1. Why am I taking AXIT?

AXIT contains the active ingredient mirtazapine. AXIT is used in the treatment of depression including relapse prevention.
For more information, see Section 1. Why am I taking AXIT? in the full CMI.

2. What should I know before I take AXIT?

Do not use if you have ever had an allergic reaction to mirtazapine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take AXIT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AXIT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take AXIT?

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

More instructions can be found in Section 4. How do I take AXIT? in the full CMI.

5. What should I know while taking AXIT?

For more information, see Section 5. What should I know while taking AXIT? in the full CMI.

6. Are there any side effects?

Common side effects include increased appetite and weight gain, lethargy, drowsiness or sleepiness, dizziness, headache, dry mouth, nausea, vomiting, constipation, diarrhoea, back pain, muscle aches and pains, memory problems, nightmares/vivid dreams, anxiety, insomnia, swollen ankles or feet, skin rash. Serious side effects include suicidal ideation and suicidal behaviour, confusion, shaking or tremors, severe skin reactions, and disturbances in the production of blood cells that may cause fever, chills, sore throat or mouth ulcers or other signs of frequent infections.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

AXIT®

Active ingredient(s): mirtazapine

Consumer Medicine Information (CMI)

This leaflet provides important information about using AXIT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using AXIT.

Where to find information in this leaflet:

1. Why am I taking AXIT?

AXIT contains the active ingredient mirtazapine.

AXIT 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.

Ask your doctor if you have any questions about why it has been prescribed for you.

AXIT is not addictive.

2. What should I know before I take AXIT?

Warnings

Do not take AXIT if:

• you are allergic to mirtazapine, or any of the ingredients listed at the end of this leaflet.
  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.

Always check the ingredients to make sure you can use this medicine.

• you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) or have been taking an MAOI within the last 14 days. If you stop taking AXIT, do not take MAOI during the next two weeks either.

Taking AXIT 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.

Ask your doctor or pharmacist if you are not sure if you are or if you have been taking a MAOI medicine.

• the packaging is torn or shows signs of tampering, or the expiry date printed on the pack has passed.

Check with your doctor if you:

• have or have had any other medical conditions especially the following:
  • thoughts of suicide or self-harm
  • epilepsy (fits or convulsions)
  • liver disease such as jaundice
  • kidney disease
  • heart disease
  • low blood pressure
  • certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart's rhythm.
  • any mental illness (e.g. schizophrenia, manic depression)
  • diabetes
  • glaucoma (increased pressure in the eye)
  • problems in urinating due to an enlarged prostate
  • unexplainable high fever, sore throat and mouth ulcers
  • galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, as this medicine contains lactose.
• take any medicines for any other condition.
• are allergic to any other medicines, foods, dyes or preservatives.
• react badly to lactose or milk before you start taking AXIT.
• are not sure whether you should start taking AXIT.

If you have not told your doctor about any of the above, tell them before you take AXIT.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

Like most medicines of this kind, AXIT is not recommended to be taken during pregnancy. Your doctor will discuss the risks and benefits of taking AXIT when pregnant.

Tell your doctor if you are breastfeeding or wish to breastfeed.

It is not known whether AXIT passes into breast milk.

Use in Children

Do not give AXIT to a child or adolescent.

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

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with AXIT and affect how it works.

Medicines that may increase the effect of AXIT include:

• erythromycin, an antibiotic
• medicines used to treat fungal infections such as ketoconazole
• HIV/AIDS medications
• cimetidine, a medicine used to treat reflux and stomach ulcers
• nefazodone, a medicine used to treat depression and anxiety

Medicines that may reduce the effect of AXIT include:

• phenytoin or carbamazepine, medicines used to treat epilepsy
• rifampicin, a medicine used to treat tuberculosis

Medicines that may increase the risk of side effects if taken with AXIT include:

• other medicines (eg. SSRIs, venlafaxine, L-tryptophan) for depression, anxiety, obsessive compulsive disorders or pre-menstrual dysphoric disorder
• Monoamine Oxidase Inhibitors (such as tranylcypromine, phenelzine, and selegiline)
• medicines containing St. John's Wort (hypericum perforatum)
• benzodiazepines, medicines used to treat anxiety and sleeping problems
• morphine, a medicine for severe pain
• lithium, a medicine used to treat some psychiatric conditions
• methylene blue (used to treat high levels of methemoglobin in the blood)
• tramadol, a pain killer
• linezolid, an antibiotic
• triptans such as sumatriptan, naratriptan and zolmitriptan, medicines used to treat migraine
• cetirizine, a medicine for allergies
• medicines that may affect the heart's rhythm such as certain antibiotics and some anti-psychotics.

Medicines whose effect may be reduced if taken with AXIT include:

• warfarin, a medicine used to prevent blood clotting

Your doctor can 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 AXIT.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect AXIT.

4. How do I take AXIT?

How much to take

• Your doctor will tell you how much AXIT to take each day. Take exactly the amount your doctor tells you.
• The usual starting dose is 15 mg per day. Your doctor may slowly increase this dose depending on how you respond to AXIT. The effective dose for most people is usually between 30 mg and 45 mg per day.
• Your doctor may have prescribed a different dose.
• If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
• Keep taking AXIT until your doctor tells you to stop.
• 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 to 4 weeks to feel the full benefit of the medicine.
• Even when you feel well, you will usually have to take AXIT for 4 to 6 months or even longer to make sure the benefits will last.

When to take AXIT

• Take AXIT at about the same time each day.
• 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, AXIT may be taken in sub-doses equally divided over the day (once in the morning and once at night-time before going to bed).

How to take AXIT

• Swallow the tablet(s) with some water or other fluid with or without food.
• Do not crush or chew the tablets.
• AXIT 15 and AXIT 30 tablets can be divided in half along the breakline, if advised by your doctor or pharmacist.

If you forget to take AXIT

AXIT should be taken regularly at the same time each day.

Once Daily Dosing

• If you forget to take the tablet before you go to bed, do not take the missed dose next morning. It may cause drowsiness or sleepiness during the day.
• Continue treatment in the evening with your normal dose.

Twice Daily Dosing

• Morning dose forgotten - simply take it together with your evening dose.
• Evening dose forgotten - do not take it with the next morning dose. Continue treatment with your normal morning and evening doses.
• Both doses forgotten - do not try to make up for the missed tablets. Continue with your usual morning and evening dose the next day.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much AXIT

If you think that you or anyone else has taken too much AXIT, urgent medical attention maybe needed.

If you take too many AXIT 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 Torsades de Pointes.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking AXIT?

Things you should do

• Tell your doctor if you become pregnant while taking this medicine. Do not stop taking your tablets until you have spoken to your doctor.
• If you take AXIT until, or shortly before birth, your baby should be supervised for possible adverse effects.
• Ask your doctor whether you can breastfeed, while taking AXIT.
• Tell your doctor for any reason you have not taken your medicine exactly as prescribed for any reason.

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

• Tell your doctor if you feel the tablets are not helping your condition.
• Be sure to keep all of your appointments with your doctor so your progress can be checked.
• You may need to have blood tests from time to time.
• Remind any doctor, dentist or pharmacist you visit that you are taking AXIT.
• Before starting any new medicine, tell your doctor pr pharmacist that you are taking AXIT.

Call your doctor straight away if you:

• or go to the nearest hospital for treatment if you have any suicidal thoughts or other mental/mood changes.
  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 AXIT, contact your doctor or a mental health professional right away or go to the nearest hospital for treatment. These signs include:
  • thoughts or talk about death or suicide
  • thoughts or talk of self-harm or harm to others
  • any recent attempts of self-harm
  • increase in aggressive behaviour, irritability or agitation.

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.

• develop a fever, chills, sore throat or mouth ulcers or other signs of frequent infections. Stop taking AXIT and consult with your doctor for a blood test.

In rare cases AXIT can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because AXIT can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases AXIT can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anaemia), 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.

Things you should not do

• Do not suddenly stop taking AXIT, or lower the dose, without first checking with your doctor.
• Do not let yourself run out of medicine over the weekend or on holidays.
• Do not stop taking AXIT, even if you feel better, unless advised by your doctor.

Suddenly stopping AXIT may cause nausea (feeling sick), headache, dizziness, anxiety, agitation. Your doctor may want to gradually reduce the amount of AXIT you are taking before stopping completely.

• Do not take AXIT to treat any other conditions unless your doctor tells you to.
• Do not give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.

Driving or using machines

Do not drive or use any machines or tools until you know how AXIT affects you.

AXIT 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.

Drinking alcohol

You are advised not to drink any alcohol while taking AXIT.

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

Looking after your medicine

• Store below 30°C.
• Keep your tablets in their blister pack until it is time to take them.

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

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Medicines should not be disposed of via waste water or household waste.

Do not take this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What AXIT contains

Do not take this medicine if you are allergic to any of these ingredients.

What AXIT looks like

• AXIT 15: 8 mm, normal convex, yellow, film-coated tablets marked "MR 15" on one side and "G" on the other. (AUST R 97194)
• AXIT 30: 9.5 mm, normal convex, buff, film-coated tablets marked "MR 30" on one side and "G" on the other. (AUST R 97195)
• AXIT 45: 11 mm, normal convex, white, film-coated tablets marked with "MR 45" on one side and "G" on the other. (AUST R 164493)

The tablets for the 15 mg and 30 mg strengths have a breakline and can be broken into two halves if required.

All strengths of AXIT tablets are available in blister packs of 30 tablets.

Who distributes AXIT

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

This leaflet was prepared in April 2025.

AXIT® is a Viatris company trade mark.

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