Duloxetine Viatris: detailed information

Package leaflet: Information for the user

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

duloxetine
Please read 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 pass it on to other people, even if their symptoms are the same as yours, as 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:

What Duloxetina Viatris is and what it is used for
What you need to know before taking Duloxetina Viatris
How to take Duloxetina Viatris
Possible side effects
How to store Duloxetina Viatris
Contents of the pack and other information

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

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

depression
generalized anxiety disorder (chronic feelings of anxiety or nervousness)
- diabetic neuropathic pain (often described as burning, sharp, stabbing, shooting, or crushing pain, or as an electric shock. The affected area may have reduced sensation, or sensations where touch, heat, cold, or pressure can cause pain)

Duloxetina Viatris begins 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 feeling better. Contact your doctor if you do not begin to feel better after this time. Your doctor may continue your treatment with Duloxetina Viatris once you feel better to prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, it may take several weeks before you start feeling better. Inform your doctor if you do not feel better after 2 months.

2. What you should know before taking Duloxetina Viatris

Do not take Duloxetina Viatris 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 Duloxetina Viatris")
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 Duloxetina Viatris")

Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise you whether you can take Duloxetina Viatris.
Warnings and precautions
Reasons why Duloxetina Viatris may not be suitable for you include the following. 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 opioid dependence (narcotics). Using these medicines together with Duloxetina Viatris may lead to serotonin syndrome, a condition that can be fatal (see "Other medicines and Duloxetina Viatris").
you are taking St. John’s Wort (Hypericum perforatum), a herbal preparation
you have kidney disease
you have had seizures (epileptic fits)
you have experienced a manic episode
you suffer from bipolar disorder
you have eye problems, such as certain types of glaucoma (increased pressure inside the eye)
you have a history of blood clotting disorders (tendency to bruise easily), especially if you are pregnant (see "Pregnancy and breastfeeding")
you are at risk of low sodium levels (e.g. if you are taking diuretics, particularly if you are elderly)
you are being treated with another medicine that may cause liver damage
you are taking other medicines containing duloxetine (see "Other medicines and Duloxetina Viatris")

Duloxetina Viatris may cause a feeling of restlessness or inability to sit still. If this happens, inform your doctor.
You should also contact your doctor if you experience signs and symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, vomiting, as you may be suffering from serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).
Medicines such as Duloxetina Viatris (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression and anxiety disorders
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you first start treatment with antidepressants, as these medicines may take some time to become effective, usually about 2 weeks, but sometimes longer.
You may be more likely to have such thoughts 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 committing 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 under 18 years of age
Duloxetina Viatris 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 may 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 Duloxetina Viatris to patients under 18 years of age if he/she considers it the best option for them. If your doctor has prescribed Duloxetina Viatris to a patient under 18 years of age and you have questions, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking Duloxetina Viatris. In addition, long-term effects on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Duloxetina Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
The main active ingredient in Duloxetina Viatris, duloxetine, is also found in other medicines used for other conditions:

diabetic neuropathic pain, depression, anxiety, and urinary incontinence

Concurrent 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 Duloxetina Viatris with other medicines. Do not start or
stop taking any medicine, including those bought without a prescription 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 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, may cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Viatris. In addition, you must wait at least 5 days after stopping Duloxetina Viatris before starting an MAOI.
Medicines that cause drowsiness: These include prescription medicines 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 cause symptoms such as involuntary rhythmic muscle contractions, including in the muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms, as they may indicate a potentially fatal condition known as serotonin syndrome.
Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent blood clots. These medicines may increase the risk of bleeding.
Duloxetina Viatris with food, drinks and alcohol
Duloxetina Viatris can be taken regardless of meals. You should be cautious about drinking alcohol while being treated with Duloxetina Viatris.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Inform your doctor if you are pregnant or planning to become pregnant while taking Duloxetina Viatris. You should use Duloxetina Viatris only after discussing with your doctor the potential benefits and any possible risks to the unborn child.
Make sure your midwife and/or doctor knows you are taking Duloxetina Viatris. 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 the baby to breathe rapidly and appear bluish. 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 Duloxetina Viatris near the end of pregnancy, your newborn may experience certain symptoms shortly after birth. These usually appear at birth or within a few days. Symptoms may include floppy muscles, tremors, agitation, feeding difficulties, breathing problems, and seizures. If your newborn shows any of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife for advice.
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 should be informed that you are taking duloxetine so they can advise you appropriately.
Available data on the use of duloxetine during the first three months of pregnancy do not show an increased overall risk of birth defects in the baby. If Duloxetina Viatris is taken during the second half of pregnancy, there may be an increased risk of premature birth (6 additional premature births per 100 women taking duloxetine in the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.
Inform your doctor if you are breastfeeding. The use of Duloxetina Viatris during breastfeeding is not recommended. Consult your doctor or pharmacist for advice.

