Duloxetine Zentiva

duloxetine

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This is a summary of the European public assessment report (EPAR) for Duloxetine Zentiva. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Duloxetine Zentiva. 

For practical information about using Duloxetine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.

What is Duloxetine Zentiva and what is it used for?

Duloxetine Zentiva is used to treat adults with the following diseases:

  • major depression;
  • pain due to diabetic peripheral neuropathy (damage to the nerves in the feet, legs, hands and arms that can occur in patients with diabetes);
  • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

Duloxetine Zentiva contains the active substance duloxetine and is is a ‘generic medicine’. This means that Duloxetine Zentiva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Cymbalta. 

How is Duloxetine Zentiva used?

Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being destroyed by the acid in the stomach. The medicine can only be obtained with a prescription.

For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Duloxetine Zentiva, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.

For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day. The response to treatment should be assessed regularly.

For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient’s response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Duloxetine Zentiva, treatment should continue for several months, to prevent the disorder coming back.

The dose of Duloxetine Zentiva should be reduced gradually when stopping treatment.

How does Duloxetine Zentiva work?

The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.

Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between nerve cells, increasing the level of communication between the cells. Since these neurotransmitters are involved in maintaining mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

How has Duloxetine Zentiva been studied?

Because Duloxetine Zentiva is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine’s.

What are the benefits and risks of Duloxetine Zentiva?

Because Duloxetine Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Duloxetine Zentiva approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Zentiva has been shown to have comparable quality to Cymbalta and to be bioequivalent to Cymbalta. Therefore, the CHMP’s view was that, as for Cymbalta, the benefit outweighs the identified risk. The Committee recommended that Duloxetine Zentiva be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Duloxetine Zentiva?

A risk management plan has been developed to ensure that Duloxetine Zentiva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Duloxetine Zentiva

The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Zentiva on 20 August 2015.

For more information about treatment with Duloxetine Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Duloxetine Zentiva : EPAR - Summary for the public BG = bălgarski 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public ES = español 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public CS = čeština 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public DA = dansk 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public DE = Deutsch 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public ET = eesti keel 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public EL = elliniká 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public FR = français 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public IT = italiano 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public LV = latviešu valoda 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public LT = lietuvių kalba 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public HU = magyar 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public MT = Malti 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public NL = Nederlands 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public PL = polski 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public PT = português 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public RO = română 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public SK = slovenčina 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public SL = slovenščina 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public FI = suomi 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public SV = svenska 2015-08-27  
Duloxetine Zentiva : EPAR - Summary for the public HR = Hrvatski 2015-08-27  
Name Language First published Last updated
Duloxetine Zentiva : EPAR - Risk-management-plan summary (English only) 2015-08-27  

This EPAR was last updated on 31/05/2017 .

Authorisation details

Product details

Product details for Duloxetine Zentiva
NameDuloxetine Zentiva
Agency product numberEMEA/H/C/003935
Active substance

duloxetine

International non-proprietary name (INN) or common name

duloxetine

Therapeutic area Depressive Disorder, MajorAnxiety DisordersDiabetes MellitusNeuralgia
Anatomical therapeutic chemical (ATC) code N06AX21
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Duloxetine Zentiva
Marketing-authorisation holder

Zentiva, k.s.

Revision2
Date of issue of marketing authorisation valid throughout the European Union20/08/2015

Contact address:

Zentiva, k.s.
U kabelovny 
130 Dolni Mecholupy 
102 37 Praha 10 
Czech Republic
 

Product information

Product information

17/05/2017  Duloxetine Zentiva -EMEA/H/C/003935 -IB/0002

Name Language First published Last updated
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31
Duloxetine Zentiva : EPAR - Product Information EN = English 2015-08-27 2017-05-31

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  
Duloxetine Zentiva : EPAR - All Authorised presentations EN = English 2015-08-27  

Pharmacotherapeutic group

Gastro-resistant capsule, hard

Therapeutic indication

Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder.

Duloxetine Zentiva is indicated in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Duloxetine Zentiva : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-12-02 2017-05-31

Initial marketing-authorisation documents

Name Language First published Last updated
Duloxetine Zentiva : EPAR - Public assessment report EN = English 2015-08-27  
CHMP summary of positive opinion for Duloxetine Zentiva EN = English 2015-06-26  

Authorised

This medicine is approved for use in the European Union

More information on Duloxetine Zentiva