Acriflex 0.25% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acriflex 0.25% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Acriflex 0.25% w/w Cream contains:
Chlorhexidine Gluconate 0.25% w/w (included as Chlorhexidine Gluconate 20% solution 1.25% v/w).
For the full list of excipients, see sections 6.1.
3. PHARMACEUTICAL FORM
Cream for topical administration to human beings.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the treatment of minor burns and scalds, scratches, cuts and abrasions, sunburn blisters and infected cracked skin.
4.2. Posology and method of administration
For general use, apply freely and smooth gently into the skin. For cuts abrasions, burns etc. spread freely and, if necessary, cover with a dressing.
There are no recommended dosage schedules as the product is for use as needed.
4.3.
Contraindications
Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8)
4.4. Special warnings and precautions for use
Acriflex contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Acriflex should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).
Keep away from the eyes.
Avoid contact with the brain, meninges and middle ear. Not for use in body cavities.
4.5. Interactions with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
No harmful effects in human pregnancy have been reported. Nevertheless, like all medicines, care should be exercised during pregnancy and lactation.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Skin disorders
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Immune disorders
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
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 Care Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdosage is extremely unlikely. Chlorhexidine is poorly absorbed and systemic effects are unlikely even if large amounts are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Chlorhexidine is a bisbiguanide disinfectant which is effective against a wide range of vegetative gram-positive and gram-negative bacteria.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Arlatone 983 S Cetostearyl Alcohol Liquid Paraffin Dimeticone 20 Glycerol (E422)
Quinoline Yellow Lake (E104)
Purified Water
6.2. Incompatibilities
None known.
6.3. Shelf life
Three years unopened.
6.4. Special precautions for storage
None stated.
6.5 Nature and contents of container
Internally lacquered aluminium, blind end tubes containing 30gm of product, closed with a polyolefin cap in a cardboard outer.
6.6. Instructions for use/handling
For general use, apply freely and smooth gently into the skin. For cuts, abrasions, burns, etc. spread freely and, if necessary, cover with a dressing.
There are no recommended dosage schedules as the product is for use as needed.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 00240/0116
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/03/2005
10 DATE OF REVISION OF THE TEXT
03/08/2016