BRINTELLIX PACKAGE INSERT PDF

It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Brintellix. For practical information about using Brintellix, patients should read the package leaflet or contact their doctor or pharmacist. Brintellix is an antidepressant medicine containing the active substance vortioxetine.

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If your country is not on the list , please refer to our global contacts. This leaflet answers some common questions about Brintellix. It does not contain all the available information. All medicines have risks and benefits.

Your doctor has weighed the risks of you taking Brintellix against the benefits they expect it will have for you. If you have any concerns about taking this medicine ask your doctor or pharmacist. Depression is longer lasting or more severe than the "low moods" everyone has from time to time due to the stress of everyday life.

It is thought to be caused by a chemical imbalance in parts of the brain. Brintellix is thought to work by its actions on multiple brain chemicals including serotonin, noradrenaline, dopamine, histamine and acetylcholine which are thought to be involved in controlling mood and related mental processes.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Taking Brintellix with MAOIs may cause a serious reaction including sudden changes in mental state, twitching, rapid heartbeat, high blood pressure, fever and diarrhoea. If you have used moclobemide, one day must elapse after you stop taking moclobemide before you start taking Brintellix.

Do not take Brintellix after the expiry date EXP printed on the pack. The expiry date refers to the last day of the month. It may have no effect at all or, an entirely unexpected effect if you take it after the expiry date. Do not take Brintellix if the packaging is torn or shows signs of having been tampered with.

If you are not sure whether you should start taking this medicine, talk to your doctor. Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Brintellix should not be used during pregnancy unless the benefit outweighs the risk.

Your doctor can discuss with you the risks and benefits involved. These symptoms usually begin during the first 24 hours after the baby is born. Other effects on your baby may include difficulty breathing, fits, body temperature changes, feeding difficulties, vomiting, stiff or floppy muscles, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. It is recommended that you do not breast-feed while taking Brintellix, as it may be excreted in the milk.

There is no experience with the use of Brintellix in children or adolescents less than 18 years of age. If you have not told your doctor about any of the above, tell them before you use Brintellix. Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

You must wait at least one day after finishing moclobemide before you start Brintellix. These medicines may be affected by Brintellix, or may affect how well it works. You may need to use different amounts of medicines, or take different medicines. Your doctor will tell you how much Brintellix to take each day. Take the amount your doctor tells you to. The usual dose for Brintellix in adults less than 65 years of age is 10 mg taken orally as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day or lowered to a minimum of 5 mg per day.

Continue to take Brintellix even if it takes some time before you feel any improvement in your condition. Do not change the dose or stop taking this medicine without first checking with your doctor. Immediately telephone your doctor or Poisons Information Centre Telephone 13 11 26 for advice, or go to the Accident and Emergency department at your nearest hospital if you think that you or anyone else may have taken too much Brintellix.

Take the Brintellix container with you when you go to the hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Some of the signs of an overdose could be dizziness, feeling sick nausea , diarrhoea, stomach discomfort, itching on the whole body, sleepiness and flushing.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Brintellix. Keep all of your doctor's appointments so that your progress can be checked.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking Brintellix. Occasionally, the symptoms of depression may include thoughts of suicide or self-harm. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent.

You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour. Patients and care givers should pay attention for any of the following warning signs of suicide-related behaviour while taking Brintellix:. Do not take Brintellix to treat any other complaints unless your doctor tells you to.

Do not give Brintellix to anyone else, even if they have the same condition as you. Do not stop taking Brintellix, or lower the dosage, without checking with your doctor. Be careful driving or operating machinery until you know how Brintellix affects you. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Brintellix.

Brintellix helps most people with depression, but it may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by the following lists of side effects. You may not experience any of them. Tell your doctor if you notice any of the following side effects and they worry you:. Side effects are generally mild to moderate and occur within the first two weeks of treatment.

They are usually temporary and generally do not require treatment cessation. Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:. The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Do not store Brintellix or any other medicine in the bathroom or near a sink or stove. Do not leave it on a window sill or in the car. A locked cupboard at least one-and a-half metres above ground is a good place to store medicines.

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you may have left over. Brintellix is a registered trade mark of H.

Product Information PI. South Africa. Australia New Zealand. Global contacts we operate in more than 57 countries around the world. View contacts. Lundbeck worldwide. It does not take the place of talking to your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Brintellix is used for Brintellix contains vortioxetine, which is used to treat major depression in adults. Your doctor may have prescribed it for another reason.

Brintellix is available only with a doctor's prescription. Brintellix is not addictive. Brintellix should not be given to children under 18 years of age.

Before you start to take it Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you are pregnant or plan to become pregnant. If your newborn baby has any of the above symptoms, you should contact your doctor immediately.

Tell your doctor if you are breastfeeding or planning to breast-feed It is recommended that you do not breast-feed while taking Brintellix, as it may be excreted in the milk.

Tell your doctor if you have, or have had, the following medical conditions: A tendency to bleed or bruise easily Low sodium levels in the blood Seizures or fits A history of suicide-related events or suicidal ideas A history, or family history, of mania or bipolar disorder manic depression Other diseases affecting the brain, including psychiatric conditions Other significant medical illnesses, such as unstable heart disease, stroke or severe liver or kidney disease Tell your doctor if are 65 years of age or older.

Tell your doctor if you are receiving electroconvulsive therapy. Do not give Brintellix to a child or adolescent. Ask your doctor or pharmacist for advice before taking any medicine. Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Brintellix may interfere with each other. These include: Monoamine oxidase inhibitors MAOIs , including selegiline, rasagiline, linezolid and moclobemide. How to take Brintellix Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How much to take Your doctor will tell you how much Brintellix to take each day. For elderly people 65 years of age or older, the starting dose is 5 mg taken once daily.

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It may take up to four weeks after starting this treatment before you feel the full benefit. Do not stop taking it, feeling it is not helping. Tell your doctor if you feel that you are not getting any better, or if you experience any troublesome side-effects. Vortioxetine is prescribed for depression that has not been helped by treatment with other antidepressant medicines. Depression can develop for no apparent reason, or it can be triggered by a life event such as a relationship problem, bereavement, or an illness. Depression is caused by an imbalance of certain chemicals in the brain.

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