DULOXETINA 30 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Duloxetina Viatris 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules
   1. What is Duloxetina Viatris and what it is used for
   2. What you need to know before taking Duloxetina Viatris
   3. How to take Duloxetina Viatris
   4. Possible side effects
   5. How to store Duloxetina Viatris
   6. Contents of the pack and other information

Duloxetina Viatris 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules

duloxetina

Read this leaflet carefully before you start taking this medicine as 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 Duloxetina Viatris is and what it is used for
• 2. What you need to know before you take Duloxetina Viatris
• 3. How to take Duloxetina Viatris
• 4. Possible side effects
• 5. How to store Duloxetina Viatris
• 6. Contents of the pack and other information

1. What is Duloxetina Viatris and what it is used for

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

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, sharp, stabbing, shooting, or oppressive, or as an electric shock. In the affected area, there may be loss of sensation, or sensations in which contact, heat, cold or pressure can cause pain)

Duloxetina Viatris starts to be effective in most people with depression or
anxiety within two weeks of starting treatment, but it may take 2-4 weeks
before you start to feel better. Talk to your doctor if you do not start to feel better after this time. Your
doctor may continue to give you Duloxetina Viatris when you feel better to prevent
depression or anxiety from returning.
In people with diabetic neuropathic pain, it may take several weeks before
you start to feel better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina Viatris

Do not take Duloxetina Viatris if you

• are allergic to duloxetine or 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 Duloxetina Viatris”)
• are taking fluvoxamine which is commonly 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 Duloxetina Viatris”)

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

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

• you are taking other medicines to treat depression or medicines known as opioids used to relieve pain or for the treatment of opioid dependence (narcotics). The use of these medicines together with Duloxetina Viatris may lead to serotonin syndrome, a condition that can be life-threatening (see “Other medicines and Duloxetina Viatris”).
• you are taking St. John's Wort ( Hypericum perforatum), a herbal medicinal product
• you have a kidney disease
• you have had seizures (convulsions)
• you have had a manic episode
• you suffer from bipolar disorder
• you have problems with your eyes, such as certain types of glaucoma (increased pressure inside the eye)
• you have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see “Pregnancy and breastfeeding”)
• you are at risk of having low sodium levels (for example if you are taking diuretics, especially if you are an elderly person)
• you are being treated with another medicine that can cause liver damage
• you are taking other medicines that contain duloxetine (see ‘Other medicines and Duloxetina Viatris)

Duloxetina Viatris may cause a feeling of restlessness or an inability to sit still or
remain immobile. If this happens to you, you should tell your doctor.
Also, contact your doctor if:
You experience signs and symptoms of restlessness, hallucinations, loss of coordination, rapid heartbeat,
increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting, you may be suffering from serotonin syndrome.
In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by a blood test).
Medicines like Duloxetina Viatris (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping the
treatment.

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

If at any time you have thoughts of harming yourself or of killing yourself, 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 might ask them to tell you if they think that
your depression or anxiety is getting worse, or if they are worried about changes in your
behavior.

Children and adolescents under 18 years of age
Normally Duloxetina Viatris 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
medicines, have an increased risk of undesirable effects such as suicide attempt,
suicidal thoughts and hostile behavior (especially aggressive behavior, opposition and anger).
Despite this, the doctor may prescribe Duloxetina Viatris to patients under 18 years of age if he/she
believes that this is the best solution for them. If the doctor has prescribed Duloxetina Viatris to a
patient under 18 years of age and you would like clarification, return to the doctor. You should inform the doctor if
any of the above symptoms appear or worsen when patients under 18 years of age are
taking Duloxetina Viatris. Furthermore, long-term safety effects of Duloxetina Viatris relating to growth, maturity and cognitive and behavioral development have not yet been demonstrated in this age group.

