AXSAIN 0.075% W/W CREAM

Active substance: CAPSAICIN

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0182/14 Axsain P1.ai

Cephalon Job No.:
Iteration No.:

ARK 006

0182/14
01
PACKAGE LEAFLET: INFORMATION FOR THE USER

PMS Black

Axsain 0.075% w/w Cream
Capsaicin 0.075% w/w

100% 95%

50%

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Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- 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.

5%

Axsain
UK/Ireland
PIL
1 (One)
Supplied
147 x 208mm

In this leaflet:
1. What Axsain is and what it is used for.
2. Before you use Axsain.
3. How to use Axsain.
4. Possible side effects.
5. How to store Axsain.
6. Further information.

N/A

N/A
MP00820
Pharmasol
27 February 2012

1. WHAT AXSAIN IS AND WHAT IT IS USED FOR
The name of this medicine is Axsain cream. The active ingredient in this medicine is
capsaicin which is a naturally occurring substance found in plants.
Axsain cream is used to relieve the pain arising from nerves near to the surface of the skin.
This can happen after having Shingles (Herpes Zoster).
Axsain cream is also used to relieve pain in patients who have nerve damage to their hands
or feet caused by diabetes.

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2. BEFORE YOU USE AXSAIN CREAM
Do not use Axsain cream:
- If you are allergic (hypersensitive) to capsaicin or any of the other ingredients.
- On broken or irritated skin.
This medicine is not suitable for use in children.
Take special care with Axsain cream
- Keep away from the eyes (if it does accidentally get into your eyes or onto broken or
irritated skin, wash off with plenty of water).
- Wash your hands immediately after applying the cream, unless the hands are the
treated areas, in which case, they should be washed 30 minutes after applying.
- Avoid hot baths or showers immediately before or just after applying Axsain cream.
- Do not apply tight bandages on top of Axsain cream.
- Avoid breathing in any vapours from the cream, as this can cause irritation of the
eyes and breathing difficulties (including making asthma worse).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, or are breast-feeding, you should ask
your doctor or pharmacist for advice before taking Axsain.
Important information about some of the ingredients of Axsain
Axsain may cause local skin reactions (e.g. contact dermatitis) due to the product
containing cetyl alcohol.

3. HOW TO USE AXSAIN CREAM
It is important to use this product as directed by your doctor/hospital consultant.
Axsain should be applied to the affected area 3 to 4 times a day, with a gap of at least
4 hrs between each application.
A small amount of cream (about the size of a pea) should be rubbed onto the area to be
treated with your fingers. Make sure that all the cream is rubbed in so it is no longer visible.
Wash your hands immediately after application of Axsain, unless you are treating nerve
damage in your hands, when you should wait 30 minutes before washing your hands.
When using Axsain cream to relieve pain caused by nerve damage due to diabetes the
treatment normally lasts for 8 weeks.
4. POSSIBLE SIDE EFFECTS
Like all medicines Axsain can cause side effects, although not everybody gets them.
Axsain cream can cause a brief burning feeling when applied. This burning is more
common when:
• The cream is used less than 3 or 4 times a day.
• Too much cream is applied.
• The cream is applied just before or after a hot bath or shower.
Rarely when Axsain cream is applied the vapour can cause brief irritation of the eyes, nose,
and throat, such as runny nose, cough or sneezing, breathlessness or worsening of asthma.
Axsain may also cause irritation of the skin for example itching or stinging.
If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE AXSAIN CREAM
Keep out of the reach and sight of children.
Store below 25ºC.
Do not use after the expiry date printed on the carton and tube.
6. FURTHER INFORMATION
What Axsain contains
Axsain cream contains 0.075% capsaicin as the active ingredient. It also contains purified
water, sorbitol solution, isopropyl myristate, cetyl alcohol, white soft paraffin, glycerol
stearate, PEG-100 stearate and benzyl alcohol as the inactive ingredients.
What Axsain cream looks like and contents of pack
Axsain cream is a white cream packed in aluminium tubes with epoxyphenolic lining and
polypropylene spiked cap containing 45 gm Axsain cream.
Marketing Authorisation Holder
Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire,
WF10 5HX, UK
Manufacturer
Pharmasol Limited, North Way, Walworth Industrial Estate, Andover, Hampshire,
SP10 5AZ, UK.
This leaflet was last approved in March 2012
Axsain is a registered trademark of Cephalon, Inc., or its affiliates.

0182/14
MP00820

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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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