Dutilox

Package Leaflet: Information for the User

Dutilox, 30 mg, Gastro-Resistant Hard Capsules

Dutilox, 60 mg, Gastro-Resistant Hard Capsules

Duloxetine (as hydrochloride)

Read all of this leaflet carefully before taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 Dutilox is and what it is used for
• 2. Before you take Dutilox
• 3. How to take Dutilox
• 4. Possible side effects
• 5. How to store Dutilox
• 6. Contents of the pack and other information

1. What Dutilox is and what it is used for

Dutilox contains the active substance duloxetine. Dutilox increases the levels of serotonin and noradrenaline in the nervous system.
Dutilox is used in adults to treat:

• depression,
• generalized anxiety disorder (excessive worry, nervousness, or fear that lasts for at least 6 months),
• diabetic neuropathic pain (usually described as a burning, shooting, stabbing, or electric shock-like pain, or as a chronic ache or cramp, or as a feeling of numbness or tingling in a specific area of the body, which may also be sensitive to touch or changes in temperature).

In most people with depression or anxiety, Dutilox starts to work within 2 weeks of starting treatment, although it may take up to 2-4 weeks for the full effect to be felt. If no improvement is seen after this time, you should consult your doctor. Your doctor may continue to prescribe Dutilox to help prevent your depression or anxiety from returning, even if you feel better.
In people with diabetic neuropathic pain, improvement in pain may occur, but this can take several weeks.

2. Before you take Dutilox

Do not take Dutilox

• 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,

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• 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 taking other medicines containing duloxetine (see "Taking other medicines").

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

Warnings and precautions

Before taking Dutilox, tell your doctor if you have:

• taken other antidepressant medicines (see "Taking other medicines") or buprenorphine. Taking these medicines with Dutilox may lead to serotonin syndrome, a potentially life-threatening condition (see "Taking other medicines"),
• taken herbal medicines containing St. John's Wort (Hypericum perforatum),
• kidney disease,
• had seizures in the past,
• had episodes of mania in the past,
• bipolar disorder,
• eye problems, such as certain types of glaucoma (increased pressure in the eye),
• bleeding disorders (a tendency to bruise or bleed easily), especially if you are taking a blood thinner or have a history of bleeding disorders,
• a risk of low sodium levels (e.g., if you are taking diuretics, especially if you are elderly),
• taken other medicines that may harm the liver,
• taken other medicines containing duloxetine (see "Taking other medicines").

Dutilox may cause dizziness or drowsiness. If you experience these symptoms, you should tell your doctor.
Medicines like Dutilox (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
Suicidal thoughts and worsening depression or anxiety
Depression and (or) anxiety can lead to thoughts of suicide or self-harm. These thoughts may worsen when you first start taking antidepressants, as it can take up to 2 weeks or longer for the medicine to start working.
These thoughts may worsen if you:

• have previously had thoughts of suicide or self-harm,
• are a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (less than 25 years old) with mental health conditions who were treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, you should immediately contact your doctor or go to the hospital.
It may be helpful to tell a relative or close friend that you are depressed or anxious and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents under 18 years

Dutilox should not normally be given to children and adolescents under 18 years. In children and adolescents under 18 years, the use of Dutilox has been associated with increased risk of adverse reactions, including attempted suicide, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). However, your doctor may prescribe Dutilox to a child or adolescent under 18 years if they decide that it is in their best interest. If your doctor has prescribed Dutilox to a child or adolescent under 18 years and you are concerned about any adverse reactions, you should discuss this with your doctor.

Dutilox 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 substance in Dutilox, is also available in other medicines used to treat other conditions:

• diabetic neuropathic pain, depression, anxiety, and stress urinary incontinence. You should not take more than one of these medicines at the same time. If you are already taking another medicine containing duloxetine, you should consult your doctor.

Your doctor will decide whether you can take Dutilox with other medicines. Do not start or stop taking any other medicines, including those obtained without a prescription, 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):Do not take Dutilox at the same time as another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI. Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medicines, including Dutilox, can cause serious or even life-threatening side effects. After stopping an MAOI, you must wait at least 14 days before starting Dutilox. You can start taking an MAOI only after you have stopped taking Dutilox for at least 5 days.
• Sedatives:These include prescription medicines such as benzodiazepines, strong painkillers, antipsychotic medicines, phenobarbital, and antihistamines.
• Medicines that increase serotonin levels:Triptans, tryptophan, selective serotonin reuptake inhibitors (e.g., paroxetine and fluoxetine), selective noradrenaline reuptake inhibitors (e.g., venlafaxine), tricyclic antidepressants (e.g., clomipramine and amitriptyline), St. John's Wort, MAOIs (e.g., moclobemide and linezolid), buprenorphine, tramadol, and pethidine. These medicines can interact with Dutilox and cause serotonin syndrome, which can be life-threatening.
• Oral anticoagulants or antiplatelet agents:These medicines can thin the blood or prevent blood clotting. They can increase the risk of bleeding.

Taking Dutilox with food, drink, and alcohol

Dutilox can be taken with or without food.
Be careful when drinking alcohol while taking Dutilox.

