ABRIX 15 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: Patient information
2. Abrix, 5 mg, film-coated tablets
3. Abrix, 10 mg, film-coated tablets
4. Abrix, 15 mg, film-coated tablets
5. Abrix, 20 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Abrix and what is it used for
7. Important information before taking Abrix
   1. When not to take Abrix
   2. Warnings and precautions
   3. Suicidal thoughts and depression worsening
   4. Children and adolescents
   5. Abrix and other medicines
   6. Taking Abrix with alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Abrix contains sodium
8. How to take Abrix
   1. Method of administration
   2. Duration of treatment
   3. Taking a higher dose of Abrix than recommended
   4. Missing a dose of Abrix
   5. Stopping Abrix treatment
9. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
10. How to store Abrix
11. Contents of the pack and other information
    1. What Abrix contains:
    2. What Abrix looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet:

Leaflet attached to the packaging: Patient information

Abrix, 5 mg, film-coated tablets

Abrix, 10 mg, film-coated tablets

Abrix, 15 mg, film-coated tablets

Abrix, 20 mg, film-coated tablets

Vortioxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Abrix and what is it used for
• 2. Important information before taking Abrix
• 3. How to take Abrix
• 4. Possible side effects
• 5. How to store Abrix
• 6. Contents of the pack and other information

1. What is Abrix and what is it used for

Abrix contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
Abrix is used to treat major depressive episodes in adults.
It has been shown that Abrix alleviates many symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (less sleep), decreased appetite, difficulty concentrating, feeling of worthlessness, loss of interest in performing favorite activities, and feeling of slowing down.

2. Important information before taking Abrix

When not to take Abrix

Warnings and precautions

Before starting to take Abrix, talk to your doctor or pharmacist if the patient:
➢ is taking medicines with serotonergic activity, such as:

• tramadol and similar medicines (strong painkillers).
• sumatriptan and similar medicines whose active substance names end with "triptan" (used to treat migraines). Taking these medicines with Abrix may increase the risk of serotonin syndrome.

serotonin syndrome. This syndrome can occur with hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhea;
➢ has had seizures (epileptic fits).
Treatment will be carried out with caution if the patient has had seizures or if they currently have uncontrolled seizures/epilepsy. The use of antidepressant medicines carries a risk of seizures. Treatment should be discontinued in any patient who experiences seizures for the first time or whose seizure frequency increases;
➢ has experienced mania;
➢ has a tendency to bleed or bruise, or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
➢ has low sodium levels in the blood;
➢ is 65 years of age or older;
➢ has severe kidney disease;
➢ has severe liver disease or liver disease called cirrhosis;
➢ currently has or has had increased pressure in the eye or glaucoma. If eye pain and blurred vision occur during treatment, consult a doctor.
Patients taking antidepressant medicines, including vortioxetine, may also experience feelings of aggression, agitation, anger, and irritability. In such cases, consult a doctor.

Suicidal thoughts and depression worsening

In patients with depression and/or anxiety disorders, suicidal thoughts or thoughts of self-harm may sometimes occur. These thoughts may worsen after starting to take antidepressant medicines, as all these medicines start to work only after some time, usually after two weeks, and sometimes later.
The occurrence of suicidal thoughts is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult.

Clinical trial data indicate an increased risk of suicidal behavior in adults under 25 years of age with mental health disorders treated with antidepressant medicines.
If the patient ever experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask these people to monitor them and inform them if they notice that the depression or anxiety disorder has worsened or if there are any worrying changes in the patient's behavior.

Children and adolescents

Abrix should not be used in children and adolescents (under 18 years of age) due to the lack of demonstrated efficacy. The safety of Abrix in children and adolescents aged 7 to 17 years is described in section 4.

Abrix and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tell your doctor if the patient is taking any of the following medicines:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines used to treat depression, known as non-selective monoamine oxidase inhibitors); do not take any of these medicines with Abrix. If the patient has taken any of these medicines, they must wait 14 days before starting to take Abrix. After stopping Abrix treatment, wait 14 days before taking any of these medicines.

and other medicines used to treat depression, such as mirtazapine, trazodone, and tricyclic antidepressants.

