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. It is used to treat major depression in adults. Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.

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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.

It is used to treat major depression in adults. Major depression is a condition in which patients have mood disturbances that interfere with their everyday life. Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.

The usual dose is 10 mg once a day. Patients 65 years of age and over should be started on a lower dose of 5 mg daily. Lower doses may also be needed in patients taking certain medicines that reduce the breakdown of vortioxetine in the body and conversely higher doses may be considered in those taking medicines that increase the breakdown of vortioxetine. Treatment with Brintellix should continue for at least 6 months after the depressive symptoms have resolved.

For further information, see the package leaflet. The active substance in Brintellix, vortioxetine, is an antidepressant. It acts on different receptors for serotonin in the brain, blocking the action of some receptors and having some stimulant action on others. In addition, vortioxetine blocks the action of the serotonin transporter, which is responsible for clearing serotonin from its sites of activity in the brain, thus increasing the activity of serotonin.

Serotonin is a neurotransmitter, a chemical that transmits signals between nerve cells. Because serotonin is involved in the control of mood, and can regulate the actions of other neurotransmitters that may be involved in depression and anxiety, these actions of vortioxetine are thought to result in its effect in improving depression. Brintellix has been studied in 12 main short-term studies involving more than 6, patients with major depression including one study in patients aged 65 and over , in which it was compared with placebo a dummy treatment for 6 or 8 weeks.

The main measure of effectiveness in each study was the change in a standard score for symptoms of depression; the studies showed that doses of Brintellix ranging from 5 to 20 mg were generally more effective than placebo in improving depression and resulted in a clinically relevant decrease of the depression scores.

Supportive data from week extensions of several of these studies suggested that the improvements that were seen were maintained longer-term. In addition, the company presented results from two other main studies.

In a week comparison of Brintellix with another antidepressant, agomelatine, Brintellix was more effective than agomelatine in improving the symptom score. The most common side effect with Brintellix, seen in more than 1 in 10 people is nausea feeling sick.

Side effects were usually mild or moderate, short-lasting and occurred in the first two weeks of treatment. Effects on the gut such as nausea are more common in women than in men.

Brintellix must be used with care and sometimes in adjusted doses in patients taking certain other medicines; it must not be used in patients also taking medicines known as nonselective monoamine oxidase inhibitors MAOIs or selective monoamine oxidase A MAO-A inhibitors.

For the full list of all side effects and restrictions, see the package leaflet. Studies have shown a clinically relevant improvement in major depressive episodes, and the types of side effects seen were similar to those with other antidepressants that act through serotonin. Although there was limited information about the use of doses above 10 mg daily in the elderly this was addressed in the product information. A risk management plan has been developed to ensure that Brintellix is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Brintellix, including the appropriate precautions to be followed by healthcare professionals and patients. The European Commission granted a marketing authorisation valid throughout the European Union for Brintellix on 18 December More detail is available in the summary of product characteristics.

Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Brintellix RSS. Table of contents Overview Authorisation details Product information Assessment history. Expand section Collapse section. Authorisation details. Product details Name Brintellix. Depressive Disorder, Major. Publication details Marketing-authorisation holder H. Ottiliavej 9 DK Valby Denmark.

Product information. List item. You are therefore advised to be selective about which sections or pages you wish to print.

Treatment of major depressive episodes in adults. Assessment history. Changes since initial authorisation of medicine List item. Initial marketing-authorisation documents List item.

Related content. Brintellix: Paediatric investigation plan. How useful was this page? View all 7 ratings. Your name. Tell us more. Leave this field blank. I'm a spammer. International non-proprietary name INN or common name. Anatomical therapeutic chemical ATC code. Date of issue of marketing authorisation valid throughout the European Union.

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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. Altering the levels of the chemicals in the brain can help ease symptoms of depression.

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