DULOXETINA 30 mg Kapsułki Twarde Powlekane

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1. DULOXETINA LILLY 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules
   1. What is Duloxetina Lilly and what it is used for
   2. What you need to know before taking Duloxetina Lilly
   3. How to take Duloxetina Lilly
   4. Possible side effects
   5. How to store Duloxetina Lilly
   6. Package contents and other information

DULOXETINA LILLY 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules

duloxetine (as hydrochloride)

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 they have the same symptoms as you, as it may 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 Lilly is and what it is used for
• 2. What you need to know before you take Duloxetina Lilly
• 3. How to take Duloxetina Lilly
• 4. Possible side effects
• 5. How to store Duloxetina Lilly
• 6. Contents of the pack and other information

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

Duloxetina Lilly contains the active ingredient duloxetina. Duloxetina Lilly increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetina Lilly 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 Lilly 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
feeling better. Contact your doctor if you do not start to feel better after this time. Your doctor may
continue to give you Duloxetina Lilly when you feel better to prevent depression or anxiety
from returning.
In people with diabetic neuropathic pain, it may take several weeks before
feeling better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina Lilly

DO NOT take Duloxetina Lilly if you

• are allergic to duloxetine or to 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 Lilly’)
• 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 Lilly’) Tell your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if you can take Duloxetina Lilly.

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

• are taking other medicines to treat depression (see ‘Other medicines and Duloxetina Lilly’)
• are taking St John’s Wort ( Hypericum perforatum), a herbal medicinal product
• have a kidney disease
• have had convulsions (seizures)
• have had a manic episode
• suffer from bipolar disorder
• have problems with your eyes, such as certain types of glaucoma (increased pressure inside the eye)
• have a history of blood clotting disorders (tendency to bruise easily), especially if you are pregnant (see “Pregnancy and breastfeeding”)
• there is a risk for you to have low sodium levels (for example if you are taking diuretics, especially if you are an elderly person)
• are being treated with another medicine that can cause liver damage
• are taking other medicines that contain duloxetine (see ‘Other medicines and Duloxetina Lilly’)

Duloxetina Lilly may cause a feeling of restlessness or an inability to sit still or remain calm.
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 can include a combination of fever, rapid heartbeat,
sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Medicines such as Duloxetina Lilly (so-called selective serotonin reuptake inhibitors
(SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual
dysfunction (see section 4). In some cases, persistence of these symptoms after stopping
treatment has been observed.

Suicidal thoughts 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 be increased 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:

• have had thoughts of killing yourself or harming yourself in the past
• are young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric disorders who were treated with an antidepressant

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 anxious, and
ask them to read this leaflet. You might ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents under 18 years of age
Normally Duloxetina Lilly 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 medicine,
have an increased risk of undesirable effects such as suicide attempt, suicidal thoughts
and hostility (particularly aggressive behaviour, oppositional behaviour and anger). Despite this, the
doctor may prescribe Duloxetina Lilly to patients under 18 years if he/she considers that this is
the best solution for them. If the doctor has prescribed Duloxetina Lilly to a patient under 18 years
and you want clarification, return to the doctor. You must inform the doctor if any of the
above symptoms appear or worsen when patients under 18 years are taking Duloxetina
Lilly. Furthermore, long-term safety effects regarding growth, maturity and cognitive and
behavioural development have not yet been demonstrated in this age group.

Other medicines and Duloxetina Lilly
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 Lilly, 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 if you can take Duloxetina Lilly 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 Lilly if you
are taking, or have recently taken (within the last 14 days) another antidepressant
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 Lilly, 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 Lilly. Also, you must wait at least 5 days after you have stopped taking Duloxetina
Lilly 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, tramadol, tryptophan, Selective Serotonin
Reuptake Inhibitors (SSRIs) (such as paroxetine and fluoxetine), Serotonin-Noradrenaline Reuptake
Inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants
(such as clomipramine, amitriptyline), pethidine, St John’s Wort (hypericum) and MAOIs (such as
moclobemide and linezolid). These medicines increase the risk of side effects; if you experience
any unusual symptoms while taking one of these medicines together with Duloxetina
Lilly, you should consult your doctor.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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 Lilly. You should only use Duloxetina Lilly after discussing with your doctor the potential benefits and any potential risk to the unborn child.
• Make sure your midwife and/or doctor knows that you are being treated with Duloxetina Lilly. 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 involves the newborn having a fast breathing rate and a bluish skin colour. 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 Lilly near the end of your pregnancy, your newborn may experience some symptoms just after birth. Generally, these appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremor, nervousness, difficulty feeding, a breathing disorder and convulsions. 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 Lilly near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after delivery, particularly if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking duloxetine so that they can advise you.
• Available data on the use of Duloxetina Lilly during the first 3 months of pregnancy do not show an increased risk of overall birth defects in the baby. If Duloxetina Lilly 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 Duloxetina Lilly in the second part of the pregnancy), mostly between weeks 35 and 36 of pregnancy.
• Tell your doctor if you are breastfeeding. The use of Duloxetina Lilly is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and using machines
Duloxetina Lilly may have a mild to moderate influence on your ability to drive and
operate machines. It may cause drowsiness or dizziness. Do not drive or do not
use tools or machines until you know how Duloxetina Lilly affects you.

Duloxetina Lilly contains sucrose
Duloxetina Lilly contains sucrose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

Duloxetina Lilly contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say it is essentially
‘sodium-free’.

