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Minulet 75 micrograms/30 micrograms Coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    EthinylestradiolGestodene

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

Updated on 16 January 2023

File name

Reg SPC MN 16_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

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

Updated on 16 January 2023

File name

Reg PIL MN 18_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 6 - date of revision

Updated on 16 August 2022

File name

Reg SPC MN 15_1 IE clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 12 August 2022

File name

Reg PIL MN 17_1 IE clean.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 29 June 2021

File name

DEC202143515_Reg SPC MN 14_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

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:

Below sections have been updated to include drug- drug interaction with glecaprevir/pibrentasvir;

Section 4.3- Contraindications

Section 4.4- Special warnings and precautions for use

Section 4.5- Interaction with other medicinal products and other forms of interaction

Updated on 29 June 2021

File name

DEC202143515_Reg PIL MN 16_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
  • Correction of spelling/typing errors

Updated on 21 November 2019

File name

DEC201964540_Reg SPC MN 12_1 IE_clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

 

Section 2: Include sodium calcium edetate as an excipient of a known effect with the amount

Section 4.4: In line with the PRAC recommendation adopted in October 2019 plenary on suicidality with hormonal contraceptives (EMA/PRAC/689235/2018)

Section 5.1: To clarify the mechanism of action (MOA)

 

Updated on 21 November 2019

File name

DEC201964540_Reg PIL MN 14_1 IE_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains

Updated on 28 November 2018

File name

Reg SPC MN 11_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_MN_11_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 02 May 2018

File name

Reg_SPC_MN_11_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 MN 13_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_8438_250.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 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 22 March 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 11 May 2016

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • 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, 5.1, 5.2, 5.3, 6.1, 6.5, 9 and 10  updated in line with QRD v10, along with minor formatting and editorial corrections

Updated on 09 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 21 November 2014

Reasons for updating

  • Change to appearance of the medicine
  • Change to name of manufacturer
  • Correction of spelling/typing errors

Updated on 20 October 2014

Reasons for updating

  • 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

Section 4.8 – updated with HPRA details

Updated on 16 October 2014

Reasons for updating

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

Updated on 23 July 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 – addition of aluminium foil pouch together with a silica gel desiccant sachet.

Section 10 – date of revision updated

Updated on 16 July 2014

Reasons for updating

  • Change to packaging
  • Change of manufacturer
  • Change to date of revision

Updated on 18 February 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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


Updates to sections: 2, 4.1 - 4.6, 4.8, 5.1 6.6, 9, 10

Updated on 10 February 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 09 December 2011

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Update to Section 6.4 of SmPC – Special precautions for storage

Updated on 09 December 2011

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 22 November 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 July 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 7 - MAH address change
Section 8 - PA number change
Section 10 - Revision of text

Updated on 15 July 2011

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Addition of marketing authorisation holder

Updated on 08 March 2011

Reasons for updating

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

Updated on 02 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 15 January 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 - addition of strength of the medicinal product to the Trade name
Section 2 - Quantities of excipients added
Section 9 - Addition of Renewal date
Section 10 - Update to date of revision

Updated on 15 January 2010

Reasons for updating

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

Updated on 12 March 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 07 March 2007

Reasons for updating

  • Change to marketing authorisation holder address
  • Change to dosage and administration
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 17 January 2007

Reasons for updating

  • 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

7.  MARKETING AUTHORISATION HOLDER - 'Trading as: Wyeth Laboratories' has been changed to 'Trading as Wyeth Pharmaceuticals'.

Updated on 31 October 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 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 25 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 26 April 2004

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Updated on 06 June 2003

Reasons for updating

  • New SPC for medicines.ie

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