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PANOXYL 2.5 AQUACREAM

Active substance(s): BENZOYL PEROXIDE

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PanOxyl Aquacream 2.5
2.5% w/w Benzoyl Peroxide Cream
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 gets 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 Aquacream (called PanOxyl in this leaflet).
PanOxyl contains a medicine called benzoyl peroxide.
Benzoyl peroxide works by killing the bacteria on your skin that can cause acne

PanOxyl Aquacream is an effective treatment for spots and pimples on the face.
PanOxyl Aquacream is for use by adults and adolescents with spots and pimples. 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 an acne treatment in addition to PanOxyl. If used at the same
time, it may make skin irritation worse.



If you are using 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.

Important information about some of the ingredients of PanOxyl
PanOxyl contains propylene glycol. Propylene glycol may cause skin irritation.
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.
If you know you are allergic to benzoyl peroxide you should not use PanOxyl. If you
are unsure or have not used this product before, rub in PanOxyl to a small area of the
lower arm above the wrist at least 48 hours before use; if swelling or itching occurs
with severe redness do not use PanOxyl.
 Use PanOxyl once a day
Tingling or a mild burning sensation may be felt when PanOxyl is applied. Apply
with care for the first few days to avoid redness and peeling. Mild to moderate
redness and peeling sometimes arise with continued use of the cream. A sudden
increase in peeling and reddening of the skin can occur during the first weeks of
treatment. If any of these reactions are too severe or persist, apply less cream, less
often or discontinue use and see your doctor if it does not subside.
 Ask your doctor or pharmacist for advice if the condition of your spots has not
improved within fourteen days. Do not use PanOxyl continuously for more
than one month without advice from your doctor or pharmacist. Use PanOxyl
for as long as your doctor or pharmacist tells you to. Do not stop using it
without asking advice. If you stop too soon your spots and pimples 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 layer of the cream on the affected skin, using your fingertips and smooth
in.
4. Apply to all of the area of your skin that has spots and pimples, 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 cream. Applying too much, or applying it more
often than advised, will not help your spots and pimples clear up more quickly and
may cause skin irritation.
6. Wash your hands after using the cream.

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 at room temperature (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
The active ingredient is benzoyl peroxide. PanOxyl Aquacream contains 2.5% w/w
benzoyl peroxide.
The other ingredients are isopropyl palmitate, Macrogol 1000 monostearate, glyceryl
monostearate, propylene glycol, stearic acid, zinc stearate and purified water.
What PanOxyl looks like
PanOxyl Aquacream is a cream and comes in 20g 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
PL No: 19494/0071
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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