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

3

5.0%
0.5%

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

CLINICAL PARTICULARS

4.1

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

PHARMACOLOGICAL PROPERTIES

5.1

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

PHARMACEUTICAL PARTICULARS

6.1

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 5ºC and not more than 30ºC.

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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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