Dulsevia

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Dulsevia (Duloxetine Krka)
60 mg, hard enteric-coated capsules
Duloxetinum
Dulsevia and Duloxetine Krka are different trade names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Dulsevia is and what it is used for
2. Important information before taking Dulsevia
3. How to take Dulsevia
4. Possible side effects
5. How to store Dulsevia
6. Contents of the pack and other information

1. What Dulsevia is and what it is used for

Dulsevia contains the active substance duloxetine. Dulsevia increases the levels of serotonin and
noradrenaline in the nervous system.
Dulsevia is indicated in adults for the treatment of:

• depression,
• generalized anxiety disorder (chronic feeling of anxiety or nervousness),
• pain associated with diabetic neuropathy (usually described as burning, stabbing, sharp, shooting pain or pain like an electric shock. In a specific part of the body, there may be loss of sensation, or sensations of touch, heat or cold may occur, and pressure may cause pain).

In most people with depression or anxiety, Dulsevia starts to work within two weeks of starting
treatment, but it may take 2 to 4 weeks before improvement occurs. If no improvement is seen after
this time, consult your doctor. Even if the patient's condition improves, the doctor may recommend
continuing treatment with Dulsevia to prevent recurrence of depression or anxiety.
In people with pain due to diabetic neuropathy, improvement may occur after several weeks. Please
consult your doctor if no improvement is seen after 2 months.

2. Information before using Dulsevia

When not to use Dulsevia:

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

Tell your doctor if the patient has high blood pressure or heart disease.
Your doctor will decide whether the patient should take Dulsevia.
Warnings and precautions
Below is a list of reasons why Dulsevia may not be suitable for the patient. Before taking Dulsevia, the patient should inform the doctor if any of the following apply:

• taking other antidepressant medicines (see "Dulsevia with other medicines"),
• taking herbal remedies containing St John's wort ( Hypericum perforatum ),
• kidney disease,
• history of seizures (epilepsy),
• current or past episodes of mania,
• bipolar affective disorder,
• eye disorders, such as a specific type of glaucoma (increased pressure in the eye),
• history of bleeding disorders (tendency to bruise easily),
• risk of developing low sodium levels (for example, when taking diuretics, especially in elderly patients),
• taking other medicines that may cause liver damage,
• taking other medicines containing duloxetine (see "Dulsevia with other medicines").

Medicines such as Dulsevia (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may persist after stopping treatment.
Dulsevia may cause feelings of restlessness or an inability to sit still or remain motionless. If such symptoms occur, inform your doctor.
Suicidal thoughts and worsening depression or anxiety
Depression and (or) anxiety may lead to thoughts of self-harm or suicide. These may worsen after starting antidepressant medicines, because it takes some time, usually two weeks or longer, before these medicines begin to work.
These thoughts may worsen:

• in patients who previously had suicidal thoughts or thoughts of self-harm,
• in young adults. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If thoughts of self-harm or suicide occur, contact your doctor immediately
or go directly to hospital.
It may be helpful to inform a relative or close friend about the depressive or anxious condition and ask them to read this leaflet. You may also ask them whether they notice any worsening of depression or anxiety or any changes in behaviour that are concerning.
Children and adolescents under 18 years of age
Dulsevia is generally not recommended for use in children and adolescents under 18 years of age. In patients under 18 years of age taking medicines of this class, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger). However, the doctor may decide to prescribe Dulsevia for patients under 18 years of age if they consider it beneficial. If you have any doubts when the doctor prescribes Dulsevia for a patient under 18 years of age, contact the doctor again. Inform the doctor if any of the adverse reactions listed above occur or worsen in a patient under 18 years of age taking Dulsevia. In addition, there are no long-term safety data on the use of duloxetine in this age group regarding growth, puberty, cognitive development, and behavioural development.
Dulsevia with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
Duloxetine, the main component of Dulsevia, is also present in other medicines used to treat other conditions:

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

Avoid taking more than one of these medicines at the same time. The patient should consult their doctor if taking other medicines containing duloxetine.
The doctor will decide whether Dulsevia can be taken together with other medicines. Do not
start or stop taking other medicines, including those available without a prescription and
herbal remedies, without consulting your doctor.
Inform your doctor if you are taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs): Do not take Dulsevia at the same time as another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) or within a short time interval (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 Dulsevia, may cause serious or even life-threatening adverse effects. At least 14 days must pass after stopping an MAOI before starting Dulsevia. At least 5 days must pass after stopping Dulsevia before starting an MAOI.
Medicines causing drowsiness: These 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), meperidine, 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 Dulsevia, contact your doctor.
Oral anticoagulants or antiplatelet medicines: Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.
Dulsevia with food, drink and alcohol
Dulsevia can be taken during or between meals. Exercise caution when consuming alcohol while taking Dulsevia.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The patient should inform her doctor if:

• she becomes pregnant or plans to become pregnant while taking Dulsevia. The patient may take Dulsevia only after discussing with her doctor the expected benefits of treatment and the possible risks to the unborn child.

