DULXETENON 90 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Dulxetenon 90 mg hard gastro-resistant capsules, 120 mg hard gastro-resistant capsules
   1. What is Dulxetenon and what it is used for
   2. What you need to know before taking Dulxetenon:
   3. How to take Dulxetenon
   4. Possible side effects
   5. How to store Dulxetenon
   6. Package Contents and Other Information

Dulxetenon 90 mg hard gastro-resistant capsules, 120 mg hard gastro-resistant capsules

Duloxetine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dulxetenon is and what it is used for
• 2. What you need to know before you take Dulxetenon
• 3. How to take Dulxetenon
• 4. Possible side effects
• 5. How to store Dulxetenon
• 6. Contents of the pack and other information

1. What is Dulxetenon and what it is used for

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

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)

Dulxetenon, in most people with depression or anxiety, begins to be effective within two
weeks of starting treatment, but it may take 2-4 weeks before you feel better. Contact your doctor if you do not begin to feel better after this time. Your doctor may continue to prescribe
Dulxetenon when you feel better to prevent depression or anxiety from returning.

2. What you need to know before taking Dulxetenon:

DO NOT take Dulxetenon if you:

• are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
• have a liver disease
• have a severe kidney disease
• are taking or have taken within the last 14 days, another medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see ‘Other medicines and Dulxetenon’)
• are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
• are taking other medicines that contain duloxetine (see ‘Other medicines and Dulxetenon’)

Tell your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if you can take
Dulxetenon.

Warnings and precautions
The reasons why Dulxetenon may not be suitable for you are as follows.
Talk to your doctor before taking Dulxetenon if you:

• are taking other medicines to treat depression (see ‘Other medicines and Dulxetenon’)
• are taking St. John's Wort (Hypericum perforatum), a herbal remedy
• have a kidney disease
• have had seizures (convulsions)
• have had a manic episode
• suffer from bipolar disorder
• have problems with your eyes, such as certain types of glaucoma (increased pressure inside the eye)
• have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breastfeeding’)
• are at risk of having low sodium levels in your blood (for example if you are taking diuretics, especially if you are an elderly person)
• are being treated with another medicine that can cause liver damage
• are taking other medicines that contain duloxetine (see ‘Other medicines and Dulxetenon’)
• medicines like "Dulxetenon" (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Dulxetenon may cause a feeling of restlessness or an inability to sit still or remain calm. If this happens
to you, you should tell your doctor.

Suicidal thoughts and worsening of depression and anxiety
If you are depressed and/or anxious, sometimes you may have thoughts of harming yourself or of suicide. These
thoughts may be increased when you first start taking antidepressants, as these medicines take time to work, usually around 2 weeks but sometimes longer.
You may be more likely to have these thoughts if you:

• have had thoughts of harming yourself or of suicide in the past
• are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric disorders who were treated with an antidepressant

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go
immediately to hospital.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and
ask them to read this leaflet. You could ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents
Normally Dulxetenon should not be used in children and adolescents under 18 years of age. Also, you
should know that patients under 18 years of age, when taking this type of medicine, have an increased
risk of undesirable effects such as suicide attempt, suicidal thoughts and hostility (especially
aggressive behaviour, oppositional behaviour and anger). Despite this, the doctor may prescribe Dulxetenon to patients
under 18 years of age if he/she believes that this is the best solution for them. If the doctor has prescribed
Dulxetenon to a patient under 18 years of age and you would like clarification, return to the doctor. You must inform the
doctor if any of the symptoms above appear or worsen when patients under 18 years of age are
taking Dulxetenon. Furthermore, long-term effects on safety, regarding growth, maturity and cognitive and
behavioural development, have not yet been demonstrated in this age group..

Other medicines and Dulxetenon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
The main component of Dulxetenon, duloxetine, is found in other medicines for other conditions:

• diabetic neuropathic pain, depression, anxiety and urinary incontinence.

The simultaneous use of more than one of these medicines should be avoided. Check with your doctor if you are already
taking medicines that contain duloxetine.
The doctor must decide if you can take Dulxetenon with other medicines. Do not start or stop taking
any medicine, including those bought without a prescription and herbal remedies, before consulting
your doctor.
Also tell your doctor if you are taking any of the following medicines:

Monoamine Oxidase Inhibitors (MAOIs): You must not take Dulxetenon if you are taking, or have recently taken (within the last 14 days) another antidepressant called a monoamine
oxidase inhibitor (MAOI). Examples of MAOI medicines include moclobemide (an antidepressant) and
linezolid (an antibiotic). Taking an MAOI together with many prescription medicines, including Dulxetenon, can cause serious or potentially life-threatening adverse effects. You must wait at least 14
days after stopping taking an MAOI before you can take Dulxetenon. Also, before
taking an MAOI, you must wait at least 5 days after stopping taking Dulxetenon.

