Patient Information Leaflet

AuroDulox, 30 mg enteric hard capsules
AuroDulox, 60 mg enteric hard capsules
Duloxetine (as hydrochloride)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What AuroDulox is and what it is used for
Before you take AuroDulox
How to take AuroDulox
Possible side effects
How to store AuroDulox
Contents of the pack and other information

1. What AuroDulox is and what it is used for

AuroDulox contains the active substance duloxetine. This medicine increases the levels of serotonin and noradrenaline in the nervous system.
AuroDulox is indicated in adults for the treatment of:

depression
generalized anxiety disorder (a long-term feeling of anxiety or worry)
diabetic neuropathic pain (usually described as burning, stabbing, shooting, or electric-shock-like pain. Numbness may occur in a specific part of the body, or sensations such as touch, heat, or cold may be altered, and pressure may cause pain).

In most people with depression or anxiety, AuroDulox begins to work within two weeks of starting treatment, although it may take 2 to 4 weeks before improvement occurs. If there is no improvement after this time, you should consult your doctor. Even if your condition improves, your doctor may recommend continuing treatment with AuroDulox to prevent recurrence of depression or anxiety.
In patients with diabetic neuropathic pain, improvement may occur after several weeks.
Please consult your doctor if there is no improvement after 2 months.

2. Important information before using AuroDulox

When not to use AuroDulox:

if the patient is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
if the patient has liver disease
if the patient has severe kidney disease
if the patient is taking or has taken within the last 14 days another medicine which is a monoamine oxidase inhibitor (MAOI), see "AuroDulox and other medicines"
if the patient is taking fluvoxamine, which is usually used to treat depression,
ciprofloxacin or enoxacin, medicines used to treat certain infections,
if the patient is taking other medicines containing duloxetine, see "AuroDulox and other medicines".

Tell your doctor if the patient has high blood pressure or heart disease. The doctor will decide whether the patient should take AuroDulox.

Warnings and precautions

Medicines such as AuroDulox (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Below are several reasons why AuroDulox should not be used in a patient.

Before starting AuroDulox, discuss the following with the doctor if the patient:

is taking other antidepressant medicines, see "AuroDulox and other medicines"
is taking herbal medicines containing St. John's wort (Hypericum perforatum)
has kidney disease
has had seizures (epilepsy) in the past
has had episodes of mania in the past
has bipolar affective disorder
has eye diseases, such as a certain type of glaucoma (increased pressure in the eye)
has had bleeding disorders (tendency to bruise), especially if the patient is pregnant (see "Pregnancy and breastfeeding")
is at risk of low sodium levels (e.g. when taking diuretics, particularly in elderly patients)
is taking other medicines that may cause liver damage
is taking other medicines containing duloxetine, see "AuroDulox and other medicines"
has depression or other conditions treated with antidepressants
is taking medicines containing buprenorphine. Taking these medicines together with duloxetine may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and AuroDulox").

AuroDulox may cause a feeling of restlessness or inability to sit or stand still. If such symptoms occur, inform the doctor.

Contact the doctor also if the patient experiences subjective and objective symptoms such as anxiety, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhoea, coma, nausea, vomiting, as these may indicate serotonin syndrome.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome.

Subjective and objective symptoms of neuroleptic malignant syndrome may include: a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected by blood tests).

Suicidal thoughts and worsening depression or anxiety

Depression and (or) anxiety disorders may lead to thoughts of self-harm or suicide. These may worsen at the beginning of treatment with antidepressants, as it usually takes a few weeks, typically two weeks or longer, before the medicines start to work.

Such thoughts may worsen:

in patients who previously had suicidal thoughts or thoughts of self-harm
in young adults. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If thoughts of self-harm or suicide occur, contact the doctor immediately or go directly to hospital.

It may be helpful to inform a relative or close friend about the patient's depression or anxiety and ask them to read this patient leaflet. You may also ask for their opinion on whether the depression or anxiety has worsened or whether changes in behaviour are causing concern.