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 or plan to become pregnant while taking Dutilox. You can take Dutilox after discussing the benefits and risks of treatment with your doctor.

Tell your midwife and (or) doctor that you are taking Dutilox.
Using similar medicines during pregnancy, especially during the last few months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which can make the baby breathe faster and turn blue. This condition can happen in about 1-2 babies per 1,000 born to mothers who took similar medicines during the last few months of pregnancy. If you notice any of these symptoms in your baby, you should contact your midwife and (or) doctor immediately.
If you take Dutilox near the end of your pregnancy, your baby may experience some symptoms after birth, usually within the first 24 hours. These symptoms are usually mild and short-lived but can be serious in some cases. They include being floppy, jittery, having difficulty feeding, having trouble breathing, and having seizures. If you notice any of these symptoms in your baby, you should contact your doctor or midwife.

• Tell your doctor if you are breastfeeding. It is not recommended to take Dutilox while breastfeeding. If you are breastfeeding, you should ask your doctor or pharmacist for advice.

Driving and using machines

Dutilox may cause drowsiness or dizziness. You should not drive or operate machinery until you know how Dutilox affects you.

Dutilox contains sugar

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Dutilox contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially sodium-free.

3. How to take Dutilox

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dutilox is taken by mouth, with or without food. Swallow the capsule whole with water.

Missed dose

If you forget to take a dose, take it as soon as you remember. However, if it is nearly 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.

Stopping treatment

DO NOT stop taking Dutilox without talking to your doctor first. If your doctor decides that you can stop taking Dutilox, your doctor will gradually reduce your dose over at least 2 weeks.

Overdose

If you take more Dutilox than you should, contact your doctor or pharmacist immediately. Symptoms of overdose include drowsiness, sleepiness, serotonin syndrome (a rare but serious condition that can cause excessive happiness, sleepiness, confusion, agitation, hallucinations, coma, excessive sweating, shivering, or stiffness), seizures, vomiting, and rapid heartbeat.

4. Possible side effects

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

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

• headache, drowsiness,
• nausea, dry mouth.

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

• loss of appetite,
• sleep disturbances, restlessness, decreased libido, anxiety, difficulty achieving orgasm, abnormal dreams,
• dizziness, feeling sluggish, tremors, numbness, including numbness, tingling, or prickling sensations of the skin,
• blurred vision,
• ringing in the ears (hearing a sound in the ears when there is no external source of the sound),
• palpitations,
• increased blood pressure, flushing,
• yawning,
• constipation, diarrhea, abdominal pain, vomiting, heartburn or acid reflux, gas,
• increased sweating, rash (itching),
• muscle pain, muscle spasms,
• painful urination, frequent urination,
• erectile dysfunction, ejaculation disorder,
• falls (especially in elderly patients), fatigue,
• weight loss.

In children and adolescents under 18 years with depression, treated with this medicine, weight decreased after starting treatment. After 6 months of treatment, weight increased and was similar to that of other children and adolescents of the same age and sex.

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

• sore throat, which can cause hoarseness,
• suicidal thoughts, difficulty sleeping, teeth grinding or clenching, disorientation, lack of motivation,
• sudden involuntary movements or muscle twitching, feeling restless or unable to sit still, agitation, difficulty concentrating, changes in taste, difficulty controlling movements, such as lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor quality sleep,
• dilated pupils, vision problems,
• dizziness, dizziness due to problems with the inner ear, ear pain,
• rapid or irregular heartbeat,
• fainting, dizziness, feeling lightheaded or fainting when standing up, feeling cold in the fingers and (or) toes,
• throat tightness, nosebleeds,
• vomiting blood or black, tarry stools, stomach inflammation, acid reflux, difficulty swallowing,
• liver inflammation, which can cause stomach pain and yellowing of the skin or whites of the eyes,
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise,
• stiffness and muscle twitching,
• difficulty or inability to urinate, frequent urination at night, need to urinate more often than usual, weak urine stream,
• abnormal vaginal bleeding, changes in menstrual cycle, including heavy, painful, irregular, or prolonged menstrual periods, or absence of menstrual periods,
• chest pain, feeling hot or cold,
• weight gain,
• Dutilox can cause side effects that you may not be aware of, such as increased liver enzymes or potassium levels in the blood, increased creatine phosphokinase, blood glucose, or cholesterol levels.

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

• severe allergic reaction, which can cause difficulty breathing, dizziness with swelling of the tongue or throat, allergic reactions,
• decreased thyroid function, which can cause tiredness or weight gain,
• dehydration, low sodium levels in the blood (especially in elderly patients; symptoms may include dizziness, weakness, confusion, sleepiness, excessive tiredness, or nausea, or vomiting, more severe symptoms include fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• suicidal behavior, mania (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and anger,
• serotonin syndrome (a rare but serious condition that can cause excessive happiness, sleepiness, confusion, agitation, hallucinations, coma, excessive sweating, shivering, or stiffness), seizures,
• increased pressure in the eye (glaucoma),
• cough, wheezing, shortness of breath, which can occur with fever,
• mouth inflammation, red blood in the stool, bad breath, stomach inflammation (which can cause diarrhea),
• liver failure, yellowing of the skin or whites of the eyes (jaundice),
• Stevens-Johnson syndrome (a serious condition with skin ulcers, mouth ulcers, eye ulcers, and genital ulcers), severe allergic reaction, which can cause swelling of the face or throat (angioedema),
• jaw muscle spasms,
• abnormal urine odor,
• menopausal symptoms, abnormal milk production in men or women,
• excessive bleeding from the womb after childbirth (postpartum hemorrhage).