Medicines that cause drowsiness: These include medicines prescribed by your doctor, such as benzodiazepines,
strong painkillers, antipsychotics, phenobarbital and antihistamines.

Medicines that increase serotonin levels: Triptans, tramadol, tryptophan, Selective Serotonin
Reuptake Inhibitors (SSRIs) (such as paroxetine and fluoxetine), Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants (such as clomipramine,
amitriptyline), pethidine, St. John's Wort and MAOIs (such as moclobemide and linezolid). These medicines
increase the risk of undesirable effects; if you experience any unusual symptoms while taking one of
these medicines together with Dulxetenon, you should consult your doctor.

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

Dulxetenon with food, drinks and alcohol
Dulxetenon can be taken independently of meals. Caution should be exercised if you drink
alcoholic beverages while being treated with Dulxetenon.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant, or trying to become pregnant, while taking duloxetine. You should only use duloxetine after discussing the potential benefits and any potential risk to the unborn child with your doctor.
• Make sure your midwife and/or doctor knows that you are being treated with duloxetine. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which involves rapid breathing and bluish skin colour in the newborn. These symptoms usually appear within the first 24 hours after birth. If this happens to your baby, contact your midwife or doctor immediately.

If you take duloxetine near the end of your pregnancy, the newborn may experience some symptoms. Generally these appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremor, nervousness, difficulty feeding, a breathing disorder and convulsions. If your newborn presents any of these symptoms at birth, or you are

worried about the baby's health, contact your doctor or midwife who will be able to advise you.

• If you take duloxetine near the end of your pregnancy there is an increased risk of excessive vaginal bleeding immediately after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking duloxetine so that they can advise you.
• Tell your doctor if you are breastfeeding. The use of duloxetine during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

Driving and using machines
Duloxetine may cause drowsiness or dizziness. Do not drive or use tools or machines
until you know how duloxetine affects you.

Dulxetenon contains sucrose
Dulxetenon contains sucrose. If you have been diagnosed with intolerance to certain sugars, contact
your doctor before taking this medicine.

3. How to take Dulxetenon

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Duloxetine is for oral use. Swallow the capsule whole, with the help of a glass of water.

For depression:
The usual dose of duloxetine is 60 mg once a day, but your doctor will prescribe the dose that he/she considers right
for you.

For generalized anxiety disorder:
The usual starting dose of duloxetine is 30 mg once a day, after which most patients
will receive 60 mg once a day, but your doctor will prescribe the dose that he/she considers right for you. The dose may be
adjusted up to 120 mg per day, based on your response to duloxetine.
If you are prescribed a dose of 30 mg or 60 mg, other medicines containing duloxetine must be used
with these dosages.
To help you remember to take duloxetine, you may find it easier to take it at the same time each day.
Talk to your doctor about how long you need to continue taking duloxetine. Do not stop
taking duloxetine, or change the dose, without talking to your doctor. Appropriate treatment
of the disorder is important to help you feel better. If left untreated, the disorder may not improve and may
become more serious and difficult to treat.

If you take more Dulxetenon than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Dulxetenon greater
than what your doctor has prescribed. Symptoms of overdose include drowsiness, coma, serotonin
syndrome (a rare reaction that can cause feelings of great happiness, drowsiness, clumsiness,
restlessness, feeling drunk, fever, sweating or muscle rigidity), seizures, vomiting and
increased heart rate.

If you forget to take Dulxetenon
If you forget a dose, take it as soon as you remember. However, if this is the time to take the next
dose, skip the missed dose and take only a single dose as usual. Do not take a double
dose to make up for the missed dose. Do not take more of duloxetine than has been
prescribed to you for one day.

If you stop taking Dulxetenon
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor. If
your doctor believes you no longer need duloxetine, he/she will ask you to gradually reduce the dose over a
period of at least 2 weeks before stopping treatment completely.
Some patients who suddenly stop taking duloxetine have experienced symptoms such as:

• dizziness, sensations of tingling like pinpricks and needles or electric shock-like sensations (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or unwellness (vomiting), tremor, headache, muscle pain, feeling irritable, diarrhea, excessive sweating or dizziness.

Usually these symptoms are not serious and disappear within a few days, but if you experience symptoms that are
troublesome you should consult your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
These effects are normally mild to moderate and often disappear after a few weeks.