• moclobemide (a medicine used to treat depression).
• selegiline, rasagiline (medicines used to treat Parkinson's disease).
• linezolid (an antibiotic).
• medicines with serotonergic activity, such as tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines whose active substance names end with "triptan" (used to treat migraines). Taking these medicines with Abrix may increase the risk of serotonin syndrome (see section "Warnings and precautions").
• lithium (a medicine used to treat depression and mental disorders) or tryptophan.
• medicines that lower sodium levels.
• rifampicin (an antibiotic used to treat tuberculosis and other infections).
• carbamazepine, phenytoin (medicines used to treat epilepsy and other conditions).
• warfarin, dipyridamole, phenprocoumon, some antipsychotic medicines, phenothiazines, tricyclic antidepressants, acetylsalicylic acid in low doses, and non-steroidal anti-inflammatory medicines (blood thinners and pain relievers). These may increase the risk of bleeding.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines whose active substance names end with "triptan".
• tramadol (a strong painkiller).
• mefloquine (a medicine used to prevent and treat malaria).
• bupropion (a medicine used to treat depression and to help people stop smoking).
• fluoxetine, paroxetine, and other medicines used to treat depression, known as SSRI/SNRI, tricyclic antidepressants.
• St. John's Wort (Hypericum perforatum) (a herbal medicine used to treat depression).
• quinidine (a medicine used to treat heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines used to treat mental disorders, belonging to the groups of phenothiazines, thioxanthenes, and butyrophenones).

Tell your doctor about taking any of the above medicines, as your doctor should know that you are already at risk of seizures.
If the patient is undergoing a urine screening test while taking Abrix, a positive result for methadone may occur with certain analytical methods, even if the patient is not taking methadone. In such cases, a more specific test can be performed.

Taking Abrix with alcohol

It is not recommended to take this medicine with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Abrix should not be used during pregnancy, unless the doctor considers it absolutely necessary.
Women who have taken antidepressant medicines, including Abrix, during the last three months of pregnancy should be aware of the risk of the following symptoms in the newborn: breathing difficulties, blue discoloration of the skin, apnea, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, consult a doctor immediately.
Tell the midwife and/or doctor about taking Abrix. Medicines like Abrix used during pregnancy, especially during the last three months, may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN), causing rapid breathing and blue discoloration of the skin in the baby. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, tell the midwife and/or doctor immediately.
Taking Abrix at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Abrix, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
It is expected that the ingredients of Abrix will pass into breast milk. Do not take Abrix while breastfeeding. The doctor will decide whether the patient should stop breastfeeding or stop taking Abrix, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Abrix has no or negligible influence on the ability to drive and use machines. However, caution is advised when performing these activities after starting treatment with Abrix or changing the dose, as side effects such as dizziness have been reported.

Abrix contains sodium

Abrix contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Abrix

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Abrix is 10 mg of vortioxetine per day in one dose for adults under 65 years of age. The doctor may increase the dose of Abrix to a maximum of 20 mg of vortioxetine per day or decrease it to a minimum dose of 5 mg of vortioxetine per day, depending on the patient's response to treatment.
For patients 65 years of age or older, the initial dose is 5 mg of vortioxetine once daily.

Method of administration

Take one tablet with a glass of water.
The tablet can be taken with or without food.

Duration of treatment

Take Abrix for as long as your doctor recommends.
Continue to take Abrix even if you do not feel better for some time.
Treatment should be continued for at least 6 months after the patient feels better.

Taking a higher dose of Abrix than recommended

If the patient has taken more Abrix than prescribed, they should immediately contact their doctor or go to the emergency department of the nearest hospital. Take the medicine package and any remaining tablets with them. Do this even if there are no symptoms of discomfort. Symptoms of overdose are dizziness, nausea, diarrhea, discomfort in the stomach, itching all over the body, drowsiness, and flushing of the face.
After taking doses several times higher than recommended, seizures and rarely occurring serotonin syndrome have been reported.

Missing a dose of Abrix

If the patient forgets to take a tablet, they should take Abrix at the usual time the next day. Do not take a double dose to make up for the missed dose.

Stopping Abrix treatment

Do not stop taking Abrix without consulting your doctor.
The doctor may decide to reduce the dose before stopping treatment with Abrix.
In some patients who stopped taking Abrix, symptoms such as dizziness, headache, pins and needles, or a feeling like an electric shock (especially in the head), insomnia, nausea, or vomiting, restlessness, irritability, or agitation, feeling tired or trembling, occurred. These symptoms may occur within the first week after stopping Abrix treatment.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Abrix can cause side effects, although not everybody gets them.
The observed side effects were usually mild to moderate and occurred during the first two weeks of treatment. The reactions were usually transient and did not lead to treatment discontinuation.
The following side effects have been reported with the following frequencies.
Very common: may affect more than 1 in 10 people

• nausea

Common: may affect up to 1 in 10 people

• diarrhea, constipation, vomiting
• dizziness
• itching all over the body
• strange dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• flushing of the face
• night sweats
• blurred vision
• involuntary tremors

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

• dilated pupils (pupil dilation), which may increase the risk of glaucoma (see section 2)

Frequency not known: frequency cannot be estimated from the available data

• low sodium levels in the blood (symptoms may include dizziness, weakness, disorientation, drowsiness, extreme fatigue, nausea, or vomiting; more serious symptoms include fainting, seizures, or falls)
• serotonin syndrome (see section 2)
• allergic reactions, which can be severe, causing swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, and/or a sudden drop in blood pressure (causing dizziness or a feeling of emptiness in the head)
• hives
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding, and vaginal bleeding)
• rash
• sleep disturbances (insomnia)
• agitation and aggression. If these side effects occur, consult a doctor (see section 2)
• headache
• increased levels of a hormone called prolactin in the blood
• constant need to move (akathisia)
• grinding of the teeth (bruxism)
• inability to open the mouth (lockjaw/trismus)
• restless legs syndrome (an urge to move the legs to stop uncomfortable or unusual sensations, often occurring at night)
• abnormal milk secretion from the breasts (galactorrhea)

Patient groups treated with medicines like Abrix have shown an increased risk of fractures.
There have been reports of increased risk of sexual disturbances at a dose of 20 mg, and in some patients, this side effect has been observed at lower doses.

Additional side effects in children and adolescents

The side effects of vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain, which was reported more frequently in children and adolescents than in adults, and suicidal thoughts, which were reported more frequently in adolescents than in adults.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abrix

Keep the medicine out of the sight and reach of children.
Do not use Abrix after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Abrix contains:

The active substance of Abrix is vortioxetine.
Abrix, 5 mg, film-coated tablets
Each tablet contains vortioxetine hydrobromide equivalent to 5 mg of vortioxetine.
The other ingredients are: mannitol, microcrystalline cellulose 101, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, microcrystalline cellulose 102, magnesium stearate, hypromellose 2910 (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), iron oxide red (E 172).

• Abrix, 10 mg, film-coated tablets

Each tablet contains vortioxetine hydrobromide equivalent to 10 mg of vortioxetine.
The other ingredients are: mannitol, microcrystalline cellulose 101, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, microcrystalline cellulose 102, magnesium stearate, hypromellose 2910 (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), iron oxide yellow (E 172)

• Abrix, 15 mg, film-coated tablets

Each tablet contains vortioxetine hydrobromide equivalent to 15 mg of vortioxetine.
The other ingredients are: mannitol, microcrystalline cellulose 101, hydroxypropylcellulose, sodium carboxymethylcellulose (type A), microcrystalline cellulose 102, magnesium stearate, hypromellose 2910 (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), iron oxide yellow (E 172), iron oxide red (E 172).
Abrix, 20 mg, film-coated tablets
Each tablet contains vortioxetine hydrobromide equivalent to 20 mg of vortioxetine.
The other ingredients are: mannitol, microcrystalline cellulose 101, hydroxypropylcellulose, sodium carboxymethylcellulose (type A), microcrystalline cellulose 102, magnesium stearate, hypromellose 2910 (E 464), iron oxide red (E 172), titanium dioxide (E 171), macrogol 8000 (E 1521), talc (E 553b).

What Abrix looks like and contents of the pack

Abrix, 5 mg:
Oval, pink, film-coated tablet with "5" engraved on one side and smooth on the other, 8.7 x 6.1 mm in size.
Abrix, 10 mg:
Oval, yellow, film-coated tablet with "10" engraved on one side and smooth on the other, 8.7 x 6.1 mm in size.
Abrix, 15 mg:
Round, orange, film-coated tablet with "15" engraved on one side and smooth on the other, 6.1 mm in diameter.
Abrix, 20 mg:
Oval, red, film-coated tablet with "20" engraved on one side and smooth on the other, 8.7 x 6.1 mm in size.
Packaging:28 film-coated tablets. The tablets are packaged in PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blisters, and then in a carton box.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone: (22) 811 18 14

Manufacturer

Elpen Pharmaceutical Co. Inc.
Marathonos Avenue 95, 190 09 Pikermi
Greece
To obtain more detailed information about this medicine, consult the marketing authorization holder.

Date of last revision of the leaflet: