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Venlofex 75 mg prolonged-release capsules, hard

*
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Venlafaxine Hydrochloride

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

Updated on 23 April 2024

File name

ie-spc-nl1091-v058-clean .pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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 11 March 2024

File name

ie-pl-nl1091-75mg-v057-clean_11mar2024.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 September 2023

File name

ie-pl-nl1091-75mg-v056-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 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 21 September 2023

File name

ie-spc-nl1091-v056+rtq-clean .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 4.9 - Overdose
  • 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 January 2023

File name

ie-pl-nl1091-75mg-v055-clean.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 04 January 2022

File name

ie-pl-nl1091-75mg-v053g-clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - marketing authorisation holder

Updated on 04 October 2021

File name

ie-pl-nl1091-75mg-v050-rtq2-clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 October 2021

File name

ie-spc-nl1091-v050-rtq2-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 29 March 2021

File name

ie-spc-nl1091-v047-clean.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 10 - Date of revision of the text

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

Updated on 29 March 2021

File name

ie-pl-nl1091-75mg-v047-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 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 20 January 2021

File name

ie-spc-nl1091-v046-rtq-clean.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 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 20 January 2021

File name

ie-pl-nl1091-75mg-v046-rtq2-clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 October 2019

File name

ie-spc-nl1091-v045-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 14 October 2019

File name

ie-pl-nl1091-75mg-v045-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 27 February 2019

File name

ie-pl-nl1091-75mg-v042-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 27 February 2019

File name

ie-spc-nl1091-v042-clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 June 2018

File name

Venoflex ie-spc-nl1091-clean-v040.docx

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

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

Updated on 05 June 2018

File name

Venoflex ie-pl-nl1091-75mg-clean-v040.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 08 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 08 February 2018

File name

PIL_14091_283.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 February 2018

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • 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)

Free text change information supplied by the pharmaceutical company

4.6 Fertility, pregnancy and lactation

Fertility
Reduced fertility was observed in a study in which both male and female rats were exposed to O-desmethylvenlafaxine. The human relevance of this finding is unknown (see section 5.3).

4.8 Undesirable effects

Summary of the safety profile

Adverse reactions reported as very common The most commonly (>1/10) reported adverse reactions in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).

Tabulated list of adverse reactions

Adverse reactions are listed below by system organ class, and frequency category and decreasing order of medical seriousness within each frequency category.

Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

System organ class

 

 

Very

Common

Common

Uncommon

Rare

Very rare

Not Known

Blood and lymphatic system disorders

 

 

 

Agranulocytosis*,

aplastic anaemia*,

neutropenia*,

pancytopenia*

Thrombocytopenia*

 

 

 

Thrombocytopaenia, blood disorder
including
agranulocytosis,
aplastic anaemia,
neutropaenia and
pancytopaenia

Immune system disorders

 

 

 

Anaphylactic reaction*

 

 Anaphylactic reaction

Endocrine disorders

 

 

 

Inappropriate antidiuretic hormone secretion*

Blood prolactin increased*

 

 Syndrome of Inappropriate antidiuretic hormone secretion (SIADH)

Metabolism and nutrition disorders

 

dDecreased appetite

 

Hyponatraemia*

 

 

 

 

Hyponatraemia

 

 

Psychiatric disorders

Insomnia

Confusional state*, depersonalisation*, anorgasmia, libido decreased, nervousness, insomnia, abnormal dreams

Mania Hallucination, derealisation, agitation, orgasm abnormal (female), apathy, hypomania, bruxism*

Mania Delirium*

 

Suicidal ideation and suicidal behavioursa**, delirium,

aggressionb***

Nervous system disorders

Dizziness, headache *c,  sedation

Somnolence  Akathisia*, dysgeusia hypertonia paraesthesia, tremor 

Akathisia/ Psychomotor restlessness syncope Syncope, dysgeusia  myoclonus,  coordination abnormal*, and balance disorder* dyskinaesia*

convulsion Convulsion,  neuroleptic malignant syndrome (NMS)*, serotonin syndrome*, dystonia*

Tardive dyskinesia*

 Neuroleptic malignant syndrome (NMS), serotonergic syndrome, extrapyramidal disorder including dystonia and dyskinaesia, tardive dyskinaesia,

Eye disorders

 

 

 

 

Accommodation disorder,  including vision blurred, mydriasis, visual

impairment  including vision blurred

 

Angle-closure

glaucoma*

 

 

 

Angle-closure

glaucoma

 

 

Ear and labyrinth disorders

 

Tinnitus*

 

