AURODULOX 30 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. AuroDulox, 30 mg Gastro-Resistant Capsules, Hard
3. AuroDulox, 60 mg Gastro-Resistant Capsules, Hard
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What AuroDulox is and what it is used for
5. What you need to know before you take AuroDulox
   1. Do not take AuroDulox:
   2. Warnings and precautions
   3. Children and adolescents under 18 years
   4. AuroDulox with other medicines
   5. Taking AuroDulox with food, drink, and alcohol
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. AuroDulox contains sugar
6. How to take AuroDulox
   1. If you take more AuroDulox than you should
   2. If you forget to take AuroDulox
   3. If you stop taking AuroDulox
7. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people)
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1,000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
   6. Frequency not known (cannot be estimated from the available data)
   7. Reporting of side effects
8. How to store AuroDulox
9. Contents of the pack and other information
   1. What AuroDulox contains
   2. What AuroDulox looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Aurovitas Pharma Polska Sp. z o.o.
   5. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 08/2024

Package Leaflet: Information for the User

AuroDulox, 30 mg Gastro-Resistant Capsules, Hard

AuroDulox, 60 mg Gastro-Resistant Capsules, Hard

Duloxetine (as hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What AuroDulox is and what it is used for
• 2. What you need to know before you take AuroDulox
• 3. How to take AuroDulox
• 4. Possible side effects
• 5. How to store AuroDulox
• 6. 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 brain.

AuroDulox is used in adults to treat:

• depression
• generalised anxiety disorder (excessive worry, nervousness, fear)
• diabetic neuropathic pain (burning, stabbing, shooting, aching, tingling sensation in the feet and hands)

Most people with depression or anxiety will start to feel better within 2-4 weeks of starting treatment. If you do not feel better after this time, you should talk to your doctor.

2. What you need to know before you take AuroDulox

Do not take AuroDulox:

• if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• if you have liver disease
• if you have severe kidney disease
• if you are taking or have taken other medicines for depression called MAOIs (see "Other medicines and AuroDulox") within the last 14 days
• if you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are used to treat some infections

if you are taking other medicines containing duloxetine (see "Other medicines and AuroDulox").

• if you are taking other medicines containing duloxetine (see "Other medicines and AuroDulox").

Tell your doctor if you have high blood pressure or heart disease. Your doctor will decide whether you can take AuroDulox.

Warnings and precautions

Medicines like AuroDulox (SSRI/SNRI) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

The following are some of the reasons why you should not take AuroDulox:

• if you are taking other antidepressant medicines (see "Other medicines and AuroDulox")
• if you are taking herbal remedies containing St John's Wort (Hypericum perforatum)
• if you have kidney disease
• if you have had fits (seizures) in the past
• if you have had manic episodes (see "Depression and anxiety")
• if you have bipolar disorder
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye)
• if you have had bleeding disorders or have been taking medicines that thin the blood (see "Other medicines and AuroDulox")
• if you are at risk of having low sodium levels (for example, if you are taking diuretics or are elderly)
• if you are taking other medicines that may affect the liver
• if you are taking other medicines containing duloxetine (see "Other medicines and AuroDulox")
• if you have depression or other mental health conditions treated with antidepressants
• If you are taking medicines containing buprenorphine. Taking these medicines with duloxetine may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and AuroDulox").

AuroDulox may cause dizziness or fainting, especially when standing up. If you feel dizzy or faint when standing up, tell your doctor.

You should also tell your doctor if you experience any of the following symptoms:

• agitation, hallucinations, confusion, rapid heart rate, high blood pressure, increased body temperature, overactive reflexes, diarrhoea, coma, nausea, vomiting, as these may be signs of a condition called serotonin syndrome

In severe cases, serotonin syndrome can resemble a life-threatening condition called neuroleptic malignant syndrome, with symptoms such as:

combination of fever, rapid heartbeat, sweating, rigidity, confusion, raised levels of muscle enzymes (seen in blood tests)

Suicidal thoughts and worsening of your depression or anxiety

Depression and anxiety can make you feel like harming or killing yourself. Taking antidepressants can increase the risk of these thoughts, especially when you first start treatment. Most people find that their depression and anxiety get better with antidepressant treatment.

Children and adolescents under 18 years

AuroDulox should not normally be given to children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger) when they take this class of medicines.

AuroDulox with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Duloxetine, the active ingredient in AuroDulox, is used in other medicines for other conditions:

• diabetic neuropathic pain, depression, anxiety, and stress urinary incontinence. Do not take more than one of these medicines at the same time.

