Dulxetenon

Patient Information Leaflet: Information for the User

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

Duloxetine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Dulxetenon is 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)

In most people with depression or anxiety, Dulxetenon starts to be effective within two
weeks of starting treatment, but it may take 2–4 weeks before you start to feel better.
If you do not begin to feel better after this time, speak to your doctor. Your doctor may
continue to prescribe Dulxetenon once you are feeling 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 liver disease
• have 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 commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• are taking other medicines containing duloxetine (see 'Other medicines and Dulxetenon')

Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise you whether you can take
Dulxetenon.
Warnings and precautions
Reasons why Dulxetenon may not be suitable for you include the following.
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 preparation
• have kidney disease
• have had seizures (epileptic fits)
• have had a manic episode
• suffer from bipolar disorder
• have eye problems, such as certain types of glaucoma (increased pressure inside the eye)
• have a history of bleeding disorders (tendency to bruise easily), especially if you are pregnant (see 'Pregnancy and breastfeeding')
• are at risk of low sodium levels (e.g. if you are taking diuretics, particularly if you are elderly)
• are being treated with another medicine that may cause liver damage
• are taking other medicines containing duloxetine (see 'Other medicines and Dulxetenon')
• medicines such as "Dulxetenon" (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Dulxetenon may cause a feeling of restlessness or inability to sit still. If this happens to you, tell your doctor.
Suicidal thoughts and worsening of depression and anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These
thoughts may increase when you first start treatment with antidepressants, as these medicines require some time to become effective, usually about 2 weeks but sometimes longer.
This may be more likely if you:

• have previously had thoughts of suicide or self-harm
• are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders 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 inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Children and adolescents
Dulxetenon is generally not recommended for use in children and adolescents under 18 years of age. In addition, you
should know that patients under 18 years of age taking this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggressive behaviour, oppositional behaviour and anger). Nevertheless, your doctor may prescribe Dulxetenon to patients under 18 years if he/she considers it the best option for them. If your doctor has prescribed Dulxetenon to a patient under 18 years and you would like clarification, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years are taking Dulxetenon. In addition, long-term effects on safety regarding growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Dulxetenon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
The main active ingredient in Dulxetenon, duloxetine, is found in other medicines for different conditions:

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

Concomitant use of more than one of these medicines should be avoided. Check with your doctor if you are already taking medicines containing duloxetine.
Your doctor must decide whether you can take Dulxetenon with other medicines. Do not start or stop taking
any medicine, including over-the-counter medicines and herbal preparations, before consulting your doctor.
Also inform your doctor if you are taking any of the following medicines:
Monoamine Oxidase Inhibitors (MAOIs): You must not take Dulxetenon if you are currently taking, or have recently taken (within the last 14 days) another antidepressant medicine 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, may cause serious or potentially fatal adverse effects. You must wait at least 14 days after stopping an MAOI before starting Dulxetenon. Also, before taking an MAOI, you must wait at least 5 days after stopping Dulxetenon.
Medicines that cause drowsiness: These include prescribed medicines 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), meperidine, St. John’s Wort and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with Dulxetenon, you must consult your doctor.
Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent blood clots. These medicines may increase the risk of bleeding.
Dulxetenon with food, drink and alcohol
Dulxetenon can be taken regardless of meals. Exercise caution if consuming alcoholic beverages while being treated with Dulxetenon.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

• Inform your doctor if you become pregnant or are trying to become pregnant while taking duloxetine. You should use duloxetine only after discussing with your doctor the potential benefits and any potential risks for the unborn child.
• Ensure that your midwife and/or doctor knows you are taking 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 causes rapid breathing and a bluish colour in the newborn. These symptoms usually occur 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 pregnancy, the newborn may experience certain symptoms. These usually appear at birth or within a few days after birth. These symptoms may include floppy muscles, tremors, irritability, feeding difficulties, breathing problems and seizures. If the newborn shows any of these symptoms at birth, or if you are

concerned about your 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 they can provide appropriate advice.
• Inform your doctor if you are breastfeeding. The use of duloxetine during breastfeeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines
Duloxetine may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how duloxetine affects you.
Dulxetenon contains sucrose
Dulxetenon contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Dulxetenon

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

For depression:
The usual dose of duloxetine is 60 mg once daily, but your doctor will prescribe the dose that is right for you.

For generalized anxiety disorder:
The usual starting dose of duloxetine is 30 mg once daily. Most patients will then be given 60 mg once daily, but your doctor will prescribe the dose that is right for you. The dose may be adjusted up to 120 mg per day, depending on your response to duloxetine.
If you are prescribed a dose of 30 mg or 60 mg, other duloxetine-containing medicines with these strengths should be used.

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 should continue taking duloxetine. Do not stop taking duloxetine or change the dose without first discussing it with your doctor. Appropriate treatment of the condition is important to help you feel better. If left untreated, the condition may not improve and could become worse and more difficult to treat.

