Dulxetenon

Package leaflet: Information for the user

Dulxetenon, 90 mg, hard enteric capsules
Dulxetenon, 120 mg, hard enteric capsules
Duloxetinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the 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 indicated in adults for the treatment of:

• depression
• generalized anxiety disorder (persistent feelings of anxiety or nervousness)

In most people with depression or anxiety, Dulxetenon starts to work within two weeks of starting treatment,
but it may take 2 to 4 weeks before improvement is noticed. Please consult your doctor if you do not feel better
after this time. Even if your condition improves, your doctor may recommend continuing to take Dulxetenon
to prevent recurrence of depression or anxiety.

2. Important information before using Dulxetenon

Do not use Dulxetenon if:

• the patient is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
• the patient has liver disease;
• the patient has severe kidney disease;
• the patient is taking or has taken within the last 14 days another medicine which is a monoamine oxidase inhibitor (MAOI) (see “Dulxetenon with other medicines”);
• the patient is taking fluvoxamine, which is mainly used to treat depression, or ciprofloxacin or enoxacin, medicines used to treat certain infections;
• the patient is taking other medicines containing duloxetine (see “Dulxetenon with other medicines”).

Tell the doctor if the patient has high blood pressure or heart disease.
The doctor will decide whether the patient should take Dulxetenon.
Warnings and precautions
Below are several reasons why Dulxetenon may not be suitable for the patient.
Before starting Dulxetenon, discuss with the doctor if:

• the patient is taking other antidepressant medicines (see “Dulxetenon with other medicines”).
• the patient is taking herbal medicines containing St. John’s wort (Hypericum perforatum)
• the patient has kidney disease
• the patient has previously had seizures
• the patient has previously had episodes of mania
• the patient has bipolar affective disorder
• the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eye)
• the patient has previously had bleeding disorders (tendency to bruise), especially if the patient is pregnant (see “Pregnancy and breastfeeding”)
• the patient is at risk of low sodium levels (for example, when taking diuretics, especially in elderly people)
• the patient is currently taking other medicines that may cause liver damage
• the patient is taking other medicines containing duloxetine (see “Dulxetenon with other medicines”). Medicines such as Dulxetenon (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Dulxetenon may cause feelings of restlessness or an inability to sit still or remain in place. If such symptoms occur, inform the doctor.
Also contact the doctor:
If the patient experiences objective and subjective symptoms such as agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhea, drowsiness, nausea, vomiting, as this may indicate serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome.
Objective and subjective symptoms of neuroleptic malignant syndrome may include:
fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected by blood tests).

Suicidal thoughts and worsening depression or anxiety

Patients with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressants, as these medicines take time to work, usually about 2 weeks, but sometimes longer. The risk of suicidal thoughts, thoughts of self-harm or suicide is higher if:

• the patient has previously had suicidal thoughts or self-harm tendencies
• the patient is a young adult – clinical studies have shown an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders taking antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact the doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. You may also ask them for their opinion on whether the patient’s depression or anxiety has worsened or whether behavioural changes cause concern. The patient may ask them to inform him/her if they notice worsening depression or anxiety or concerning changes in behaviour.

Children and adolescents under 18 years of age
Dulxetenon is generally not recommended for use in children and adolescents under 18 years of age. In patients under 18 years of age taking medicines from this group, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and anger). Nevertheless, the doctor may prescribe Dulxetenon for patients under 18 years of age if he/she decides it is beneficial for them. If there are any doubts regarding the recommendation to use Dulxetenon in a patient under 18 years of age, contact the doctor again. Inform the doctor if any of the adverse reactions listed above occur in a patient under 18 years of age taking Dulxetenon.
Furthermore, there is a lack of long-term safety data on the use of Dulxetenon in this age group regarding growth, maturation, and cognitive and behavioural development.

Dulxetenon with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Duloxetine, the main ingredient in Dulxetenon, is also present in other medicines used to treat other conditions:

• pain in diabetic neuropathy,
• depression,
• anxiety,
• urinary incontinence.