Your doctor will decide whether you can take AuroDulox with other medicines.

Do not start or stop taking any other medicines, including those obtained without a prescription, natural products, or herbal products, without talking to your doctor first.

Tell your doctor if you are taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs): see "Do not take AuroDulox" and "Other medicines and AuroDulox"

Some medicines may increase the risk of side effects when taken with AuroDulox. In some cases, your doctor may need to adjust your dose or monitor you more closely.

Taking AuroDulox with food, drink, and alcohol

AuroDulox can be taken with or without food.

Be careful when drinking alcohol while you are taking this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

When taken during pregnancy, duloxetine has been associated with an increased risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear bluish.

These symptoms usually occur in the first 24 hours after birth.

If you take AuroDulox near the end of your pregnancy, your baby might have some symptoms such as:

• muscle weakness, rigidity, or jitteriness, poor feeding, respiratory distress, or apnoea (pauses in breathing)

Tell your doctor or midwife if you are taking AuroDulox and they will be able to advise you.

Driving and using machines

AuroDulox may cause dizziness or drowsiness. Do not drive or operate machinery until you know how AuroDulox affects you.

AuroDulox contains sugar

AuroDulox contains sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take AuroDulox

Always take this medicine exactly as your doctor or pharmacist has told you.

AuroDulox is for oral use. Swallow the capsule whole with water.

Treatment of depression and diabetic neuropathic pain

The usual dose of AuroDulox is 60 mg once a day. However, your doctor will tell you which dose is right for you.

Treatment of generalised anxiety disorder

The recommended starting dose of AuroDulox is 30 mg once daily. Your doctor will usually increase your dose to 60 mg once daily.

Take AuroDulox at the same time each day. This will help you to remember to take your capsules.

Your doctor will tell you how long you should keep taking AuroDulox.

If you take more AuroDulox than you should

If you take more AuroDulox than you should, talk to a doctor or pharmacist immediately.

If you forget to take AuroDulox

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only the next one.

If you stop taking AuroDulox

Do not stop taking AuroDulox without talking to your doctor first. If your doctor thinks that you should stop taking AuroDulox, they will tell you how to do this gradually over a period of at least 2 weeks.

4. Possible side effects

Like all medicines, AuroDulox can cause side effects, although not everybody gets them.

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

• headache, somnolence
• nausea, dry mouth

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

• reduced appetite, sleep disturbances, agitation, decreased libido, anxiety, erectile dysfunction, abnormal dreams
• dizziness, drowsiness, tremors, paraesthesia (tingling sensation), including hypoaesthesia (reduced sense of touch)
• blurred vision
• tinnitus (ringing in the ears)
• palpitations
• increased blood pressure, flushing
• yawning
• constipation, diarrhoea, abdominal pain, vomiting, dyspepsia, flatulence
• increased sweating, rash (pruritic)
• muscle spasms, muscle tension
• urinary hesitation, urinary frequency
• erectile dysfunction, ejaculation disorder
• falls (especially in the elderly), fatigue
• weight decrease

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

• pharyngitis, increased heart rate

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

• severe allergic reactions, including anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis

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

• vasculitis (inflammation of blood vessels)

Frequency not known (cannot be estimated from the available data)

• Takotsubo cardiomyopathy (a condition where the heart muscle becomes weakened and cannot function properly)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 which is stated on the carton after EXP.

30 mg:

PVC/PVDC/Aluminium blister:Store in a cool, dry place, below 30°C. Store in the original package in order to protect from light and moisture.

60 mg:

PVC/PVDC/Aluminium blister:Store in a cool, dry place, below 30°C. Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What AuroDulox contains

• The active substance is duloxetine.
• Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
• The other ingredients are: capsule content: hypromellose, talc, titanium dioxide (E 171), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, sucrose, maize starch, and sucrose

What AuroDulox looks like and contents of the pack

AuroDulox is a gastro-resistant capsule, hard.

AuroDulox is available in two strengths: 30 mg and 60 mg.

The 30 mg capsules have a blue and white cap and body, with "DU" and "30" printed on them.

The 60 mg capsules have a blue and green cap and body, with "DU" and "60" printed on them.

AuroDulox 30 mg is available in packs of 7 and 28 capsules.

AuroDulox 60 mg is available in packs of 28 and 56 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warszawa
Polska
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 Member States of the European Economic Area under the following names:

Poland: AuroDulox

Date of last revision of the leaflet: 08/2024