Vortioxetine 5 mg/10 mg/15 mg/20 mg Film-Coated Tablets

VORTIOXETINE LUNDBECK belongs to a group of medicines called antidepressants. VORTIOXETINE LUNDBECK is used to treat major depressive episodes in adults.

Do not take VORTIOXETINE LUNDBECK

• if you are allergic to vortioxetine or any of the other ingredients of this medicine (see What VORTIOXETINE LUNDBECK contains)
• if you are taking other medicines for depression such as monoamine oxidase inhibitors. Ask your doctor if you are uncertain.

Warnings and special precautions

Talk to your doctor or pharmacist before taking VORTIOXETINE LUNDBECK if you:

• are taking medicines with a so-called serotonergic effect, such as:
• tramadol and similar medicines (strong painkillers)
• sumatriptan and similar medicines to VORTIOXETINE LUNDBECK with active substance names ending in “triptans” (used to treat migraine).
• have had fits
• have had mania (elevated mood)
• have a tendency to easily develop bleedings or bruises, or if you are pregnant (see ‘Pregnancy, breastfeeding and fertility’).
• are elderly
• have a liver disease called cirrhosis
• have or previously have had increased pressure in the eye or glaucoma. If your eyes become painful and you develop blurred vision during treatment, contact your doctor
• have low sodium level in the blood
• are treated with other medicines known to cause low sodium level.

When you are on antidepressant treatment, including VORTIOXETINE LUNDBECK, you may also experience feelings of aggression, agitation, anger and irritability. If this occurs, you should talk to your doctor.

Thoughts of suicide and worsening of your depression

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting to take VORTIOXETINE LUNDBECK, since it takes time to work, usually about two weeks but sometimes longer. You may be more likely to think like this if you:

• have previously had thoughts about killing or harming yourself.
• are a young adult.

Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant such as VORTIOXETINE LUNDBECK. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents

VORTIOXETINE LUNDBECK is not recommended in children and adolescents under 18 years.

Other medicines and VORTIOXETINE LUNDBECK

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Also 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:

• moclobemide (a medicine to treat depression)
• selegiline, rasagiline (a medicine to treat Parkinson’s disease)
• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called monoamine oxidase inhibitors)

You must not take any of these medicines together with VORTIOXETINE LUNDBECK. If you have taken any of these medicines you will need to wait 14 days before you start taking VORTIOXETINE LUNDBECK. After stopping VORTIOXETINE LUNDBECK you must allow 14 days before taking any of these medicines.

• linezolid (a medicine to treat bacterial infections)
• medicinal products with serotonergic effect e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with VORTIOXETINE LUNDBECK may increase the risk of serotonin syndrome (see section warnings and precautions)
• lithium (a medicine to treat depression and mental disorders) or tryptophan
• medicines that increase the risk of fits; sumatriptan and similar medicines to VORTIOXETINE LUNDBECK with active substance names ending in “triptans”
• tramadol (a strong painkiller)
• mefloquin (a medicine to prevent and treat malaria)
• bupropion (a medicine to treat depression and also used to wean from smoking)
• fluoxetine, paroxetine and other medicines to treat depression called SSRI/SNRIs, tricyclics
• St John’s Wort (a medicine to treat depression)
• quinidine (a medicine to treat heart rhythm disorders)
• medicines to treat mental disorders and belongs to the groups called phenothiazines, thioxanthenes, butyrophenones
• rifampicin (a medicine to treat tuberculosis)
• carbamazepine, phenytoin (medicines to treat epilepsy or other illness)
• Warfarin and low-dose aspirin (blood thinning medicines)

If you are having a urine drug screen, taking VORTIOXETINE LUNDBECK may cause positive results for methadone when some test methods are used, even though you may not be taking methadone. If this happens, a more specific test can be performed.

VORTIOXETINE LUNDBECK with food, drink and alcohol

VORTIOXETINE LUNDBECK can be taken with or without food. Combining VORTIOXETINE LUNDBECK with alcohol is not advisable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking VORTIOXETINE LUNDBECK.

