Trintogen 5 mg Film-Coated Tablets

    Trintogen 5 mg Film-Coated Tablets

    S5


    1. What TRINTOGEN is and what it is used for

    TRINTOGEN contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.

    TRINTOGEN is used to treat major depressive episodes in adults.

    TRINTOGEN 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.

    2. What you need to know before you take TRINTOGEN

    Do not take TRINTOGEN:

    • if you are hypersensitive (allergic) to vortioxetine or any of the other ingredients of TRINTOGEN (listed in section 6).
    • if you are taking other medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors.

    Warnings and precautions

    Take special care with TRINTOGEN:

    • taking medicines with a so-called serotonergic effect, such as:
      • tramadol (a strong pain killer).
      • sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine).

    Taking these medicines together with TRINTOGEN may increase the risk of serotonin syndrome. This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea.

    • 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. If you develop fits or you experience an increase in the frequency of fits your doctor may stop your treatment.
    • have had mania
    • have a tendency of bleeding or bruising easily.
    • have low sodium level in the blood.
    • are 65 years of age or older.
    • have a severe kidney disease.
    • have a severe liver disease or a liver disease called cirrhosis.

    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 antidepressants, 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.
    • 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.

    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

    TRINTOGEN is not recommended in children and adolescents under 18 years due to lack of information for this age group.

    Other medicines and TRINTOGEN

    Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

    Tell your doctor if you are taking any of the following medicines:

    • tranylcypromine (medicine to treat depression called non-selective monoamine oxidase inhibitors). You must not take this medicine together with TRINTOGEN. If you have taken this medicine, you will need to wait 14 days before you start taking TRINTOGEN. After stopping TRINTOGEN, you must allow 14 days before taking this medicine.
    • moclobemide (a medicine to treat depression).
    • selegiline and rasagiline (medicines to treat Parkinson’s disease).
    • linezolid (a medicine to treat bacterial infections).
    • lithium (a medicine to treat depression and mental disorders) or tryptophan.
    • medicines known to cause low sodium level.
    • rifampicin (a medicine to treat tuberculosis and other infections).
    • carbamazepine, phenytoin (medicines to treat epilepsy or other illness).
    • warfarin, dipyridamole, low-dose acetylsalicylic acid (blood thinning medicines).

    Medicines that increase the risk of fits:

    • sumatriptan and similar medicines with active substance names ending in “triptans”.
    • tramadol (a strong painkiller).
    • mefloquine (a medicine to prevent and treat malaria).
    • bupropion (a medicine to treat depression also used to wean from smoking).
    • fluoxetine, paroxetine and other medicines to treat depression called SSRI/SNRIs, tricyclics.
    • St John’s wort ( hypericum perforatum ) (a medicine to treat depression).
    • quinidine (a medicine to treat heart rhythm disorders).
    • chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the group called phenothiazines, thioxanthenes, butyrophenones).

    TRINTOGEN with food, drink and alcohol

    TRINTOGEN can be taken with food and drink. Combining TRINTOGEN with alcohol is not advisable.

    Pregnancy, breastfeeding and fertility

    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 TRINTOGEN.

    Pregnancy

    TRINTOGEN should not be used during pregnancy unless the doctor says it is absolutely necessary. If you take medicine to treat depression including TRINTOGEN during the last 3 months of your pregnancy you should be aware that 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.

    TRINTOGEN 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. Contact your doctor immediately if your newborn baby has any of these symptoms.

    Breastfeeding

    It is expected that the ingredients of TRINTOGEN will pass into breast milk. TRINTOGEN is not to be used during breastfeeding. Your doctor will make a decision on whether you should stop breastfeeding, or stop using TRINTOGEN taking into account the benefit of breastfeeding for your child, and the benefit of therapy for you.

    Driving and using machines:

    TRINTOGEN has no or negligible influence on the ability to drive and use machines. However, as adverse reactions such as dizziness have been reported, caution is advised during such activities when beginning TRINTOGEN treatment or changing the dose. It is not always possible to predict to what extent TRINTOGEN may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which TRINTOGEN affects them.

    3. How to take TRINTOGEN

    Do not share medicines prescribed for you with any other person.

    Always take TRINTOGEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

    The usual dose 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 vortioxetine 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.

    Method of administration

    Take one tablet with a glass of water. The tablet can be taken with or without food.

    Duration of treatment

    Your doctor will tell you how long your treatment with TRINTOGEN will last. Continue to take TRINTOGEN 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 have the impression that the effect of TRINTOGEN is too strong or too weak, tell your doctor or pharmacist.

    If you take more TRINTOGEN than you should

    In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Overdose signs could be 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 missed a dose of TRINTOGEN

    Do not take a double dose to make up for forgotten individual doses.

    If you stop taking TRINTOGEN

    Do not stop taking TRINTOGEN without talking with your doctor.

    4. Possible side effects

    TRINTOGEN can have side effects. Not all side effects reported for TRINTOGEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TRINTOGEN, please consult health care provider for advice.

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

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

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

    In general, the observed side effects were mild to moderate and occurred within the first two weeks of treatment. The reactions were usually temporary and did not lead to cessation of therapy.

    Tell your doctor if you notice any of the following:

    Frequent side effects:

    • nausea.
    • constipation, diarrhoea and vomiting.
    • dizziness.
    • itching (of the whole body).
    • abnormal dreams.

    Less frequent side effects:

    • flushing.
    • night sweats
    • grinding of teeth.

    Side effects of unknown frequency:

    • 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).
    • serotonin syndrome (Take special care with TRINTOGEN).
    • allergic reactions, that may be serious, causing swelling of the face, lips, tongue or throat, difficulties breathing or swallowing, and/or a sudden drop in blood pressure (making you feel dizzy or lightheaded).
    • Hives
    • excessive or unexplained bleeding (including bruising, nose bleeding, gastrointestinal and vaginal bleeding).
    • rash.
    • swelling of the area beneath the skin.
    • An increased risk of bone fractures has been observed in patients taking this type of medicines.

    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 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 TRINTOGEN.

    5. How to store TRINTOGEN

    Store all medicines out of reach of children.

    Store at or below 25 °C.

    Do not remove the blister from the carton until required for use.

    Return all unused medicine to your pharmacist.

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

    Important Disclaimer

    The Trintogen 5 mg Film-Coated Tablets professional information leaflet below is the property of Adcock Ingram and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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