Fastum 2.5% w/w gel
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 July 2023
File name
ie-spc Fastum Gel IE Clean Approved July 23.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.6 - Pregnancy warnings updated
Updated on 10 July 2023
File name
ie-leaflet Fastum Gel clean Approved July 23.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Section 2- Pregnancy warnings added
Updated on 24 August 2021
File name
ie-spc Fastum Gel IE clean approved August 21.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 - Excipients with known effect added
Section 4.3 - "known" added before hypersensitivity in first bullet point
Section 4.4 - Excipient warnings added
Section 4.8 - HPRA AE reporting details updated
Section 6.1 - Excipients updated
Section 6.3 - Shelf life for container updated from 24 to 36 months
Section 6.3 - Storage conditions updated
Section 10 - Date of revision updated
Updated on 24 August 2021
File name
ie-leaflet Fastum Gel leaflet clean Approved August 21.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Excipient warnings added for Ethanol and fragrances
Section 4 - AE reporting details for HPRA updated
Section 5 - Storage Conditions updated
Section 6 - Ingredients updated
Section 6 - Date of revision updated
Updated on 01 August 2019
File name
ie-leaflet Fastum Gel leaflet approved QRD 20-10-15 clean.pdf
Reasons for updating
- XPIL Created
Updated on 01 August 2019
File name
ie-spc Fastum Gel IE approved QRD 20-10-15 clean.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
File name
Patient education leaflet - Fastum.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.pdf
Reasons for updating
- Improved presentation of PIL
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
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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
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 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 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 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
Updated on 18 September 2007
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
Updated on 23 November 2006
Reasons for updating
- Change to date of revision
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)