DULOXETINE LILLY

Package leaflet: Information for the user

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

duloxetine (as hydrochloride)
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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Duloxetina Lilly contains the active substance duloxetine. 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 crushing, or as an electric shock. The affected area may have reduced sensation, or sensations in which touch, 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 you start to feel better. Contact your doctor if you do not begin to feel better after this time. Your doctor may continue your treatment with Duloxetina Lilly after 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. Inform 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 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 Lilly')
• 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 Lilly')
  Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise whether you can take Duloxetina Lilly.

Warnings and precautions
Reasons why Duloxetina Lilly may not be suitable for you include the following. Talk to your doctor
before taking Duloxetina Lilly if:

• you are taking other medicines to treat depression (see 'Other medicines and Duloxetina Lilly')
• you are taking St. John’s Wort ( Hypericum perforatum ), a herbal remedy
• 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, including certain types of glaucoma (increased pressure inside the eye)
• you have a history of bleeding 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 Lilly')

Duloxetina Lilly may cause a feeling of restlessness or inability to sit still.
If this occurs, 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, overactive reflexes, diarrhoea, coma, nausea, vomiting – you may be experiencing 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 Lilly (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (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 disorder
If you are depressed and/or have anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. These thoughts may increase when you first start treatment with antidepressants, as these medicines take 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
to hospital immediately.
You may find it helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may wish to ask them to inform you if they believe 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 Lilly is generally not intended 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 Lilly to patients under 18 years if they consider it the best option. If your doctor has prescribed Duloxetina Lilly to a patient under 18 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 are taking Duloxetina Lilly. Furthermore, long-term effects on growth, maturation, and cognitive and behavioural development have not yet been established for Duloxetina Lilly in this age group.

Other medicines and Duloxetina Lilly
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
The main active ingredient in Duloxetina Lilly, duloxetine, is 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 must be avoided. Check with your doctor if you are already taking medicines containing duloxetine.

Your doctor must decide whether you can take Duloxetina Lilly with other medicines. Do NOT start or
stop taking any medicine, including those purchased without a prescription and herbal remedies,
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 Lilly if you are currently taking, or have recently taken (within the last 14 days) another antidepressant medicine known as 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, may cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Lilly. Also, you must wait at least 5 days after stopping Duloxetina Lilly 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, 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 adverse effects; if you experience any unusual symptoms while taking any of these medicines together with Duloxetina Lilly, you must consult your doctor.

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

Duloxetina Lilly with food, drinks and alcohol
Duloxetina Lilly can be taken regardless of meals. You should be cautious if consuming alcohol while being treated with Duloxetina Lilly.

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

• Inform your doctor if you are pregnant or planning to become pregnant while taking Duloxetina Lilly. You should use Duloxetina Lilly only after discussing with your doctor the potential benefits and any possible risks to the unborn child.
• Ensure that your midwife and/or doctor knows 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 causes the baby to breathe rapidly and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this occurs in your newborn, contact your midwife or doctor immediately.
• If you take Duloxetina Lilly near the end of pregnancy, the newborn may show certain symptoms shortly after birth. These usually appear at birth or within a few days. Symptoms may include floppy muscles, tremors, irritability, 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 Lilly 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 Duloxetina Lilly during the first three months of pregnancy do not show an overall increased risk of birth defects in the baby. If Duloxetina Lilly 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 Duloxetina Lilly 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 Lilly during breastfeeding is not recommended. Seek advice from your doctor or pharmacist.

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

Duloxetina Lilly contains sucrose
Duloxetina Lilly contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Duloxetina Lilly contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Duloxetina Lilly

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Duloxetina Lilly is taken orally. Swallow the capsule whole with a glass of water, without chewing it.

For depression and diabetic neuropathic pain:
The usual recommended dose of Duloxetina Lilly is 60 mg once daily. However, your doctor will prescribe the dose that is right for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Lilly is 30 mg once daily. Most patients will then be increased to 60 mg once daily, but your doctor will determine the dose that is right for you. The dose may be adjusted up to a maximum of 120 mg per day, depending on your response to Duloxetina Lilly.

To help you remember to take Duloxetina Lilly, 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 Lilly. Do not stop taking Duloxetina Lilly 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 could become worse and more difficult to treat.

