Summary of medicine characteristics - TRAXAM 3%W/W GEL, FELBINAC 3% W/W GEL
Traxam 3% w/w Gel
Felbinac 3% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient:
Felbinac 3% w/w
Excipient(s) with known effect Ethanol-300 mg/g
For the full list of excipients, see section 6.1.
A clear non-greasy, non-staining gel containing 30mg felbinac in each gram.
4.1 Therapeutic indications
Prescription Only Medicine
This medicine is a topical anti-inflammatory and analgesic. It is indicated for the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions.
This medicine may be used as a coupling agent for ultrasound where both treatments are indicated.
4.2 Posology and method of administration
Posology
Rub 1g of this medicine (approximately 1 inch (2.5cm) of gel) into the affected area(s) 2 to 4 times a day. If symptoms do not resolve within 14 days, the patient should be reviewed.
The total daily dose should not exceed 25g per day irrespective of the number of affected areas.
Elderly: No special dosage recommendations are made for elderly patients.
Paediatric population: Safe use of this medicine in early childhood has not been established.
Method of administration
Topical application to affected area.
Hands should be washed following application of this medicine unless they are the treatment site.
4.3 Contraindications
Prescription Only Medicine
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs.
4.4 Special warnings and precautions for use
Use of this medicine should be limited to intact and non-diseased skin. Contact with mucous membranes and the eyes should be avoided.
Discontinue if rash develops.
This medicine should not be applied with occlusive dressings at the same site as other topical preparations.
Topical application of large amounts may result in systemic effects, such as hypersensitivity, asthma and renal disease.
To avoid the possibility of photosensitivity, patients should be advised against excessive exposure to sunlight of treated areas.
Safe use of this medicine in early childhood has not been established.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
4.5 Interaction with other medicinal products and other forms of interaction
Felbinac is highly protein bound. However, serum levels following topical application are extremely low and therefore clinical drug interactions are unlikely.
Concurrent use of aspirin or other NSAIDs may result in an increased incidence of adverse reactions.
4.6 Fertility, pregnancy and lactation
Pregnancy and Breast-feeding
Since the safety of felbinac in human pregnancy and lactation has not been established, its use in these circumstances is not recommended. As with other nonsteroidal anti-inflammatory agents which inhibit prostaglandin synthesis, dystocia and delayed parturition were observed when felbinac was administered simultaneously in animal studies.
4.7 Effects on ability to drive and use machines
Not relevant
4.8 Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: common (>1/100, <1/10), rare (>1/10,000, <1/1000), Not known (cannot be estimated from the available data).
The overall incidence of side effects reported with this medicine is low (less than 2%).
| MedDRA System Organ Class | Frequency | Undesirable Effects |
| Immune system disorders | Rare | Hypersensitivity reactions such as widespread rashes (including urticaria) and bronchospasm |
| Not known | Anaphylaxis | |
| Nervous system disorders | Common | Paraesthesia which recover spontaneously upon cessation of treatment are the most common reactions. |
| Respiratory, thoracic and mediastinal disorders | Not known | Respiratory reactivity comprising asthma, aggravated asthma or dyspnoea |
| Gastrointestinal disorders | Rare | Gastrointestinal disturbances |
| Skin and subcutaneous tissue disorders | Common | Mild erythema, irritation, dermatitis, pruritis which recover spontaneously upon cessation of treatment are the most common reactions. |
| Not known | Purpura, angioedema, bullous dermatoses (including epidermal necrolysis and erythema multiforme) and skin photosensitivity. |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseIf accidentally ingested, treatment should be symptomatic and supportive. Correction of severe electrolyte abnormalities should be considered.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Topical products for joint and muscular pain, ATC code: M02AA08
Felbinac is an anti-inflammatory/analgesic agent which has been developed into a topical gel for local treatment and pain and inflammation associated with conditions of the musculo-skeletal system.
5.2 Pharmacokinetic properties
Absorption
Clinical pharmacokinetic studies show that a topical dose of 10g of this medicine results in low circulating levels of felbinacin serum (600ng/ml). This is more than 20 times less than the levels recorded following oral administration of a single dose of 600mg fenbufen.
Distribution
Results of distribution studies demonstrate that felbinac is transferred preferentially to a site of inflammation when applied topically.
Biotransformation
The metabolism of felbinac is consistent with the known metabolic profile of fenbufen.
5.3 Preclinical safety data
5.3 Preclinical safety dataTesting of biphenylacetic acid includes single and repeat dose studies, foetal toxicity and fertility studies, mutagenic and carcinogenic potential studies which show an acceptable toxicity profile for the active ingredient.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbomer
Diisopropanolamine
Ethanol (96%)
Purified Water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
1. Fluorovinyl resin-coated blind ended Aluminium Tubes with a plastic cap-
18 months
2. LDPE/Aluminium Foil/LDPE laminate tubes with a plastic cap:
18 months
3. Polyamide-imide or epoxyphenolic coated blind ended aluminium tubes with a plastic cap:
18 months
4. In use shelf life – Once opened, use within 1 month
6.4 Special precautions for storage
Do not store above 25°C.
Keep the tube tightly closed
6.5 Nature and contents of container
This medicine is packed in fluorovinyl resin coated blind ended Aluminium Tubes with a Polypropylene cap, LDPE/Aluminium Foil/LDPE laminate tubes with a polypropylene cap or Polyamide-imide or epoxyphenolic coated blind ended aluminium tubes with a polypropylene cap.
Pack sizes: 50g, 100g (Prescription Only)
Not all pack sizes may be marketed
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements for disposal
7 MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 12762/0085
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
31/03/2009