Cymbalta

duloxetine hydrochloride


CYMBALTA®

Duloxetine hydrochloride

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 pharmacist.

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 (excessive worry).

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 years.

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 CYMBALTA.

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 syndrome).

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 or dyes.

Tell your doctor if you have or have had any medical conditions, especially if you have:

a condition in which the pressure of fluid in the eye may be high (glaucoma)

high blood pressure

heart problems

kidney problems as you may need to take a lower dose of CYMBALTA

history of fits (seizures)

bipolar disorder

bleeding/clotting disorders

diabetes

If you have high blood pressure or heart problems your doctor may monitor your blood pressure.

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 risks.

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 CYMBALTA.

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 shop.

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, 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

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 for help.

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 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 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 medical attention.

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 this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

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 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.

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 or mood.

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:

itchy skin

dark urine

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 you.

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 liver injury.

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.

Side effects

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 side effects.

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

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

bad breath

loss of appetite, weight loss

headache

trouble sleeping

abnormal dreams (including nightmares)

drowsiness

feeling tired, having no energy, or weakness

sexual disturbances (decreased sexual drive, problems with orgasm, ejaculation, or erection)

dizziness

tremor

blurred vision, dry eye, dilated pupils

feeling anxious, agitated or restless

tingling and numbness of hands, arms, face, mouth, legs, and feet

yawning,

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

excessive sweating

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

flushing

skin rash

restless legs

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 urine

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

stiff neck

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

Storage

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.

Disposal

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.

Product description

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) and 28.

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) and 28.

Ingredients

Active Ingredients

30 mg capsule - duloxetine hydrochloride equivalent to duloxetine 30 mg

60 mg capsule - duloxetine hydrochloride equivalent to duloxetine 60 mg

Inactive Ingredients

indigo carmine CI73015

gelatin

hypromellose

hypromellose acetate succinate

sodium lauryl sulfate

sucrose

sugar spheres

talc - purified

titanium dioxide

triethyl citrate

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.

Suppliers

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.

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