Product Details

What you need to know before you take Fluoxetine Oral Solution

Do not take Fluoxetine Oral Solution if you: • are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). • taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs), since serious or even fatal reactions can occur (e.g., iproniazid used to treat depression). • combined with metoprolol in cardiac failure (see section Other medicines and Fluoxetine Oral Solution) Warnings and precautions Talk to your doctor or pharmacist before taking Fluoxetine Oral Solution if any of the following applies to you: • have epilepsy or fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately as treatment with Fluoxetine Oral Solution may need to be discontinued • have mania now or in the past; if you have a manic episode, contact your doctor immediately as treatment with Fluoxetine Oral Solution may need to be discontinued • suffer from diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic treatment) • have liver problems, as your doctor may need to adjust your dose • have heart problems • have a history of bleeding disorders or you develop bruises or unusual bleeding or if you are pregnant (see ‘Pregnancy, breast-feeding and fertility’) • are taking diuretics (water tablets) particularly if you are elderly • ongoing ECT (electroconvulsive therapy) • glaucoma (increased pressure in the eye) • are taking medicines that thin the blood (see section Other medicines and Fluoxetine Oral Solution) • are taking tamoxifen (used to treat breast cancer) (see section Other medicines and Fluoxetine Oral Solution ) • starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of fluoxetine 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. You should contact your doctor immediately as treatment with Fluoxetine Oral Solution may need to be discontinued. • 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). Medicines like Fluoxetine Oral Solution (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. Treatment with fluoxetine 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 Oral Solution. If Fluoxetine Oral Solution has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor. 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 Oral Solution 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 Oral Solution on growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this, and if you are a patient under 18 years, your doctor may prescribe Fluoxetine Oral Solution 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 Oral Solution for a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform them if any of the symptoms listed develop or worsen when patients under 18 years are taking Fluoxetine Oral Solution. Fluoxetine Oral Solution should not be used in the treatment of children under the age of 8 years. Other medicines and Fluoxetine Oral Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Fluoxetine Oral Solution may affect the following medicines work (interaction): • Metoprolol (for hypertension); there is an increased risk of excessive bradycardia (decrease heart rate). • Mequitazine (for allergies); there is an increased risk of QT prolongation (abnormal ECG). • Medicines that may affect the heart’s rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derviatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine, certain antihistamines (astemizole, mizolastine), because taking one or more of these drugs with Fluoxetine Oral Solution may increase the risk of changes in the electrical activity of the heart. • Monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also called methylene blue, used for the treatment of medicinal or chemical product induced methemoglobinemia): 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 drugs. • Lithium, tryptophan, selegiline (MAOI-B); there is an increased risk of serotonin syndrome when these drugs are taken with Fluoxetine Oral Solution. Your doctor will carry out more frequent check-ups. • Phenytoin (for epilepsy); because Fluoxetine Oral Solution may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out checkups when given with Fluoxetine Oral Solution. • Tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure) • Flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (for example imipramine, desipramine and amitriptyline) or resperidone (for schizophrenia); because Fluoxetine Oral Solution may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine Oral Solution. • Anti-coagulants (such as warfarin), NSAID (such as ibuprofen, diclofenac), aspirin or other medicines which can thin the blood (including clozapine, used to treat certain mental disorders). Fluoxetine Oral Solution may alter the effect of these medicines on the blood. If Fluoxetine Oral Solution 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. • Tamoxifen (used to treat breast cancer); because Fluoxetine Oral Solution may change the blood levels of this drug, resulting in the possibility of a reduction in the effect of tamoxifen, your doctor may need to consider prescribing a different antidepressant treatments. • You should not take the herbal remedy St Johns wort (Hypericum perforatum), while you are being treated with Fluoxetine Oral Solution since this may result in an increase in side effects. If you are already taking St Johns wort when you start taking Fluoxetine Oral Solution, stop taking St Johns wort and tell your doctor at your next visit. • Cyproheptadine (for allergics); because it may reduce the effect of Fluoxetine Oral Solution. • 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 Oral Solution. 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 Oral Solution may increase the risk of seizures when taken with these medicines. Fluoxetine Oral Solution with food and alcohol Fluoxetine Oral Solution can be taken with or without food. You should avoid alcohol while you are 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 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 during the first few months of pregnancy, there have been some studies describing 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. 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 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. 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 sleeping. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetine Oral Solution 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. If you take Fluoxetine Oral Solution 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 Oral Solution so they can advise you. Breast-feeding Fluoxetine is excreted in breast milk and can cause side effects in babies. You should only breastfeed if it is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower dose of fluoxetine. 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 Psychotropic drug such as Fluoxetine Oral Solution may affect your judgment or co-ordination. Do not drive or use machinery until you know how Fluoxetine Oral Solution affects you. Fluoxetine Oral Solution contains sorbitol and benzoic acid This medicine contains 1250 mg sorbitol in each 5 mL which is equivalent to 250 mg/mL This medicine contains 2.5 mg benzoic acid in each 5 mL which is equivalent to 0.5 mg/mL.