Children and adolescents under 18 years of age

AuroDulox is generally not recommended for use in children and adolescents under 18 years of age. In patients under 18 years of age taking medicines of this class, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger). However, the doctor may decide to prescribe AuroDulox for patients under 18 years of age if they consider it beneficial. If in doubt when the doctor prescribes this medicine for a patient under 18 years of age, contact the doctor again. Inform the doctor if any of the adverse reactions listed above occur or worsen in a patient of this age. In addition, long-term safety data on the effects of duloxetine on growth, puberty, cognitive development, and behavioural development in this age group are lacking.

AuroDulox and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take, even those available without a prescription.

Duloxetine, the main ingredient of this medicine, is also present in various medicines used to treat other conditions:

diabetic neuropathic pain, depression, anxiety, and urinary incontinence. Avoid taking more than one of these medicines at the same time. The patient should consult the doctor if taking other medicines containing duloxetine.

The doctor will decide whether AuroDulox can be taken together with other medicines. Do not
start or stop taking other medicines, including those available without a prescription and herbal
preparations, without consulting the doctor.

Inform the doctor if the patient is taking any of the following medicines:

Monoamine oxidase inhibitors (MAOIs): AuroDulox must not be taken together with another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) or within a short interval (within 14 days) after stopping an MAOI. Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs together with many prescription medicines, including AuroDulox, may cause severe or even life-threatening adverse reactions. At least 14 days must pass after stopping MAOI treatment before starting AuroDulox. At least 5 days must pass after stopping AuroDulox before starting an MAOI.

Medicines causing drowsiness: These include prescription medicines such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.

Medicines increasing serotonin levels: triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs, e.g. paroxetine and fluoxetine), selective norepinephrine reuptake inhibitors (SNRIs, e.g. venlafaxine), tricyclic antidepressants (e.g. clomipramine, amitriptyline), pethidine, St. John's wort (Hypericum perforatum), and MAOIs (e.g. moclobemide and linezolid). These medicines increase the risk of adverse reactions. If any symptoms occur while taking these medicines together with AuroDulox, contact the doctor.

Oral anticoagulants or antiplatelet medicines: Medicines that thin the blood or prevent blood clotting. These may increase the risk of bleeding.

Some medicines may worsen the adverse effects of AuroDulox and sometimes cause very severe reactions. While taking AuroDulox, do not take any other medicines without first consulting the doctor, especially:

medicines containing buprenorphine. These medicines may interact with AuroDulox and cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, contact the doctor.

Taking AuroDulox with food, drink and alcohol

AuroDulox can be taken with or without food. Exercise caution when consuming alcohol while taking AuroDulox.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

The patient should inform the doctor if she becomes pregnant or plans to become pregnant while taking AuroDulox. The patient may take AuroDulox only after discussing with the doctor the expected benefits of treatment and possible risks to the unborn child.

The patient should inform the midwife and (or) doctor about taking AuroDulox.

Taking similar medicines (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue.

Such symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in her baby, she should contact the midwife and (or) doctor immediately.

If the patient takes AuroDulox towards the end of pregnancy, such symptoms may occur in the newborn. They usually appear at birth or within a few days after birth. These symptoms include: muscle weakness, tremor, jitteriness, feeding difficulties, breathing problems, and seizures. If the patient notices any of these symptoms or is concerned about the baby's health, she should seek advice from the doctor or midwife, who will provide appropriate guidance.

Available data on the use of duloxetine during the first three months of pregnancy generally do not show an increased risk of congenital malformations in the child. If the patient takes duloxetine during the second half of pregnancy, there may be an increased risk of premature birth, mainly between weeks 35 and 36 of pregnancy (6 additional premature births per 100 women taking duloxetine in the second half of pregnancy).

If the patient takes AuroDulox towards the end of pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. Inform the doctor or midwife about taking duloxetine so they can recommend appropriate management.

The patient should inform the doctor if she is breastfeeding. This medicine is not recommended during breastfeeding. Consult the doctor or pharmacist for advice.

