Contains the active ingredient mirtazapine
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
Read this leaflet carefully before taking your medicine. This leaflet answers some common questions about mirtazapine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
The name of your medicine is GenRx Mirtazapine. It contains the active ingredient mirtazapine.
It is used to treat depression.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
Depression is longer lasting or more severe than the "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. Mirtazapine corrects this chemical imbalance and may help relieve the symptoms of depression.
There is no evidence that this medicine is addictive.
This medicine must not be used in children or adolescents under 18 years of age.
Do not take this medicine if you have or have had any of the following:
Do not take this medicine if you are taking other medicines called Monoamine Oxidase Inhibitors (MAOIs). MAOIs may be used for the treatment of depression (phenelzine, tranylcypromine, moclobemide), Parkinson's disease (selegiline), infections (linezolid), or diagnosis of certain conditions/treatment of certain blood disorders (methylene blue). There may be others MAOIs also so check with your doctor or pharmacist.
Do not take mirtazapine until 14 days after stopping any MAOI, and do not take MAOIs until 14 days after stopping mirtazapine. Taking this medicine with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
Ask your doctor or pharmacist if you are not sure if you have been taking a MAOI medicine.
Do not give mirtazapine to a child or adolescent. The safety and efficacy of this medicine in patients under 18 years has not been established.
Before you start taking this medicine, tell your doctor if:
These tablets contain lactose.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with mirtazapine.
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
The usual starting dose is 15 mg per day. Your doctor may slowly increase your dose depending on how you respond to mirtazapine.
The effective dose for most people is usually between 30 mg and 45 mg per day.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Swallow the tablet(s), without chewing, together with some water or other fluid.
This medicine should preferably be taken as a single night-time dose before going to bed.
If recommended by your doctor, your dose may be taken in sub-doses equally divided over the day (e.g. once in the morning and once at night-time before going to bed).
Take this medicine at the same time or times each day.
Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
Continue taking your medicine for as long as your doctor tells you.
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 1-2 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 your medicine for 4-6 months, or even longer, to make sure the benefits will last.
Make sure you have enough to last over weekends and holidays.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much mirtazapine you may feel drowsy, dizzy, confused, agitated, have increased heart rate or lose consciousness.
Tell your doctor that you are taking this medicine if:
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell your doctor immediately if you develop fever, chills, sore throat or mouth ulcers or experience other signs of infections. In rare cases mirtazapine can cause a shortage of white blood cells, resulting in lowering body resistance to infection. These symptoms may appear after 2-6 weeks of treatment.
Tell your doctor immediately or go to the nearest hospital for treatment if you have any suicidal thoughts or other mental/mood changes.
Young adults aged 18 to 24 are at particularly high risk of having this happen to them. Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. Until the full antidepressant effect of the medicine becomes apparent, it is possible that these symptoms may increase in the first few weeks of treatment.
If you or someone you know is demonstrating any of the following warning signs of suicide while taking this medicine, contact your doctor or health professional immediately or go to the nearest hospital for treatment:
All mention of suicide or violence must be taken seriously.
If you have diabetes take care to monitor your blood sugar levels. Your diabetes medication may need to be adjusted.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel this medicine is not helping your condition.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Stopping your medicine suddenly may cause nausea, headache, dizziness, anxiety or agitation.
Your doctor may want to gradually reduce the amount of medicine you are taking before stopping completely.
Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause drowsiness, sleepiness or dizziness 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.
Be careful when drinking alcohol while taking mirtazapine. Taking this medicine with alcohol can make you more sleepy and less alert.
Your doctor may suggest you avoid alcohol while being treated with this medicine.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking mirtazapine or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
# may be symptoms of depression.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
Some side effects may occur with no symptoms, and may only be identified by tests. For example, high blood pressure, high cholesterol or fat levels, changes in levels of white or red blood cells.
If you think you are having an allergic reaction to mirtazapine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
# Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
GenRx is a registered trademark of Apotex Pty Ltd.
This leaflet was last updated in:
Published by MIMS January 2013