1. Name Of The Medicinal Product
Difflam Cream
or
Difflam-P Cream
2. Qualitative And Quantitative Composition
Each tube of Difflam Cream/ Difflam-P Cream contains Benzydamine Hydrochloride 3% w/w.
3. Pharmaceutical Form
Cream.
4. Clinical Particulars
4.1 Therapeutic Indications
Difflam Cream/ Difflam-P Cream is a topical analgesic and non-steroidal anti-inflammatory agent.
It is recommended as a short-term treatment for the relief of symptoms associated with painful inflammatory conditions of the musculo-skeletal system, including:
Acute inflammatory disorders such as myalgia and bursitis.
Traumatic conditions such as sprains, strains, contusions and the after-effects of fractures.
Difflam Cream/ Difflam-P Cream is well absorbed through the skin and has been shown to have anti-inflammatory and local anaesthetic actions.
4.2 Posology And Method Of Administration
Difflam Cream/ Difflam-P Cream should be massaged lightly into the affected area. Depending on the size of the site to be treated, 35 - 85 mm (1 - 2 g) should be applied three times daily and at the discretion of the doctor, up to six times daily in more severe conditions. It is recommended that treatment be limited to not more than ten days.
ELDERLY:
No special dosage recommendations are made for elderly patients.
4.3 Contraindications
Difflam Cream is contraindicated in patients with known hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
To avoid possible irritation, Difflam Cream/ Difflam-P Cream should be kept away from eyes and mucosal surfaces.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None.
4.6 Pregnancy And Lactation
Difflam should not be used in pregnancy or lactation unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
Photosensitivity reactions have been reported and local skin reactions which have varied from erythema to papular eruption. The skin returned to normal on stopping treatment.
4.9 Overdose
Difflam is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. No special measures are required.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis.
5.2 Pharmacokinetic Properties
Following topical administration, benzydamine is absorbed through intact skin and reaches peak levels between 24 - 32 hours, amounting to about 20 - 25% of the plasma levels obtained after the oral administration of the same dose.
About half of the benzydamine is excreted unchanged via the kidney at a rate of 10% of the dose within the first 24 hours. The remainder is metabolised, mostly to N-oxide.
5.3 Preclinical Safety Data
Non-Clinical Data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated toxicity, genotoxicity, cardiogenic potential, and toxicity to reproduction.
6. Pharmaceutical Particulars
6.1 List Of Excipients
'Cutina' MD
Cetyl Alcohol USNF
'Cetiol' V
'Eumulgin' B1
Propylene Glycol Ph Eur
Perfume, 'Crematest' 0/064060
Methyl Hydroxybenzoate Ph Eur
Propyl Hydroxybenzoate Ph Eur
Purified Water Ph Eur
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store between 5 - 30°C. Do not freeze.
6.5 Nature And Contents Of Container
Collapsible Aluminium tube closed with plastic screwcap
or
Laminate tube closed with plastic screwcap.
Contents: 35 g, 50 g or 100 g
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
249 West George Street
Glasgow
G2 4RB
Trading as:
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
8. Marketing Authorisation Number(S)
PL 15142/0044
9. Date Of First Authorisation/Renewal Of The Authorisation
6 March 1980/ 6 September 2002
10. Date Of Revision Of The Text
17th June 2011
No comments:
Post a Comment