Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CYMBALTA. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
CYMBALTA against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
What CYMBALTA is used for
CYMBALTA is used to treat major depressive disorder (depression), Diabetic Peripheral
Neuropathic Pain (nerve pain caused by diabetes) and Generalised Anxiety Disorder
CYMBALTA 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 physical symptoms of depression.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
CYMBALTA is not recommended for use in children and adolescents under the age of 18
Before you take CYMBALTA
When you must not take it
Do not take CYMBALTA if you have an allergy to:
any medicine containing duloxetine hydrochloride;
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include 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.
Do not take CYMBALTA if you have liver disease.
This could increase the chance of you having liver problems during treatment with
Do not take this medicine if you are taking another medicine for depression called
a monoamine oxidase inhibitor (MAOI) or have been taking a MAOI within the last 14
days. Check with your doctor or pharmacist if you are unsure as to whether or not
you are taking a MAOI.
If you do take CYMBALTA while you are taking a MAOI, you may experience shaking (tremor),
shivering, muscle stiffness, fever, rapid pulse, rapid breathing and mental state
from extreme agitation progressing to confusion and coma (a condition called serotonin
Do not take CYMBALTA if you are taking another medicine that strongly interferes with
how the liver works (potent CYP1A2 inhibitor). For example, another medicine for depression
called fluvoxamine. Check with your doctor or pharmacist if you are unsure as to whether
or not you are taking a potent CYP1A2 inhibitor.
Do not take CYMBALTA with thioridazine, a medicine used to treat schizophrenia
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any medical conditions, especially if you
a condition in which the pressure of fluid in the eye may be high (glaucoma)
high blood pressure
kidney problems as you may need to take a lower dose of CYMBALTA
history of fits (seizures)
If you have high blood pressure or heart problems your doctor may monitor your blood
Tell your doctor if you are pregnant or plan to become pregnant.
CYMBALTA should only be used in pregnancy if the potential benefits outweigh the potential
Your doctor can discuss with you the risks and benefits involved.
When taken in the last 3 months of pregnancy, CYMBALTA may affect your newborn baby.
They may experience symptoms such as irritability, constant crying, feeding difficulties,
vomiting, fluctuating temperature, seizures, tremors, jitteriness, bluish appearance
(cyanosis), breathing interruptions, wheezing or shallow breathing, low blood sugar,
muscle stiffness, muscle weakness, or overresponsive reflexes, These symptoms are
uncommon and may be due to the effect of CYMBALTA or the discontinuation of CYMBALTA.
These symptoms usually begin immediately after the baby is born, or within a few days
of birth, and should only last for a short time. If this happens to your baby, you
should contact your doctor and/or midwife immediately.
Taking CYMBALTA during pregnancy may increase the risk of pre-term birth. If you take
CYMBALTA near the end of your pregnancy, there may be an increased risk of heavy vaginal
bleeding shortly after birth. Tell your doctor or midwife if you are taking CYMBALTA
so that they can advise you.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Breastfeeding while on CYMBALTA is not recommended.
Talk to your doctor about how much alcohol you drink. People who drink excessive
amounts of alcohol should not take CYMBALTA.
Drinking too much alcohol could increase the chance of you having liver problems during
treatment with CYMBALTA.
If you have not told your doctor about any of the above, tell them before you start
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines and CYMBALTA may interfere with each other. These include:
monoamine oxidase inhibitors (MAOIs), medicines used to treat some types of depression.
You should stop taking MAOIs at least two weeks before starting CYMBALTA.
You must stop taking CYMBALTA at least 5 days before you start taking a MAOI.
other medicines used to treat depression, panic disorder, anxiety or obsessive illnesses,
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
tricyclic antidepressants such as nortriptyline, imipramine, and desipramine
medicines used to treat heart problems such as flecainide or propafenone
phenothiazines such as chlorpromazine and prochlorperazine, used to treat schizophrenia/mood
disorders and nausea
SSRIs used to treat depression (e.g. paroxetine, escitalopram, sertraline)
Other SNRIs used to treat depression (e.g. venlafaxine, desvenlafaxine)
medicines used to treat blood pressure
medications to pass urine (diuretics)
herbal medicines such as St John's Wort (Hypericum perforatum)
warfarin, a medicine used to thin the blood (anticoagulant) or other medicines known
to affect blood clotting (NSAIDs, aspirin)
antacids or medicines for indigestion
Do not start to take any other medicine unless prescribed or approved by your doctor.
These medicines may be affected by CYMBALTA or may affect how well it works. You may
need different amounts of your medicines or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to take CYMBALTA
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the carton, ask your doctor or pharmacist
How much to take
The usual recommended dose of CYMBALTA in Major Depressive Disorder or Diabetic Peripheral
Neuropathic Pain is one 60 mg capsule taken once daily.
The recommended dose of CYMBALTA in Generalised Anxiety Disorder is between 30 mg
and 120 mg, taken once daily.
Your doctor may start you on a lower dose to help reduce side effects.
If you have severe kidney disease, the recommended starting dose of CYMBALTA is one
30 mg capsule taken 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.
CYMBALTA may be taken with or without meals.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How long to take it
The length of treatment with CYMBALTA will depend on how quickly your symptoms improve.
Most medicines of this type take time to work so don't be discouraged if you do not
feel better right away.
Although you may notice an improvement, continue taking your medicine for as long
as your doctor tells you.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
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 the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
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 the nearest hospital, if you
think that you or anyone else may have taken too much CYMBALTA.
