MILIVIN OD 15, 30 & 45

Mirtazapine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about MILIVIN OD. 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 MILIVIN OD 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 MILIVIN OD is used for

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

MILIVIN OD is not addictive.

Before you take MILIVIN OD

When you must not take it

Do not take MILIVIN OD:

• 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 trouble breathing.

Do not take MILIVIN OD 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 MILIVIN OD 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.

Do not take MILIVIN OD if the packaging is torn or shows signs of tampering.

Do not take MILIVIN OD if the expiry date printed on the pack has passed.

If you are not sure whether you should start taking MILIVIN OD, talk to your doctor.

Before you start to take it

Do not give MILIVIN OD to a child or adolescent. The safety of MILIVIN OD in patients under 18 years has not been established.

Tell your doctor if:

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

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

Taking other medicines

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

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

• other medicines (e.g. SSRIs, venlafaxine, L-tryptophan, nefazodone) 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)
• phenytoin or carbamazepine, medicines used to treat epilepsy
• benzodiazepines, medicines used to treat anxiety and sleeping problems
• lithium, a medicine used to treat some psychiatric conditions
• tramadol, a pain killer
• morphine, a medicine for severe pain
• cetrizine, a medicine for allergies
• warfarin, a medicine used to prevent blood clotting
• linezolid or erythromycin, both antibiotic
• rifampicin, a medicine used to treat tuberculosis
• medicines used to treat fungal infections such as ketoconazole
• HIV/AIDS medications
• cimetidine, a medicine used to treat reflux and stomach ulcers
• triptans such as sumatriptan, naratriptan and zolmitriptan, medicines used to treat migraine

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 MILIVIN OD.

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

How to take MILIVIN OD

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

How much to take

Your doctor will tell you how much MILIVIN OD to take each day. Take exactly the amount your doctor tells you.

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

MILIVIN OD can be taken with or without water.

Please read the following instructions carefully.

• To prevent crushing the tablet, do not push against the tablet pocket (see Figure 1).

• Each blister contains ten tablet pockets, which are separated by perforations (dotted lines). Bend the strip several times along the dotted lines, and then tear off one tablet pocket (see Figure 2).

• Carefully peel off the lidding foil, starting in the corner indicated by the arrow (see Figure 3).

• Take out the tablet with dry hands and place it on the tongue. The tablet will rapidly disintegrate and can be swallowed with or without water (see Figure 4 & 5)

Take the tablet immediately after it is removed from the tablet pocket. Once removed it cannot be stored.

How long to take it

Keep taking MILIVIN OD 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 - 4 weeks to feel the full benefit of the medicine.

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

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 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 (overdose)

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

You may need urgent medical attention.

If you take too many MILIVIN OD tablets, you may feel drowsy, dizzy, confused, agitated, have increased heart rate or lose consciousness.

While you are taking MILIVIN OD

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 MILIVIN OD 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. 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.

If you or someone you know is showing warning signs of suicide- related behaviour while taking MILIVIN OD, 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 taking 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 appointments with your doctor 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 MILIVIN OD.

Tell all doctors, dentists and pharmacists who are treating you that you are taking MILIVIN OD.

Things you must not do

Do not drive or operate machinery until you know how MILIVIN OD affects you. MILIVIN OD 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 MILIVIN OD, 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 MILIVIN OD, even if you feel better, unless advised by your doctor. Suddenly stopping MILIVIN OD may cause nausea, headache, dizziness, anxiety, agitation.

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

Do not use MILIVIN OD 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.

Things to be careful of

Be careful when drinking alcohol while taking MILIVIN OD. Combining MILIVIN OD and alcohol can make you sleepier and less alert. Your doctor may suggest you avoid alcohol while being treated with this medicine.

Side effects

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

Ask your doctor or pharmacist any questions you may have.

Do not be alarmed by this list of possible 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 as a result of fluid accumulation (oedema)
• rash
• nightmares/vivid dreams
• tingling fingers or toes
• painful joints
• back pain, muscle aches and pains
• restless legs
• anxiety#
• insomnia#

# May be symptoms of depression

Tell your doctor immediately, or go to 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)
• agitation
• confusion
• hallucinations
• yellow colouring of eyes or skin; this may suggest disturbance in liver function
• generalised fluid retention with weight gain
• skin rash, 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, diarrhoea, (uncontrollable) 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.

After Taking MILIVIN OD

Storage

Keep your tablets in their blister pack until it is time to take them. The tablets will not keep if you take them out of their blister.

Store below 30 degrees C.

Do not store MILIVIN OD, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. 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 MILIVIN OD looks like

MILIVIN OD 15, 30 & 45 (15, 30 & 45 mg mirtazapine) are presented in pack size of 30 & 90 tablets in blister.

• MILIVIN OD 15 (AUST R 183404)
  White, round tablets debossed with ‘36’ on one side and ‘A’ on the other side with an embossed circular edge .
• MILIVIN OD 30 (AUST R 183405)
  White, round tablets debossed with ‘37’ on one side and ‘A’ on the other side with an embossed circular edge.
• MILIVIN OD 45 (AUST R 183406)
  White, round tablets debossed with ‘38’ on one side and ‘A’ on the other side with an embossed circular edge.

Ingredients

Active Ingredient:
Mirtazapine
Each tablet may contain either 15 mg, 30 mg or 45 mg of mirtazapine.

Other Ingredients:

• Crospovidone
• Mannitol
• Microcrystalline cellulose
• Aspartame*
• Colloidal anhydrous silica
• Magnesium stearate
• Strawberry Guarana 586997 AP0551 (PI-ARTG No. 13076)
• (HF82) N&A Peppermint FL SD #517 (PI-ARTG No. 106768)

*Aspartame may be harmful for people with phenylketonuria.

Please read this leaflet carefully before you start taking MILIVIN OD. You may wish to keep it to read again.

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd
Unit 3, North Rydelink
277-283 Lane Cove Road
MACQUARIE PARK
NSW 2113
Australia

Date of Approval
19 January 2012

Published by MIMS/myDr September 2012

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