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Duloxetine Mylan 30 mg & 60 mg hard gastro-resistant capsules

*
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Duloxetine Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 22 October 2021

File name

ie-pil-h-3981-en-clean-maht.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 22 October 2021

File name

ie-spc-h-3981-en-clean-maht.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 February 2021

File name

ie-spc-h-3981-en-clean-v026.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 February 2021

File name

ie-pil-h-3981-en-clean-v026.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 03 November 2020

File name

ie-spc-h-3981-en-clean-v024rtq-2.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 November 2020

File name

ie-pil-h-3981-en-clean-v024rtq-2.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 07 October 2020

File name

ie-spc-h-3981-en-clean-023.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 March 2020

File name

ie-spc-h-3981-en-clean-r001.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 March 2020

File name

ie-pil-h-3981-en-clean-r001.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 29 October 2019

File name

Duloxetine PIL v022.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 October 2019

File name

Duloxetine SPC v022.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 September 2019

File name

ie-pl-dk1509-v028g-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 September 2019

File name

ie-SPC-h-3981-en-clean-v020.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 September 2019

File name

ie-PIL-h-3981-en-clean-v020-2.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 June 2019

File name

Duloxetine SmPC.pdf

Reasons for updating

  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 May 2019

File name

Duloxetine PIL v018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 18 May 2018

File name

IE-UK_Dual-pack-PIL_clean_v013.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 16 May 2018

File name

Duloxetine SmPC.docx

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 24 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 24 October 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8 Undesirable effects


Very common

Common

Uncommon

Rare

Very rare

Infections and infestations

 

 

Laryngitis

 

 

Immune system disorders

 

 

 

Anaphylactic reaction

Hyper‑sensitivity disorder

 

Endocrine disorders

 

 

 

Hypo‑thyroidism

 

Metabolism and nutrition disorders

 

Decreased Appetite

Hyperglycaemia (reported especially in diabetic patients)

Dehydration

Hyponatraemia

SIADH6

 

Psychiatric disorders

 

Insomnia Agitation

Libido decreased

Anxiety

Orgasm abnormal

Abnormal dreams

Suicidal ideation5,7

Sleep disorder

Bruxism

Disorientation

Apathy

Suicidal

behaviour5,7

Mania

Hallucinations

Aggression and anger4

 

Nervous system disorders

Headache

Somnolence

Dizziness

Lethargy

Tremor

Paraesthesia

Myoclonus

Akathisia7

Nervousness

Disturbance in attention

Dysgeusia

Dyskinesia

Restless legs syndrome

Poor quality sleep

Serotonin syndrome6

Convulsion1

Psychomotor restlessness6

Extra-pyramidal symptoms6

 

Eye disorders

 

Blurred vision

Mydriasis

Visual impairment

Glaucoma

 

Ear and labyrinth disorders

 

Tinnitus1

Vertigo

Ear pain

 

 

Cardiac disorders

 

Palpitations

Tachycardia

Supra-ventricular arrhythmia, mainly atrial fibrillation

 

 

Vascular disorders

 

Blood pressure increase3

Flushing

Syncope2

Hypertension3,7

Orthostatic hypotension2

Peripheral coldness

Hypertensive crisis3,6

 

Respiratory, thoracic and mediastinal disorders

 

Yawning

Throat tightness

Epistaxis

 

 

Gastrointestinal disorders

Nausea

Dry mouth

Constipation Diarrhoea

Abdominal pain

Vomiting

Dyspepsia

Flatulence

Gastrointestinal haemorrhage7

Gastroenteritis

Eructation

Gastritis

Dysphagia

Stomatitis

Haematochezia

Breath odour

Microscopic colitis9

 

 

Hepato-biliary disorders

 

 

Hepatitis3

Elevated liver enzymes (ALT, AST, alkaline phosphatase)

Acute liver injury

Hepatic failure6

Jaundice6

 

Skin and subcutaneous tissue disorders

 

Sweating increased

Rash

Night sweats

Urticaria

Dermatitis contact

Cold sweat

Photo-sensitivity reactions

Increased tendency to bruise

Stevens-Johnson Syndrome6

Angio-neurotic oedema6

Cutaneous vasculitis

Musculoskeletal and connective tissue disorders

 

Musculo‑skeletal pain

Muscle spasm

Muscle tightness

Muscle twitching

Trismus

 

Renal and urinary disorders

 

Dysuria

Pollakiuria

Urinary retention

Urinary hesitation

Nocturia

Polyuria

Urine flow decreased

Urine odour abnormal

 

Reproductive system and breast disorders

 

Erectile dysfunction

Ejaculation disorder

Ejaculation delayed

Gynaecological haemorrhage

Menstrual disorder

Sexual dysfunction

Testicular pain

Menopausal symptoms

Galactorrhoea

Hyperprolactinaemia

 

General disorders and administration site conditions

 

Falls8

Fatigue

Chest pain7

Feeling abnormal

Feeling cold

Thirst

Chills

Malaise

Feeling hot

Gait disturbance

 

 

Investigations

 

Weight decrease

Weight increase

Blood creatine phosphokinase increased

Blood potassium increased

Blood cholesterol increased

 

1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.

2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.

3 See section 4.4.

4 Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.

5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).

6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo‑controlled clinical trials.

7 Not statistically significantly different from placebo.

8 Falls were more common in the elderly (≥65 years old)

9 Estimated frequency based on all clinical trial data.



6.5 Nature and contents of container

30 mg capsules
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium blister pack containing 7, 14, 28, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro resistant capsules
HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro resistant capsules

60 mg capsules
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium blister pack containing 14, 28, 84, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
PVC/PCTFE/Aluminium or OPA/Aluminium/PVC – Aluminium perforated unit dose blister pack containing 28 x 1, 30 x 1 and 100 x 1 hard gastro resistant capsules
HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro resistant capsules














































Updated on 19 October 2016

File name

PIL_16558_414.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 October 2016

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 23 February 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition to Duloxetine 60mg were made, this caused the date of revision of text to change for Duloxetine 30mg.

Updated on 18 February 2016

Reasons for updating

  • Introduction of new pack/pack size

Updated on 07 January 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

 

4.8 Undesirable effects

 

 

a. Summary of the safety profile

 

 

 

The most commonly reported adverse reactions in patients treated with duloxetine were nausea, headache, dry mouth, somnolence, and dizziness. However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.

 

 

 

b. Tabulated summary of adverse reactions

 

 

 

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials

 

(comprising a total of 9454 patients, 5703 on duloxetine and 3751 on placebo) in depression, generalised anxiety disorder and diabetic neuropathic pain.

 

 

 


6.5 Nature and contents of container

 

 

PVC/PCTFE/Al

 

uminium or OPA/Aluminium/PVC – Aluminium blister pack containing 7, 14, 28 and 98 hard gastro-resistant capsules.

 

PVC/PCTFE/Al

 

uminium or OPA/Aluminium/PVC – Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules

 

HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro-resistant capsules

Not all packs sizes may be marketed.



8. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1010/001

EU/1/15/1010/002

EU/1/15/1010/003

EU/1/15/1010/004

EU/1/15/1010/005 19

EU/1/15/1010/006

EU/1/15/1010/007

EU/1/15/1010/008

EU/1/15/1010/009

EU/1/15/1010/010

EU/1/15/1010/021

EU/1/15/1010/022

EU/1/15/1010/023

EU/1/15/1010/024

EU/1/15/1010/025

EU/1/15/1010/026

EU/1/15/1010/027

EU/1/15/1010/028

Updated on 05 January 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 23 December 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 18 December 2015

Reasons for updating

  • New PIL for new product