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Loniten 5 mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland Unlimited Company

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Minoxidil

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

Updated on 17 October 2024

File name

Reg PIL LN 22_0 IE clean.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address

Updated on 17 October 2024

File name

Reg SPC LN 15_0 IE clean.pdf

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

The SPC has been updated as follows:

Section 7 Change of MAH name and address. 


Updated on 14 February 2023

File name

DEC202080340_Reg SPC LN 14_0 IE clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 26 January 2022

File name

Reg PIL LN 21_0 IE clean.pdf

Reasons for updating

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

Updated on 19 January 2022

File name

Reg PIL LN 21_0 IE clean.pdf

Reasons for updating

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

Updated on 02 December 2020

File name

DEC202080340_Reg SPC LN 14_0 IE clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 14 October 2020

File name

DEC202068502_Reg SPC LN 13_0 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

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

Updated on 06 October 2016

Reasons for updating

  • New SPC for new product

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

Updated on 06 October 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Section 3, change to “white to light tan”

Section 6.4, addition of: “Store in the original package in order to protect from moisture”

Updated on 05 October 2016

File name

PIL_10719_535.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 October 2016

Reasons for updating

  • Change to storage instructions
  • Change to appearance of the medicine

Updated on 04 March 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 18 February 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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 QRD template, section: 1, 4.2, 4.3, 4.4, 4.8, 5.1, 5.2, 5.3, 6.4, 6.5,

Updated on 18 February 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 03 November 2015

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 18 June 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

sections 4.2 & 5.2 – Information on use in hepatic impairment added

Updated on 10 June 2014

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 09 April 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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; 3; 4.1; 4.2; 4.4; 4.6; 4.8 5.1; 5.2; 5.3

Updated on 08 April 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 07 April 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 06 February 2014

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.6/4.8/5.1/5.2/5.3

Updated on 30 September 2013

Reasons for updating

  • 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

Update to section 5.1  to include the text  in line with current Core Safety Profile. 

Updated on 18 September 2013

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)

Free text change information supplied by the pharmaceutical company

SPC – sections 4.4 & 4.8

Updated on 18 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to dosage and administration
  • Improved electronic presentation

Updated on 24 May 2013

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.6 is revised to contain updated information on pregnancy; Section 4.8 update to adverse reactions

Section 5.1, 5, 2 and 5.3 are updated to contain relevant information for minoxidil.

 

Updated on 16 May 2013

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 30 November 2012

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
  • 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 4.3 (Contraindications); 4.4 (Special warnings and precautions  ); 4.5 (Drug interactions) 4.6 (Fertility, Preg and lactation); 4.8 (undesirable effects); 4.9 (Overdose) 10 (date of revision of text).

Updated on 22 November 2012

Reasons for updating

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

Updated on 26 September 2012

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Update to section 7: Name and address of MAH holder; from Pharmacia to Pfizer Healthcare Ireland
Update Section 8 MA number

Updated on 17 September 2012

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 24 October 2011

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC changes to section 7 -  MA Holder’s name change and Section 10 – revision date.

Updated on 20 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 14 June 2011

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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Section 4.4 – Additional information relating to renal failure and dosing.
Section 4.6 – Pregnancy information has been completely revised.
Section 4.7 – Common statement added.
Section 4.8 – Side effects section updated to include frequencies and MeDRA SOC terms.
Section 5.3 – New section added, includes cardiac lesions, reproductive toxicity and a teratogenicity statement.

Updated on 13 June 2011

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to appearance of the medicine
  • Correction of spelling/typing errors

Updated on 02 June 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • 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 2 – Addition of lactose information and reference to excipients.
Section 3 – Addition “The score line has no practical function; these tablets should not be broken in half.”
Section 4.6 – Minor heading change.
Section 4.8 – Minor formatting changes.

Updated on 01 June 2011

Reasons for updating

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

Updated on 01 March 2011

Reasons for updating

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

Updated on 24 February 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 16 September 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 09 September 2008

Reasons for updating

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

Section 4.4 - Addition of lactose warning

Section 4.8 - Undesirable effects categorised to MedDRA terminology 

Section 5.1 - Addition of the ATC code.

Updated on 22 January 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

4.2 (posology and method of administration) BAN to INN change - Chlorthalidone to Chlortalidone and Frusemide to Furosemide

 

4.5 (Interactions) BAN to INN change  – bethanidine to betanidine

Updated on 26 July 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 Heading updated as per guidelines

Section 4.1 Addition of text

Section 4.2 Addition of higher dosage limits

Section 4.2 Update to dosage for renal failure or dialysis

Section 4.2 Update to dosage for children

Section 4.3 Addition of contraindication for hypersensitivity reaction to any components of preparation

Section 4.4 Addition of advice to monitor bodyweight, fluid and electrolyte balance

Section 4.4 Deletion of advice regarding cardiac output

Section 4.4 Addition of reports of thrombocytopenia and leukopenia

Section 4.4 Addition of reports of pericarditis

Section 4.4 Update and rewording of reports of pericardial effusion

Section 4.5 Heading updated as per guidelines

Section 4.5 Addition of information regarding guanethidine

Section 4.8 Addition of Stevens Johnson syndrome and Bullous eruptions

Section 6.6 Heading updated as per guidelines

Section 10 Revision date updated

Updated on 26 July 2006

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 20 February 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 February 2006

Reasons for updating

  • New SPC for medicines.ie

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