Aurodulox

Package Leaflet: Information for the User

AuroDulox, 30 mg gastro-resistant hard capsules

AuroDulox, 60 mg gastro-resistant hard capsules

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 nervous system.

AuroDulox is used in adults to treat:

• depression
• generalised anxiety disorder (excessive worry, nervousness, fear)
• diabetic neuropathic pain (burning, stabbing, shooting, aching, tingling, numbness, or feeling of pins and needles in your body)

For most patients, AuroDulox starts to work within 2-4 weeks of starting treatment. If you don't feel better after this time, you should see 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
• if you have liver disease
• if you have severe kidney disease
• if you are taking or have taken within the last 14 days another medicine called a monoamine oxidase inhibitor (MAOI), see "Taking other medicines"
• 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 not sure if any of the above applies to you, talk to your doctor or pharmacist before taking 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.

Before taking AuroDulox, tell your doctor:

• if you are taking other antidepressants, see "Taking other medicines"
• if you are taking any herbal remedies, especially St. John's Wort
• if you have kidney disease
• if you have had seizures or fits
• if you have had mania
• if you have bipolar disorder
• if you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
• if you have had bleeding disorders or have been taking medicines that thin the blood (see "Taking other medicines")
• if you are at risk of getting low blood sodium levels (for example, if you are taking diuretics, especially if you are an elderly person)
• if you are taking other medicines that may cause liver damage
• if you are taking other medicines that contain duloxetine, see "Taking other medicines"
• if you have depression or other mental health conditions treated with antidepressants

AuroDulox with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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.

Some medicines may interact with AuroDulox, including:

• monoamine oxidase inhibitors (MAOIs)
• medicines that cause drowsiness
• medicines that increase serotonin levels
• oral anticoagulants or antiplatelet agents

AuroDulox with food, drink, and alcohol

AuroDulox can be taken with or without food. However, be careful when drinking alcohol while taking AuroDulox.

Pregnancy and breastfeeding

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

• Tell your doctor if you become pregnant while taking AuroDulox.

AuroDulox should not be used during pregnancy unless clearly necessary. If you are taking AuroDulox during pregnancy, your doctor will monitor you closely, especially during the last few months of pregnancy.

Driving and using machines

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

AuroDulox contains sugar

AuroDulox contains sugar (sucrose). 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. Check with your doctor or pharmacist if you are not sure.

AuroDulox is taken by mouth, once a day, with or without food.

The recommended dose is:

• 60 mg once a day for depression and diabetic neuropathic pain
• 30 mg once a day for generalized anxiety disorder, which may be increased to 60 mg once a day

Do not stop taking AuroDulox without talking to your doctor first. If your doctor decides that you should stop taking AuroDulox, your dose will be reduced gradually over at least 2 weeks.

If you take more AuroDulox than you should

If you take more AuroDulox than you should, talk to a doctor or go to a hospital straight away.

If you forget to take AuroDulox

If you forget to take a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking AuroDulox

Do not stop taking AuroDulox without talking to your doctor first. If you stop taking AuroDulox suddenly, you may get withdrawal effects such as:

• dizziness, tingling sensations (like pins and needles), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, feeling anxious, headaches, feeling sick (nausea), being sick (vomiting), shaking (tremor), muscle pain, irritability, excessive sweating, vertigo (a spinning sensation)

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, tremor, paraesthesia (tingling sensation), taste disturbance
• blurred vision
• tinnitus (ringing in the ears)
• palpitations
• increased blood pressure, flushing
• yawning
• constipation, diarrhea, abdominal pain, vomiting, dyspepsia (indigestion), flatulence
• increased sweating, rash (pruritus)
• muscle pain, muscle spasms
• urinary hesitation, urinary frequency
• erectile dysfunction, ejaculation disorder
• falls (especially in elderly), fatigue
• weight decrease

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

• pharyngitis, purpura (discoloration of the skin)
• suicidal thoughts, insomnia, bruxism (grinding teeth), disorientation, lack of motivation, akathisia (restlessness), aggression, hallucinations, mania, seizures

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

• severe allergic reactions, anaphylaxis
• hypothyroidism (underactive thyroid gland)
• hyponatremia (low sodium levels in the blood), SIADH (syndrome of inappropriate antidiuretic hormone secretion)
• suicidal ideation, mania, hallucinations, aggression
• serotonin syndrome (a potentially life-threatening condition caused by high levels of serotonin)

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. The expiry date refers to the last day of that month.

Store in the original package to protect from light and moisture.

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: 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 hard capsule.

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

The 30 mg capsules are blue and white, with "DU" and "30" printed on them.

The 60 mg capsules are blue and green, with "DU" and "60" printed on them.

AuroDulox is available in packs of 7, 28, and 56 capsules.

Marketing Authorisation Holder and Manufacturer

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:

Polska: AuroDulox

Date of last revision of the leaflet: 08/2024