5 mg film-coated tablets 
Vortioxetine (Vortioxetinum)

1. What Brintellix is ​​and what it is used for

Brintellix contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.

Brintellix is ​​used to treat major depression in adults.

Brintellix has been shown to reduce a wide range of depressive symptoms, including depression, inner tension (feeling anxious), sleep disturbances (reduced sleep), decreased appetite, difficulty concentrating, feeling worthless, loss of interest in favorite activities, and feeling slow.

2. What you need to know before using Brintellix

Do not use Brintellix

  • if you are allergic to the active substance vortioxetine or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking other antidepressants known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. Ask your doctor if you are unsure.

Warnings and cautions

Talk to your doctor or pharmacist before taking Brintellix if you:

  • take other drugs with a so-called serotonergic effect, such as:
    • tramadol (a strong painkiller).
    • sumatriptan and similar drugs with an active substance ending in “triptan” (used to treat migraines ).
      A combination of these drugs with Brintellix may increase the risk of the serotonergic syndrome. This syndrome can include hallucinations, involuntary twitching, faster heart rate, high blood pressure, fever, nausea, and diarrhea.
  • have suffered seizures (seizures).Your doctor will treat you with caution if you have previously had seizures or have an unstable seizure/epilepsy. Seizures are a potential risk in the treatment of depression. Treatment should be discontinued in any patient who suffers from seizures or where the frequency of seizures increases.
  • has suffered from mania.
  • have a tendency to bleed and bruise easily, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”)
  • have low levels of sodium in the blood.
  • is 65 years or older.
  • have serious kidney disease.
  • have serious liver disease or a liver disease called cirrhosis.
  • have or have previously had increased pressure in the eye or glaucoma. If you get sore eyes and develop blurred vision during treatment, consult a doctor.

You may also experience emotions such as aggression, agitation , anger and irritability while you are being treated with antidepressant drugs, e.g. vortioxetine. If this happens, talk to your doctor.

Thoughts of suicide or worsening of your depression

If you are depressed and/or suffering from anxiety, you may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • if you have previously had thoughts of harming yourself or committing suicide.
  • if you are a young adult.

Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and young people

Brintellix is ​​not recommended for use in children aged 7 to 11 years due to a lack of information. Brintellix should not be given to adolescents aged 12 to 17 years as the effect has not been demonstrated. For information on the safety of Brintellix in adolescents aged 12 to 17 years, see 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 (antidepressants, so-called non-selective monoamine oxidase inhibitors ). You must not take any of these medicines with Brintellix. If you have taken any of these medicines, you must wait 14 days before starting Brintellix. After stopping treatment with Brintellix, you must wait 14 days before taking any of these medicines.
  • moclobemide (antidepressant).
  • selegiline, rasagiline (a medicine used to treat Parkinson’s disease ).
  • linezolid (medicines for bacterial infections ).
  • lithium (medicines for depression and mental illness) or tryptophan.
  • drugs are known to cause low levels of sodium.
  • rifampicin (medicine for tuberculosis and other infections ).
  • carbamazepine, phenytoin (medicines for epilepsy or other diseases).
  • warfarin , dipyridamole, phenprocoumon, low dose acetylsalicylic acid (blood thinners).

Medicines that increase the risk of seizures:

  1. sumatriptan and similar drugs with an active substance ending in “triptan”.
  2. tramadol (a strong painkiller).
  3. mefloquine (a drug used to prevent and treat malaria ).
  4. bupropion (antidepressant also used in smoking cessation).
  5. fluoxetine, paroxetine, and other medicines used to treat depression called SSRIs / SNRIs, tricyclics
  6. St. John’s wort (Hypericum perforatum) (herbal medicine for depression)
  7. quinidine (medicine to treat heart rhythm disorders).
  8. chlorpromazine, chlorprotixen, haloperidol (medicines for mental disorders belonging to the groups’ phenothiazines, thioxanthenes, butyrophenones).

Tell your doctor if you are taking any of the above medicines, as your doctor needs to know if you are already at increased risk of seizures.

If you are undergoing drug screening for urine and taking Brintellix, the test results for methadone may be positive when certain test methods are used, even if you are not taking methadone. If this happens, a more specific test can be done.

Brintellix with food, drink, and alcohol

This medicine should not be used with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Brintellix should not be used during pregnancy unless your doctor tells you it’s absolutely necessary.

If you are taking medicines to treat depression, including Brintellix, during the last 3 months of your pregnancy, you should be aware that the following symptoms may be seen in your newborn baby: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, breastfeeding difficulties, vomiting, low blood sugar, tense or slack muscles, overactive reflexes, tremors, jerkiness, irritability, listlessness, persistent crying, increased sleepiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor or midwife as soon as possible.

Tell your midwife or doctor that you are using Brintellix. When drugs such as Brintellix are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

If you take Brintellix at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Brintellix so that they can advise you on this.

Breast-feeding

The ingredients in Brintellix are expected to pass into breast milk. Brintellix should not be used during breast-feeding. Your doctor will decide if you should stop breast-feeding or stop using Brintellix, and will take into account your baby’s benefit from breast-feeding and your benefit from treatment.

Driving and using machines

Brintellix has no or negligible effect on the ability to drive and use machines, but as side effects such as dizziness have been reported, you should be careful with such activities at the beginning of Brintellix treatment or when changing your dose.

Brintellix contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Brintellix

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose of Brintellix is ​​10 mg vortioxetine once daily for adults under 65 years of age. Dose one can be increased by your doctor to a maximum of 20 mg of vortioxetine per day or reduced to a minimum of 5 mg per day depending on how you respond to treatment.

For patients 65 years of age or older, the starting dose is 5 mg vortioxetine once daily.

Treatment method

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 recommends.

Continue taking Brintellix even if it takes a while before you feel an improvement in your condition.

The treatment should continue for at least 6 months after you feel well again.

At doses that are several times higher than the prescribed dose, there have been cases of seizures and a rare condition called serotonergic syndrome.

If you forget to use Brintellix

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Brintellix

Do not stop taking Brintellix without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The adverse reactions observed were generally mild to moderate and occurred within the first two weeks of treatment. The reactions were usually transient and did not result in discontinuation of treatment.

The following side effects have been reported with frequency as follows:

Very common (may affect more than 1 user in 10):

  • nausea

Common (may affect up to 1 in 10 people):

  • diarrhea, constipation, vomiting
  • dizziness
  • itching all over the body
  • abnormal dreams

Uncommon (may affect up to 1 in 100 people):

  • redness
  • night sweats

Rare (may affect up to 1 in 1,000 people):

  • enlarged pupils ( mydriasis ) which may increase the risk of glaucoma (see section 2)

No known frequency (cannot be calculated from the available data):

  • low sodium levels in the blood (symptoms may include dizziness, weakness, confusion, drowsiness or severe fatigue and nausea or vomiting. More serious symptoms are fainting, seizures, or falls)
  • serotonergic syndrome (see section 2)
  • allergic reactions that can be severe and cause swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, and/or a sudden drop in blood pressure (which makes you feel dizzy or dizzy)
  • hives
  • heavy or unexplained bleeding (including bruising, nosebleeds, and bleeding from the gastrointestinal tract or vagina )
  • rash
  • sleep disorders (insomnia)
  • agitation and aggression. If you experience these side effects, consult your doctor (see section 2).

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Additional side effects in children and adolescents

The side effects of vortioxetine that have been observed in adolescents are similar to those seen in adults, except that abdominal pain-related events and suicidal thoughts are observed more often in adolescents than in adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Brintellix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is vortioxetine. Each film-coated tablet contains 5 mg of vortioxetine (as hydrobromide).
  • The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), red iron oxide (E172).

What the medicine looks like and the contents of the pack

Pink, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “5” on the other side.

Brintellix 5 mg film-coated tablets are available as blister packs of 14, 28, 56×1, 98, 98×1, 126 (9×14), 490 (5x (98×1)) tablets and as cans of 100 and 200 tablets.

Pack sizes of 56 x 1, 98 x 1, and 490 film-coated tablets are available as single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

H. Lundbeck A / S

Ottiliavej 9

2500 Valby

Denmark

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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