Contains the active ingredient duloxetine (as duloxetine hydrochloride)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about duloxetine. 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:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au. 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.
What this medicine is used for
The name of your medicine is APO-Duloxetine. It contains the active ingredient duloxetine hydrochloride.
It is used to treat:
major depressive disorder (MDD)
generalised anxiety disorder (GAD) - excessive worry.
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.
How it works
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.
Use in children
This medicine should not be used in children and adolescents under the age of 18 years.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You have or have had liver disease.
You are taking a medicine called a monoamine oxidase inhibitor (MAOI), including moclobemide which is a reversible MAOI (RIMA), or have been taking a MAOI within the last 14 days.
Check with your doctor you are unsure whether or not you are taking a MAOI.
You are taking a medicine that is a potent inhibitor of CYP1A2, such as fluvoxamine or ciprofloxacin.
Check with your doctor if you are unsure whether or not you are taking a potent inhibitor of CYP1A2.
You are hypersensitive to, or have had an allergic reaction to, duloxetine or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
glaucoma (an eye disease where the fluid pressure in the eye may be high)
high blood pressure
heart problems
kidney problems
history of fits (seizures)
diabetes.
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.
Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
5.You are currently breast-feeding or you plan to breast-feed.
Do not take this medicine whilst breast-feeding until you and your doctor have discussed the risks and benefits involved.
6.You are planning to have surgery or an anaesthetic.
7.You are currently receiving or are planning to receive dental treatment.
People who drink excessive amounts of alcohol should not take duloxetine. Drinking too much alcohol could increase the risk of liver problems during treatment with duloxetine.
9.You are taking or are planning to take any other medicines.
This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with duloxetine. These include:
monoamine oxidase inhibitors (MAOIs), medicines used to treat some types of depression.
You must stop taking MAOIs at least two weeks before starting duloxetine.
You must stop taking duloxetine at least 5 days before you start taking a MAOI.
other medicines used to treat depression, panic disorder, anxiety or obsessive illnesses, including tryptophan
strong painkillers such as tramadol, pethidine
a type of migraine treatment called 'triptans', such as sumatriptan or zolmitriptan
medicines used to treat stress urinary incontinence such as tolteridone
medicines used to treat heart problems such as flecainide or propafenone
thioridazine, a medicine used to treat schizophrenia
herbal medicines such as St John's Wort (Hypericum perforatum)
warfarin, a medicine used to thin the blood (anticoagulant).
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.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
How much to take
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.
How to take it
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.
When to take it
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.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
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 take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or 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.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if you:
are about to be started on any new medicine
are pregnant or are planning to become pregnant
are breast-feeding or are planning to breast-feed
are about to have any blood tests
are going to have surgery or an anaesthetic or are going into hospital.
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:
worsening of your depression
thoughts or talk of 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 any other unusual changes in behaviour or mood.
If you notice any of the following, contact your doctor immediately:
itchy skin
dark urine
yellowing of the skin or eyes
tenderness over the liver
symptoms of the 'flu'.
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.
Things you must not do
Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Things to be careful of
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.
Possible side effects
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:
dry mouth, mouth ulcers, thirst, bad taste
burping or belching, indigestion, stomach pain, nausea, vomiting
difficulty swallowing
constipation, diarrhoea, wind (flatulence)
bad breath
loss of appetite, weight loss
headache
trouble sleeping
dream abnormalities
drowsiness
feeling tired or having no energy
dizziness
tremor
blurred vision
feeling anxious, agitated or restless
confusion and attention problems
tingling and numbness of hands, face, mouth and feet
yawning or throat tightness
sexual problems
pain in testicles
difficulty urinating (passing water), urinating frequently or needing to urinate at night
irregular heart beat
hot and cold sweats
flushing
skin rash
tendency to bruise
sore ears, sore throat
ringing in ears
muscle pain, stiffness or twitching
walking problems
restless legs.
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.
signs of a possible liver problem
such as itchy skin, dark urine, yellowing of the skin or eyes, tenderness over the liver, symptoms of the 'flu'
high pressure in the eye (glaucoma)
feeling tired, weak or confused and having aching, stiff or uncoordinated muscles.
This may be because you have low sodium levels in the blood (hyponatraemia or syndrome of inappropriate antidiuretic hormone)
abdominal pain, traces of blood in your stools, or if your stools are dark in colour. This may because you have increased bleeding, possibly in the gastric tract (gastrointestinal bleeding). You may also feel weakness, dizziness and experience nausea and/or vomiting
seeing or hearing things (hallucinations)
dizziness or fainting when you stand up, especially from a lying or sitting position
uncontrollable movements
if you have some or all of the following symptoms you may have something called serotonin syndrome: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations, sudden jerks in your muscles or a fast heart beat
stiff neck or jaw muscles (lockjaw)
fits or seizures
mood of excitement, over-activity and uninhibited behaviour.
aggression or anger especially after starting or stopping taking this medicine.
Other changes you may not be aware of:
increased blood pressure
heart rhythm changes
underactive thyroid gland
liver function changes.
Other side effects not listed above may occur in some patients.
Allergic reactions
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:
cough, shortness of breath, wheezing or difficulty breathing.
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin
fainting
hayfever-like symptoms.
Storage and disposal
Storage
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.
Disposal
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.
Product description
What APO-Duloxetine looks like
30 mg capsules: Hard gelatin capsules with white opaque body and blue opaque cap, imprinted "157" on the body and "A" on the cap in green ink. Filled with white to off-white granules.
Blister packs of 28 capsules.
60 mg capsules: Hard gelatin capsules with green opaque body and blue opaque cap, imprinted "158" on the body and "A" on the cap in white ink. Filled with white to off-white granules.
Blister packs of 28 capsules.
APO-Duloxetine is available in*:
30 mg:
Blister packs of 28
60 mg:
Blister packs of 28
* Not all strengths, pack types and/or pack sizes may be available
Ingredients
Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride) as the active ingredient.
It also contains the following inactive ingredients:
Sugar Spheres (ARTG ID 2535)
hypromellose
purified talc
purified water
sucrose
hypromellose phthalate
triethyl citrate
gelatin
titanium dioxide
brilliant blue FCF
iron oxide yellow (60 mg capsule only)
Tekprint SB-4020 Green Ink (ARTG ID 2652; 30 mg capsule only)
TekPrint SW-0012 White Ink (ARTG ID 13175; 60 mg capsule only).
This medicine is gluten-free, lactose-free, tartrazine-free and free of other azo dyes.