Pregnancy

VORTIOXETINE LUNDBECK should not be used during pregnancy as it may harm your baby. If you are of childbearing age you should use effective contraception while taking VORTIOXETINE LUNDBECK. The following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. VORTIOXETINE LUNDBECK may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin 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.

Breastfeeding

Mothers should not breastfeed their infants when taking VORTIOXETINE LUNDBECK.

Driving and using machines

As adverse reactions such as dizziness have been reported, caution is advised when driving and using machines when beginning VORTIOXETINE LUNDBECK treatment or changing the dose.

VORTIOXETINE LUNDBECK contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Do not share medicines prescribed for you with any other person. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The normally recommended dose of VORTIOXETINE LUNDBECK is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day or lowered to a minimum of 5 mg per day depending on your response to treatment. For elderly people 65 years of age or older, the starting dose is of VORTIOXETINE LUNDBECK 5 mg taken once daily. Do not change the dose of your medicine without talking to your doctor first. Take one tablet with a glass of water. The tablet can be taken with or without food. If you have the impression that the effect of VORTIOXETINE LUNDBECK is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

VORTIOXETINE LUNDBECK is not for use in children and adolescents under 18 years.

Duration of treatment

Your doctor will tell you how long your treatment with VORTIOXETINE LUNDBECK will last. Take VORTIOXETINE LUNDBECK for as long as your doctor recommends. Continue to take VORTIOXETINE LUNDBECK even if it takes some time before you feel any improvement in your condition. Treatment should be continued for at least 6 months after you feel well again.

If you take more VORTIOXETINE LUNDBECK than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Have the container and any remaining tablets available. Do this even if there are no signs of discomfort. Overdose signs are dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, sleepiness and flushing. Following intake of dosages several times higher than the prescribed dose, fits (seizures) and a rare condition called serotonin syndrome have been reported.

If you forget to take VORTIOXETINE LUNDBECK

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

If you stop taking VORTIOXETINE LUNDBECK

Do not stop taking VORTIOXETINE LUNDBECK without talking with your doctor. If you have any further questions on the use of VORTIOXETINE LUNDBECK, ask your doctor or pharmacist.

VORTIOXETINE LUNDBECK can cause side effects. Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VORTIOXETINE LUNDBECK, please consult your health care professional for advice.

If any of the following happens, stop taking VORTIOXETINE LUNDBECK and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the face, lips, tongue or throat
• difficulties in breathing or swallowing
• rash or itching
• a sudden drop in blood pressure (making you feel dizzy or lightheaded).

These are all very serious side effects. If you have them, you may have had a serious reaction to VORTIOXETINE LUNDBECK. You may need urgent medical attention or hospitalisation.

Side effects listed below have been reported by patients taking VORTIOXETINE LUNDBECK in the following frequencies:

Frequently:

• nausea
• diarrhoea, constipation, vomiting
• dizziness
• itching of the whole body
• abnormal dreams
• increased sweating
• drowsiness, feeling tired

Less frequent:

• flushing
• night sweats
• low levels of sodium in the blood (the symptoms may include feeling dizzy, weak, confused, sleepy or even very tired, or feeling of being sick; more serious symptoms are fainting, fits or falls).
• serotonin syndrome (see Warnings and special precautions)
• hives
• excessive or unexplained bleeding (including bruising, nose bleeding, gastrointestinal and vaginal bleeding).
• headache
• increase in a hormone called prolactin in the blood
• enlarged pupils (mydriasis), which can increase the risk of glaucoma (see section 2)
• sleep disorders (insomnia)
• agitation and aggression. If you experience these side effects, contact your doctor (see section 2).

You may experience less satisfaction with orgasm or sexual arousal, especially at the 20 mg VORTIOXETINE LUNDBECK dose. An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to the South African Health Products Regulatory Authority (SAHPRA) via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VORTIOXETINE LUNDBECK.

Store all medicines out of the reach of children. Store at or below 30 °C. Do not use VORTIOXETINE LUNDBECK after the expiry date which is stated on the packaging after ‘EXP’. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).