Vortioxetine Dyna Film-Coated Tablets

VORTIOXETINE DYNA belongs to a group of medicines called antidepressants and has been shown to reduce the broad range of depressive symptoms, including sadness, inner tension (feeling anxious), sleep disturbances (reduced sleep), reduced appetite, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, feeling of being slowed down.

VORTIOXETINE DYNA is used to treat major depressive episodes in adults.

Do not take VORTIOXETINE DYNA :

• if you are hypersensitive (allergic) to vortioxetine, or to any of the ingredients of VORTIOXETINE DYNA (see section 6)
• if you are taking other medicines used to treat depression, known as monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors.

Warnings and precautions

Take special care with VORTIOXETINE DYNA :

• if you are depressed, you can sometimes have thoughts of harming or killing yourself. These feelings may be increased when first starting antidepressants such as VORTIOXETINE DYNA, since these medicines all take 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.
• if you are a young adult as information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
• 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, 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.
• if you have had fits (seizures). Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy. Fits are a potential risk with medicines used to treat depression. Treatment should be discontinued in any patient who develops fits or where there is an increase in the frequency of fits.
• if you are taking medicines with a so-called serotonergic effect, such as tramadol (a strong painkiller), sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with VORTIOXETINE DYNA may increase the risk of serotonin syndrome. This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea, vomiting and diarrhoea.
• if blood tests indicate that you have low sodium level.
• if you have had, or experience mania. This is characterized by profuse and rapidly changing ideas, exaggerated happiness and excessive physical activity. In such cases, it is important to contact your doctor who probably will change your medicine.
• if you tend to bruise or bleed easily, including gastrointestinal and menstrual bleeding.
• if you are taking bupropion or fluoxetine (to treat major depressive disorder), quinidine (treatment for irregular heartbeat), paroxetine (treatment for depression, anxiety).
• if you are 65 years of age or older.
• if you have kidney disease or liver disease.

Paediatric population

VORTIOXETINE DYNA is not recommended for the treatment of depression in patients aged less than 18 years since the safety and efficacy of VORTIOXETINE DYNA have not been established in this age group.

Other medicines and VORTIOXETINE DYNA

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines).

Take special care if you take:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors). You must not take any of these medicines together with VORTIOXETINE DYNA. If you have taken any of these medicines, you will need to wait 14 days before you start taking VORTIOXETINE DYNA. After stopping VORTIOXETINE DYNA you must allow 14 days before taking any of these medicines.
• moclobemide (a medicine to treat depression) (see section 2 Do not take VORTIOXETINE DYNA).
• linezolid (a medicine to treat bacterial infections).

Do not share medicines prescribed for you with any other person. Always use VORTIOXETINE DYNA exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

Adults : The recommended dose of VORTIOXETINE DYNA is 10 mg taken as one daily dose in adults less than 65 years of age. The dose may be increased by your doctor to a maximum of 20 mg vortioxetine 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 5 mg vortioxetine taken once daily.

Children : VORTIOXETINE DYNA is not recommended for use in children and adolescents (less than 18 years old). Your doctor will tell you how long your treatment with VORTIOXETINE DYNA will last. Do not stop treatment without talking to your doctor.

If you have the impression that the effect of VORTIOXETINE DYNA is too strong or too weak, speak to your doctor or pharmacist.

If you take more VORTIOXETINE DYNA 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. Symptoms of overdose may include:

• dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, sleepiness and flushing.

If you forget to take VORTIOXETINE DYNA: If you forget to take VORTIOXETINE DYNA, take as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking VORTIOXETINE DYNA: Do not stop taking VORTIOXETINE DYNA without talking with your doctor or other healthcare professional.

Not all side effects reported for VORTIOXETINE DYNA are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using VORTIOXETINE DYNA, please consult your healthcare provider for advice.

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• rash or itching.

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• rapid heart rate and high blood pressure, dilated pupils, loss of muscle coordination or twitching muscles, muscle rigidity, heavy sweating, agitation or restlessness, confusion (symptoms of a condition called serotonin syndrome).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• runny or stuffy nose, sneezing, coughing, sore throat, watery or itchy eyes, flu.
• decreased appetite.
• insomnia, abnormal dreams (nightmares).
• headache, dizziness, sleepiness, slurred speech.
• nausea, diarrhoea, dry mouth, constipation, vomiting, flatulence, abdominal pain, bloated feeling.
• excessive sweating, severe itching of the skin with bumps, spots or blisters (pruritis).
• back pain, swollen or painful joints.
• fatigue (extreme tiredness).
• accidental overdose.

Less frequent side effects:

• grinding of teeth.
• flushing (hot flush).
• night sweats.

The following side effects have been reported but the frequency for them to occur is not known:

• low levels of sodium in the blood (the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick; more serious symptoms are fainting, fits or falls).
• bleeding, skin discolouration due to bruising, bleeding from the nose, teeth, gums, vaginal bleeding (symptoms of haemorrhage).
• swelling of the lower layer of skin and tissue, skin rash, rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling (urticaria).
• bone fractures.
• not wanting or able to perform sexual activity or enjoying sexual activity.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VORTIOXETINE DYNA. An email can be sent directly to the company, [email protected] to ensure safety of the product.

Store all medicines out of reach of children.

Store at or below 25 °C.

Keep tablets in blisters until time for use.

Keep blisters in the carton until required for use.

Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).