Do this even if there are no signs of discomfort or poisoning. You may need urgent
Symptoms of an overdose may include drowsiness, convulsions, and vomiting. Symptoms
may also include some or all of the following: feeling confused, feeling restless,
sweating, shaking, shivering, hallucinations, muscle jerks, fast heart beat.
While you are taking CYMBALTA
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking CYMBALTA.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Tell your doctor immediately if you have any suicidal thoughts or other mental/ mood
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.
Suicidal thoughts or other mental/mood changes may also worsen when the dose of CYMBALTA
is increased or decreased.
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
All mentions of suicide or violence must be taken seriously.
If you notice any of the following contact your doctor right away.
Your doctor may do some blood tests to check your liver or tell you to stop taking
your medicine. Signs of liver problems include:
yellowing of the skin or eyes
tenderness over the liver
symptoms of the 'flu'
These may be signs of serious liver damage.
Things you must not do
Do not take CYMBALTA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
Do not stop taking CYMBALTA or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects like dizziness, nausea, headache, tingling or numbness, fatigue, vomiting,
irritability, nightmares, difficulty sleeping, diarrhoea, anxiety, excessive sweating,
drowsiness, imbalance, and muscle pain. If possible, your doctor will gradually reduce
the amount you take each day before stopping the medicine completely.
CYMBALTA may cause dizziness or drowsiness in some people. It may also impair your
judgment, affect your thinking or motor skills.
Do not drive or operate machinery until you know how CYMBALTA affects you.
Do not let yourself run out of CYMBALTA over the weekend or on holidays.
Things to be careful of
Be careful when drinking alcohol while you are taking this medicine.
Drinking large amounts of alcohol during treatment with CYMBALTA can cause severe
You should avoid 'binge drinking' or drinking excessively during treatment with CYMBALTA.
Drinking alcohol with this medicine 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 or pharmacist as soon as possible if you do not feel well while you
are taking CYMBALTA.
This medicine helps many 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
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
The following side effects are the more common side effects of CYMBALTA and are often
mild and short-lived.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
dry mouth, sore mouth, thirst, changes to taste
burping or belching, indigestion, stomach pain, nausea, vomiting
constipation, diarrhoea, wind (flatulence), loose stools
loss of appetite, weight loss
abnormal dreams (including nightmares)
feeling tired, having no energy, or weakness
sexual disturbances (decreased sexual drive, problems with orgasm, ejaculation, or
blurred vision, dry eye, dilated pupils
feeling anxious, agitated or restless
tingling and numbness of hands, arms, face, mouth, legs, and feet
throat tightness, difficulty swallowing
difficulty starting to urinate (urinary hesitation), incomplete emptying of the bladder
(urinary retention) urinating more frequently, pain when urinating, or needing to
urinate at night,
irregular heart beat
hot and cold sweats, fever, chills
sore throat, cough
ringing in ears, ear pain
muscle pain, cramps, stiffness or twitching
changes to the way you walk
These are the more common side effects of your medicine.
Tell your doctor immediately if you notice any of the following:
signs of a possible serious liver problem such as nausea, vomiting, loss of appetite,
feeling generally unwell, fever, itching, yellowing of the skin and/or eyes, dark
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
clenching or grinding teeth
mood of excitement, over-activity and uninhibited behaviour
confusion and attention problems
aggression or anger especially after starting or stopping taking this medicine
You may need urgent medical attention.
Other changes you may not be aware of:
increased blood pressure
heart rhythm changes
underactive thyroid gland
liver function changes
high pressure in the eye (glaucoma)
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
itching, skin rash or hives
shortness of breath, wheezing or trouble breathing
swelling of the face, lips, tongue or other parts of the body
fits or seizures
feeling tired, dizziness, nausea, vomiting, sleepy, weak or confused and having achy,
stiff or uncoordinated muscles, fainting, falls and seizures. This may be because
you have low sodium levels in the blood (hyponatraemia or syndrome of inappropriate
antidiuretic hormone). Elderly and dehydrated patients are at increased risk.
if you have some or all of the following symptoms you may have something called serotonin
syndrome: feeling confused, feeling restless, agitation, mood swings, sweating, shaking,
diarrhoea, shivering, tremor, loss of coordination, overactive reflexes, hallucinations,
sudden jerks in your muscles or a fast heart beat
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects. Others may occur in some
people and there may be some side effects not yet known.
After taking CYMBALTA
Keep your capsules in the pack until it is time to take them.
If you take the capsules out of the pack they may not keep as well.
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Do not store CYMBALTA 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 it 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 tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What it looks like
CYMBALTA 30 mg capsules have an opaque white body and opaque blue cap imprinted with
"9543" and "30 mg" using green ink and are available in packs of 7 (starter packs)
CYMBALTA 60 mg capsules have an opaque green body and opaque blue cap imprinted with
"9542" and "60 mg" using white ink and are available in packs of 7 (starter packs)
30 mg capsule - duloxetine hydrochloride equivalent to duloxetine 30 mg
60 mg capsule - duloxetine hydrochloride equivalent to duloxetine 60 mg
indigo carmine CI73015
hypromellose acetate succinate
sodium lauryl sulfate
talc - purified
iron oxide yellow CI77492 (60mg capsules)
TekPrint SB-4028 Green Ink (30mg capsules)
TekPrint SB-0007P White Ink (60mg capsules)
This medicine does not contain lactose, gluten, tartrazine or any other azo dyes.
Eli Lilly Australia Pty Ltd
112 Wharf Road
WEST RYDE NSW 2114
®= Registered Trademark
Australian Registration Number
30 mg capsules: AUST R 120382
60 mg capsules: AUST R 120389
This leaflet was prepared in October 2022.