VORTIOXETINE TECNIGEN 15 mg FILM-COATED TABLETS

2. What you need to know before you take Vortioxetina Tecnigen

Do not take Vortioxetina Tecnigen:

• if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines for depression known as monoamine oxidase inhibitors or selective MAO-A inhibitors. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take vortioxetine if:

• you are taking medicines with a so-called serotonergic effect, such as:
• • tramadol and similar medicines (strong painkillers).
  • sumatriptan and similar medicines, with active ingredient names ending in "-triptan" (used to treat migraine).

Taking these medicines with vortioxetine may increase the risk of serotonin syndrome. This syndrome can be associated with hallucinations, involuntary jerks, rapid heartbeat, high blood pressure, fever, nausea, and diarrhea.

• you have had seizures.

Your doctor will treat you with caution if you have a history of seizures or unstable/epileptic seizure disorders. Seizures are a potential risk of medicines used to treat depression. Treatment should be discontinued in any patient who experiences seizures or an increase in their frequency.

• you have had mania.
• you have a tendency to bleed or bruise easily or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• you have low sodium levels in the blood.
• you are 65 years of age or older.
• you have severe kidney disease.
• you have severe liver disease, or a liver disease called cirrhosis.
• you have increased eye pressure or glaucoma. If you experience eye pain and blurred vision during treatment, contact your doctor.

If you are receiving treatment with antidepressants, including vortioxetine, you may also experience feelings of aggression, agitation, anger, and irritability. If this happens, you should consult your doctor.

Suicidal thoughts and worsening of your depression

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may be longer.

You would be more likely to have these thoughts:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult.

Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital. It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Children and adolescents

Vortioxetine should not be used in pediatric patients (under 18 years of age) because its efficacy has not been established. The safety of vortioxetine in children and adolescents aged 7 to 17 years is described in section 4.

Other medicines and Vortioxetina Tecnigen

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 (medicines for treating depression called non-selective monoamine oxidase inhibitors); you must not take any of these medicines with vortioxetine. If you have taken any of these medicines, you must wait 14 days before starting to take vortioxetine. After stopping vortioxetine, you must wait 14 days before taking any of these medicines.
• moclobemide (a medicine for treating depression).
• selegiline, rasagiline (medicines for treating Parkinson's disease).
• linezolid (a medicine for treating bacterial infections).
• medicines with a serotonergic effect, for example, tramadol or similar medicines (strong painkillers) and sumatriptan and similar medicines with active ingredient names ending in "-triptan" (administered to treat migraine). Taking these medicines with vortioxetine may increase the risk of serotonin syndrome (see section 2).
• lithium (a medicine for treating depression and mental disorders) or tryptophan.
• medicines known to decrease sodium levels.
• rifampicin (a medicine for treating tuberculosis and other infections).
• carbamazepine, phenytoin (a medicine for treating epilepsy or other diseases).
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid at low doses, and non-steroidal anti-inflammatory drugs (anticoagulants and medicines used to relieve pain). These may increase the tendency to bleed.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines with active ingredient names ending in "-triptan".
• tramadol (a strong painkiller).
• mefloquine (a medicine for preventing and treating malaria).
• bupropion (a medicine for treating depression also used to quit smoking).
• fluoxetine, paroxetine, and other medicines for treating depression called SSRIs/SNRIs, tricyclics.
• St. John's Wort (Hypericum perforatum) (a medicine for treating depression).
• quinidine (a medicine for treating heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines for treating mental disorders belonging to the groups called phenothiazines, thioxanthenes, or butyrophenones).

Please consult your doctor if you are taking any of the medicines mentioned, as your doctor needs to know if you are at risk of having seizures.

If you are given a urine test, taking vortioxetine may cause positive results for methadone when some test methods are used, even if you are not taking methadone. If this happens, a more specific test can be performed.

Taking Vortioxetina Tecnigen with alcohol

It is not recommended to combine this medicine with alcohol.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medicine should not be used during pregnancy unless your doctor considers it absolutely necessary.

If you take medicines for depression, including vortioxetine, during the last 3 months of pregnancy, you should be aware that the following effects may be seen in the newborn: breathing problems, blue-colored skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, exaggerated reflexes, tremors, restlessness, irritability, or agitation, lethargy, constant crying, and sleep disturbances. If your baby shows any of these symptoms, contact your doctor immediately.

Make sure your midwife and/or doctor knows you are taking vortioxetine. When taken during pregnancy, especially during the last 3 months, medicines like vortioxetine may increase the risk of a serious disease in the baby called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take this medicine in the final stages of 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 know you are taking this medicine so they can advise you.

Breastfeeding

It is expected that the ingredients of this medicine will pass into breast milk. Vortioxetine should not be used during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop using vortioxetine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.

Driving and using machines

Vortioxetine has little or no influence on the ability to drive or use machines. However, as dizziness has been reported, caution is recommended during these activities when starting treatment with vortioxetine or changing the dose.

Vortioxetina Tecnigen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Vortioxetina Tecnigen

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of this medicine is 10 mg of vortioxetine once a day in adults under 65 years of age. Your doctor may increase the dose up to a maximum of 20 mg of vortioxetine per day or reduce it to a minimum of 5 mg of vortioxetine per day, depending on your response to treatment.

For elderly patients 65 years of age or older, the initial dose is 5 mg of vortioxetine once a day.

Method of administration

Take one tablet with a glass of water.

The tablet can be taken with or without food.

Duration of treatment

Take vortioxetine for the time your doctor indicates.

Continue taking vortioxetine even if it takes some time to start feeling better.

You should continue treatment for at least 6 months after feeling better again.

