Product Details

What you need to know before you take Fluoxetine Capsules

Do not take Fluoxetine Capsules if you are: • allergic (hypersensitive) to fluoxetine or any of the other ingredients of Fluoxetine Capsules (see Section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately. • taking other medicines used to treat depression, known as irreversible, non-selective monoamine oxidase inhibitors ( MAOIs) or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include medicines used to treat depression such as nialamide, iproniazid, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood). Treatment with Fluoxetine Capsules should only be started 2 weeks after discontinuation of an irreversible non selective MAOI (for instance tranylcypromine). However, treatment with fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide) Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking fluoxetine Capsules. If fluoxetine Capsules has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor. • Taking metoprolol (to treat heart failure) since there is an increased risk of your heart beat becoming too slow. Warnings and precautions Tell your doctor if any of the following applies to you: • have epilepsy or fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately; Fluoxetine Capsules might need to be discontinued. • mania now or in the past; if you have a manic episode, contact your doctor immediately because Fluoxetine Capsules might need to be discontinued. • diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic treatment) • liver problems (your doctor may need to adjust your dosage) • heart problems • low resting heart-rate and/or if you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets); • glaucoma (increased pressure in the eye); • ongoing treatment with diuretics (water tablets), especially if you are elderly • ongoing ECT (electro-convulsive therapy) treatment • history of bleeding disorders or you develop bruises or unusual bleeding, or if you are pregnant (see ‘Pregnancy’) • ongoing treatment with medicines that thin the blood (see ‘other medicines and fluoxetine capsules’) • ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘other medicines and fluoxetine capsules’’); • starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetine capsules may make this worse; • appearance of fever, muscle stiffness or tremor, changes in your mental state like 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; contact your doctor immediately, Fluoxetine Capsules might need to be discontinued. • Medicines like Fluoxetine capsules (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. • The use of Buprenorphine together with Fluoxetine capsules can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Fluoxetine capsules”). 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. Children and adolescents aged 8 to 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. • Fluoxetine Capsule 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 psychological therapy) and it should not be used to treat other conditions. • Additionally, 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. Despite this, your doctor may prescribe Fluoxetine Capsule for patients under 18 for moderate to severe major depressive episodes in combination with psychological therapy because he/she decides that this is in your best 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. Fluoxetine Capsules should not be used in the treatment of children under the age of 8 years. Other medicines and Fluoxetine Capsules 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. Some medicines may increase the side effects of Fluoxetine capsules and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Fluoxetine capsules without first talking to your doctor, especially: • buprenorphine/opioids. These medicines may interact with Fluoxetine capsules and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38ºC. Contact your doctor when experiencing such symptoms. Do not take Fluoxetine Capsules with: • Certain irreversible, non-selective monoamine oxidase inhibitors MAO-inhibitors (used to treat depression). Irreversible, Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) must not be used with Fluoxetine Capsules as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not take Fluoxetine Capsules”). Treatment with Fluoxetine Capsules should only be started at least 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking Fluoxetine Capsules. If Fluoxetine Capsules has been prescribed for a long period and/or at a high dose, a longer interval than 5 weeks may need to be considered by your doctor. • metoprolol when used for heart failure; there is an increased risk of your heart beat becoming too slow. Fluoxetine Capsules may affect the way following medicines work (interaction) • lithium, selegiline,St.John’s wort, tramadol ( a pain killer) , buprenorphine (a type of opioid) triptans (for migraine) and tryptophan( used to treat mental illness): there is an increased risk of serotonin syndrome when these drugs are taken with Fluoxetine Capsules. Your doctor will carry out more frequent check-ups. monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine can be started the day after stopping treatment with reversible MAOIs but the doctor may wish to monitor you carefully and use a lower dose of the MAOI-A drug. However, treatment with fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue)). Some MAO-inhibitors type B (selegiline) can be used with Fluoxetine Capsules provided that your doctor monitors you closely. • mequitazine (for allergies); because taking this drug with Fluoxetine Capsules may increase the risk of changes in the electrical activity of the heart. • phenytoin (for epilepsy): because Fluoxetine Capsules may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with Fluoxetine Capsules. • tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure). • medicines that may affect the heart’s rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derviatives, phenothiazine derivatives pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine, certain antihistamines (astemizole, mizolastine). Taking one or more of these drugs with Fluoxetine Capsules may increase the risk of changes in the electrical activity of the heart. • Flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine tricyclic antidepressants (for example imipramine, desipramine and amitriptyline or risperidone for schizophrenia); because Fluoxetine Capsules may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine Capsule. • tamoxifen (used to treat breast cancer), because Fluoxetine capsules may change the blood levels of this drug and a reduction of the effect of tamoxifen cannot be excluded, your doctor may need to consider different antidepressant treatments. • Anti-coagulants such as Warfarin, NSAID (such as ibuprofen,diclofenac) or aspirin and other medicines used to thin the blood (including clozapine, used to treat certain mental disorders) ; Fluoxetine Capsules may alter the effect of these medicines on the blood. If Fluoxetine Capsules treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests, adjust your dose and check on you more frequently. • cyproheptadine (for allergies); because it may reduce the effect of Fluoxetine Capsules. • drugs that lower sodium levels in the blood (including, drug that causes increase in urination, desmopressin, carbamazepine and oxcarbazepine); because these drugs may increase the risk of sodium levels in the blood becoming too low when taken with Fluoxetine Capsules. • anti-depressants such as tricyclic anti-depressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain) or anti-psychotics such as phenothiazines or butyrophenones; because Fluoxetine Capsules may increase the risk of seizures when taken with these medicines. • You should not start to take the herbal remedy St John’s wort while you are being treated with Fluoxetine Capsules since this may result in an increase in side effects. If you are already taking St John’s wort when you start on Fluoxetine Capsules, stop taking St John’s wort and tell your doctor at your next visit. Fluoxetine Capsule with food, drink and alcohol • You can take this medicine with or without food, whatever you prefer. • You are advised NOT to drink alcohol with 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 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. 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 new born (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. In babies whose mothers took Fluoxetine Capsules during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those 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. It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. You and your doctor may decide that it is better for you to gradually stop taking Fluoxetine Capsules while you are pregnant or before being pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine Capsules. 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. If you take Fluoxetine Capsules near the end of your 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 Capsules so they can advise you. 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. 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. Driving and using machines: Your medicine can affect your judgement or co-ordination. Do not drive or use machinery without advice from your doctor or pharmacist