of 8 years. bulimia nervosa: fluoxetine is used alongside psycho-therapy for the reduction of binge-eating Taking other medicines and purging. Please tell your doctor or pharmacist if you are In children and adolescents aged 8 years and above: taking or have recently taken any other medicines moderate to severe major depressive disorder, if (up to five weeks ago), including medicines the depression does not respond to psychological obtained without prescription. This medicine may therapy after 4-6 sessions. Fluoxetine should be affect the way some other medicines work offered to a child or young person with moderate (interaction). An interaction could occur with: to severe major depressive disorder only in MAO inhibitors (used to treat depression). combination with psychological therapy. Non-selective MAO inhibitors and MAO Ask your doctor or pharmacist if you need additional inhibitors type A (moclobemide) should not be information. used with Fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see BEFORE YOU TAKE FLUOXETINE section 'Do not take Fluoxetine'). MAO inhibitors type B (selegiline) can be used with Do not take Fluoxetine and tell your Fluoxetine provided that your doctor monitors doctor or pharmacist if the following you closely apply: lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are if you are allergic (hypersensitive) to fluoxetine co-administered with Fluoxetine. When or any of the other ingredients in the medicine, fluoxetine is used in combination with lithium listed above. An allergy may include rash, your doctor will carry out more frequent itching, swollen face or lips or shortness of check-ups breath. phenytoin (for epilepsy); because Fluoxetine if you are taking medicines known as may influence blood levels of this drug, your non-selective monoamine oxidase inhibitors or doctor may need to introduce phenytoin more reversible monoamine oxidase inhibitors carefully and carry out check-ups when given type A (also called MAOIs, which are also used with Fluoxetine to treat depression), since serious or even fatal clozapine (used to treat certain mental reactions can occur. disorders), tramadol (a painkiller) or triptans Treatment with fluoxetine should only be started 2 (for migraine); there is an increased risk of weeks after discontinuation of an irreversible MAOI hypertension (for instance tranylcypromine). flecainide or encainide (for heart problems), However, treatment with Fluoxetine can be started carbamazepine (for epilepsy), tricyclic the following day after discontinuation of certain antidepressants (for example imipramine, MAOIs called reversible MAOI-A (for instance desipramine and amitriptyline); because moclobemide). Fluoxetine may possibly change the blood Do not take any MAOIs for at least five weeks after levels of these medicines, your doctor may you stop taking Fluoxetine. If Fluoxetine has been need to lower their dose when administered prescribed for a long period and/or at a high dose, a with Fluoxetine longer interval needs to be considered by your warfarin or other medicines used to thin the doctor. Examples 0of MAOIs include nialamide, blood; Fluoxetine may alter the effect of these iproniazide, selegiline, moclobemide, phenelzine, medicines on the blood. If Fluoxetine treatment tranylcypromine, isocarboxazid and toloxatone. is started or stopped when you are taking Take special care with Fluoxetine and tell your warfarin, your doctor will need to perform doctor or pharmacist if you: certain tests. develop a rash or other allergic reactions (like you should not start to take the herbal remedy itching, swollen lips or face or shortness of St John's wort while you are being treated with breath), stop taking the capsules straight away Fluoxetine since this may result in an increase and contact your doctor immediately of undesirable effects. If you are already taking have epilepsy or have had a fit in the past; if St John's wort when you start on Fluoxetine, you have a fit (seizure) or experience an increase stop taking the St John's wort and tell your in seizure frequency, contact your doctor doctor at your next visit. immediately, the use of fluoxetine might need to be discontinued Taking Fluoxetine with food and drink have suffered from mania in the past; if you You should avoid alcohol whilst taking fluoxetine. have a manic episode, contact your doctor immediately, the use of fluoxetine may need to Pregnancy and breast-feeding be discontinued Ask your doctor or pharmacist for advice before have diabetes (your doctor may need to adjust taking any medicine. your dose of insulin or other antidiabetic treatment) Pregnancy have liver problems (your doctor may need to Information collected to date does not indicate an adjust your dosage) increased risk when used during pregnancy. have heart problems However, caution should be exercised when used are taking diuretics (water tablets), especially during pregnancy, especially during late pregnancy when you are elderly or just before giving birth, since the following are having ECT electro-convulsive therapy) effects have been reported in newborn children: treatment irritability, tremor, muscle weakness, persistent have a history of bleeding disorders or you crying, difficulty in sucking or in sleeping.

Top of page cut-off to middle of registration mark: 44 mm.

FLUOXETINE CAPSULES 20 mg

Pharma code 211

(Main)

Driving and using machines Fluoxetine may affect your judgement or co-ordination. Do not drive or use machinery until you are sure you are not affected.

Like all medicines, Fluoxetine can cause side effects, although not everybody gets them. If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking the capsules straight away and tell your doctor immediately If you feel restless and feel like you cannot sit or stand still, you may have something called akathisia. Increasing your dose of Fluoxetine may make you feel worse. If you feel like this, contact your doctor. Tell your doctor immediately if your skin starts to turn red or you develop a varied skin reaction or your skin starts to blister or peel. This is very rare.

