Fastum 2.5% w/w gel

Product Information *

  • Company:

    A. Menarini Pharmaceuticals Ireland Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01 August 2019

File name

ie-leaflet Fastum Gel leaflet approved QRD 20-10-15 clean_1561038800.pdf

Reasons for updating

  • XPIL Created

Updated on 01 August 2019

File name

ie-spc Fastum Gel IE approved QRD 20-10-15 clean_1564671181.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to pdf

EDM Updated on 25 July 2019

File name

Patient education leaflet - Fastum_1561038670.pdf

Reasons for updating

  • Add New Doc

Updated on 20 June 2019

File name

ie-leaflet Fastum Gel leaflet approved QRD 20-10-15 clean_1561038800.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 29 October 2015

Reasons for updating

  • New SPC for new product

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

Updated on 29 October 2015

File name

PIL_7919_66.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 October 2015

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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 4.6 - Pregnancy and lactation
  • 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)

Free text change information supplied by the pharmaceutical company

Update to sections 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.8, 5.2, 6.6 & 7 of the SmPC to align to the latest QRD template.  Includes an update to section 4.8 on the reporting of suspected adverse reactions.

 

Updated on 29 October 2015

Reasons for updating

  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 16 December 2014

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 12 March 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 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

SmPC: main changes:

 

Information added:

 

4.3       Contra-indications

·        pathological skin changes such as eczema or acne or on infected skin

·        third trimester of pregnancy

 

4.4              Special warnings and precautions:

·        Isolated cases of systemic adverse reactions consisting of renal dysfunction have been reported.

·        The treatment should be interrupted if rash appears.

·        The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increasing over time.

·        Duration of treatment should be kept to a minimum as the risk of developing contact dermatitis and photosensitivity reactions increases over time.

·        The gel must not come into contact with mucous membranes or the eyes.

·        Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population.

 

Paediatrics: The safety and efficacy of ketoprofen gel in children have not been established.

 

Information updated:

 

4.4      Special warnings and precautions:

·        It is recommended to avoid exposure to direct sunlight including solarium (sunbeds), and to protect treated areas by wearing clothing during treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation. (Note the warning re avoiding sunlight is included under section 4.3 Contra-indications)

 

4.6       Fertility, pregnancy and lactation

 

As there has been no such experience with the topical formulation, the following is stated according to the systemic formulation:

 

Pregnancy

During the first and second trimester:

In mice and rats, there is no evidence of teratogenic or embryotoxicity. In the rabbit, slight embryotoxicity likely related to maternal toxicity has been reported.

As the safety of ketoprofen in pregnant women has not been evaluated, the use of ketoprofen during the first and second trimester of pregnancy should be avoided.

 

During the third trimester of pregnancy:

All prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy, prolonged bleeding time in both the mother and child may occur. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.

 

Lactation

No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

 

4.7       Effects on ability to drive and use machines

Not known.

 

4.8       Undesirable effects

New side-effects added: eczema, angioedema, renal insufficiency aggravated

Frequency changed: erythema, pruritus, burning sensation, photosensitivity reaction, dermatitis bullous, urticaria.

4.9       Overdose

Overdose is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be symptomatic and supportive in accordance with overdosage of oral anti-inflammatories.

 

Updated on 12 March 2013

Reasons for updating

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

Updated on 16 November 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 24 June 2011

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Update to the following sections:

4.2 Posology and method of administration:
Product is now approved for prescription use only.

4.3 Contraindications
Contraindications updated and the following statements added:

History of any photosensitivity reaction.
Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs.
History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes.
Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation.
Hypersensitivity to any of the excipients of the product.

4.4 Special warnings and precautions
Warnings updated and the following statements added:

Hands should be washed thoroughly after each application of the product.
Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene containing products.
It is recommended to avoid exposure to direct sunlight including solarium (sunbeds), and to protect treated areas by wearing clothing during treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation.

4.8 Undesirable effects.
Sentence added: Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
2 new side-effects added: hypersensitivity reaction and burning sensation.

Updated on 23 June 2011

Reasons for updating

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

Updated on 30 November 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 July 2008

Reasons for updating

  • Introduction of new pack/pack size

Updated on 06 November 2007

Reasons for updating

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

Updated on 06 November 2007

Reasons for updating

  • 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 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 - hypersensitivity warning amended

Section 4.4 - updated warning to keep out of the reach and sight of children

Section 4.8 - section updated and adverse reactions tabulated

Section 5.1 - section updated

Section 5.2 - section updated

Section 10 - date of revision updated

Updated on 18 September 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Section 9: Date of last renewal

Updated on 18 September 2007

Reasons for updating

  • Change to date of revision

Updated on 23 November 2006

Reasons for updating

  • Change to date of revision

Updated on 23 November 2006

Reasons for updating

  • 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

Section 6.5 New pack size. 

Updated on 25 May 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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

Updated on 25 May 2005

Reasons for updating

  • Change to, or new use for medicine
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to storage instructions
  • Change to packaging

Updated on 05 August 2004

Reasons for updating

  • New PIL for new product

Updated on 04 August 2004

Reasons for updating

  • New SPC for new product

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