If you take more Dulxetenon than you should
Contact your doctor or pharmacist immediately if you have taken more Dulxetenon than prescribed. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that may cause feelings of extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

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

If you stop taking Dulxetenon
Even if you feel better, DO NOT stop taking the capsules without first talking to your doctor. If your doctor decides you no longer need duloxetine, they will ask you to gradually reduce the dose over a period of at least 2 weeks before stopping treatment completely.

Some patients who stop taking duloxetine suddenly may experience symptoms such as:

• dizziness, tingling sensations like pins and needles or electric shock sensations (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, feelings of restlessness or agitation, anxiety, nausea or feeling unwell (vomiting), tremor, headache, muscle pain, irritability, diarrhoea, excessive sweating, or dizziness.

These symptoms are usually not severe and disappear within a few days. However, if you experience bothersome symptoms, 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 everybody gets them. These side effects are usually mild to moderate and often disappear after a few weeks.

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

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

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

• loss of appetite
• difficulty falling asleep, feeling restless, reduced sex drive, anxiety, difficulty or inability to reach orgasm, unusual dreams
• dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or pins and needles in the skin
• blurred vision
• tinnitus (perception of ringing or other sound in the ear in the absence of external auditory stimulus)
• awareness of heartbeat (palpitations)
• increased blood pressure, hot flush
• increased yawning
• constipation, diarrhoea, stomach ache, retching (vomiting), heartburn or indigestion, build-up of gas in the intestines
• increased sweating, skin rash (itchy)
• muscle pain, muscle spasm
• painful urination, frequent urination
• difficulty achieving 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 first starting treatment. After 6 months of treatment, weight increased to levels comparable to 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 hoarseness

• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, feeling disoriented, lack of motivation

• sudden and involuntary muscle spasms or contractions, feeling restless or unable to sit still or remain motionless, feeling nervous, difficulty concentrating, changes in taste sensation, difficulty controlling movements, such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor quality of sleep

• dilation of the pupils (the dark centre of the eye), visual disturbances

• feeling dizzy or lightheaded (vertigo), ear pain

• rapid or irregular heartbeat

• fainting, dizziness, feeling of emptiness in the head or impending faint when standing up, cold sensation in fingers of hands and/or feet

• sensation of tightness in the throat, nosebleeds

• vomiting blood or passing black, tar-like stools, gastroenteritis, belching, difficulty swallowing

• liver inflammation which may cause abdominal pain and yellowing of the skin or whites of the eyes

• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise

• muscle stiffness, muscle contraction

• difficulty or inability to urinate, difficulty starting urination, need to urinate during the night, need to urinate more than usual, reduced urinary flow

• abnormal vaginal bleeding, abnormal menstrual cycles, including heavy, painful, irregular or prolonged periods, unusually light or absent periods, testicular or scrotal pain

• chest pain, feeling cold, thirst, trembling, feeling hot, abnormal gait

• weight gain

• Duloxetine may cause effects you may not be aware of, such as increases in liver enzymes, blood potassium levels, creatine phosphokinase, blood sugar or cholesterol levels

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
• reduced activity of the thyroid gland which may cause tiredness or weight gain
• dehydration, low levels of sodium in the blood (especially in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness or extreme fatigue, nausea or feeling like vomiting; more severe symptoms include loss of consciousness, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behaviour, mania (overactivity, racing thoughts and reduced need for sleep), hallucinations, aggressive behaviour and anger
• "Serotonin syndrome" (a rare reaction which may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, drunkenness-like sensations, fever, sweating or muscle rigidity), seizures
• increased pressure inside the eye (glaucoma)
• inflammation of the mouth, presence of bright red blood in stools, bad breath, inflammation of the large intestine (colon) (causing diarrhoea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition with blistering of 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 odour of urine
• menopausal symptoms, abnormal production of breast milk in men and women
• Cough, wheezing and shortness of breath which may be accompanied by high temperature
• excessive vaginal bleeding immediately after childbirth (postpartum haemorrhage)

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

• Inflammation of blood vessels in the skin (cutaneous vasculitis)

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Blister (PA/Al/PVC): this medicine does not require any special storage conditions.
Blister (PVC/PE/PVDC//Al): do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dulxetenon contains
The active substance 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 other components are:
Capsule contents: hypromellose, sugar spheres (sucrose and maize starch), talc, sucrose, hypromellose phthalate, triethyl citrate.
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172 only for Dulxetenon 90 mg), indigo carmine (E132).

Description of the appearance of Dulxetenon and package contents
Dulxetenon is a gastro-resistant hard capsule.
Dulxetenon is available in two strengths: 90 mg and 120 mg.
90 mg capsules: hard gelatin capsule size 0E with an opaque white body and an opaque green cap.
120 mg capsules: hard gelatin capsule size 00 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 European Economic Area countries under the following names:
Germany: Dulxetenon 90, 120 mg magensaftresistente Hartkapseln
Italy: Dulxetenon
Poland: Dulxetenon
Portugal: Dulxetenon 90, 120 mg cápsula duras gastro-resistente