The patient should inform her midwife and (or) doctor that she is taking Dulsevia.
Taking similar medicines (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension, which causes the baby to breathe faster and appear blue. These symptoms usually occur within the first 24 hours after birth. If the patient notices any of these symptoms in her baby, she should contact her midwife and (or) doctor immediately.
If the patient takes Dulsevia towards the end of pregnancy, certain symptoms may occur in her newborn baby at birth. These usually occur at birth or within a few days after birth. Symptoms may include muscle weakness, tremor, jitteriness, feeding difficulties, breathing problems, and seizures. 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.

• The patient should inform her doctor if she is breastfeeding. Dulsevia is not recommended during breastfeeding. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and operating machinery
Dulsevia may cause drowsiness or dizziness. The patient should not drive or operate machinery until they know how they react to Dulsevia.
Dulsevia contains sucrose
If the doctor has previously diagnosed the patient with an intolerance to certain sugars, contact the doctor before starting this medicine.

3. How to take Dulsevia

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dulsevia is available in the following strengths: 30 mg and 60 mg.
Dulsevia is taken orally. The capsule should be swallowed whole with water.

Treatment of depression and diabetic neuropathic pain
The usual dose of Dulsevia is 60 mg taken once daily. However, your doctor will determine the dose
appropriate for you.

Treatment of generalized anxiety disorders
The usual starting dose of Dulsevia is 30 mg once daily. In most patients, the dose is then 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 your response to treatment.

Taking Dulsevia at the same time each day will help you remember to take it.
Your doctor will inform you how long you should continue taking Dulsevia. Do not stop taking
Dulsevia or change the dose without consulting your doctor. Proper treatment of the condition is
important so that you feel better. Without treatment, your condition may persist, worsen, and become
more difficult to treat.

Taking more Dulsevia than prescribed
If you take more Dulsevia than prescribed, contact your doctor or pharmacist immediately.
Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction which may cause
feelings of excessive well-being, drowsiness, lack of coordination, restlessness, sensation of
alcohol intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Dulsevia
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 the next dose at the regular time. Do not take a double dose to make up
for a missed dose. Do not exceed the daily dose of Dulsevia prescribed by your doctor.

Stopping Dulsevia
Even if you feel better, DO NOT stop taking Dulsevia without consulting your doctor. If your doctor
decides that you no longer need to take Dulsevia, they will recommend gradually reducing the dose over
at least 2 weeks.

In some patients who stop duloxetine suddenly, the following symptoms may occur:

• dizziness, tingling sensations like pins and needles or electric shock sensations (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, and excessive sweating or dizziness caused by vestibular disturbances.

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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, reduced sexual drive, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling of sluggishness, muscle tremor, numbness, including numbness, prickling or tingling sensation of the skin
• blurred vision
• tinnitus (perception of sound in the ears in the absence of external sound sources)
• 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 duloxetine, weight loss has been observed after starting the medicine. After 6 months of treatment, body weight increased and caught up with that observed in other children and adolescents of the same age and sex.
Uncommon side effects (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 of restlessness or inability to sit still or remain still, irritability, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g. lack of coordination or unintended muscle movements, restless legs syndrome, worsened quality of sleep
• dilated pupils (dark central point of the eye), vision problems
• dizziness, vertigo due to vestibular disorders, ear pain
• rapid and (or) irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or fainting upon standing, cold sensation in fingers and (or) toes
• throat tightness, 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 twitching
• 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, rarely scanty periods or absence of periods, testicular or scrotal pain
• chest pain, cold sensation, thirst, chills, hot flushes, gait disturbances
• weight gain
• the Dulsevia medicine may cause side effects that are not apparent, such as increased liver enzyme activity or blood potassium levels, increased creatine phosphokinase activity, or increased blood glucose or cholesterol levels

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

• severe allergic reaction causing breathing difficulties, dizziness with swollen tongue or lips, allergic reactions
• reduced 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, nausea, or 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, lack of motor coordination, anxiety, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness), seizures
• increased eye pressure (glaucoma)
• cough, wheezing and shortness of breath, possibly accompanied by fever
• inflammation of the mouth, bright red blood in stools, 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 condition with skin, mouth, eye and genital ulceration), 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

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

• vasculitis of the skin

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also 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.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Dulsevia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dulsevia contains

• The active substance is duloxetine. Each enteric hard capsule contains 60 mg of duloxetine (as duloxetine hydrochloride).
• The other ingredients are: capsule contents: sucrose, pellets (sucrose, corn starch), hypromellose 6 cP, sucrose, hypromellose phthalate, talc and triethyl citrate; capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172), ink [shellac, black iron oxide (E 172)].

See section 2 "Dulsevia contains sucrose".

What Dulsevia looks like and contents of the pack
White to almost white pellets in a size 1 hard gelatin capsule (average length: 19.4 mm). The body of the capsule is yellowish-green and the cap is dark blue. A black "60" is printed on the body of the capsule.
Pack sizes: 7, 14, 28, 56 or 84 enteric hard capsules in blister packs, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Ireland, country of export:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Irish Marketing Authorisation Number, country of export: PA1347/051/004
Parallel Import Licence Number: 169/22