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Gyno-Pevaryl Once 150mg vaginal pessary

*
Pharmacy Only: Non-prescription

  • Company:

    Karo Pharma AB

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Econazole Nitrate

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

Updated on 21 February 2023

File name

SmPC 20210702 Gyno-Pevaryl Depot pessaries IE.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

uploading anew to comply with the correct format

Updated on 21 February 2023

File name

PL 20210702 Gyno-Pevaryl Depot pessaries IE.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

uploading anew to comply with the correct format

Updated on 11 October 2021

File name

PL 20210702 Gyno-Pevaryl Depot pessaries IE.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Change to section 6 - Marketing authorisation holder

Change to section 6 - Date of revision

Updated on 11 October 2021

File name

SmPC 20210702 Gyno-Pevaryl Depot pessaries IE.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 7 - Marketing authorisation holder - (transfered from Janssen cliag to Karo Pharma AB)

Change to section 8 - Marketing authorisation Number.

Change to section 10 - Date of revision of text

 

Updated on 08 April 2019

File name

Gyno-pev Once-PIL-C14-29Mar19_clean.pdf

Reasons for updating

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

Updated on 08 April 2019

File name

Gyno-pev Once 150mg SPC-C11-29Mar19_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 23 December 2016

File name

PIL_10771_259.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 December 2016

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 June 2015

Reasons for updating

  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 03 November 2014

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 03 November 2014

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.6:  Deletion of wording re effects of the cream on pregnancy and addition of;

'Animal studies have shown reproductive toxicity (see section 5.3).'

'Fertility
Results of econazole animal reproduction studies showed no effects on fertility'

4.8: Reporting of suspected adverse reactions: IMB changed to HPRA and email address updated
5.3 Addition of 'Low neonatal survival and fetal toxicity was associated only with maternal toxicity. In animal studies, econazole nitrate has shown no teratogenic effects but was fetotoxic in rodents at maternal subcutaneous doses of 20 mg/kg/day and at maternal oral doses of 10 mg/kg/day. The significance of this in humans is unknown.'

10: 31 October 2014

Updated on 31 October 2014

Reasons for updating

  • Change to side-effects

Updated on 13 May 2014

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2:

In pregnant women, it is recommended that administration takes place without the use of the applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self-administering Gyno-Pevaryl Once 150mg vaginal pessaries.


4.4:

Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by this preparation.

 

Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.5).


4.5: Contact between latex products such as contraceptive diaphragms or condoms and this product must be avoided since the constituents of the product may damage the latex. Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.4).

4.8: Addition of wording re how to report adverse reactions

10: 08 May 2014

Updated on 12 May 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 12 May 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 04 November 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 12 July 2012

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 4.4: Added: For intravaginal use only
Change to section 4.5: Reworded. No new interactions.
Change to section 4.8: Revised table of ADRs and information on clinical trials.
Change to section 4.9: Cross reference to section 4.8 added.
Change to section 10: July 2012

Updated on 06 July 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 24 February 2011

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 23 February 2011

Reasons for updating

  • 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 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.3 Contraindications 

Hypersensitivity to any imidazole preparation, or other vaginal antifungal products or  to any ingredients of Gyno- Pevaryl Once150mg vaginal pessary.

4.4 Special warnings and precautions
addtion of:

Gyno-Pevaryl  vaginal pessary should not be used in conjunction with other internal or external treatment of the genitalia.Hypersensitivity has rarely been recorded; if it should occur, administration should be discontinued

4.5.      Interaction with other Medicaments and other forms of Interactions
Addition of :
Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole

4.6-Pregnancy and Lactation

addtion of 'because there is vaginal absorption'
and

Lactation 

Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Pevaryl 1 vaginal pessary  if the patient is breast-feeding


section 4.8 undesirable efects , side effect now in category (frequency not know.
#

4.9       Overdose This product is intended for vaginal use and by that route overdose is extremely unlikely.   If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.  Overdose with econazole nitrate has not been reported to date. In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically




Updated on 25 June 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 17 November 2009

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

3.

PHARMACEUTICAL FORM

Change of description from bullet to torpedo shaped. Removal of fat like odour

10.

DATE OF REVISION OF THE TEXT

 

Changed to  05 November 2009

 

Updated on 13 November 2009

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 16 October 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.3 - Shelf life
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 (name of the medicinal product) product name changed to Gyno-Pevaryl Once 150mg Vaginal Pessaries
Section 6 (parmaceutical particulars) fragments submitted to IMB
Section 6.3 (shelf life) changed from 5 years t0 3 years
Section 6.4 (special precautions for storage) changed to do not store above 30 deg C
Section 10 (date of revision of text) changed to October 2008
Update to PIL  PIL also updates

Updated on 16 October 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to date of revision

Updated on 09 April 2008

Reasons for updating

  • Change of licence holder
  • Change to marketing authorisation holder address

Updated on 07 April 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder

50 100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

Change to section 8 – Marketing Authorisation Numbers

 

Change to section 9 – Date of Renewal of Authorisation

 

Change to section 10 – Date of revision of the text

27th March 2006

Updated on 20 March 2006

Reasons for updating

  • 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 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 20 March 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only