Driving and using machines
Duloxetina Viatris may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Viatris affects you.
Duloxetina Viatris contains sucrose and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult him 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 exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Duloxetina Viatris is taken orally. Swallow the capsule whole, without chewing, with a glass of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Viatris is 60 mg once daily, but your doctor will prescribe the dose they consider appropriate for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Viatris is 30 mg once daily. Most patients will then be given 60 mg once daily, but your doctor will prescribe the dose they consider appropriate for you. The dose may be adjusted up to 120 mg per day, depending on your response to Duloxetina Viatris.

To help you remember to take Duloxetina Viatris, it may be easier to take it at the same time each day.

Talk to your doctor about how long you should continue taking Duloxetina Viatris. Do not stop taking Duloxetina Viatris 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 may become worse and more difficult to treat.

If you take more Duloxetina Viatris than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Viatris than prescribed. Symptoms of overdose may 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 Duloxetina Viatris
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 the next single dose as usual. Do not take a double dose to make up for the forgotten dose. Do not take more Duloxetina Viatris than prescribed 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 decides you no longer need Duloxetina Viatris, they will ask you to gradually reduce the dose over a period of at least two weeks before stopping treatment completely.

Some patients who stop taking Duloxetina Viatris suddenly have experienced symptoms such as:

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

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 how to use 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. Usually these side 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, drowsiness
feeling unwell (nausea), dry mouth

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

loss of appetite
difficulty in falling asleep, restlessness, reduced sex drive, anxiety, difficulty or inability to reach orgasm, unusual dreams
dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or skin tingling
blurred vision
tinnitus (perception of sound in the ear in the absence of an external sound stimulus)
awareness of heartbeat (palpitations)
increased blood pressure, hot flush
increased yawning
constipation, diarrhoea, stomach ache, retching (vomiting), heartburn, indigestion, gas accumulation in the intestine
increased sweating, skin rash (pruritic)
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, their weight increased to match that of 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 or clenching, disorientation, lack of motivation
sudden and involuntary muscle spasms or contractions, restlessness or inability to sit still, feeling nervous, difficulty concentrating, changes in taste sensation, difficulty controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
pupil dilation (the dark centre of the eye), visual disturbances
dizziness or spinning sensation (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 and/or toes
sensation of throat tightness, 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 (jaundice)
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, sexual dysfunction, testicular or scrotal pain
chest pain, cold sensation, thirst, tremor, hot sensation, abnormal gait
weight gain
Duloxetina Viatris may cause side 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 breathing difficulties or dizziness with swelling of the tongue and lips, allergic reactions
reduced thyroid gland activity which may cause fatigue or weight gain
dehydration, low sodium levels in the blood (especially in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness or extreme tiredness, 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 (hyperactivity, 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 sensation, fever, sweating or muscle stiffness), seizures
increased pressure inside the eye (glaucoma)
mouth inflammation, 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 illness 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, shortness of breath and laboured breathing, 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)

Frequency not known (cannot be estimated from the 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 experience any side effect, 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 listed in Annex V. By reporting side effects, you can help 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 stated on the package.
Store in the original container to protect it from moisture.
For bottles only:
Use within 6 months after opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Duloxetina Viatris Contains
The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other components are:
Capsule contents: sugar spheres (sucrose, maize 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 Pack Contents
Duloxetina Viatris is a hard gastro-resistant capsule. Each Duloxetina Viatris capsule contains
duloxetine hydrochloride granules with a coating designed to protect them from stomach acid.
Duloxetina Viatris is available in two strengths: 30 mg and 60 mg.
The 30 mg capsules have an opaque blue cap and an opaque white body, printed in gold ink with “MYLAN” above “DL 30” on both cap and body.
The 60 mg capsules have an opaque blue cap and an opaque yellow body, printed in white ink with “MYLAN” above “DL 60” on both cap and body.

Duloxetina Viatris 30 mg is available in blister packs containing 7, 14, 28, 49, and 98 capsules, and in multiple packs of 98 comprising two boxes of 49 capsules, in perforated blister packs containing 7 x 1, 28 x 1, and 30 x 1 capsules, and in bottles containing 30, 100, 250, and 500 capsules with a desiccant. Do not eat the desiccant.

Duloxetina Viatris 60 mg is available in blister packs containing 14, 28, 49, 84, and 98 capsules, and in multiple packs of 98 comprising two boxes of 49 capsules, in perforated blister packs containing 28 x 1, 30 x 1, and 100 x 1 capsules, and in bottles containing 30, 100, 250, and 500 capsules with a desiccant. Do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd.
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: + 371 676 055 80

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.