 

 

Vertigo

Cardiac disorders

 

 

 

 

Palpitations*, Tachycardia

 Tachycardia

Ventricular

fibrillation,

ventricular

tachycardia*,

Torsade

de pointes*, Electrocardiogram QT prolonged

 

 

 

Ventricular

fibrillation,

ventricular

tachycardia*,

(including torsade

de pointes)

 

Vascular disorders

 

Hypertension, hot flush Vasodilation (mostly flush)

Orthostatic hypotension, hypotension*

 

 

 Hypotension, Bleeding (mucous membrane bleeding)

Respiratory, thoracic and mediastinal disorders

 

 

Dyspnoea* Yawning

 Dyspnoea*

Interstitial lung disease*, pulmonary

eosinophilia*

 

 pulmonary

 

eosinophilia

 

 

Gastrointestinal disorders

Nausea, dry mouth, constipation

Constipation, vVomiting, diarrhoea

Gastrointestinal haemorrhage*

Pancreatitis*

 

 

 

Pancreatitis

 

 

Hepatobiliary disorders

 

 

Liver function test abnormal*

Hepatitis*

 

 

 

Hepatitis,

 

Liver function test abnormal*

 

 

 

 

Skin and subcutaneous tissue disorders

 

 

Hyperhidrosis*

(including night

sweats)*

 

Rash,

pruritus*

Angioedema*, photosensitivity reaction, ecchymosis, rash, alopecia*,

urticaria*

Stevens-

Johnson syndrome*, erythema multiforme*, toxic

epidermal

necrolysis*

 

 

 

Erythema

multiforme, Toxic

epidermal

necrolysis, Stevens-

Johnson syndrome,

pruritus, urticaria

 

Musculoskeletal and connective tissue disorders

 

Hypertonia

 

Rhabdomyolysis*

 

 

 

Rhabdomyolysis

 

 

Renal and urinary disorders

 

Urinary hesitation,  urinary

retention, pollakiuria*

Urinary incontinence*

 

 

 

Reproductive system and breast disorders

 

Menstrual disorders associated with increased bleeding or irregular bleeding (e.g. menorrhagia
Menorrhagia*, metrorrhagia*), Eejaculation disorder, Eerectile dysfunction

 

 

 

 

General disorders and administration site conditions

 

Asthenia, fatigue,

chills*

 

 

Muccosal haemorrhage*

 

Investigations

 

Blood cholesterol, increased weight increased, weight decreased

 weight increased

 

Bleeding time prolonged*

 Electrocardiogram QT prolonged, bleeding time prolonged, blood prolactin increased
 














































































 

* ADR identified post-marketing In pooled clinical trials, the incidence of headache with venlafaxine and placebo were similar.
a** Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 4.4).
b***  see See section 4.4
c In pooled clinical trials, the incidence of headache with venlafaxine and  placebo were similar.

6.5 Nature and contents of container
PVC/PE/PVDC/Aluminium foil blister packs of 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, 500, 1000 and multipacks containing 90 (3 packs of 30) or 100 (2 packs of 50)  capsules and HDPE Bottles of 60 ml,  100 ml, 400 ml, 600 ml containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100 and 250 capsules.

7. MARKETING AUTHORISATION HOLDER
McDermott Laboratories Ltd. t /a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13












 

Updated on 08 February 2018

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 January 2017

Reasons for updating

  • 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

6.5 Nature and contents of container

PVC/PE/PVDC/Aluminium foil blister packs of 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, 500, 1000 and multipacks containing 90 (3 packs of 30) or 100 (2 packs of 50) capsules and HDPE Bottles of 60 ml,  100 ml, 400 ml, 600 ml containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100 and 250 capsules.

Updated on 11 January 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 19 August 2015

Reasons for updating

  • Change to product name

Updated on 24 July 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • 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

Extensive updates to the SmPC in line with the brand leader and QRD template as part of the renewal application.

Updated on 08 May 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 03 October 2014

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 25 July 2011

Reasons for updating

  • Change due to harmonisation of SPC
  • Introduction of new pack/pack size

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

Free text change information supplied by the pharmaceutical company

Changes due to harmonisation of SPC, PIL as result of Article 30(2) referral & PhVWPCMDh decision. Addition of HDPE bottles.

Updated on 28 May 2009

Reasons for updating

  • Change of trade or active ingredient name
  • Change to further information section
  • Change to date of revision

Updated on 10 February 2009

Reasons for updating

  • New PIL for new product

Updated on 09 February 2009

Reasons for updating

  • New SPC for new product

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