BRINTELLIX PI PDF

Laboratory Tests Trintellix has not been associated with any clinically important changes in laboratory test parameters in serum chemistry except sodium , hematology and urinalysis as measured in the 6 to 8 week placebo-controlled studies. Hyponatremia has been reported with the treatment of Trintellix [see Warnings and Precautions 5. In the six month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to Trintellix during the initial 12 week, open-label phase, there were no clinically important changes in lab test parameters between Trintellix and placebo-treated patients. Weight Trintellix had no significant effect on body weight as measured by the mean change from baseline in the 6 to 8 week placebo-controlled studies. In the six month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to Trintellix during the initial 12 week, open-label phase, there was no significant effect on body weight between Trintellix and placebo-treated patients. Vital Signs Trintellix has not been associated with any clinically significant effects on vital signs, including systolic and diastolic blood pressure and heart rate, as measured in placebo-controlled studies.

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It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. 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. 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. 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. Your doctor may have prescribed it for another reason. Brintellix is not addictive. Brintellix should not be given to children under 18 years of age.

Before you take Brintellix When you must not take it Do not take Brintellix if you have an allergy to: vortioxetine any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: shortness of breath swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin Do not take Brintellix at the same time as the following other medicines: monoamine oxidase inhibitors MAOIs , such as phenelzine, tranylcypromine, selegiline, rasagiline and moclobemide medicines which act like a monoamine oxidase inhibitor, such as the antibiotic linezolid 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. 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. 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.

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. 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. 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. You must wait at least one day after finishing moclobemide before you start Brintellix.

You may need to use different amounts of medicines, or take different medicines. 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. 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.

For elderly people 65 years of age or older, the starting dose is 5 mg taken once daily. Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take. Follow the instructions they give you. If you take the wrong dose, Brintellix may not work as well and your condition may not improve. How to take it Swallow the tablets whole with a full glass of water. When to take it Take Brintellix as a single dose either in the morning or in the evening.

Take your medicine at about the same time each day. It does not matter if you take Brintellix before or after food. How long to take it Continue to take Brintellix even if it takes some time before you feel any improvement in your condition. It may take two weeks, sometimes longer, before you feel any improvement. Continue to take Brintellix for as long as your doctor recommends. Your doctor will check your progress at regular intervals.

Do not change the dose or stop taking this medicine without first checking with your doctor. If you forget to take it Take the next dose at the usual time. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure what to do, ask your doctor or pharmacist. If you take too much overdose 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. Keep the telephone number handy. Some of the signs of an overdose could be dizziness, feeling sick nausea , diarrhoea, stomach discomfort, itching on the whole body, sleepiness and flushing. While you are taking Brintellix Things you must do Tell your doctor immediately if you become pregnant while taking Brintellix.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Brintellix. If you are going to have surgery, tell the surgeon or anaesthetist that you are taking Brintellix. It may affect other medicines used during surgery.

All mentions of suicide or violence must be taken seriously. 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. This is more likely to occur: if you are a young adult, i. 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: worsening of depression thoughts or talk of death or suicide thoughts or talk of self-harm or harm to others any recent attempts of self-harm increase in aggressive behaviour, irritability, agitation or any other unusual changes in behaviour or mood.

Things you must not do 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. If you stop taking it suddenly, or reduce the amount you take, your condition may worsen.

Things to be careful of Be careful driving or operating machinery until you know how Brintellix affects you. Avoid alcohol while you are taking Brintellix. Side effects 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.

All medicines can have side effects. 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. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following side effects and they worry you: feeling sick nausea.

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BRINTELLIX PI PDF

Tegar The brinteklix analyses of placebo-controlled studies in children and adolescents with MDD, obsessive compulsive disorder OCDor other psychiatric disorders included a total of 24 short-term studies of nine antidepressant drugs in over 4, patients. Monoamine oxidase inhibitors MAOIsincluding selegiline, rasagiline, linezolid and moclobemide. Brintellix should not be used during pregnancy unless the benefit outweighs the risk. However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily see section 4. No apparent difference in the plasma protein binding between healthy subjects and subjects with hepatic mild, moderate or renal mild, moderate, severe, ESRD impairment is observed. Vortioxetine is considered a safe medicine for long term use in most people.

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Wait, other people feel this way too? Hypothetical Patient Want patient stories? Watch as these patients tell it like it is about their experience with depression and how talking to their doctor made a difference for them. Individual results may vary. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

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It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. 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.

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