Avoid taking more than one of these medicines simultaneously. The patient should consult the doctor if taking other medicines containing duloxetine.
The doctor will decide whether it is safe to take Dulxetenon together with other medicines. Do not
start or stop taking other medicines, including those available without a prescription and herbal
supplements, without consulting the doctor.
Inform the doctor if taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs):
Do not take Dulxetenon together with another antidepressant medicine called a monoamine oxidase inhibitor (MAOI), or within a short time (within 14 days) after stopping an MAOI.
Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs together with many prescription medicines, including Dulxetenon, may cause severe or even life-threatening adverse reactions.
At least 14 days must pass after stopping an MAOI before starting Dulxetenon. At least 5 days must pass after stopping Dulxetenon before starting an MAOI.
Medicines causing drowsiness:
These may include prescription medicines such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Medicines increasing serotonin levels:
Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (e.g. paroxetine and fluoxetine), selective norepinephrine reuptake inhibitors (e.g. venlafaxine), tricyclic antidepressants (e.g. clomipramine, amitriptyline), pethidine, St. John’s wort (Hypericum perforatum), and MAOIs (e.g. moclobemide and linezolid). These medicines increase the risk of adverse effects.
If any symptoms occur while taking these medicines together with Dulxetenon, contact the doctor.
Oral anticoagulants or antiplatelet medicines:
Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.

Dulxetenon with food, drink and alcohol
Dulxetenon can be taken during or between meals. Exercise caution when consuming alcohol while taking Dulxetenon.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

• If the patient becomes pregnant while taking duloxetine or is trying to become pregnant, she should inform her doctor. The patient may take duloxetine only after discussing with her doctor the expected benefits of treatment and possible risks to the unborn child.
• The patient should inform her midwife and (or) doctor that she is taking duloxetine. Use during pregnancy of similar medicines (selective serotonin reuptake inhibitors) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn, causing the baby to breathe faster and appear blue. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in her baby, she should contact her midwife and (or) doctor immediately.
• If the patient takes duloxetine towards the end of pregnancy, her baby may experience the following symptoms: muscle weakness, tremors, jitteriness, feeding difficulties, breathing problems, and seizures. These usually occur at birth or within a few days after birth. If the patient notices any of these symptoms or is concerned about her baby’s health, she should contact her doctor or midwife for help.
• If the patient takes duloxetine towards the end of pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if she has previously had bleeding disorders. Inform the doctor or midwife about taking duloxetine so they can recommend appropriate management.
• The patient should inform her doctor if she is breastfeeding. Duloxetine is not recommended during breastfeeding. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and operating machinery
Duloxetine may cause drowsiness or dizziness. The patient should not drive or operate machinery until he/she knows how he/she reacts to duloxetine.

Dulxetenon contains sucrose
Dulxetenon contains sucrose. If the doctor has previously diagnosed the patient with an intolerance to certain sugars, contact the doctor before starting treatment.

3. How to use Dulxetenon

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts, you should
consult your doctor or pharmacist.
Duloxetine is taken orally. The capsule should be swallowed whole with water.
Treatment of depression:
The usual dose of duloxetine is 60 mg taken once daily. However, your doctor will determine the dose
appropriate for you.
Treatment of generalized anxiety disorders:
The usual initial dose of duloxetine is 30 mg once daily. In most patients, the dose is subsequently
increased to 60 mg once daily. However, your doctor will determine the appropriate dose for you.
The dose may be increased up to 120 mg, depending on the patient's response to treatment.
If a dose of 30 mg or 60 mg is prescribed, other medicines containing duloxetine should be used at these
doses.
Taking duloxetine at the same time each day will help you remember to take it.
Your doctor will inform you how long you should continue taking Dulxetenon. Do not stop
taking Dulxetenon or change the dose without consulting your doctor. Proper treatment of the condition is
important so that you feel better. If left untreated, your condition may persist, worsen, and become more difficult to treat.
Taking more Dulxetenon than prescribed
If you take more Dulxetenon than prescribed, contact your doctor or pharmacist immediately. Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction that may cause excessive feelings of well-being, drowsiness, lack of coordination, restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.
Missing a dose of Dulxetenon
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed dose. Do not exceed the daily dose of duloxetine prescribed by your doctor.
Stopping Dulxetenon treatment
Even if you feel better, DO NOT stop taking Dulxetenon without consulting your doctor. If your doctor decides that you no longer need to take duloxetine, they will recommend gradually reducing the dose over at least 2 weeks.
Some patients who suddenly stop taking duloxetine may experience symptoms such as: dizziness, tingling sensations like pins and needles or electric shocks (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or dizziness.
These symptoms are usually not serious and resolve within a few days. However, if they are bothersome, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate and generally resolve after a few weeks.