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

• headache, feeling sleepy
• feeling unwell (nausea), dry mouth

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

• loss of appetite
• difficulty sleeping, feeling agitated, decreased sexual desire, anxiety, difficulty or

impossibility to achieve orgasm, unusual dreams

• dizziness, feeling lazy, tremor, numbness including a sensation of tingling or pins and needles in the skin
• blurred vision
• tinnitus (perception of a sound in the ear when there is no external sound stimulus)
• feeling your heart beating in your chest
• increased blood pressure, hot flush
• increased yawning
• constipation, diarrhea, stomach pain, retching (vomiting), heartburn or indigestion, accumulation of gas in the intestines
• increased sweating, itchy rash
• muscle pain, muscle spasm
• painful urination, frequent urination
• difficulty getting an erection, changes in ejaculation
• falls (especially in elderly people), fatigue
• weight loss

Children and adolescents under 18 years of age with depression, treated with this medicine have experienced some
weight loss when they first started taking this medicine. After 6 months of
treatment the weight increased to be equal to that of other children and adolescents of the same age and sex.

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

• inflammation of the throat causing a hoarse voice
• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, feeling disoriented, lack of motivation
• sudden and involuntary spasms or contractions of the muscles, feeling restless or inability to sit still or remain quiet, feeling nervous, difficulty concentrating, changes in the sense of taste, difficulty controlling movements, such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• dilated pupils (the dark center of the eye), vision disorders
• feeling dizzy or “lightheaded” (vertigo), ear pain
• fast or irregular heartbeat
• fainting, dizziness, feeling lightheaded or about to faint when standing up, feeling cold in the hands and/or feet
• feeling of tightness in the throat, nosebleeds
• vomiting blood or presence of black, tarry stools, gastroenteritis, belching, difficulty swallowing
• liver inflammation that can cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to develop bruises
• muscle stiffness, muscle contraction
• difficulty or inability to urinate, difficulty starting urination, needing to urinate during the night, needing to urinate more than usual, reduced urine flow
• abnormal vaginal bleeding, abnormal menstrual cycles, including heavy, painful, irregular or prolonged periods, unusually light or absent periods, pain in the testicles or scrotum
• chest pain, feeling cold, thirst, tremor, feeling hot, abnormal gait
• weight gain
• Duloxetine can cause effects of which you may not be aware, such as increases in liver enzymes, or levels in the blood of potassium, creatine phosphokinase, sugars or cholesterol

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

• severe allergic reaction causing difficulty breathing or dizziness with swelling of the tongue and lips, allergic reactions
• decreased activity of the thyroid gland which can cause fatigue or weight gain
• dehydration, low levels of sodium in the blood (especially in elderly people; symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling sick or being sick, more serious symptoms are loss of consciousness, convulsions or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, mania (hyperactivity, racing thoughts and decreased need for sleep), hallucinations, aggressive behavior and anger
• “Serotonin Syndrome” (a rare reaction that can cause feelings of great happiness, sleepiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• inflammation of the mouth, presence of bright red blood in the stool, bad breath, inflammation of the large intestine (colon) (causing diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious illness with the appearance of blisters on the skin, mouth, eyes and genitals), severe allergic reaction causing swelling of the face or throat angioedema
• contraction of the muscles of the mouth
• altered smell of urine
• menopause symptoms, abnormal production of breast milk in men and women
• Cough, wheezing and shortness of breath which may be accompanied by a high temperature
• excessive bleeding from the vagina immediately 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 (cutaneous vasculitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Dulxetenon

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 package and on the blister after “Exp.”. The
expiry date refers to the last day of that month. Blister (PA/Al/PVC): this medicine does not require
particular storage conditions
Blister (PVC/PE/PVDC//Al): do not store at a temperature above 30° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Dulxetenon contains
The activeingredient is duloxetine.
Dulxetenon 90 mg gastro-resistant hard capsules
Each capsule contains 90 mg of duloxetine (as hydrochloride).
Dulxetenon 120 mg gastro-resistant hard capsules
Each capsule contains 120 mg of duloxetine (as hydrochloride).
The otheringredients are:

Capsule content: hypromellose, sugar spheres (sucrose and corn starch), talc, sucrose, phthalate
hypromellose, triethyl citrate.

Capsule body: gelatin, titanium dioxide (E171), yellow iron oxide (E172 only for Dulxetenon 90
mg), indigotin (E 132).

Description of Dulxetenon and package contents
Dulxetenon is a gastro-resistant hard capsule.
Dulxetenon is available in 2 dosages: 90 mg and 120 mg.
90 mg capsules: size 0E hard gelatin capsule with an opaque white body and an opaque green cap.
120 mg capsules: size 00 hard gelatin capsule with an opaque blue body and an opaque blue cap,.
Dulxetenon 90 mg is available in packs of 28 and 98 capsules.
Dulxetenon 120 mg is available in packs of 28 and 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno,
Italy

Manufacturer
Laboratorios Lesvi, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:>
Germany: Dulxetenon 90, 120, mg magensaftresistente Hartkapseln
Italy: Dulxetenon
Poland: Dulxetenon
Portugal: Dulxetenon 90, 120 mg cápsulas duras gastro-resistente