The name of your medicine is APO-Duloxetine. It contains the active ingredient duloxetine hydrochloride.
It is used to treat:
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.
Duloxetine belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). SNRIs are believed to work by their action on serotonin and noradrenaline in the brain. Serotonin and noradrenaline are the chemical messengers responsible for controlling the psychological and painful symptoms of depression.
This medicine should not be used in children and adolescents under the age of 18 years.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You, or members of your family, have experienced bipolar disorder, depression or suicide.
4. You are currently pregnant or you plan to become pregnant.
5. You are currently breast-feeding or you plan to breast-feed.
6. You are planning to have surgery or an anaesthetic.
7. You are currently receiving or are planning to receive dental treatment.
8. You drink alcohol.
9. You are taking or are planning to take any other medicines.
Some medicines may interact with duloxetine. These include:
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 duloxetine.
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
Your doctor 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.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
For major depressive disorder, the recommended dose is usually one 60mg capsule once daily.
For generalised anxiety disorder, the recommended dose is 30mg to 120mg, taken once daily.
You may be started on a lower dose to help reduce side effects. If you have severe kidney disease, the recommended starting dose is one 30mg capsule once daily.
Swallow the capsule whole with a full glass of water.
Do not open the capsules and crush the pellets inside because the medicine may not work as well. Duloxetine may be taken with or without meals.
Take this medicine at the same time 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.
Make sure you have enough to last over weekends and holidays.
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
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.
Symptoms of an overdose may include drowsiness, convulsions and vomiting. They may also include feeling confused, feeling restless, sweating, shaking, shivering, hallucinations, muscle jerks, or fast heartbeat.
Tell your doctor that you are taking this medicine if you:
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Tell your doctor immediately 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. These symptoms may continue or get worse during the first one or two months of treatment, until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur in young adults under 25 years of age.
All mention of suicide or violence must be taken seriously. Contact your doctor or a mental health professional right away or go to the nearest hospital for treatment if you or someone you know is showing any of the following warning signs of suicide:
If you notice any of the following, contact your doctor immediately:
These could be signs of liver damage.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Visit your doctor regularly for a check-up.
Be careful when driving or operating machinery until you know how this medicine affects you. It may cause dizziness or drowsiness.
Be careful when drinking alcohol while you are taking this medicine.
You should avoid 'binge drinking' or drinking excessively during treatment with duloxetine as it can cause severe liver injury.
Drinking alcohol with duloxetine may also cause dizziness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Tell your doctor as soon as possible if you do not feel well while you are taking duloxetine 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.
Other changes you may not be aware of:
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to duloxetine, 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 25°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.
APO-Duloxetine 30 mg enteric capsules: Hard gelatin capsules with white opaque body and blue opaque cap, imprinted "APO D30" in green ink. Filled with white to off-white granules.
APO-Duloxetine 60 mg enteric capsules: Hard gelatin capsules with green opaque body and blue opaque cap, imprinted "APO D60" in white ink. Filled with white to off-white granules.
APO-Duloxetine is available in*:
Blister packs of 7 and 28
Bottle packs of 28, 100 and 500
Blister packs of 7 and 28
Bottle packs of 28, 100 and 500
* Not all strengths, pack types and/or pack sizes may be available.
Each capsule contains 30mg or 60mg of duloxetine (as hydrochloride) as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Duloxetine 30mg blister pack: AUST R 195343.
APO-Duloxetine 60mg blister pack: AUST R 195356.
APO-Duloxetine 30mg bottle: AUST R 195350.
APO-Duloxetine 60mg bottle: AUST R 195362.