Driving and using machines

AuroDulox may cause drowsiness or dizziness. Do not drive or operate machinery until you know how your body reacts to AuroDulox.

AuroDulox contains sucrose

AuroDulox contains sucrose. If the doctor has previously diagnosed the patient with an intolerance to certain sugars, consult the doctor before starting this medicine.

3. How to take AuroDulox

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
AuroDulox is taken orally. The capsule should be swallowed whole with water.

Treatment of depression and diabetic neuropathic pain
The usual dose of AuroDulox is 60 mg taken once daily. However, your doctor will determine the
appropriate dose for each individual patient.

Treatment of generalized anxiety disorders
The usual starting dose of AuroDulox is 30 mg once daily. In most patients, the dose is subsequently
increased to 60 mg once daily. However, your doctor will determine the appropriate dose for each
individual patient. The dose may be increased up to 120 mg depending on the patient's response to
treatment.

Taking AuroDulox at the same time each day will help you remember to take it.
Your doctor will inform you how long you should continue taking AuroDulox. Do not stop taking
this medicine or change the dose without consulting your doctor. Proper treatment of the condition
is important so that you feel better. If you discontinue treatment, your condition may persist, worsen,
and become more difficult to treat.

Taking more AuroDulox than recommended
If you take more AuroDulox than recommended, contact your doctor or pharmacist immediately.
Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction which may cause
excessive feelings of well-being, drowsiness, lack of coordination, restlessness, alcohol-like intoxication,
fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of AuroDulox
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, do not take the
missed dose; instead, take your next dose at the regular time. Do not take a double dose to make up
for a missed dose. Do not exceed the daily dose of AuroDulox recommended by your doctor.

Stopping AuroDulox
Even if you feel better, DO NOT stop taking AuroDulox without consulting your doctor. If your doctor
decides that you no longer need to take AuroDulox, they will recommend gradually reducing the dose
over at least two weeks before stopping completely.

In some patients who abruptly stop taking AuroDulox, the following symptoms may occur:

dizziness, tingling sensations like pins and needles or electric shocks (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or dizziness due to vestibular disturbances.

These symptoms are usually mild and resolve within a few days. If they are troublesome, contact your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are usually mild or moderate and usually resolve after a few weeks.

Very common adverse effects (may affect more than 1 in 10 people)

headache, drowsiness
nausea, dry mouth

Common adverse effects (may affect up to 1 in 10 people)

loss of appetite, sleep disturbances, restlessness, reduced sexual drive, anxiety, difficulty or inability to achieve orgasm, unusual dreams
dizziness, feeling of sluggishness, muscle tremor, numbness, including numbness, prickling or tingling sensation of the skin
blurred vision
tinnitus (hearing a sound in the ears without an external source)
sensation of palpitations
increased blood pressure, sudden flushing of the face
excessive yawning
constipation, diarrhoea, abdominal pain, vomiting, heartburn or indigestion, flatulence
increased sweating, rash (itchy)
muscle pain, muscle cramps
painful urination, frequent urination
erectile dysfunction, changes in ejaculation
falls (especially in elderly people), fatigue
weight loss

In children and adolescents under 18 years of age with depression treated with this medicine, weight loss has been observed after starting treatment. After 6 months of treatment, weight gain occurred and body weight normalized compared to that observed in children and adolescents of the same age and sex.

Uncommon adverse effects (may affect up to 1 in 100 people)