Other medicines and Duloxetina Viatris
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 Duloxetina Viatris, 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 whether you can take Duloxetina Viatris with other medicines. Do not start or
stop taking any medicine, including those bought without a prescription
and herbal medicinal products, 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 Duloxetina Viatris if you are
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 Duloxetina Viatris, can cause serious or even life-threatening side effects. You must wait at least 14 days after you have
stopped taking an MAOI before you can take Duloxetina Viatris. Also, you must
wait at least 5 days after you have stopped taking Duloxetina Viatris before taking
an MAOI.

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, 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), St. John's Wort (hypericum), MAOIs (such as moclobemide and
linezolid), opioids (such as buprenorphine, tramadol and pethidine). These medicines may interact
with Duloxetina Viatris and symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma,
excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever
above 38 °C may occur. Contact your doctor if you experience such symptoms, as they may indicate a
condition that can be life-threatening known as serotonin syndrome.

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

Duloxetina Viatris with food, drink and alcohol
Duloxetina Viatris can be taken independently of meals. You should be careful if you drink alcohol
while being treated with Duloxetina Viatris.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant, or planning to become pregnant, while taking Duloxetina Viatris. You should only use Duloxetina Viatris 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 Duloxetina Viatris. When taken during pregnancy, similar medicines (SSRIs) can increase the risk of a serious condition occurring in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which involves the newborn having a fast breathing rate and a bluish skin color. These symptoms usually appear during the first 24 hours after birth. If this happens to the newborn, contact your midwife or doctor immediately.
• If you take Duloxetina Viatris near the end of your pregnancy, your newborn may experience some symptoms shortly after birth. These usually appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremor, agitation, difficulty feeding, a breathing disorder and seizures. If your newborn experiences any of these symptoms after birth, or you are concerned about the baby's health, contact your doctor or midwife who will be able to advise you.
• If you take Duloxetina Viatris 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 must be informed that you are taking duloxetine so that they can advise you.
• Available data on the use of duloxetine during the first 3 months of pregnancy do not show an increased risk of overall birth defects in the baby. If Duloxetina Viatris is taken during the second half of pregnancy there may be an increased risk that the newborn may be born prematurely (6 more newborns born prematurely per 100 women taking duloxetine in the second part of pregnancy), mostly between weeks 35 and 36 of pregnancy.
• Tell your doctor if you are breastfeeding. The use of Duloxetina Viatris is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

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

Duloxetina Viatris contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Duloxetina Viatris

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Duloxetina Viatris is taken orally. Swallow the capsule without chewing, with the help of a
glass of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Viatris 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 Duloxetina Viatris 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
Duloxetina Viatris.
To help you remember to take Duloxetina Viatris, it may be easier for you to take it every day
at the same time.
Talk to your doctor about how long you should continue to take Duloxetina Viatris. Do not stop
taking Duloxetina Viatris, 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 Duloxetina Viatris than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Duloxetina Viatris
greater than what your doctor prescribed. Symptoms of overdose include
drowsiness, coma, serotonin syndrome (a rare reaction that can cause feelings of
great happiness, drowsiness, clumsiness, restlessness, feeling of drunkenness, fever, sweating
or muscle rigidity), seizures, vomiting and increased heart rate.

If you forget to take Duloxetina Viatris
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 forgotten dose and take only a single dose as usual. Do not
take a double dose to make up for the forgotten dose. Do not take more than the amount of
Duloxetina Viatris that has been prescribed for you for one day.

If you stop taking Duloxetina Viatris
Even if you feel better, DO NOT stop taking the capsules without consulting your
doctor. If your doctor believes you no longer need Duloxetina Viatris, 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 Duloxetina Viatris 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 of restlessness or agitation, feeling of anxiety, nausea or unwellness (vomiting), tremor, headache, muscle pain, feeling of irritability, diarrhea, excessive sweating or dizziness.

Usually these symptoms are not serious and disappear within a few days, but if you experience symptoms that
are bothersome, 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 will experience them.
Normally these effects are mild to moderate and often disappear after a few
weeks.

