Abrix

Package leaflet: Information for the patient

Abrix, 5 mg, film-coated tablets
Abrix, 10 mg, film-coated tablets
Abrix, 15 mg, film-coated tablets
Abrix, 20 mg, film-coated tablets
Vortioxetinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abrix is and what it is 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 package and other information

1. What Abrix is and what it is used for

Abrix contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
Abrix is used for the treatment of major depressive episodes in adults.
Abrix has been shown to alleviate many symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced amount of sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, and loss of interest in performing enjoyable activities, as well as a sense of slowing down.

2. Important information before using Abrix

When not to use Abrix

• if the patient is allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking other antidepressant medicines known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. If in doubt, consult a doctor.

Warnings and precautions
Before starting treatment with Abrix, talk to your doctor or pharmacist if the patient:
➢ is taking medicines with so-called serotonergic activity, such as:

• tramadol and similar medicines (strong painkillers).

• sumatriptan and similar medicines whose active substance names end in “triptan” (used to treat migraine). Taking these medicines together with Abrix may increase the risk of developing serotonin syndrome. This syndrome may include hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhoea;
  ➢ has experienced seizures (epileptic fits).
  Treatment will be carried out with caution if the patient has had seizures or currently has unstable seizures/epilepsy. Treatment with 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 bleeding or bruising, 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 known as cirrhosis;
  ➢ currently has or has previously had increased pressure in the eye or glaucoma. If during treatment eye pain or blurred vision occurs, contact 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 worsening of depression
  Patients with depression and (or) anxiety disorders may occasionally experience thoughts of self-harm or suicide. These thoughts may intensify after starting treatment with antidepressant medicines, as all these medicines take some time to become effective, usually about two weeks, sometimes longer.
  The risk of suicidal thoughts is higher if:

• the patient has previously experienced thoughts of self-harm or suicide;

• the patient is a young adult.

Clinical trial data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressant medicines.
If the patient ever experiences thoughts of self-harm or suicide, they should contact a doctor immediately or go to hospital. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask these people to inform them if they notice worsening of depression or anxiety, or concerning changes in the patient’s behaviour.
Children and adolescents
Abrix should not be used in children and adolescents (under 18 years of age) due to lack of demonstrated efficacy. The safety of Abrix in children and adolescents aged 7 to 17 years is described in section 4.
Abrix with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform 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); none of these medicines must be used together with Abrix. If the patient has taken any of these medicines, they must wait 14 days before starting Abrix. After stopping Abrix, wait 14 days before starting any of these medicines.

• moclobemide (a medicine used to treat depression).

• selegiline, rasagiline (medicines used to treat Parkinson’s disease).

• linezolid (a medicine used to treat bacterial infections).

• serotonergic medicines, e.g. tramadol and similar medicines (strong painkillers), and sumatriptan and similar medicines whose active substance names end in “triptans” (used to treat migraine). Taking these medicines together with Abrix may increase the risk of serotonin syndrome (see section Warnings and precautions).

• lithium (a medicine used to treat depression and psychiatric disorders) or tryptophan.

• medicines that lower sodium levels.

• rifampicin (a medicine used to treat tuberculosis and other infections).

• carbamazepine, phenytoin (medicines used to treat epilepsy and other conditions).

• warfarin, dipyridamole, phenprocoumon, certain antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (medicines that thin the blood and medicines used to relieve pain). These may increase the tendency to bleed.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines containing an active substance with a name ending in “triptan”.
• tramadol (a strong painkiller).
• mefloquine (a medicine used for prevention and treatment of malaria).
• bupropion (a medicine used to treat depression and also in people quitting smoking).
• fluoxetine, paroxetine and other medicines used to treat depression, known as SSRIs/SNRIs, tricyclic antidepressants.
• St John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression).
• quinidine (a medicine used to treat heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines used in psychiatric disorders belonging to groups known as phenothiazines, thioxanthenes, butyrophenones).

Inform the treating doctor if any of the above medicines are being taken, as the treating doctor should be aware that the patient is already at risk of seizures.
If the patient undergoes urine screening tests 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
Concomitant use of this medicine and alcohol is not recommended.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using 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, bluish skin colour, apnoea, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, increased reflexes, tremor, jitteriness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the midwife and (or) doctor about taking Abrix. Medicines such as Abrix used during pregnancy, especially during the last three months, may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish skin in the baby. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, inform the midwife and (or) doctor immediately.
Taking Abrix towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Abrix, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
It is expected that components of Abrix will pass into breast milk. Abrix should not be used during breastfeeding. The doctor will decide whether the patient should discontinue breastfeeding or discontinue Abrix treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
Abrix has no effect or has a negligible effect on the ability to drive and use machines. However, caution is advised when performing these activities after starting treatment with Abrix or after a dose change, as adverse reactions such as dizziness have been reported.
Abrix contains sodium
Abrix contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Abrix

