Product Details

Product Information Brintellix

What you need to know before you take Brintellix

Do not take Brintellix: – if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6). – if you are taking other medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. Ask your doctor if you are uncertain. Warnings and precautions Talk to your doctor or pharmacist before taking Brintellix if you: – are taking medicines with a so-called serotonergic effect, such as: – tramadol and similar medicines (strong painkillers). – sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). 2 Taking these medicines together with Brintellix may increase the risk of serotonin syndrome. This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea. – have had fits (seizures). Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy. Fits are a potential risk with medicines used to treat depression. Treatment should be discontinued in any patient who develops fits or where there is an increase in the frequency of fits. – have had mania – have a tendency to bleed or bruise easily, or if you are pregnant (See ‘Pregnancy, breast-feeding and fertility’). – have low sodium level in the blood. – are 65 years of age or older. – have a severe kidney disease. – have a severe liver disease or a liver disease called cirrhosis. – have or previously have had increased pressure in the eye or glaucoma. If your eyes become painful and you develop blurred vision during treatment, contact your doctor. When you are on antidepressant treatment, including vortioxetine, you may also experience feelings of aggression, agitation, anger and irritability. If this occurs, you should talk to your doctor. Thoughts of suicide and worsening of your depression 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. * 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 Brintellix is not recommended in children aged 7 to 11 years due to lack of information. Brintellix should not be used in adolescents aged 12 to 17 years because efficacy has not been demonstrated. The safety of Brintellix in adolescents aged 12 to 17 years is described in section 4. Other medicines and Brintellix Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are taking any of the following medicines: * phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors); you must not take any of these 3 medicines together with Brintellix. If you have taken any of these medicines, you will need to wait 14 days before you start taking Brintellix. After stopping Brintellix you must allow 14 days before taking any of these medicines. * moclobemide (a medicine to treat depression). * selegiline, rasagiline (medicines to treat Parkinson’s disease). * linezolid (a medicine to treat bacterial infections). * medicinal products with serotonergic effect e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with Brintellix may increase the risk of serotonin syndrome (see section warnings and precautions) * lithium (a medicine to treat depression and mental disorders) or tryptophan. * medicines known to cause low sodium level. * rifampicin (a medicine to treat tuberculosis and other infections). * carbamazepine, phenytoin (medicines to treat epilepsy or other illness). * warfarin, dipyridamole, phenprocoumon, low-dose acetylsalicylic acid (blood thinning medicines). Medicines that increase the risk of fits: * sumatriptan and similar medicines with active substance names ending in “triptans”. * tramadol (a strong painkiller). * mefloquine (a medicine to prevent and treat malaria). * bupropion (a medicine to treat depression also used to wean from smoking). * fluoxetine, paroxetine and other medicines to treat depression called SSRI/SNRIs, tricyclics. * St John’s wort (hypericum perforatum) (a medicine to treat depression). * quinidine (a medicine to treat heart rhythm disorders). * chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the groups called phenothiazines, thioxanthenes, butyrophenones). Please tell your doctor if you are taking any of the medicines above, since your doctor needs to know if you already are at risk for seizures. If you are having a urine drug screen, taking Brintellix may cause positive results for methadone when some test methods are used, even though you may not be taking methadone. If this happens, a more specific test can be performed. Brintellix with alcohol Combining this medicine with alcohol is not advisable. 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 for advice before taking this medicine. Pregnancy Brintellix should not be used during pregnancy unless the doctor says it is absolutely necessary. If you take medicines to treat depression, including Brintellix, during the last 3 months of your pregnancy, you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. Contact your doctor immediately if your newborn baby has any of these symptoms. 4 Make sure your midwife and/or doctor know you are on Brintellix. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Brintellix 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 Brintellix 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 Brintellix so they can advise you. Breast-feeding It is expected that the ingredients of Brintellix will pass into breast milk. Brintellix is not to be used during breast-feeding. Your doctor will make a decision on whether you should stop breast-feeding, or stop using Brintellix taking into account the benefit of breast-feeding for your child, and the benefit of therapy for you. Driving and using machines Brintellix has no or negligible influence on the ability to drive and use machines. However, as adverse reactions such as diziness have been reported, caution is advised during such activities when beginning Brintellix treatment or changing the dose. Brintellix contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.