Avortaxo

Package leaflet: information for the patient

Avortaxo, 5 mg, film-coated tablets
Avortaxo, 10 mg, film-coated tablets
Avortaxo, 15 mg, film-coated tablets
Avortaxo, 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Avortaxo is and what it is used for

Avortaxo contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
Avortaxo is used for the treatment of major depressive episodes in adults.
Avortaxo has been shown to relieve many symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced amount of sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, loss of interest in performing favourite activities, and sensation of mental or physical slowing.

2. Important information before using Avortaxo

When not to take Avortaxo

• 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 Avortaxo, talk to your doctor or pharmacist if the patient:

• is taking medicines with a so-called serotonergic effect, 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 Avortaxo may increase the risk of serotonin syndrome. This syndrome may present with 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 if seizures/epilepsy are currently unstable. 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 bleeding or bruising, or if the patient is pregnant (see “Pregnancy and breastfeeding”);
  • 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 eye pressure or glaucoma. If during treatment eye pain or blurred vision occurs, contact a doctor. Patients taking antidepressants, including vortioxetine, may also experience feelings of aggression, agitation, anger and irritability. In such a case, speak with your doctor.

Suicidal thoughts and worsening of depression

Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicide. These thoughts may intensify after starting treatment with antidepressants, as all these medicines take time to work, usually about two weeks, and sometimes longer.

The occurrence of suicidal thoughts is more likely 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 antidepressants.

If the patient ever experiences thoughts of self-harm or suicide, they should contact their 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

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

Avortaxo with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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); none of these medicines must be taken together with Avortaxo. If the patient has taken any of these medicines, they must wait 14 days before starting Avortaxo. After stopping Avortaxo, 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 “triptan” (used to treat migraine). Taking these medicines together with Avortaxo 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 who have stopped 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 doctor should be aware that the patient is already at risk of seizures.

If the patient undergoes urine screening while taking Avortaxo, a positive result for methadone may occur with certain analytical methods, even if the patient is not taking methadone. In such a case, a more specific test can be performed.

Taking Avortaxo with alcohol

Concomitant use of this medicine and alcohol is not recommended.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.

Pregnancy

Avortaxo must not be used during pregnancy unless the doctor considers it absolutely necessary.

Women who have taken antidepressants, including Avortaxo, 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, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, exaggerated reflexes, tremor, shivering, irritability, lethargy, constant 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 Avortaxo. Medicines such as Avortaxo 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 the baby to breathe rapidly and have a bluish skin colour. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, inform the midwife and (or) doctor immediately.

Taking Avortaxo 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 Avortaxo, she should inform her doctor or midwife so they can provide appropriate advice.

Breastfeeding

It is expected that components of Avortaxo will pass into human milk. Avortaxo must not be used during breastfeeding. The doctor will decide whether the patient should stop breastfeeding or discontinue Avortaxo, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

Avortaxo has no effect or a negligible effect on the ability to drive and use machines. However, caution is advised when performing these activities after starting treatment with Avortaxo or after a dose change, as adverse effects such as dizziness have been reported.

Avortaxo contains sodium

Avortaxo contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered “sodium-free”.

3. How to take Avortaxo

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose of Avortaxo is 10 mg of vortioxetine as a single daily dose in adults under 65 years of age. Your doctor may increase the dose of this 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 patients aged 65 years and older, the starting 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 treatment
Continue taking Avortaxo for as long as your doctor recommends.
Keep taking Avortaxo even if you do not feel improvement for some time.
Treatment should be continued for at least 6 months after you start feeling better.

Taking more Avortaxo than recommended
If you have taken more Avortaxo than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine packaging and any remaining tablets with you. Do this even if you do not experience any discomfort. Symptoms of overdose may 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 intake of doses several times higher than the recommended dose.

If you forget to take Avortaxo
If you forget to take a tablet, take your next dose at the usual time the following day.
Do not take a double dose to make up for the missed dose.

