Quinoderm®

Lotio-Gel 5%

Benzoyl Peroxide/

Potassium Hydroxyquinoline Sulfate

Quinoderm Lotio-Gel 5% belongs to a group of medicines called peroxides. It contains two active ingredients; benzoyl peroxide, which provides a peeling action, and potassium hydroxyquinoline sulfate, which has antimicrobial and antifungal properties.

Quinoderm Lotio-Gel 5% is used for the treatment of acne vulgaris (common acne).

Do not use Quinoderm Lotio-Gel 5% if:

• you are allergic to benzoyl peroxide or potassium hydroxyquinoline sulfate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

•    Avoid contact with eyes, mouth and mucous membranes (such as nose or throat).

•    Caution is required when applying to the neck and other sensitive areas.

•    May bleach hair or dyed fabrics. If accidental contact occurs, rinse thoroughly with warm water.

•    Quinoderm Lotio-Gel 5% can make your skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds/lamps and minimise the time spent in the sun. Use a sunscreen and wear protective clothing while using Quinoderm Lotio-Gel 5%.

In a few isolated cases an over-reaction to Quinoderm Lotio-Gel 5% may occur. If you have not used this medicine before, perform the sensitivity test described in section 3. If you experience mild irritation or inflammation, use Quinoderm Lotio-Gel 5% less often, for example once a day or every few days. If severe irritation or pronounced redness occurs, stop treatment and tell your doctor or pharmacist.

Fair skinned individuals are likely to be particularly sensitive to irritation. Quinoderm Lotio-Gel 5% should not be used in patients with fair or sensitive skin if there is extensive exposure to sunlight or ultraviolet light.

Other medicines and Quinoderm Lotio-Gel 5%

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

Quinoderm Lotio-Gel 5% should not be used at the same time as any other skin preparation that would react with benzoyl peroxide, which is an oxidising agent.

Zinc oxide inhibits the antibacterial and antifungal effects of hydroxyquinoline. The use of zinc oxide at the same time is not recommended.

The use of oral isotretinoin should be avoided at the same time as Quinoderm Lotio-Gel 5%.

If combination topical treatment with tretinoin, isotretinoin or tazarotene is required the products should be applied at different times of the day (e.g. one in the morning and the other in the evening) to minimise irritation and to provide maximum effect.

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you use Quinoderm Lotio-Gel 5% whilst you are breast-feeding ensure that the infant’s skin does not come into direct contact with the areas of skin that have been treated.

Quinoderm Lotio-Gel 5% contains cetyl stearyl alcohol:

Quinoderm Lotio-Gel 5% contains cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is: apply one to three times daily.

For external use only.

Sensitivity Test:

If you have not used Quinoderm Lotio-Gel 5% before, perform the following test. Select a small area of skin behind the ear, apply the lotio-gel and leave for 12 hours. If severe irritation or pronounced redness occurs, do not proceed with the treatment and tell your doctor or pharmacist.

Application - adults, children and the elderly:

•    Spread thinly over all the affected areas and gently massage until no trace of the lotio-gel remains.

•    Take care not to apply too much lotio-gel. Applying too much, or applying it more often than advised, will not help your acne clear up more quickly and may cause skin irritation.

•    It is important that the whole area is treated, not just individual spots or blemishes.

•    After application, wash your hands thoroughly.

If you accidentally swallow Quinoderm Lotio-Gel 5%

If you accidentally swallow Quinoderm Lotio-Gel 5% it may cause nausea, sickness and diarrhoea. If you, or someone else swallows Quinoderm Lotio-Gel 5% contact your doctor or pharmacist for advice.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

•    hypersensitivity (allergic reaction) including local irritation or inflammation

•    swollen face

•    itch

•    rash

•    dry skin

•    peeling

•    redness of skin.

It is common for some slight redness of the skin to occur during the early weeks of treatment. This should gradually disappear as your skin becomes accustomed to the treatment.

Stop using the medicine and tell your doctor or pharmacist:

•    if the original condition worsens.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month.

•    Store in a cool, dry place.

•    Do not store above 30°C. Do not refrigerate.

•    Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Quinoderm Lotio-Gel 5% contains:

The active substances are:

benzoyl peroxide 5% w/w and potassium hydroxyquinoline sulfate 0.5% w/w.

The other ingredients are lactic acid, edetic acid, sodium acid phosphate, maize starch, ceto macrogol 1000, cetyl stearyl alcohol, sodium cetyl stearyl sulfate, P.E.G. 40, castor oil, light liquid paraffin and purified water.

What Quinoderm Lotio-Gel 5% looks like and contents of the pack:

Quinoderm Lotio-Gel 5% is a homogeneous astringent gel with the colour and consistency of creamy white lotion. It is presented in a printed carton containing a bottle with a flip-top cap, and an information leaflet.

Each bottle contains 30ml of product.

Marketing Authorisation Holder:

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.

Manufacturer:

Quinoderm Limited, Manchester Road, Hollinwood, Oldham, Lancashire, OL8 4PB, UK. This leaflet was last revised in: June 2014.

Quinoderm, Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

© Alliance Pharmaceuticals Limited 2014.

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