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

• inflammation of the blood vessels in the skin.

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

• symptoms of a condition called stress cardiomyopathy, which can include chest pain, shortness of breath, dizziness, fainting, and irregular heartbeat.

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Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutilox

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 blister/bottle and carton after EXP. The expiry date refers to the last day of that month.
30 mg:
OPA/Aluminium/PVC/Aluminium blisters:
No special storage precautions are required.
Store in the original package to protect from light and moisture.
PVC/PVDC/Aluminium blisters:
Store below 30°C.
Store in the original package to protect from light and moisture.
Bottle:
No special storage precautions are required.
Store in the original package to protect from light and moisture.
60 mg:
OPA/Aluminium/PVC/Aluminium blisters:
No special storage precautions are required.
Store in the original package to protect from moisture.
PVC/PVDC/Aluminium blisters:
Store below 30°C.
Store in the original package to protect from moisture.
Bottle:
No special storage precautions are required.
Store in the original package to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dutilox contains

• The active substance is duloxetine. 30 mg: each gastro-resistant hard capsule contains 30 mg duloxetine (as hydrochloride). 60 mg: each gastro-resistant hard capsule contains 60 mg duloxetine (as hydrochloride).

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• The other ingredients are: capsule content: hypromellose, talc, titanium dioxide (E 171), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, sucrose spheres, and sucrose.
  capsule shell:gelatin, titanium dioxide (E 171), indigo carmine (E 132), purified water, printing ink (iron oxide black (E 172), potassium hydroxide, and shellac), iron oxide yellow (E 172) (only in 60 mg capsules).

  What Dutilox looks like and contents of the pack

  Dutilox is a gastro-resistant hard capsule. Each Dutilox capsule contains duloxetine hydrochloride pellets coated with a protective layer to prevent degradation in the stomach.
  The 30 mg capsules with imprint (cap E/body 127) are blue and white.
  The 60 mg capsules with imprint (cap E/body 129) are blue and green.
  Dutilox is available in:

  30 mg:
  OPA/Aluminium/PVC/Aluminium blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98 (2x49), and 504 (8x63) (hospital pack) gastro-resistant hard capsules.
  PVC/PVDC/Aluminium blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98, and 504 (4x126) (hospital pack) gastro-resistant hard capsules.
  PE bottle with PP cap with a tamper-evident seal, containing a desiccant sachet:
  500 gastro-resistant hard capsules (hospital pack).
  60 mg:
  OPA/Aluminium/PVC/Aluminium blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60 (2x30), 84 (2x42), 98 (2x49), and 504 (8x63) (hospital pack) gastro-resistant hard capsules.
  PVC/PVDC/Aluminium blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98, and 504 (4x126) (hospital pack) gastro-resistant hard capsules.
  PE bottle with PP cap with a tamper-evident seal, containing a desiccant sachet:
  500 gastro-resistant hard capsules (hospital pack).
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Symphar Sp. z o.o.
  ul. Koszykowa 65
  00-667 Warsaw

  Manufacturer

  TOWA Pharmaceutical Europe S.L.
  C/ de Sant Martí, 75-97,
  Martorelles, 08107 Barcelona
  Spain
  TERAPIA SA
  Str. Fabricii, nr.124,
  Cluj-Napoca, Judet Cluj,
  400632, Romania

  This medicinal product is authorized in the Member States of the European Economic Area under the following names:

  Germany:
  Dutilox 30 mg magensaftresistente Hartkapseln
  Dutilox 60 mg magensaftresistente Hartkapseln
  Austria:
  Dutilox 30 mg magensaftresistente Hartkapseln
  Dutilox 60 mg magensaftresistente Hartkapseln
  Netherlands:
  Dutilox 30 mg maagsapresistente capsules, harde
  Dutilox 60 mg maagsapresistente capsules, harde
  Poland:
  Dutilox
  Romania:
  Duloxetină Terapia 30 mg capsule gastrorezistente
  Duloxetină Terapia 60 mg capsule gastrorezistente
  Belgium:
  {FR}: Dutilox 30 mg, gélules gastro-résistantes
  {NL}: Dutilox 30 mg maagsapresistente capsules, hard
  {DE}: Dutilox 30 mg magensaftresistente Hartkapseln
  Belgium:
  {FR}: Dutilox 60 mg, gélules gastro-résistantes
  {NL}: Dutilox 60 mg maagsapresistente capsules, hard
  {DE}: Dutilox 60 mg magensaftresistente Hartkapseln
  Date of last revision of the leaflet:July 2024
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