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PANOXYL 10 GEL

Active substance: BENZOYL PEROXIDE

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Package Leaflet: Information for the User

PanOxyl 10 Gel
10% w/w gel 
 Benzoyl Peroxide.

Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to use
PanOxyl carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see your doctor if your symptoms worsen or do not improve.
• If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What PanOxyl is and what it is used for
2. Before you use PanOxyl
3. How to use PanOxyl
4. Possible side effects
5. How to store PanOxyl
6. Further information
1. What PanOxyl is and what it is used for
The name of your medicine is PanOxyl 10 Gel (called PanOxyl in this leaflet).
PanOxyl contains an active ingredient called benzoyl peroxide.
Benzoyl peroxide works by killing the bacteria on your skin that can cause acne
PanOxyl is used to treat acne (spots).
PanOxyl is for use by adults and adolescents with acne. It is not for use by
children.
2. Before you use PanOxyl
Do not use PanOxyl if:
• you are allergic (hypersensitive) to benzoyl peroxide or any of the other
ingredients (listed in Section 6).
Do not use PanOxyl if the above applies to you. If you are not sure, ask your
pharmacist or doctor before you use this medicine.
Take special care with PanOxyl
 Only use PanOxyl on your skin. Avoid contact with the eyes, eyelids,
mouth, lips and inside the nose. If contact occurs, rinse with water.
 Take care not to use PanOxyl on areas of broken skin, such as cuts
or grazes. If contact with these areas occurs, wash the affected area
immediately with water.



Take care when applying this product to the neck and other sensitive
areas, since skin irritation is more likely to occur.



PanOxyl can make your skin more sensitive to the harmful effects of the
sun. Avoid the use of sunbeds/lamps and minimise the time you spend in
the sun. You should use a sunscreen and wear protective clothing while
using PanOxyl.



PanOxyl may bleach hair and coloured or dyed fabrics. Avoid contact with
hair, fabrics, furniture or carpeting.

Using other medicines with PanOxyl
Please tell your pharmacist or doctor if you are using or have recently used any
other medicines. This includes medicines you get without a prescription, such as
herbal medicines.
Some medicines can affect how PanOxyl works, or make it more likely that you’ll
have side effects such as redness, peeling and skin irritation.
In particular, tell your doctor or pharmacist:


If you are using other acne treatment. If used at the same time, it may make
skin irritation worse.



If you are using other acne medicines containing tretinoin, isotretinoin or
tazarotene. If used at the same time, PanOxyl may make these treatments
less effective.



If you are using sulphonamide-containing medicines such as dapsone and
sulfacetamide. If used at the same time as PanOxyl, your skin or facial hair
may turn yellow or orange. This will not be permanent.

Tell your doctor or pharmacist if you are taking any of these. Your doctor or
pharmacist will decide if you should take PanOxyl with these medicines or may
advise you to use the medicines at different times of the day (for example, one in
the morning and the other at bedtime).

Pregnancy and breast-feeding
There is only limited information about the safety of PanOxyl in pregnant women.
• Tell your doctor or pharmacist if you are pregnant or planning to
become pregnant.
• If you do become pregnant during treatment with PanOxyl tell your
doctor.
It is not known whether the ingredients of PanOxyl can pass into breast milk. If
you are breast-feeding, you must check with your doctor or pharmacist before
you use PanOxyl.


Don’t use PanOxyl on your breast if you are breast-feeding.

3. How to use PanOxyl

If this medicine is from your pharmacist or doctor, follow their instructions.
Otherwise, follow the instructions below. If you do not understand the
instructions or are not sure, ask your pharmacist or doctor.







Use PanOxyl once a day.
During the first few weeks of treatment a sudden increase in peeling and
reddening of the skin can occur. If they cause you a problem, try using
PanOxyl less often, or stop using it for a few days until the irritation goes
away then start again. Stop using PanOxyl if the irritation does not go
away.
After 6-8 weeks if your acne is no better or it gets worse, talk to your
doctor of pharmacist.
Use PanOxyl for as long as your doctor or pharmacist tells you to.
Continue using this medicine until the acne has gone.
Do not stop using it without asking advice. If you stop too soon your acne
may come back.

How to apply PanOxyl
1. Completely remove any make-up.
2. Wash the affected area and gently dry.
3. Put a thin film of the gel on the affected skin using your fingertips and smooth
in.
4. Apply to all of the area of your skin that has acne, not just to the individual
spots. You may notice a mild burning sensation. If this becomes severe, stop
using and see your doctor.
5. Take care not to apply too much 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.
6. Wash your hands after using the gel.

If you forget to use PanOxyl
• Do not use a double dose to make up for forgotten doses.
• Skip the dose and apply the next dose at the usual time.
If you accidentally swallow PanOxyl
The ingredients of PanOxyl are not expected to be harmful if swallowed in the
small amounts normally applied to the face. However, if you do accidentally get a
larger amount of PanOxyl in your mouth, rinse immediately with plenty of water.
Contact your doctor or pharmacist for advice.

4. Possible side effects
Like all medicines, PanOxyl can cause side effects, although not everybody gets
them:
Severe allergic reactions:
Signs may include:
 raised and itchy rash (hives)
 swelling of the face or mouth (angioedema), causing difficulty in breathing



collapse.

Contact a doctor immediately if you get these symptoms. Stop using
PanOxyl immediately.
Very common side effects:
These may affect more than 1 in 10 people:


redness and peeling of the skin

Common side effects:
These may affect up to 1 in 10 people:


dryness, itching or sensitivity of the skin.

Uncommon side effects:
These may affect up to 1 in 100 people:


burning sensation

Other side effects may include:


rash



allergic reaction



discoloration of the skin



other skin reactions such as irritation and pain

Tell your doctor or pharmacist if any of the side effects listed become severe
or troublesome, or if you notice any side effects not listed in this leaflet.
5. How to store PanOxyl
• Keep out of the reach and sight of children.
• PanOxyl should be stored below 25°C.
• Do not use PanOxyl after the expiry date which is printed on the tube and
carton.
• Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These measures
will help to protect the environment.
6. Further information
What PanOxyl contains
PanOxyl 10 Gel contains 10% w/w benzoyl peroxide.
The other ingredients are: colloidal magnesium aluminium silicate, hypromellose,
polyoxyethylene lauryl ether, denatured alcohol (ethanol), citric acid
monohydrate, alpine essence, purified water.

What PanOxyl looks like
PanOxyl is a white gel and comes in 40g tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Trading as Stiefel, Stockley Park West, Uxbridge, Middlesex UB11 1BT, UK
Manufacturer:
Stiefel Laboratories (Ireland) Ltd. Finisklin Business Park, Sligo, Ireland
PanOxyl 10 Gel PL No: 19494/0051
Date of preparation:
November 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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