Stopping Avortaxo
Do not stop taking Avortaxo without consulting your doctor.
Your doctor may decide to gradually reduce the dose before stopping the medicine completely.
Some patients who stopped taking vortioxetine experienced symptoms such as dizziness, headache, prickling or tingling sensations like pins and needles, or a feeling like electric shocks (especially in the head), difficulty sleeping, nausea or vomiting, feelings of anxiety, irritability or agitation, tiredness or tremor. These symptoms may occur within the first week after stopping Avortaxo.

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 can cause adverse effects, although not everyone will experience them.
The observed adverse effects were generally mild to moderate and occurred during 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 whole body
• unusual dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1000 people

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

Frequency unknown: frequency cannot be estimated from the available data

• low levels of sodium in the blood (symptoms may include dizziness, weakness, confusion, drowsiness, severe tiredness, 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
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding and vaginal bleeding)
• rash
• sleep problems (insomnia)
• agitation 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 for movement (akathisia)
• teeth grinding (bruxism)
• inability to open the mouth (trismus)
• restless legs syndrome (an urge to move the legs to relieve painful or strange sensations, often occurring at night)
• milky discharge from the breasts (galactorrhea)

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 at a dose of 20 mg, 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, tell your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Avortaxo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Avortaxo contains
The active substance is wortioxetine.
Avortaxo 5 mg, film-coated tablets

• Each film-coated tablet contains 5 mg of wortioxetine (as wortioxetine hydrobromide).
• Other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose 2910 (E 464), polyethylene glycol 400 (E 1521), titanium dioxide (E 171), iron oxide red (E 172)

Avortaxo 10 mg, film-coated tablets

• Each film-coated tablet contains 10 mg of wortioxetine (as wortioxetine hydrobromide).
• Other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose 2910 (E 464), polyethylene glycol 400 (E 1521), titanium dioxide (E 171), iron oxide yellow (E 172)

Avortaxo 15 mg, film-coated tablets

• Each film-coated tablet contains 15 mg of wortioxetine (as wortioxetine hydrobromide).
• Other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose 2910 (E 464), polyethylene glycol 400 (E 1521), titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)

Avortaxo 20 mg, film-coated tablets

• Each film-coated tablet contains 20 mg of wortioxetine (as wortioxetine hydrobromide).
• Other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose 2910 (E 464), polyethylene glycol 400 (E 1521), titanium dioxide (E 171), iron oxide red (E 172)

What Avortaxo looks like and contents of the pack
Avortaxo 5 mg, pink, almond-shaped, biconvex film-coated tablets, with the number “5” engraved on one side and smooth on the other, measuring 7.5 mm in length and 5.0 mm in width.
Avortaxo 10 mg, yellow, almond-shaped, biconvex film-coated tablets, with the number “10” engraved on one side and smooth on the other, measuring 8.5 mm in length and 5.1 mm in width.
Avortaxo 15 mg, orange, almond-shaped, biconvex film-coated tablets, with the number “15” engraved on one side and smooth on the other, measuring 10.1 mm in length and 6.4 mm in width.
Avortaxo 20 mg, red, almond-shaped, biconvex film-coated tablets, with the number “20” engraved on one side and smooth on the other, measuring 11.6 mm in length and 6.9 mm in width.
Avortaxo 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets are available in blisters containing 14, 28, 56 or 98 tablets.
Avortaxo 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets are also available in single-dose perforated blister packs of 14 x 1, 28 x 1, 56 x 1 or 98 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
e-mail: [email protected]

Manufacturer
Genepharm S.A.
18km Marathonos Avenue
153 51 Pallini, Attiki
Greece
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Avortaxo
Czech Republic Avortaxo
Hungary Avortaxo 5 mg filmtabletta
Avortaxo 10 mg filmtabletta
Avortaxo 15 mg filmtabletta
Avortaxo 20 mg filmtabletta
Slovakia Avortaxo 5 mg
Avortaxo 10 mg
Avortaxo 15 mg
Avortaxo 20 mg