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What Brintellix is and what it is used for
Brintellix contains the active substance vorthyoxetine. It belongs to a group of medicines called antidepressants. This medicine is given to you to treat your depression.
Brintellix reduces a wide range of depressive symptoms including sadness, inner tension (anxiety), sleep disturbances (reduced sleep), decreased appetite, difficulty concentrating, senselessness, loss of interest in your favorite activities, feeling slow.
Brintellix is used to treat major depressive episodes in adults.
2. What you need to know before you take Brintellix
Do not take Brintellix:
if you are allergic to vortoxetine 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 not sure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Brintellix if:
you are taking medicines with the so-called serotonergic effect, such as:
tramadol (very painkiller);
sumatriptan and similar drugs with the active substance ending with "tryptan" (used to treat migraine).
Taking these medicines together with Brintellix may increase the risk of serotonin syndrome. This syndrome may be associated with hallucinations, involuntary twitching, rapid heartbeat, high blood pressure, fever, nausea and diarrhea.
you have had seizures (seizures);
Your doctor will treat you carefully if you have a history of seizures or have unstable epilepsy. Seizures are a potential risk for medicines used to treat depression. Treatment should be discontinued in any patient who has experienced a seizure or an increased incidence of seizures.
you have had an obsession;
you have a tendency to bleed or easily bruise;
have a low level of sodium in your blood;
you are 65 years of age or older;
have severe kidney disease;
have a severe liver disease or a liver disease called cirrhosis.
Thoughts of suicide and worsening of your depression
If you have depression and / or anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts can be tightened when you first take antidepressants, as all these drugs take time to get started - usually about two weeks, but sometimes longer.
The likelihood of thinking this way may be greater if:
and before you had thoughts of suicide or self-harm.
you are a young man.
Clinical trial data show an increased risk of suicidal behavior in young people under 25 years of age with mental illness treated with an antidepressant.
If you have thoughts of self-harm or suicide at any time, contact your doctor or go to hospital immediately. You may find it helpful to tell a relative or close friend that you have depression or anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse or worrying about changes in your behavior.
Children and adolescents
Brintellix is not recommended for children and adolescents under 18 due to lack of information about this age group.
Other medicines and Brintellix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please tell your doctor if you are taking any of the following medicines:
phenelzine, iproniazide, isocarboxazide, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors); if you take any of these medicines you will have to wait 14 days before taking Brintellix. After stopping this medicine, it must take 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);
lithium (a medicine to treat depression and mental disorders) or tryptophan;
medicines known to reduce sodium levels;
rifampicin (a medicine to treat tuberculosis and other infections);
carbamazepine, phenytoin (medicines to treat epilepsy or other illnesses);
warfarin, dipyridamole, phenprocoumon, low-dose acetylsalicylic acid (blood-thinning medicines).
Medicines that increase the risk of seizures:
sumatriptan and similar drugs with active substance names ending with "tryptans";
tramadol (very painkiller);
mefloquine (a medicine for the prevention and treatment of malaria);
bupropion (a medicine to treat depression and also to quit smoking);
fluoxetine, paroxetine and other depressant medicines called CIPOP / CHFI, tricyclic antidepressants;
Brintellix with alcohol
As with many other medicines, taking alcohol during treatment with this medicine is not recommended.
Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Brintellix should not be taken during pregnancy unless the doctor thinks it is absolutely necessary.
If you are taking medicines to treat depression including Brintellix during the last 3 months of pregnancy, you may need to know that your newborn may experience the following side effects: breathing problems, bluish skin, seizures, changes in body temperature, difficulty feeding , vomiting, low blood sugar, stiff or relaxed muscles, live reflexes, trembling, nervousness, irritability, lethargy, constant crying, drowsiness and insomnia. If your baby has any of these symptoms, please contact your doctor immediately.
Make sure your midwife and / or doctor know that you are taking Brintellix. When taken during pregnancy, especially during the last 3 months, medicines similar to Brintellix could increase the risk of serious condition in babies called persistent pulmonary hypertension in the newborn (BPH), in which the baby breathes rapidly and brightens. These symptoms usually begin during the first 24 hours after the birth of the baby.
If this happens to your baby, you should immediately contact your midwife and / or doctor.
It is expected that the ingredients of Brintellix will pass into breast milk. Brintellix should not be used during breast-feeding. Your doctor will decide whether to stop breast-feeding or stop taking Brintellix, taking into account the benefit of breast-feeding to the child and the benefit of therapy for you.
In animal studies, some antidepressants such as warfarin may reduce the quality of sperm. Theoretically, this could affect fertility. Vortoxetine has not shown such an effect in animal studies; impact on humans has not yet been observed.
Driving and using machines
Brintellix has no or negligible influence on the ability to drive and use machines.
However, caution is advised during these activities when initiating treatment with Brintellix or changing the dose.
3. How to take Brintellix
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Brintellix is 10 mg vorthyoxetine once daily in adults less than 65 years of age. The dose may be increased by your doctor to a maximum of 20 mg of vorthyoxetine per day or reduced to at least 5 mg of warfarin per day, depending on how you respond to treatment.
For elderly, 65 years of age or older, the starting dose is 5 mg of vorthyoxetine once a day.
Take one tablet with a glass of water.
The tablet can be taken with or without food.
Duration of treatment
Take Brintellix for as long as your doctor has told you.
Continue to take Brintellix, even if it takes some time before you feel an improvement in your condition.
Treatment should be continued for at least 6 months after you feel well again.
If you take more Brintellix than you should
If you take more than the prescribed dose of Brintellix, contact your doctor or nearest emergency medical center immediately. Take the pack and the other tablets with you. Do this even if you have no signs of discomfort. Signs of overdose are dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness and redness.
If you forget to take Brintellix
Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Brintellix
Do not stop taking Brintellix without discussing it with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Overall, the observed side effects are mild to moderate and occur within the first two weeks of treatment. Reactions are usually temporary and do not lead to discontinuation of treatment.
The side effects listed below have been reported with the following frequencies.
Very common: may affect more than 1 in 10 people:
Common: may affect up to 1 in 10 people:
diarrhea, constipation, vomiting;
itching all over the body;
Uncommon: can affect up to 1 in 100 people:
Not known: frequency can not be estimated from the available data:
low blood sodium (symptoms may include dizziness, weakness, confusion, drowsiness or severe fatigue, nausea or vomiting, more severe symptoms such as fainting, seizures or falls);
serotonin syndrome (see section 2).
There is an increased risk of bone fracture in patients taking this type of medicine.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store Brintellix
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Brintellix contains:
The active substance is: vortyoxetine. Each film-coated tablet contains wartioxetine hydrobromide equivalent to 10 mg of vortioxetine (vortioxetine).
The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), iron oxide, yellow (E172).
What Brintellix looks like and contents of the pack
Yellow, film-coated almond shaped tablet (5 x 8.4 mm), engraved with "TL" on one side and "10" on the other side.
Brintellix 10 mg film-coated tablets are available in blister packs of 14, 28, 56 x 1, 98 x 1, 126 (9 x 14), 490 (5 x (98 x 1) and in 100 to 200 tablet tablets.
Pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are available in single dose blisters.
Not all pack sizes may be marketed.
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