|Composition||:||Pino 5%: Each 1 g Gel contains: Benzoyl Peroxide 50 mg.|
|Excipients||:||Gel vehicle of purified water, carbomer 940, 14% alcohol, sodium hydroxide, docusate sodium.|
|Pharmacodynamic properties||:||Benzoyl Peroxide is an established and effective keratolytic agent with antibacterial properties. It has been shown to be effective in reducing the local population of Propionibacterium acnes leading to a reduction in the production of irritant fatty acids in the sebaceous glands.|
|INDICATIONS||:||Pino is topical therapy for the treatment of acne vulgaris.|
|CONTRAINDICATIONS||:||Pino should not be used by patients having known Hypersensitivity to benzoyl peroxide or any of its components.|
|WARNINGS||:||For external use only.
This product may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.
A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days.
During the first weeks of treatment a sudden increase in peeling will occur in most patients.
This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued.
If severe irritation occurs, patients should be directed to use the medication less frequently or temporarily discontinue use or to discontinue use altogether.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.
This product should not come into contact with the eyes, mouth, angles of the nose or mucous membranes.
If the preparation enters the eye, wash thoroughly with water.
Caution should be exercised when applying the drug to the neck and other sensitive areas, this product may cause increased sensitivity to sunlight.
Sunlamps should not be used and deliberate or prolonged exposure to sunlight or UV radiation should be avoided or minimised.
When strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.
Contact with any coloured material including hair and dyed fabrics may result in bleaching or discoloration.
Due to the risk of sensitisation, this product should not be applied on damaged skin.
|ADVERSE REACTIONS||:||Very common: Dry skin ,Erythema ,Skin exfoliation (peeling) ,Skin burning sensation.
Common: Pruritus ,Pain of skin (stinging pain), Skin irritation (irritant contact dermatitis).
Uncommon: Allergic contact dermatitis.
|Pregnancy & lactations||:||Pregnancy:
There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from animal data.
This product should only be used by a pregnant woman if clearly needed.
It is unknown whether benzoyl peroxide or metabolites are excreted in human milk. A risk to the new-borns or infants cannot be excluded. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.
|DOSAGE||:||For external use only.
Adults and children:
Before each application, the skin should be cleaned and dried. Apply in a thin layer once or twice daily or as directed to the affected areas. Persons with sensitive skin should be directed to apply the gel once daily before going to bed. The extent of any drying or peeling may be adjusted by modifying the dosage schedule.
|Storage||:||Store at temperature below 30⁰C.|
|Packaging||:||Metallic tube of 30 g Gel in a carton box with leaflet.