3. How to take Duloxetina Lilly

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

For depression and diabetic neuropathic pain:
The usually recommended dose of Duloxetina Lilly is 60 mg once a day, but your doctor will
prescribe the dose that he/she deems right for you.

For generalized anxiety disorder:
The starting dose of Duloxetina Lilly usually recommended 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 deems right for you. The dose may be adjusted up to 120 mg per day, based on your
response to Duloxetina Lilly.
To help you remember to take Duloxetina Lilly, 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 Lilly. Do not stop
taking Duloxetina Lilly, 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 severe and difficult to treat.

If you take more Duloxetina Lilly than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Duloxetina Lilly
greater than what your doctor has prescribed. Symptoms of overdose include
drowsiness, coma, serotonin syndrome (a rare reaction that can cause feelings of
great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating
or muscle stiffness), seizures, vomiting and increased heart rate.

If you forget to take Duloxetina Lilly
If you forget a dose, take it as soon as you remember. However, if it is time to take
the next dose, skip the missed dose and take only a single dose as usual. Do not
take a double dose to make up for a missed dose. Do not take more of Duloxetina Lilly than
has been prescribed for you for one day.

If you stop taking Duloxetina Lilly
Even if you feel better, DO NOT stop taking the capsules without consulting your
doctor. If your doctor believes you no longer need Duloxetina Lilly, he/she will ask you to reduce
the dose gradually over a period of at least 2 weeks before stopping treatment completely.
Some patients who suddenly stop taking Duloxetina Lilly have had
symptoms such as:

• dizziness, sensations of tingling like pins and needles or electric shock sensations (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or unwell (vomiting), tremor, headache, muscle pain, feeling irritable, 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 drowsiness
• 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, itchy rash
• 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 18 years of age 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 disoriented, lack of motivation
• sudden and involuntary spasms or contractions of the muscles, feeling restless or inability to sit still or remain quiet, feeling nervous, difficulty concentrating, changes in the sense of taste, difficulty controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• dilated pupils (the dark center of the eye), vision disturbances
• feeling of dizziness or “spinning” (vertigo), ear pain
• accelerated or irregular heartbeat
• fainting, dizziness, feeling lightheaded or about to faint while standing up, feeling cold in the fingers of the hands and/or feet
• feeling of tightness in the throat, nosebleeds
• vomiting blood or the 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, testicular or scrotal pain
• chest pain, feeling cold, thirst, tremor, feeling hot, abnormal gait
• weight gain
• Duloxetina Lilly may cause effects of which you may not be aware, such as increases in liver enzymes, or levels in the blood of potassium, 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 sick or being sick, more serious symptoms are loss of consciousness, seizures 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, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• cough, wheezing and shortness of breath possibly accompanied by fever
• 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 condition 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
• 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 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 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 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 Lilly

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. Do not store at a temperature
above 30 °C.
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. Package contents and other information

What Duloxetina Lilly contains
The active substanceis duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The otheringredients are:

Capsule contents: hypromellose, hypromellose acetate succinate, sucrose, sugar granules,
talc, titanium dioxide (E171), triethyl citrate.

(see the end of paragraph 2 for further information on sucrose)

Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine
(E132), yellow iron oxide (E172) (only for 60 mg) and edible green ink (30 mg) or
edible white ink (60 mg).

Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172),
propylene glycol, shellac.

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

Description of the appearance of Duloxetina Lilly and package contents
Duloxetina Lilly is a hard gastro-resistant capsule. Each Duloxetina Lilly capsule contains
granules of duloxetine hydrochloride with a coating to protect them from stomach acid.
Duloxetina Lilly is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules are blue and white with ‘30 mg’ and the code ‘9543’ printed on them.
The 60 mg capsules are blue and green with ‘60 mg’ and the code ‘9542’ printed on them.
Duloxetina Lilly 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Duloxetina Lilly 60 mg is available in packs of 28, 56, 84 and 98 hard gastro-resistant capsules and
in multi-packs of 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant
capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg
83, 3528 BJ Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V
Tel: +372 6817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Dista S.A.
Tel:+ 34-91-663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia, s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: +358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

United Kingdom (Northern Ireland)
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1661 4377
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION
Scientific conclusions
Considering the assessment of the Pharmacovigilance and Risk Assessment Committee
( Pharmacovigilance and Risk Assessment Committee, PRAC) of the Periodic Safety Update Report
( Periodic Safety Update Report, PSUR) for duloxetine, the scientific conclusions of the PRAC are as
follows:
In light of the available literature data on neuroleptic malignant syndrome (Neuroleptic
malignant syndrome, NMS)and on stress-induced cardiomyopathy (Takotsubo cardiomyopathy),
spontaneous reports, including in some cases a close temporal association, a de-challenge and/or re-
challenge positive, and considering a plausible mechanism of action, the PRAC considers that a
causal relationship between duloxetine and NMS and stress-induced cardiomyopathy (Takotsubo
cardiomyopathy) is at least a reasonable possibility. The PRAC concluded that the product information
of medicines containing duloxetine should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
( Committee for Human Medicinal Products, CHMP) agrees with the related overall conclusions and
with the justification of the recommendation.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on duloxetine, the CHMP considers that the benefit/risk
balance of the medicine containing duloxetine remains unchanged, subject to the proposed changes
to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.