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Abrix is 10 mg of vortioxetine as a single daily dose in adults under 65 years of age.
The doctor may increase the dose of the medicine up to a maximum of 20 mg of vortioxetine per day or reduce it
to the minimum dose of 5 mg of vortioxetine per day, depending on the patient's response to treatment.
For people aged 65 years 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 may be taken with or without food.
Duration of use
Take Abrix for as long as your doctor has instructed.
Continue taking Abrix even if the patient does not feel improvement for some time.
Treatment should be continued for at least 6 months after the patient starts feeling better.
Taking more Abrix than prescribed
If the patient has taken more Abrix than prescribed, contact a doctor immediately or go to the emergency
department of the nearest hospital. Bring the medicine packaging and any remaining tablets with you.
Do this even if no discomfort symptoms are present. Symptoms of overdose include dizziness, nausea, diarrhoea,
stomach discomfort, itching of the whole body, drowsiness and facial flushing.
Seizures and a rare condition called serotonin syndrome have been reported after ingestion of doses several times
higher than the recommended dose.
Missed dose of Abrix
If the patient forgets to take a tablet, take Abrix at the usual time the next day. Do not take a double dose to
make up for the missed dose.
Stopping Abrix
Do not stop taking Abrix without consulting your doctor.
The doctor may decide to gradually reduce the dose before completely stopping this medicine.
In some patients who stopped taking Abrix, symptoms such as dizziness, headache, prickling or tingling sensations,
or electric shock-like feelings (especially in the head), insomnia, nausea or vomiting, feeling anxious, irritability or agitation, fatigue or tremor have occurred. These symptoms may occur within the first week after stopping Abrix.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects observed were generally mild to moderate and occurred within the first two weeks of treatment. Reactions were usually transient and did not lead to discontinuation of treatment.
The adverse effects listed below 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

• diarrhoea, constipation, vomiting
• dizziness
• itching of the skin
• unusual dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• flushing (redness of the face)
• night sweats
• blurred vision
• involuntary tremor
• hallucinations (seeing, hearing or feeling things that are not there)

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

• dilated pupils (pupil dilation), which may increase the risk of developing 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, confusion, drowsiness, severe fatigue, nausea or vomiting; more serious symptoms include: fainting, seizures or falls)
• serotonin syndrome (see section 2)
• allergic reactions, which may be severe, causing swelling of the face, lips, tongue or throat, difficulty breathing or swallowing and/or sudden drop in blood pressure (causing dizziness or a feeling of emptiness in the head)
• urticaria (hives)
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding and vaginal bleeding)
• rash
• sleep problems (insomnia)
• restlessness and aggression. If these adverse effects occur, contact your doctor (see section 2)
• headache
• increased levels of a hormone called prolactin in the blood
• constant need to move (akathisia)
• teeth grinding (bruxism)
• inability to open the mouth (trismus)
• restless legs syndrome (an urge to move the legs to prevent painful or strange sensations, often occurring at night)
• milky discharge from the breasts (galactorrhoea)

In patients taking medicines of this type, an increased risk of bone fractures has been observed.
An increased risk of sexual dysfunction has been reported with the 20 mg dose, and in some patients, this adverse effect was observed even at lower doses.

Additional adverse effects in children and adolescents
Adverse effects of vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain events, which were reported more frequently than in adults, and suicidal thoughts, which were observed more frequently in adolescents than in adults.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Abrix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after
"EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Abrix contains:
The active substance in Abrix is vortioxetine.

Abrix 5 mg, film-coated tablets
Each tablet contains vortioxetine hydrobromide equivalent to 5 mg of vortioxetine.
Other ingredients: mannitol, microcrystalline cellulose 101, sodium carboxymethyl starch (type A),
hydroxypropyl cellulose, 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.
Other ingredients: mannitol, microcrystalline cellulose 101, sodium carboxymethyl starch (type A),
hydroxypropyl cellulose, 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.
Other ingredients: mannitol, microcrystalline cellulose 101, hydroxypropyl cellulose,
sodium carboxymethyl starch (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.
Other ingredients: mannitol, microcrystalline cellulose 101, hydroxypropyl cellulose,
sodium carboxymethyl starch (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 the number "5" embossed on one side and smooth on the other,
measuring 8.7 x 6.1 mm.

Abrix 10 mg:
Oval, yellow, film-coated tablet, with the number "10" embossed on one side and smooth on the other,
measuring 8.7 x 6.1 mm.

Abrix 15 mg:
Round, orange, film-coated tablet, with the number "15" embossed on one side and smooth on the other,
with a diameter of 6.1 mm.

Abrix 20 mg:
Oval, red, film-coated tablet, with the number "20" embossed on one side and smooth on the other,
measuring 8.7 x 6.1 mm.

Pack size: 28 film-coated tablets. Tablets are packed in PVC/PVDC/Aluminum blisters or in PVC/PE/PVDC/Aluminum blisters, then placed in a cardboard carton.

Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: (22) 811 18 14

Manufacturer
Elpen Pharmaceutical Co. Inc.
Marathonos Avenue 95, 190 09 Pikermi
Greece

For further information about this medicinal product, please contact the Marketing Authorisation Holder.