Mirtazapine Film-Coated Tablets

Mirtazapine belongs to a group of medicines called antidepressants. MIRTAZAPINE VIATRIS is used to treat major depressive illness (persistently depressed mood or loss of interest in activities, causing significant impairment in daily life).

Do not take MIRTAZAPINE VIATRIS:
• If you are hypersensitive (allergic) to mirtazapine or any of the other ingredients of MIRTAZAPINE VIATRIS (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are a child and under 18 years old.
• If you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Tell your doctor before taking MIRTAZAPINE VIATRIS:
If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking mirtazapine or other medicine(s).

Take special care with MIRTAZAPINE VIATRIS:

Children and adolescents
MIRTAZAPINE VIATRIS should not be used for children and adolescents under 18 years. You should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take antidepressants such as MIRTAZAPINE VIATRIS.

Do not share medicines prescribed for you with any other person. Always take MIRTAZAPINE VIATRIS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual starting dose is 15 mg every day. Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15 and 45 mg per day).

Take MIRTAZAPINE VIATRIS at the same time each day. It is best to take MIRTAZAPINE VIATRIS as a single dose before you go to bed. However, your doctor may suggest you split your dose of MIRTAZAPINE VIATRIS, once in the morning and once at night-time before you go to bed.

However, if you are an elderly person or if you have renal or liver disease, your doctor may adapt the dose. Take your tablets orally. Swallow your prescribed dose of MIRTAZAPINE VIATRIS without chewing, with some water.

It is important that during the first few weeks of the treatment, you talk with your doctor if you have any thoughts about harming yourself. Your doctor will tell you how long your treatment with MIRTAZAPINE VIATRIS will last. If you have the impression that the effect of MIRTAZAPINE VIATRIS is too strong or too weak, tell your doctor or pharmacist.

If you take more MIRTAZAPINE VIATRIS than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MIRTAZAPINE VIATRIS
Do not take a double dose to make up for forgotten individual doses. If you stop taking MIRTAZAPINE VIATRIS

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

If any of the following happens, stop taking MIRTAZAPINE VIATRIS and tell your doctor immediately or go to the casualty department of your nearest hospital:
• swelling of the hands, feet, ankles, face, lips and mouth or throat (angioedema), which may cause difficulty in swallowing or breathing,
• skin rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MIRTAZAPINE VIATRIS. 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:

Frequent
• skin rash with fever
Less frequent
• signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis)
• feeling elated or emotionally ‘high’ (mania)
• hallucinations
• convulsions (fits)
• inability to sit or keep still
• muscle twitching or contractions
• abnormal physical weakness or lack of energy
• inflammation of the pancreas which may cause abdominal pain and nausea
• aggression
Frequency unknown
• thoughts of harming or killing yourself; • a skin reaction known as ‘erythema multiforme’ (itchy reddish purple patches on the skin, especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals, which may be accompanied by fever and tiredness); • reddish patches on the torso which are target-like macules or circular, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis); • widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome); • jaundice (yellowing of skin and/or eyes);

Store at or below 25 ºC. Protect from light and moisture. Store in the original container. Do not use after the expiry date indicated on the outer container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.