TAKING FLUOXETINE
Always take Fluoxetine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual doses are: Depression: the recommended dose is 20 mg daily. Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment. When appropriate the dosage can be gradually increased up to a maximum of 60 mg. The dose should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when you first start taking your medicine for depression. This is usual because an improvement in depressive symptoms may not occur until after the first few weeks. Patients with depression should be treated for a period of at least 6 months. Bulimia nervosa: the recommended dose if 60 mg daily. Obsessive-compulsive disorder (OCD): the recommended dose is 20 mg daily. Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment. When appropriate the dosage can be gradually increased up to a maximum of 60 mg. If no improvement is noted within 10 weeks, treatment with Fluoxetine should be reconsidered. Children and adolescents aged 8 to 18 years with depression: treatment should be started and be supervised by a specialist. The starting dose is 10 mg/day (given as 2.5 ml of fluoxetine oral liquid). After one to two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that you receive the lowest effective dose. Lower weight children may need lower doses. Your doctor should review the need for continuing treatment beyond 6 months. If you have not improved, your treatment should be reassessed. If you are elderly, your doctor will increase the dose with more caution and the daily dose should generally not exceed 40 mg. The maximum dose is 60 mg per day. If you have a liver problem or are using other medication that might have an influence on fluoxetine, your doctor may decide to prescribe a lower dose or instruct you to Fluoxetine every other day. Method of administration Swallow the capsules with a drink of water. Do not chew the capsules You can take Fluoxetine with or without food, whatever you prefer Always follow your doctor's instructions as to how many capsules to take and how often to take them Do not take more capsules than your doctor tells you. If you take more Fluoxetine than you should If you take too many capsules, go to your nearest hospital emergency department (or casualty) or tell your doctor straight away Take the pack of Fluoxetine with you if you can Symptoms of overdose include nausea, vomiting, seizures, heart problems (like irregular heart beat and cardiac arrest), lung problems and change in mental condition ranging from agitation to coma. If you forget to take Fluoxetine If you miss a dose, do not worry. Take your next dose the next day at the usual time. Do not take a double dose to make up for a forgotten dose. Taking your medicine at the same time each day may help you to remember to take it regularly. If you stop taking Fluoxetine Do not stop taking Fluoxetine until your doctor tells you to. It is important that you keep taking your medicine. Do not stop taking your medicine without asking your doctor first, even when you start to feel better Make sure you do not run out of capsules. You may notice the following effects when you stop taking Fluoxetine: dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, unusual tiredness or weakness, felling anxious, nausea/vomiting (feeling or being sick), tremor (shakiness), headaches. Most people find that any symptoms on stopping Fluoxetine are mild and go away on their own within a few weeks. If you experience symptoms when you stop treatment, contact your doctor. When stopping Fluoxetine, your doctor will help you to reduce your dose slowly over one or two weeks this should help reduce the chance of withdrawal effects.



Some patients have had: A combination of symptoms (known as serotonin syndrome) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely); Feelings of weakness, drowsiness or confusion mostly in elderly people and in (elderly) people on diuretics (water tablets) Prolonged and painful erection Irritability and extreme agitation. If you have any of the above side effects, you should tell your doctor immediately. If you have any of the following symptoms and they bother you, or last for some time, tell your doctor or a pharmacist. Whole body chills, sensitivity to sunlight, weight loss. Digestive system diarrhoea and stomach upsets, vomiting, indigestion, difficulty swallowing or a change in taste, or a dry mouth. Abnormal liver function has been reported rarely, with very rare cases of hepatitis. Nervous system headache, sleep problems or unusual dreams, dizziness, poor appetite, tiredness, abnormally high mood, uncontrollable movements, fits, extreme restlessness, hallucinations, untypical wild behaviour, confusion, agitation, anxiety, nervousness, not being able to concentrate or think properly, panic attacks, thoughts of suicide or harming yourself. Urogenital system and reproductive disorders difficulty passing urine or passing urine too frequently, poor sexual performance, prolonged erections, producing breast-milk. Respiratory system sore throat, shortness of breath. Lung problems (including inflammatory processes of varying histopathology and/or fibrosis) have been reported rarely. Other - hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, or joint or muscle pain, low levels of sodium in the blood. Most of these side effects are likely to go away with continued treatment. Additionally in children and adolescents (8-18 years) Fluoxetine may slow growth or possibly delay sexual maturity. 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.

STORING FLUOXETINE
Do not use this medicine after the expiry date shown on the outside packaging. Store in the original container. Do not store above 30 C. Do not transfer the capsules to another container. Keep them in a secure place where children cannot get at them. This medicine is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these capsules for longer than you need. Return all unused medicines to your pharmacist for safe disposal.

FURTHER INFORMATION
This leaflet only gives a brief outline of some of the more important points about Fluoxetine. If you want to know more about these capsules or their effects, please ask your doctor or pharmacist.

Revised: March 2008

68174-G

Pharma code 211

(Backup)

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.

If you have any further questions on the use of Fluoxetine, ask your doctor or pharmacist.

AFTER TAKING FLUOXETINE