Very common adverse reactions (may affect more than 1 in 10 people)

• headache, drowsiness
• nausea, dry mouth

Common adverse reactions (may affect up to 1 in 10 people)

• loss of appetite
• sleep disturbances, restlessness, reduced sexual drive, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling slowed down, muscle tremor, numbness, including tingling, prickling or pins and needles sensation of the skin
• blurred vision,
  • tinnitus (hearing sounds in the ears without an external source)
• palpitations
• increased blood pressure, sudden flushing of the face
• excessive yawning
• constipation, diarrhoea, abdominal pain, vomiting, heartburn or indigestion, flatulence
• increased sweating, rash (itchy)
• muscle pain, muscle cramps
• painful urination, frequent urination
• problems achieving erection, changes in ejaculation
• falls (especially in elderly people), fatigue
• weight loss

In children and adolescents under 18 years of age with depression treated with this medicine, weight loss has been observed after starting treatment. After 6 months of treatment, body weight increased and became comparable to that observed in other children and adolescents of the same age and sex.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty falling asleep, teeth grinding, disorientation, lack of motivation
• sudden involuntary movements or muscle twitching, feeling restless or inability to sit still or stand still, agitation, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g. lack of coordination or involuntary muscle movements, restless legs syndrome, worsened sleep quality
• dilated pupils (dark central spot of the eye), visual disturbances
• dizziness, sensation of spinning, ear pain
• rapid and (or) irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or fainting upon standing, cold sensation in fingers of hands and (or) feet
• tightness in the throat, nosebleeds
• vomiting blood or black, tarry stools, inflammation of the stomach and intestines, regurgitation of stomach contents, difficulty swallowing
• hepatitis, which may cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, urticaria, cold sweats, photosensitivity, increased tendency to bruising
• muscle stiffness and tremor
• difficulty or inability to urinate, difficulty initiating urination, need to urinate at night, need to urinate more than usual, reduced amount of urine passed
• abnormal vaginal bleeding, menstrual disorders, including heavy, painful, irregular or prolonged periods, scanty periods or absence of periods, testicular or scrotal pain
• chest pain, cold sensation, thirst, chills, feeling of heat, gait disturbances
• weight gain
• Duloxetine may cause adverse reactions of which one may be unaware, such as increased activity of liver enzymes or blood potassium levels, increased creatine kinase activity, blood glucose or cholesterol levels.

Rare adverse reactions (may affect up to 1 in 1,000 people)

• severe allergic reaction causing breathing difficulties, dizziness with swelling of the tongue or lips, allergic reactions
• decreased thyroid function, which may cause fatigue or weight gain
• dehydration, low blood sodium levels (especially in elderly people; symptoms may include: dizziness, weakness, confusion, drowsiness, excessive fatigue or nausea, vomiting, more severe symptoms include fainting, seizures and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behaviour, manic state (excessive activity, racing thoughts and reduced need for sleep), hallucinations, aggression and anger outbursts
• "serotonin syndrome" (a rare reaction which may cause feelings of excessive well-being, drowsiness, motor incoordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle rigidity), seizures
• increased eye pressure (glaucoma)
• inflammation of the mouth, bright red blood in stool, bad breath, inflammation of the large intestine (leading to diarrhoea)
• liver failure, yellow discoloration of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious illness with ulceration of the skin, mouth, eyes and genital organs), severe allergic reaction causing swelling of the face or throat (angioedema)
• jaw muscle spasm
• abnormal urine odour
• menopausal symptoms, abnormal milk production in men or women in the breast glands
• cough, wheezing and shortness of breath, possibly accompanied by fever
• excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage).

Very rare adverse reactions (may affect up to 1 in 10,000 people)

• inflammation of blood vessels in the skin (cutaneous vasculitis).

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dulxetenon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Blister (PA/Aluminum/PVC):
No special storage instructions for this medicinal product.
Blister (PVC/PE/PVDC//Aluminum):
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

Active ingredients of Dulxetenon
The active substance is duloxetine.
Dulxetenon 90 mg, gastro-resistant hard capsules
Each capsule contains 90 mg of duloxetine (as duloxetine hydrochloride).
Dulxetenon 120 mg, gastro-resistant hard capsules
Each capsule contains 120 mg of duloxetine (as duloxetine hydrochloride).

Other ingredients:
Contents of the capsule: hypromellose 2910, sucrose, granules, talc, sucrose, cellulose acetate phthalate, triethyl citrate.
Capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172) (only for Dulxetenon 90 mg), indigo carmine (E 132).

What Dulxetenon looks like and contents of the pack
Dulxetenon is gastro-resistant hard capsules.
Dulxetenon is available in two strengths: 90 mg and 120 mg.
90 mg capsules: Opaque white body and opaque green cap, hard gelatin capsule size 0E.
120 mg capsules: Opaque blue body and opaque blue cap, hard gelatin capsule size 00.
Dulxetenon 90 mg is available in packs of 28 capsules.
Dulxetenon 120 mg is available in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona 69
Sant Joan Despí
08970 Barcelona
Spain

For further information, contact the local representative of the Marketing Authorisation Holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
[email protected]

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 gastroresistente