Fastum 2.5 % gel
Cardiovascular Risk :
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events. myocardial infarction and stroke which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may
be at greater risk. N5AI0s are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CA6G) suryery.
Gastrointestinal Risk :
NSAIDs may cause an increased risk of serious gastrointestinal adverse events induding inflammation, bleeding. ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any lime during use and without warning symptoms. Elderty patients are at greater risk for serious
1-NAME OF THE MEOICINAL PROOUCT :
Fastum 2.5°,4 gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION :
Fastum gel contains ketoprofen 2.5 g/100 g.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM :
A colourless , non greasy , non-staining gel with an aromatic fragrance for topical application.
4. CLINICAL PARTICULARS :
4.1 Therapeutic Indications
For local relief of pain and inflammation associated with soft tissue injuries and acute strains and sprains.
4.2 Posology and method of administration
– Fastum shoutd be applied toptcally to the affected area two or three times daity. Maxhnum duration of use shoutd not exceed 12 days. Fastum should be applied with gentle massage onty.
– Aduhs and elderly: Tube: Apply 5 to 10 cm of gel (100- 200 mg ketoprofen) with each application.
– Children under 12 years of age: Not recommended as experience in children is limited .
Hypersensitivity to the active ingred;ent. to any of the excipients or to other substances which are dosely related to these chemically, such as acetyl salicylic acid or other non-steroid anti-inflammatory drugs and fenofibrate.
Ketoprofen gel shook( not be administered to patients in whom acetyt salicylic acid or other NSAIDs have caused asthma, rtlinitis or urticaria .
Ketoprofen gel should not be applied to open wounds or lesions of the sIOn. or near the eyes.
4. 4 Special warnings and precauttons for use :
– Discontinue use if skin rash devefops.
– Hands should be washed immediately after use.
– D0 not use with occlusive dressing. -Topical applicatlon of large amounts may result in systemic effects, including hypersensitivity and asthma.
– Ketoprofen gel should be used with caution in patients with serious kidney failure.
– The use of topical products. especially if it is prolonged, may give rise to phenomena of sensitisatoo Of local irritation.
– To prevent any phenomena of hypersensitivity or photosensitivity, avoid exposure to direct sunlight, including solarium (sunbeds), during the treatment and for 2 weeks afterwards.
– Keep out of the reach and sight of children .
– P” warning: If symptoms persist after 12 days, consult your doctor.
– Undesirable events may be minimized by using the lowest effective dose for the shortest possible duration necessary to control symptoms.
4.5 Interaction with other medicinal products and other fonns of Interaction:
No interactions of Fastum with other drugs have been reported. It is. however, advisable to monitor patients under treatment with coumarinic substances.
4.6 Pregnancy and lactation
Fastum should not be used during pregnancy and lactation.
No embryopathic effects have been demonstrated in animals but epidemiological data give no dear evidence of the safety of ketoprofen in human pregnancy. Clinical data show that the use of NSAIDs during the final three months of pregnancy may cause pulmonary and cardiac toxicity in the foetus. NSAIDs can also delay birth when administered during pregnancy.
lactation:After systemic administration, traces of ketoprofen have
been detected in mothers’ milk.
4.7 Effects on ability to drive and use machines
No effects on the ability to drive and use machinery have been reported.
4.8 Undesirable effects
There have been reports of localised skin reactions which might subsequently spread beyond the area of application and in isolated cases be severe and generalised. Other systemic effects of anti·inflammatory drugs: hypersensitivity, gastrointestinal and renal disorders (these depend on the transdermic spreading of the active
ingredient, hence on the amount of gel applied, on the surface involved, on the degree of intactness et the skin, on the duration of the treatment and on the use of occfusive bandages).Since marlteting, the following adverse reactions have been reported. They have been listed according to classes of organ and system and classified according to their frequency as foflows: very common (equal to or above 10%); common (ranging between 1% and 10 %), uncommon (ranging between 0.1% and 1%), rare (ranging between 0.01% and 0.1%); very rare (below 0.01%), including isolated reports.
Elderly patients are particular1y susceptible to the adverse effects of non-steroidal anti-inflammatory drugs.
Considering the low blood levels of ketoprofen by the percutaneous route. no overdosaqe phenomena have been described yet.
5. PHARMACOLOGICAL PROPERTIES :
5.1 Pharmacodynamic properties
Pharmacotherapeutic category: non-steroid anti- inflammatory drug for topical use.
ATe code: M02AA10
Ketoprofen ts an inhibitor of both the cyclo-oxygenase and lipoxygenase pathways. Inhibition of prostaglandin synthesis provides for potent anti-inflammatory, analgesic and antipyretic effects. Lipoxygenase inhibitors appear to attenuate cell-mediated inflammation and thus retard the progression of tissue destruction in
inflamed joints. In addition, Ketoprofen is a powerful inhibitor of bradykinin (a chemical mediator of pain and inftammation), it stabilises lysosomal membranes against osmotic damage and prevents the release of lysosomal enzymes that mediate tissue destruction in Inflammatory reactions.
5.2 Pharmacoklnetic properties
After oral administration of a single dose. maximum blood concentrations are achieved within 2 hours. Ketoprofen plasma half·life ranges from 1 to 3 hours. Plasma protein binding is 60%·90%. Elimination is mainly by urinary route and in glucuronated form; approximately 90% of the amount administered is excreted within 24 hours.
By cutaneous route, absorption is instead very low. In fact the percutaneous application of 5()..150 mg of ketoprofen produces plasma levels of the active ingredient of 0.08· 0.15 mg/mLapprox. 5-8 hours after application. Fastum allows the site specific topical delivery of ketoprofen with very low plasma concentrations of drug. Therapeutic $evels in the affected tissues provide relief from pain and inflammation, yet will satisfactorily overcome the problem of significant systemic unwanted effects.
5.3 Preclinical safety data
In animal trials no embryopathic effects have been found, while there is no epidemiological evidence of the safety of ketoprofen in human pnignancy. In preclinical and clinical trials on Ketoprofen no serious adverse effects have been observed, although anecdotal cases of systemic adverse reactions have been desaibed. There are no preclinical data of relevance to the prescriber which are additional to that already included in other parts of the SPC.
6. PHARMACEUTICAL PARTICUlARS
6.1 List of excipients
Fasturn contains the following excipients: carbomer 940. ethanol. neroli essence, lavender essence. trolamine, purified water.
6.3 Shelf life
Tube: 36 months.
6.4 Special precautions for storage
Store at temperature not exceeding 300e.
6.5 Nature and contents of container
Aluminium tube. The tubes are packed in carton box
together with a package insert. The following pack sizes
are approved:P: 15. 50 and 60g pack
6.6 Special precautions for disposal and other handling:
Manufactured by :
Minapharm for Pharmaceuticals & chemicals industries under license of Menarini – Italy.