Do not take VORTIOXETINE ADCO:
- if you are hypersensitive (allergic) to vortioxetine or any of the other ingredients of VORTIOXETINE ADCO (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 VORTIOXETINE ADCO:
- 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 VORTIOXETINE ADCO 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
VORTIOXETINE ADCO is not recommended in children and adolescents under 18 years due to lack of information for this age group.
Other medicines and VORTIOXETINE ADCO
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 VORTIOXETINE ADCO. If you have taken this medicine, you will need to wait 14 days before you start taking VORTIOXETINE ADCO. After stopping VORTIOXETINE ADCO, 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).
VORTIOXETINE ADCO with food, drink and alcohol
VORTIOXETINE ADCO can be taken with food and drink.
Combining VORTIOXETINE ADCO 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 VORTIOXETINE ADCO.
Pregnancy
VORTIOXETINE ADCO should not be used during pregnancy unless the doctor says it is absolutely necessary. If you take medicine to treat depression including VORTIOXETINE ADCO 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.
VORTIOXETINE ADCO 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 VORTIOXETINE ADCO will pass into breast milk. VORTIOXETINE ADCO is not to be used during breastfeeding. Your doctor will make a decision on whether you should stop breastfeeding, or stop using VORTIOXETINE ADCO taking into account the benefit of breastfeeding for your child, and the benefit of therapy for you.