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

• headache, feeling of sleepiness
• feeling unwell (nausea), dry mouth

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

• loss of appetite
• difficulty falling asleep, feeling of agitation, decreased sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling of sluggishness, tremor, numbness, including a sensation of tingling or pins and needles in the skin
• blurred vision
• tinnitus (perception of a sound in the ear in the absence of an external sound stimulus)
• feeling your heart beating in your chest
• increased blood pressure, hot flush
• increased yawning
• constipation, diarrhea, stomach pain, retching (vomiting), heartburn, indigestion, accumulation of gas in the intestine
• increased sweating, rash (itchy)
• 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 the age of 18 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 of disorientation, lack of motivation
• sudden and involuntary spasms or contractions of the muscles, feeling of restlessness or inability to sit still or remain quiet, feeling of nervousness, difficulty concentrating, changes in taste, difficulty controlling movements such as

for example lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality

• pupil dilation (the dark center of the eye), visual disturbances
• feeling of dizziness or “spinning” (vertigo), ear pain
• accelerated or irregular heartbeat
• fainting, dizziness, feeling of lightheadedness or impending fainting when standing up, feeling of coldness 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
• inflammation of the liver which 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, sexual dysfunction, pain in the testicles or scrotum
• chest pain, feeling of cold, thirst, tremor, feeling of warmth, abnormal gait
• weight gain
• Duloxetine Viatris can cause effects of which you may not be aware, such as increases in liver enzymes, or blood potassium levels, 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 nauseous 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
• menopausal symptoms, abnormal production of breast milk in men and women
• cough, dyspnea 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)

Frequency not known (cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Duloxetina Viatris

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 pack.
Store in the original package to protect it from moisture.
Only for bottles:
Use within 6 months of opening.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Duloxetina Viatris contains
The active ingredient is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other ingredients are:

Capsule contents: sugar spheres (sucrose, corn starch), hypromellose, macrogol,
crospovidone, talc, sucrose, hypromellose phthalate, diethyl phthalate.

Capsule shell: Brilliant Blue (E133), yellow iron oxide (E172) (only for 60 mg),
titanium dioxide (E171), gelatin, edible gold ink (only for 30 mg) or edible
white ink (only for 60 mg).

Edible gold ink: shellac, propylene glycol, concentrated ammonia solution,
yellow iron oxide (E172).

Edible white ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide
(E171).

Description of the appearance of Duloxetina Viatris and contents of the pack
Duloxetina Viatris is a hard, gastro-resistant capsule. Each Duloxetina Viatris capsule contains
granules of duloxetine hydrochloride with a coating to protect them from stomach acid.
Duloxetina Viatris is available in 2 dosages: 30 mg and 60 mg
The 30 mg capsules have an opaque blue cap and opaque white body, printed with
gold ink with “MYLAN” above “DL 30” on both the cap and the body.
The 60 mg capsules have an opaque blue cap and opaque yellow body, printed with
white ink with “MYLAN” above “DL 60” on both the cap and the body.
Duloxetina Viatris 30 mg is available in blister packs of 7, 14, 28, 49, 98 and in multiple packs of 98 comprising two boxes of 49 capsules, in perforated blisters containing 7 x 1, 28 x 1,
and 30 x 1 capsules and in bottles containing 30, 100, 250 and 500 capsules and a desiccant. Do not eat the
desiccant.
Duloxetina Viatris 60 mg is available in blister packs of 14, 28, 49, 84, 98 and in multiple packs of 98 comprising two boxes of 49 capsules, in perforated blisters containing 28 x 1, 30 x 1,
and 100 x 1 capsules and in bottles containing 30, 100, 250 and 500 capsules and a desiccant. Do not eat
the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturers
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg

• v. d. Hoehe, Hessen, 61352, Germany

For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd.
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Eesti
Viatris OÜ
Tel: +372 6363 052

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: + 33 4 37 25 75 00

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: + 371 676 055 80
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .