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MIRTAZAPINE GH

mirtazapine


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Mirtazapine GH. 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 this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Mirtazapine GH is used for

This medicine 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 this medicine has been prescribed for you.

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

This medicine is not addictive.

Before you take Mirtazapine GH

When not to take it

Do not take this medicine:

  • if you are allergic to medicines containing mirtazapine
  • if you are allergic to 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 difficulty breathing.

Do not take this medicine if you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) or have been taking an MAOI within the last 14 days.

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.

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

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

Do not take this medicine if the packaging is torn or shows signs of tampering.

Do not take this medicine if the expiry date printed on the pack has passed.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Do not give this medicine to a child or adolescent.

The safety of this medicine is patients under 18 years has not been established.

Tell your doctor if:

  • you are allergic to any other medicines, foods, dyes, or preservatives
  • you are pregnant or plan to become pregnant. Like most medicines of this kind, this medicine is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of taking this medicine when pregnant.
  • you are breastfeeding or wish to breastfeed. It is not known whether this medicine passes into breast milk
  • if you have or have had any 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
    - 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 or mouth ulcers
    - fructose intolerance
    - glucose-galactose malabsorption.

If you have not told your doctor about any of the above, tell them before you start taking Mirtazapine GH.

Taking other medicines

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

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

  • other medicines (eg SSRIs, venlafaxine, L-tryptophan, nefazodone) for depression, anxiety, obsessive compulsive disorders or pre-menstrual dysphoric disorder
  • monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, phenelzine and selegiline
  • medicines containing St John’s Wort (Hypericum perforatum)
  • phenytoin or carbamazepine, medicines used to treat epilepsy
  • benzodiazepines, medicines used to treat anxiety and sleeping problems
  • lithium, a medicine used to treat psychiatric conditions
  • tramadol, a pain killer
  • morphine, a medicine for severe pain
  • cetirizine, a medicine for allergies
  • warfarin, a medicine used to prevent blood clots
  • linezolid or erythromycin, both antibiotics
  • rifampicin, a medicine used to treat tuberculosis
  • medicines used for fungal infections, such as ketoconazole
  • medicines used to treat HIV/AIDS
  • cimetidine, a medicine used to treat reflux and stomach ulcers
  • triptans such as sumatriptan, naratriptan and zolmitriptan, medicines used to treat migraines.

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 this medicine.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

How to take Mirtazapine GH

Follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

How much to take

Your doctor will tell you how much of this medicine 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 Mirtazapine GH. 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.

When to take it

Take this medicine at about the same time each day.

Your doctor will tell your 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, this medicine may be take in sub-doses equally divided over the day (once in the morning and once at night-time before going to bed).

How to take it

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

How long to take it for

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 Mirtazapine GH for 4 to 6 months or even longer, to make sure the benefits will last.

If you take too much

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Mirtazapine GH. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention. If you take too many tablets, you may feel drowsy, dizzy, confused, agitated, have increased heart rate or lose consciousness.

While you are taking Mirtazapine GH

Things you must do

Tell your doctor immediately if you develop fever, chills, sore throat or mouth ulcers or other signs of frequent infections. In rare cases, mirtazapine can cause a shortage of while 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 iff 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, these symptoms may increase in the first few weeks of treatment.

If you or someone you know is showing warning signs of suicide-related behaviour while taking Mirtazapine GH, 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.

Tell your doctor if you become pregnant while taking this medicine. Do not stop talking your tablets until you have spoken to your doctor.

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 the tablets are not helping your condition.

Be sure to keep all of your doctor’s appointments so that your progress can be checked. You may need to have blood tests from time to time.

Before starting any new medicine, tell your doctor or pharmacist that you are taking Mirtazapine GH.

Tell all doctors, dentists and pharmacists who are treating you that are taking Mirtazapine GH.

If you forget to take it

Once daily dosing:

If you forget to take the tablet before you go to bed, do not take the missed dose the next morning.

This medicine may cause drowsiness or sleepiness during the day.

Continue treatment in the evening with your usual dose, and continue to take it as you would normally.

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.

Things you must not do

Do not drive or operate machinery until you know how Mirtazapine GH affects you. This medicine 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.

Do not suddenly stop taking your medicine, 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 this medicine, even if you feel better, unless advised by your doctor. Suddenly stopping this medicine may cause nausea, headache, dizziness, anxiety, agitation.

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

Do not use this this medicine to treat any other conditions unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seems similar to yours of if they have the same condition as you.

Things to be careful of

Be careful when drinking alcohol while you are taking this medicine. Combining this medicine and alcohol can make you more sleepy and less alert. Your doctor may suggest you avoid alcohol while being treated with tis medicine.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Mirtazapine GH.

Mirtazapine GH 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 attention if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Do not be alarmed by the list of side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they bother you:

  • lethargy, drowsiness or sleepiness
  • headache
  • tiredness
  • increase in appetite and weight gain
  • dry mouth
  • nausea, vomiting
  • diarrhoea
  • occasional dizziness or faintness, especially when getting up quickly from a lying or sitting position
  • swollen ankles or feet due to fluid accumulation (oedema)
  • rash
  • nightmares/vivid dreams
  • tingling fingers or toes
  • painful joints
  • back pain, muscle aches and pains
  • restless legs
  • speech disorder
  • anxiety*
  • insomnia*

*May be symptoms of depression

Tell your doctor immediately, or go the the Accident and Emergency at your nearest hospital if you notice any of the following:

  • suicidal ideation or behaviour
  • epileptic attack (seizures)
  • shaking or tremors
  • sudden muscle contractions (myoclonus)
  • attack of excessive excitability (mania)
  • confusion
  • hallucinations
  • yellow colouring of eyes or skin; this may suggest disturbance in liver function
  • generalised fluid retention with weight gain
  • skin rashes, itching or hives; swelling of the face, lips, or tongue which may cause difficulty breathing
  • fever, sore throat, mouth ulcers, gastrointestinal (stomach, bowels) disturbances and other signs of infection
  • fever, sweating, increased heart rate, uncontrollable diarrhoea, muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness (serotonin syndrome)

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

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

How to store Mirtazapine GH

Storage

Keep your medicine in the original container until it is time to take them.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Mirtazapine GH 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 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.

Disposal

Return any unused medicine to your pharmacist.

Product description

What Mirtazapine GH tablets look like

Mirtazapine GH comes in two types of tablets:

  • Mirtazapine GH 30mg – beige, film-coated tablets, round, biconvex with a score notch on one side.
  • Mirtazapine GH 45mg – white, film-coated tablets, circular, biconvex.

Available in blisters of 30 tablets.

Ingredients

Active ingredients:

  • Mirtazapine GH 30mg – 30mg mirtazapine
  • Mirtazapine GH 45mg – 45mg mirtazapine.

Inactive ingredients:

  • Lactose monohydrate
  • maize starch
  • hyprolose
  • colloidal anhydrous silica
  • magnesium stearate
  • hypromellose
  • titanium dioxide
  • macrogol 8000.

Mirtazapine GH 30mg tablets also contain:

  • iron oxide red
  • iron oxide yellow
  • iron oxide black.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplied in Australia by

Generic Health Pty Ltd
Level 1, 1102 Toorak Road
Camberwell VIC 3124

Australian Register Numbers

30mg tablets: AUST R 191019

45mg tablets: AUST R 191020

This leaflet was prepared in September 2017.

Published by MIMS August 2018

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