VORTIOXETINE KERN PHARMA 5 mg FILM-COATED TABLETS

2. What you need to know before you take Vortioxetina Kern Pharma

Do not take Vortioxetina Kern Pharma:

• 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 the 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.

• if 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.

• if you have had mania.
• if you have a tendency to bleed or bruise easily or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• if you have low sodium levels in your blood.
• if you are 65 years of age or older.
• if you have severe kidney disease.
• if you have severe liver disease, or a liver disease called cirrhosis.
• if you have had 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 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 data have shown an increased risk of suicidal behavior in adults under 25 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 has worsened, or if they are worried 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 from 7 to 17 years is described in section 4.

Other medicines and Vortioxetina Kern Pharma

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 (an antibiotic).
• 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 cause a decrease in sodium levels.
• rifampicin (an antibiotic).
• carbamazepine, phenytoin (a medicine for treating epilepsy or other conditions).
• 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 (an antimalarial medicine).
• bupropion (a medicine for treating depression, also used to help stop 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 talk to 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.

Medical tests

If you have a urine toxicology 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 done.

Taking Vortioxetina Kern Pharma 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 difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, exaggerated reflexes, tremors, nervousness, irritability, lethargy, constant crying, and sleep disturbances. If your baby has 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 condition 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 that 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 this medicine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.

Driving and using machines

This medicine 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 when changing the dose.

Vortioxetina Kern Pharma 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 Kern Pharma

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of vortioxetine is 10 mg of vortioxetine once daily 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.

Use in elderly patients

For elderly 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.

If you cannot swallow the tablet whole, other medicines containing vortioxetine may be available on the market in other pharmaceutical forms.

Duration of treatment

Take this medicine for as long as your doctor tells you.

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

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

If you take more Vortioxetina Kern Pharma than you should

If you take more vortioxetine than you should, contact your doctor or go to the nearest hospital emergency department immediately. 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 and a rare condition called serotonin syndrome have been reported.

In case of overdose or accidental ingestion, contact 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 Kern Pharma

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 Kern Pharma

Do not stop taking vortioxetine without talking to 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, nausea or vomiting, feeling anxious, irritable, or agitated, feeling tired or trembling. These symptoms can appear in the first week after stopping this medicine.

If you have any further questions on 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 can 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 or 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 bruising, 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 teeth (bruxism).
• inability to open the mouth (trismus).
• restless legs syndrome (an irresistible urge to move the legs to stop painful or unusual 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.

A higher 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 more frequent in children and adolescents than in adults, and suicidal ideation, which was more frequent in adolescents than in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vortioxetina Kern Pharma

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 and blister after “CAD” or “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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vortioxetina Kern Pharma

Vortioxetina Kern Pharma 5 mg film-coated tablets EFG

• The active ingredient is vortioxetine. Each film-coated tablet contains 5 mg vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E-421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), and magnesium stearate in the tablet core; and hypromellose, macrogol, titanium dioxide (E-171), and red iron oxide (E-172) in the tablet coating.

Vortioxetina Kern Pharma 10 mg film-coated tablets EFG

• The active ingredient is vortioxetine. Each film-coated tablet contains 10 mg vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E-421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), and magnesium stearate in the tablet core; and hypromellose, macrogol, titanium dioxide (E-171), and yellow iron oxide (E-172) in the tablet coating.

Vortioxetina Kern Pharma 15 mg film-coated tablets EFG

• The active ingredient is vortioxetine. Each film-coated tablet contains 15 mg vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E-421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), and magnesium stearate in the tablet core; and hypromellose, macrogol, titanium dioxide (E-171), red iron oxide (E-172), and yellow iron oxide (E-172) in the tablet coating.

Vortioxetina Kern Pharma 20 mg film-coated tablets EFG

• The active ingredient is vortioxetine. Each film-coated tablet contains 20 mg vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E-421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), and magnesium stearate in the tablet core; and hypromellose, macrogol, titanium dioxide (E-171), and red iron oxide (E-172) in the tablet coating.

Appearance of the Product and Package Contents

Vortioxetina Kern Pharma 5 mg film-coated tablets EFG

Film-coated tablet, pink, oval (11 mm x 5 mm), biconvex, with the number "5" engraved on one side.

Vortioxetina Kern Pharma 10 mg film-coated tablets EFG

Film-coated tablet, yellow, oval (13 mm x 6 mm), biconvex, with the number "10" engraved on one side.

Vortioxetina Kern Pharma 15 mg film-coated tablets EFG

Film-coated tablet, pale orange, oval (15 mm x 7 mm), biconvex, with the number "15" engraved on one side.

Vortioxetina Kern Pharma 20 mg film-coated tablets EFG

Film-coated tablet, dark red, oval (17 mm x 8 mm), biconvex, with the number "20" engraved on one side.

The film-coated tablets of Vortioxetina Kern Pharma are presented in cardboard boxes containing PVC/PVdC//Al blisters.

Pack sizes of 14, 28, 56, or 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

or

Adalvo Limited

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

San Gwann SGN 3000

Malta

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

Date of the last revision of this leaflet: December 2023

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