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Ovranette 150micrograms/30micrograms Coated Tablets

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Pharmacy Only: Prescription

Updated on 29 November 2022

File name

Reg SPC OT 11_1 IE clean.pdf

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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 November 2022

File name

Reg SPC OT 10_1 IE clean.pdf

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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 November 2022

File name

Reg PIL OT 15_1 IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect

Updated on 12 August 2022

File name

Reg SPC OT 10_1 IE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2020

File name

DEC202051407_Reg SPC OT 9_2 IE cl.pdf

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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Update to sections 4.4 and 4.8 to specify types of angioedema

Update to sections 4.3, 4.4 and 4.5 to add interaction with hepatitis c antivirals

Updated on 31 July 2020

File name

DEC202051407_Reg PIL OT 14_2 IE cl.pdf

Reasons for updating

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

Updated on 31 July 2020

File name

DEC202051407_Reg PIL OT 14_2 IE cl.pdf

Reasons for updating

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

Updated on 31 July 2020

File name

DEC202051407_Reg PIL OT 14_2 IE cl.pdf

Reasons for updating

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

Updated on 04 November 2019

File name

DEC201960403_Reg PIL OT 13_1 IE_CLEAN.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 31 October 2019

File name

DEC201960403_Reg SPC OT 8_1 IE_CLEAN.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 November 2018

File name

Reg SPC OT 7_2 IE.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 August 2018

File name

Reg_SPC_OT_7_2_IE_cl.pdf

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Update to sections 4.3, 4.4 and 4.5 for the inclusion of a contra indication regarding an interaction between combined hormonal contraceptives containing ethinylestradiol with the medicinal products containing ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir with or without ribavirin agreed by CMDh in January 2017.

Updated on 10 May 2018

File name

Reg_SPC_OT_7_2_IE_cl.docx

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Update to sections 4.3, 4.4 and 4.5 for the inclusion of a contra indication regarding an interaction between combined hormonal contraceptives containing ethinylestradiol with the medicinal products containing ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir with or without ribavirin agreed by CMDh in January 2017.

Updated on 26 April 2018

File name

Reg PIL OT 12_2 IE cl.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 24 May 2017

File name

PIL_8439_47.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 May 2017

Reasons for updating

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

Updated on 23 May 2017

Reasons for updating

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

Updated on 23 March 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 March 2017

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5: details referring to antibiotic interaction have been removed

Section 10: date of revision of text updated to 03/2017

Updated on 21 March 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 01 September 2016

Reasons for updating

  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 18 August 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

Sections 1, 2, 3, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 6.1, 6.3, 6.5, 6.6, 7, 9 – administrative update in line with QRD9

Section 10 – date last revised updated

Updated on 17 August 2015

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 September 2014

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5: Clarification of the primary and secondary packaging materials

Section 10: Date of revision of text

Updated on 10 September 2014

Reasons for updating

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

Updated on 09 April 2013

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to bring the SPC’s in line with Core Safety Profile

Updated on 03 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 24 January 2012

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 20 January 2012

Reasons for updating

  • Change to date of revision

Updated on 23 May 2011

Reasons for updating

  • Change of licence holder

Updated on 19 May 2011

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MAH address change in section 7, PA number change section 8.

Updated on 08 March 2011

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 04 February 2011

Reasons for updating

  • Change to section 4 - Clinical particulars

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

There are several changes to section 4 of the SPC

Updated on 01 February 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 02 February 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1 - the strength of each of the active ingredients has been added to the trade name

Section 9 - the renewal date has been updated

Section 10 - the date of revision has been updated

Updated on 02 February 2010

Reasons for updating

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

Updated on 26 March 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - addition of excipient information
Section 3 - update to tablet description to include the new tablet colour
Section 6.1 - update to excipients
Section 10 - update to date of revision

Updated on 26 March 2009

Reasons for updating

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

Updated on 29 October 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2: Addition of excipient information
Section 6.1: Addition of full list of excipients
Section 10: Update to date of revision

Updated on 29 October 2008

Reasons for updating

  • Change of inactive ingredient
  • Change to appearance of the medicine

Updated on 23 August 2007

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.1 - Removal of excipient that had been listed twice

Updated on 01 November 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to drug interactions
  • Change to date of revision

Updated on 30 October 2006

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3
 
Addition of 'aura'  to list of contraindications
 
Section 4.4
 
WARNINGS
Deletion of 'Certain inherited and acquired thrombophilias' in a. Myocardial Infarction of  1. Thromboembolic Disorders and Other Vascular Problems
 
Addition of 'Transient ischaemic attacks have also been associated with oral contraceptive use.' in c. Cerebrovascular Disease under
1. Thromboembolic Disorders and Other Vascular Problems
 
PRECAUTIONS FOR USE
 
New text added to

2. Lipid Disorders
'A small proportion of women will have adverse lipid changes while taking oral contraceptives.  Persistent hyperglyceridemia  may occur in a small proportion of COC users. Elevations of plasma triglycerides may lead to pancreatitis and other complications.'
 
and
 
'Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias (see WARNINGS).'
 
 Section 4.5
 
Additon of 'Atorvastatin' and 'Substances that inhibit cytochrome P450 isoenzymes, such as indinavir, fluconazole and troleandomycin' to examples of substances that may increase serum EE concentrations
 
cyclosporine changed to ciclosporin
 
Section 4.9
 
Section revised to read  "Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms."
 

Updated on 27 July 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 22 July 2005

Reasons for updating

  • 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 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 February 2004

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 03 December 2003

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)