If you take more Vortioxetina Tecnigen than you should

If you take more vortioxetine than you have been told, contact your doctor immediately or go to the nearest hospital emergency department. Take the pack and any remaining tablets with you. Do this even if you feel well. The symptoms in case of overdose are: dizziness, nausea, diarrhea, stomach upset, itching all over the body, drowsiness, and flushing.

After taking doses several times higher than the prescribed dose, seizures (convulsions) and a rare condition called serotonin syndrome have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vortioxetina Tecnigen

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

If you stop taking Vortioxetina Tecnigen

Do not stop taking vortioxetine without consulting your doctor.

Your doctor may decide to reduce your dose before you stop taking this medicine altogether.

Some patients who have stopped taking vortioxetine have experienced symptoms such as dizziness, headache, sensation of tingling or sensations similar to electric shocks (especially in the head), insomnia, discomfort or nausea, feeling of anxiety, irritability, or agitation, feeling of tiredness or tremors. These symptoms may appear in the first week after stopping this medicine.

If you have any other questions about 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 everybody gets them. The side effects observed were mostly mild or moderate and occurred in the first two weeks of treatment. These effects were usually transient and did not require discontinuation of treatment.

The following side effects have been observed with the frequencies indicated.

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.
• abnormal dreams.
• increased sweating.
• indigestion.

Uncommon: may affect up to 1 in 100 people

• flushing.
• night sweats.
• blurred vision.
• involuntary jerks (tremor).

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

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

Frequency not known: cannot be estimated from the available data

• low sodium levels in the blood (some of the symptoms may be dizziness, weakness, confusion, drowsiness, or excessive tiredness, or nausea and vomiting; other more serious symptoms are fainting, seizures, or falls).
• serotonin syndrome (see section 2).
• allergic reactions, which 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 can make you feel dizzy or faint).
• hives.
• excessive or unexplained bleeding (including bruises, nosebleeds, gastrointestinal bleeding, and vaginal bleeding).
• rash.
• sleep disorders (insomnia).
• agitation and aggression. If you experience these side effects, contact your doctor (see section 2).
• headache.
• increased levels of a hormone called prolactin in the blood.
• a constant need to move (akathisia).
• grinding of the teeth (bruxism).
• inability to open the mouth (trismus).
• restless legs syndrome (impulses to move the legs to stop painful or strange sensations, which often occur at night).
• abnormal milky secretion from the breast (galactorrhea).

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

An increased risk of sexual dysfunction has been reported with the 20 mg dose, and in some patients, this side effect was observed with lower doses.

Other side effects in children and adolescents

The side effects observed with vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain-related events, which were observed more frequently in children and adolescents than in adults, and suicidal ideation, which was observed more frequently in adolescents than in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vortioxetina Tecnigen

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 expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Vortioxetina Tecnigen

Vortioxetina Tecnigen 5 mg film-coated tablets

• The active ingredient is vortioxetina. Each film-coated tablet contains 5 mg of vortioxetina (as hydrobromide).
• The other components (excipients) are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), and red iron oxide (E172).

Vortioxetina Tecnigen 10 mg film-coated tablets

• The active ingredient is vortioxetina. Each film-coated tablet contains 10 mg of vortioxetina (as hydrobromide).
• The other components (excipients) are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), and yellow iron oxide (E172).

Vortioxetina Tecnigen 15 mg film-coated tablets

• The active ingredient is vortioxetina. Each film-coated tablet contains 15 mg of vortioxetina (as hydrobromide).
• The other components (excipients) are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Vortioxetina Tecnigen 20 mg film-coated tablets

• The active ingredient is vortioxetina. Each film-coated tablet contains 20 mg of vortioxetina (as hydrobromide).
• The other components (excipients) are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), and red iron oxide (E172).

Product Appearance and Packaging Content

Vortioxetina Tecnigen 5 mg film-coated tablets

Film-coated tablet, pink, round, biconvex with a diameter of 7.0 mm ± 0.2 mm.

Vortioxetina Tecnigen 5 mg film-coated tablets are available in blisters of 14 and 28 tablets.

Only some pack sizes may be marketed.

Vortioxetina Tecnigen 10 mg film-coated tablets

Film-coated tablet, yellow, round, biconvex with a diameter of 7.0 mm ± 0.2 mm.

Vortioxetina Tecnigen 10 mg film-coated tablets are available in blisters of 14 and 28 tablets.

Only some pack sizes may be marketed.

Vortioxetina Tecnigen 15 mg film-coated tablets

Film-coated tablet, orange, round, biconvex with a diameter of 7.0 mm ± 0.2 mm.

Vortioxetina Tecnigen 15 mg film-coated tablets are available in blisters of 14 and 28 tablets.

Only some pack sizes may be marketed.

Vortioxetina Tecnigen 20 mg film-coated tablets

Film-coated tablet, red, round, biconvex with a diameter of 7.0 mm ± 0.2 mm.

Vortioxetina Tecnigen 20 mg film-coated tablets are available in blisters of 14 and 28 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2 Abrunheira,

2710-228 Sintra

Portugal

This medicinal productis authorized in the Member States of the European Economic Area under the following names:

Portugal: Vortioxetina Tecnigen 5 mg

Vortioxetina Tecnigen 10 mg

Vortioxetina Tecnigen 15 mg

Vortioxetina Tecnigen 20 mg

Italy: Vortioxetina Tecnigen 5 mg

Vortioxetina Tecnigen 10 mg

Vortioxetina Tecnigen 15 mg

Vortioxetina Tecnigen 20 mg

Spain: Vortioxetina Tecnigen 5 mg film-coated tablets EFG

Vortioxetina Tecnigen 10 mg film-coated tablets EFG

Vortioxetina Tecnigen 15 mg film-coated tablets EFG

Vortioxetina Tecnigen 20 mg film-coated tablets EFG

Date of the last revision of this leaflet: October 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)