If you take more Duloxetina Lilly than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Lilly than prescribed. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction which may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, feelings of drunkenness, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take Duloxetina Lilly
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 your usual single dose at the regular time. Do not take a double dose to make up for the missed one. Do not take more Duloxetina Lilly than the amount prescribed 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 decides you no longer need Duloxetina Lilly, 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 Lilly suddenly have experienced symptoms such as:

• dizziness, tingling sensations like pins and needles or electric shock sensations (particularly in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), tiredness, drowsiness, feelings of restlessness or agitation, anxiety, nausea or feeling unwell (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, you should 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. 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, drowsiness
• Nausea, dry mouth

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

• Loss of appetite
• Difficulty in sleeping, restlessness, reduced sex drive, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• Dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or pins and needles in the skin
• Blurred vision
• Tinnitus (perception of ringing or noise in the ears in the absence of external sound)
• Awareness of heartbeat (palpitations)
• Increased blood pressure, hot flush
• Increased yawning
• Constipation, diarrhoea, stomach ache, retching (vomiting), heartburn, indigestion, bloating (gas accumulation in the intestine)
• Increased sweating, skin rash (itchy)
• Muscle pain, muscle spasm
• Painful urination, frequent urination
• Difficulty in 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 be comparable 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 hoarseness
• Suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, feeling disoriented, lack of motivation
• Sudden and involuntary muscle spasms or contractions, feeling restless or unable to sit still, feeling nervous, difficulty concentrating, changes in taste sensation, problems 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
• Feeling dizzy or lightheaded (vertigo), ear pain
• Fast or irregular heartbeat
• Fainting, dizziness, feeling of emptiness in the head or of impending fainting when standing up, cold sensation in fingers of hands and/or feet
• 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 (urticaria), 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 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, trembling, feeling hot, abnormal gait
• Weight gain
• Duloxetine Lilly may cause 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 activity of the thyroid gland, which may cause tiredness or weight gain
• Dehydration, low sodium levels in the blood (especially in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness, 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, 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, feeling drunk, fever, sweating or muscle stiffness), seizures
• Increased pressure inside the eye (glaucoma)
• Cough, wheezing and shortness of breath, possibly accompanied by fever
• 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 causing 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 odour of urine
• Menopausal symptoms, abnormal production of breast milk in men and women
• 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, and 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 Lilly

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack.
Store in the original packaging to protect it from moisture. Do not store above 30 °C.
Do not dispose of medicines via wastewater 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 substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other components are:
Capsule contents: hypromellose, hypromellose acetate succinate, sucrose, sugar granules,
talc, titanium dioxide (E171), triethyl citrate.
(see end of section 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 green edible printing ink (30 mg) or white edible
printing ink (60 mg).
Green edible printing ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172),
propylene glycol, shellac.
White edible printing ink: titanium dioxide (E171), propylene glycol, shellac, povidone.

Description of the appearance of Duloxetina Lilly and contents of the pack
Duloxetina Lilly is a hard gastro-resistant capsule. Each Duloxetina Lilly capsule contains
duloxetine hydrochloride granules with a coating to protect them from stomach acid.
Duloxetina Lilly is available in two strengths: 30 mg and 60 mg.
The 30 mg capsules are blue and white, printed with '30 mg' and the code '9543'.
The 60 mg capsules are blue and green, printed with '60 mg' and the code '9542'.
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 multiple 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 Authorization Holder and Manufacturer
Marketing Authorization Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600
България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B.V Eli Lilly Norge A.S.
Tel: + 372 6817 280 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780
España Polska
Dista S.A. Eli Lilly Polska Sp. z o.o.
Tel:+ 34-91-663 50 00 Tel: +48 22 440 33 00
France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: +358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Tηλ: +357 22 715000 Tel: + 46-(0) 8 7378800
Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company (Ireland) Limited
Tel: + 371 67364000 Tel: + 353-(0) 1661 4377

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

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the assessment by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for duloxetine, the scientific conclusions of the PRAC are as follows:
In light of available literature data on neuroleptic malignant syndrome (NMS) and stress-induced cardiomyopathy (Takotsubo cardiomyopathy), including spontaneous reports with, in some cases, a close temporal relationship, a positive de-challenge and/or re-challenge, and considering the 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 for medicinal products containing duloxetine should be amended accordingly.

Having reviewed the PRAC's recommendation, the Committee for Medicinal Products for Human Use (CHMP) agrees with the general conclusions and the reasoning of the recommendation.

Reasons 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 medicinal product containing duloxetine remains favourable, subject to the proposed amendments to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation.