QUINODERM LOTIO-GEL 5%
Active substance: POTASSIUM HYDROXYQUINOLINE SULPHATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
QUlNODERM LOTIO-GEL 5%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl Peroxide BP Potassium Hydroxyquinoline Sulphate BP 5.0% 0.5%
3
PHARMACEUTICAL FORM
Quinoderm Lotio-gel 5% is a homogeneous astringent gel formulated to give the colour and consistency of a creamy white lotion. It is intended for topical use only.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Acne vulgaris.
4.2
Posology and method of administration Route of administration For topical use only Adults, children and the elderly.
By gentle massage over all the affected area one to three times daily.
4.3
Contraindications Patients with known sensitivity to either of the active constituents should not use Quinoderm Lotio-gel 5%.
4.4
Special warnings and precautions for use Avoid contact with mouth and eyes and other mucosal surfaces. May bleach the hair or dyed fabrics. Avoid exposure to excessive sunlight. In a few isolated cases, overreaction to Quinoderm Lotio-gel 5% may occur. To minimise this possibility, select a small area of skin behind the ear, apply the Lotio-gel and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.
4.5
Interaction with other medicinal products and other forms of interaction Benzoyl peroxide is an oxidising agent. Hence, Quinoderm Lotio-gel 5% should not be used at the same time as other topical agents, which would react with an oxidising agent.
4.6
Fertility, Pregnancy and lactation Quinoderm Lotio-gel 5% is not contra-indicated in pregnancy or lactation.
4.7
Effects on ability to drive and use machines Not applicable.
4.8
Undesirable effects If symptoms persist or the condition worsens or if irritation, itch or rash occurs, treatment should be discontinued and the Physician or Pharmacist consulted for advice.
4.9
Overdose If accidentally ingested symptomatic and supportive management is advised.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The main pharmacological action of benzoyl peroxide is considered to be keratolytic and comedolytic. Potassium hydroxyquinoline sulphate has broad spectrum antibacterial activity. This combination is formulated in a specifically researched and developed base and is designed to aid the resolution of the polymorphic lesions of acne. The base has been developed with the objective of providing a stable pharmaceutical form which maximises the advantages of a gel and lotion in a system which does not employ organic solvents and therefore has a correspondingly lower irritancy, toxicity and abuse potential.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactic Acid BP, Edetic Acid BP, Sodium Acid Phosphate BP, Maize Starch BP, Ceto Macrogol 1000 BP, Cetyl Stearyl Alcohol, Sodium Cetyl Stearyl Sulphate, P.E.G.40 Castor Oil, Light Liquid Paraffin BP, Purified Water BP.
6.2
Incompatibilities Any topical agent that would react with an oxidising agent.
6.3
Shelf life Three Years.
6.4
Special precautions for storage Quinoderm Lotio-gel 5% should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5C and not more than 30C.
6.5
Nature and contents of container Quinoderm Lotio-gel 5% is available in polyethylene bottles with a flip-top cap containing 30ml of product. Each bottle is cartoned and contains a patient information leaflet.
6.6
Special precautions for disposal By gentle massage over all the affected area one to three times daily.
7
MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Limited Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB UK
8
MARKETING AUTHORISATION NUMBER(S)
PL 16853/0140
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23 April 2004
10
DATE OF REVISION OF THE TEXT
11/07/2012
1
NAME OF THE MEDICINAL PRODUCT
QUlNODERM LOTIO-GEL 5%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl Peroxide BP Potassium Hydroxyquinoline Sulphate BP 5.0% 0.5%
3
PHARMACEUTICAL FORM
Quinoderm Lotio-gel 5% is a homogeneous astringent gel formulated to give the colour and consistency of a creamy white lotion. It is intended for topical use only.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Acne vulgaris.
4.2
Posology and method of administration Route of administration For topical use only Adults, children and the elderly.
By gentle massage over all the affected area one to three times daily.
4.3
Contraindications Patients with known sensitivity to either of the active constituents should not use Quinoderm Lotio-gel 5%.
4.4
Special warnings and precautions for use Avoid contact with mouth and eyes and other mucosal surfaces. May bleach the hair or dyed fabrics. Avoid exposure to excessive sunlight. In a few isolated cases, overreaction to Quinoderm Lotio-gel 5% may occur. To minimise this possibility, select a small area of skin behind the ear, apply the Lotio-gel and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.
4.5
Interaction with other medicinal products and other forms of interaction Benzoyl peroxide is an oxidising agent. Hence, Quinoderm Lotio-gel 5% should not be used at the same time as other topical agents, which would react with an oxidising agent.
4.6
Fertility, Pregnancy and lactation Quinoderm Lotio-gel 5% is not contra-indicated in pregnancy or lactation.
4.7
Effects on ability to drive and use machines Not applicable.
4.8
Undesirable effects If symptoms persist or the condition worsens or if irritation, itch or rash occurs, treatment should be discontinued and the Physician or Pharmacist consulted for advice.
4.9
Overdose If accidentally ingested symptomatic and supportive management is advised.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The main pharmacological action of benzoyl peroxide is considered to be keratolytic and comedolytic. Potassium hydroxyquinoline sulphate has broad spectrum antibacterial activity. This combination is formulated in a specifically researched and developed base and is designed to aid the resolution of the polymorphic lesions of acne. The base has been developed with the objective of providing a stable pharmaceutical form which maximises the advantages of a gel and lotion in a system which does not employ organic solvents and therefore has a correspondingly lower irritancy, toxicity and abuse potential.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactic Acid BP, Edetic Acid BP, Sodium Acid Phosphate BP, Maize Starch BP, Ceto Macrogol 1000 BP, Cetyl Stearyl Alcohol, Sodium Cetyl Stearyl Sulphate, P.E.G.40 Castor Oil, Light Liquid Paraffin BP, Purified Water BP.
6.2
Incompatibilities Any topical agent that would react with an oxidising agent.
6.3
Shelf life Three Years.
6.4
Special precautions for storage Quinoderm Lotio-gel 5% should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5C and not more than 30C.
6.5
Nature and contents of container Quinoderm Lotio-gel 5% is available in polyethylene bottles with a flip-top cap containing 30ml of product. Each bottle is cartoned and contains a patient information leaflet.
6.6
Special precautions for disposal By gentle massage over all the affected area one to three times daily.
7
MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Limited Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB UK
8
MARKETING AUTHORISATION NUMBER(S)
PL 16853/0140
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23 April 2004
10
DATE OF REVISION OF THE TEXT
11/07/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