sore throat causing hoarseness
suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, disorientation, lack of motivation, sudden involuntary movements or muscle twitching, feeling of restlessness or inability to sit or stand still quietly, irritability, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g. lack of coordination or unintended muscle movements, restless legs syndrome, worsened sleep quality
dilated pupils (dark central part of the eye), visual disturbances
dizziness or sensation of spinning (due to vestibular disturbances), ear pain
rapid and/or irregular heartbeat
fainting, dizziness, feeling of emptiness in the head or fainting when standing up, cold sensation in the fingers of hands and/or feet
tightness in the throat, nosebleeds
vomiting blood, or black, tarry stools, inflammation of the stomach and intestines, regurgitation of stomach contents, difficulty swallowing
liver inflammation, which may cause abdominal pain and yellowing of the skin or whites of the eyes
night sweats, urticaria, cold sweats, photosensitivity, increased tendency to bruise
muscle stiffness and twitching
difficulty or inability to urinate, difficulty initiating urination, need to urinate at night, urinating larger amounts than usual, reduced urine output
abnormal vaginal bleeding, menstrual disorders, including heavy, painful, irregular or prolonged periods, rarely scanty periods or absence of periods, testicular or scrotal pain
chest pain, cold sensation, thirst, chills, hot flushes, gait disturbances
weight gain
AuroDulox may cause adverse effects of which one is unaware, such as increased liver enzyme activity or increased potassium levels in blood, increased creatine phosphokinase activity, increased blood glucose or cholesterol levels.

Rare adverse effects (may affect up to 1 in 1,000 people)

severe allergic reaction causing difficulty breathing, dizziness with swelling of the tongue or lips, allergic reactions
decreased thyroid function, which may cause fatigue or weight gain
dehydration, low sodium levels in blood (especially in elderly people; symptoms may include: dizziness, weakness, confusion, drowsiness, excessive fatigue or nausea, or vomiting; more severe symptoms include fainting, seizures and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
suicidal behaviour, mania (excessive activity, racing thoughts and reduced need for sleep), hallucinations, aggression and anger outbursts
"serotonin syndrome" (a rare reaction which may cause feelings of excessive well-being, drowsiness, impaired motor coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle rigidity), seizures
increased intraocular pressure (glaucoma)
inflammation of the oral cavity, bright red blood in stool, bad breath, inflammation of the large intestine (leading to diarrhoea)
liver failure, yellowing of the skin or whites of the eyes (jaundice)
Stevens-Johnson syndrome (a severe illness characterized by blister formation on the skin, in the mouth, eyes and genital organs)
severe allergic reaction causing swelling of the face or throat (angioedema)
jaw muscle spasm
abnormal urine odour
menopausal symptoms, abnormal milk production in men or women in the mammary glands, excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage)
cough, wheezing and shortness of breath, which may occur simultaneously with fever

Very rare adverse effects (may affect up to 1 in 10,000 people)

inflammation of blood vessels in the skin

Frequency not known (cannot be estimated from available data)

objective and subjective symptoms of a condition called stress cardiomyopathy, which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, al. Jerozolimskie 181c, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store AuroDulox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
30 mg:
PVC/PVDC/Aluminium foil blister: Store below 30°C. Keep in the original packaging to protect from light and moisture.
60 mg:
PVC/PVDC/Aluminium foil blister: Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What AuroDulox contains

The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (in the form of hydrochloride).
Other ingredients are: Capsule contents: hypromellose, talc, titanium dioxide (E 171), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate, sucrose, granules (corn starch and sucrose), and sucrose. Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E132), printing ink (black iron oxide (E 172), potassium hydroxide, and shellac). The 60 mg capsules also contain yellow iron oxide (E 172).

What AuroDulox looks like and contents of the pack
AuroDulox is a hard enteric capsule.
AuroDulox is available in two strengths: 30 mg and 60 mg.
The 30 mg capsules are printed with (cap DU/body 30), and are opaque blue-white (approximately 15 mm in size).
The 60 mg capsules are printed with (cap DU/body 60), and are opaque blue-green (approximately 19 mm in size).
AuroDulox 30 mg is available in packs of 7 and 28 hard enteric capsules, packed in blisters.
AuroDulox 60 mg is available in packs of 28 and 56 hard enteric capsules, packed in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
e-mail: [email protected]

Manufacturer:
TOWA PHARMACEUTICAL EUROPE, SL
c/ de Sant Martí 75-97, 08107 Martorelles,
Barcelona
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: AuroDulox

Aurodulox