Mirtazon

This leaflet answers some common questions about Mirtazon. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Mirtazon against the benefits they expect it will have for you.

You may need to read it again.

Mirtazon is used in the treatment of depression including relapse prevention.

Depression is longer lasting or more severe than "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.

This medicine corrects this chemical imbalance and may help relieve the symptoms of depression.

Your doctor, however, may prescribe it for another purpose.

This medicine is only available with a doctor's prescription.

Mirtazon is not addictive.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing.

Taking Mirtazon with an MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.

Examples of this type of medicine include phenelzine, tranylcypromine and selegiline.

The safety of Mirtazon in patients under 18 years has not been established.

Mirtazon tablets contain lactose.

Some medicines may be affected by Mirtazon or may affect how well it works. These include:

Your doctor will tell you what to do if you are taking any of these medicines.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Mirtazon

They may differ from the information contained in this leaflet.

The usual starting dose is 15mg per day. Your doctor may slowly increase this dose depending on how you respond to Mirtazon. The effective dose for most people is usually between 30mg and 45mg per day.

Your doctor may have prescribed a different dose.

Your doctor will tell you when to take your tablets.

The tablet(s) should be taken at the same time each day, preferably as a single night-time dose before going to bed; if recommended by your doctor, Mirtazon may be taken in sub-doses equally divided over the day (once in the morning and once at night-time before going to bed).

Swallow the tablet(s), without chewing, together with some water or other fluid.

For depression, the length of treatment will depend on how quickly your symptoms improve. Most antidepressants take time to work, so do not be discouraged if you don't feel better right away. Some of your symptoms may improve in 1 to 2 weeks but it can take up to 2 - 4 weeks to feel the full benefit of the medicine.

Even when you feel well, you will usually have to take Mirtazon for 4 to 6 months or even longer to make sure the benefits will last.

You may need urgent medical attention.

If you take too many Mirtazon tablets, you may feel drowsy, dizzy, confused, and agitated.

You may also have changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes.

In rare cases mirtazapine can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because Mirtazon can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Mirtazon can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia). While rare, these symptoms most commonly appear after 4-6 weeks of treatment.

Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. Until the full antidepressant effect of your medicine becomes apparent, it is possible these symptoms may increase in the first few weeks of treatment.

Information from clinical trials have shown an increased risk of suicidal behaviour in young adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you or someone you know is showing warning signs of suicide-related behaviour while taking Mirtazon, contact your doctor or a mental health professional right away or go to the nearest hospital for treatment. These signs include:

All mentions of suicide or violence must be taken seriously.

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 is getting worse, or if they are worried about changes in your behaviour.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

You may need to have blood tests from time to time.

Mirtazon may cause drowsiness, dizziness or sleepiness in some people and affect alertness and concentration. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Suddenly stopping Mirtazon may cause nausea, headache, dizziness, anxiety, agitation.

Your doctor may want to gradually reduce the amount of Mirtazon you are taking before stopping completely.

Combining Mirtazon and alcohol can make you more sleepy and less alert. Your doctor may suggest you avoid alcohol while being treated with this medicine.

Mirtazon helps most people with depression, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

You may not experience any of them.

The tablets may not keep as well if you take them out of the blister pack.

Heat and dampness can destroy some medicines.

A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Mirtazon is available in two strengths: 30mg and 45mg.

The 30 mg tablets are red-brown; one side of the tablet is marked with "Organon" or "MSD", the other with the code "TZ" and "5" on both sides of the score. The tablets have a single breakline, which means that they can easily be divided in two if necessary.

The 45 mg tablets are white; one side of the tablet is marked with "Organon", the other with the code "TZ" and "7". There is no score line.

The medicine is packed in child-resistant blisters.

Pack size: blister packs of 30 tablets.

The 30 mg oval Mirtazon tablets contain 30 mg of the active substance mirtazapine per tablet; the tablets also contain lactose, maize starch, hydroxypropylcellulose, magnesium stearate and silica colloidal anhydrous, hypromellose and macrogol 8000. The colouring agents are titanium dioxide, yellow iron oxide (CI 77492) and red iron oxide (CI 77491).

The 45 mg oval tablets contain 45 mg of the active substance mirtazapine per tablet; the tablets also contain lactose, maize starch, hydroxypropylcellulose, magnesium stearate and silica colloidal anhydrous, hypromellose and macrogol 8000; the colouring agent is titanium dioxide.