PYRALVEX SOLUTION OROMUCOSAL SOLUTION

Active substance: SALICYLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PYRALVEX Oromucosal Solution
Rhubarb Extract and Salicylic Acid
TM

Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
•  his medicine has been prescribed for you. Do not pass it on to others.
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It may harm them, even if their symptoms are the same as yours.
• f any of the side effects become serious, or you notice any side effects
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not listed in this ­eaflet, please tell your doctor or pharmacist.
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If you need the information on this leaflet in an alternative
format, such as large text, or Braille please ring from the
UK: 0800 198 5000.
In this leaflet:
1. What Pyralvex is and what it is used for
2. Before you use Pyralvex
3. How to use Pyralvex
4. Possible side effects
5. How to store Pyralvex
6. Further information
1. What Pyralvex is and what it is used for
Pyralvex contains rhubarb extract (containing anthraquinone glycosides) and
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­ alicylic acid. The anthraquinone glycosides relieve inflammation and salicylic
acid is an analgesic, which helps relieve pain.
Pyralvex is used to relieve pain associated with mouth ulcers and denture
irritation.
2. Before you use Pyralvex
Do not give to children or adolescents under the age of 16 years.
This is because there is a possible link between salicylates and
Reye’s syndrome when given to children. Reye’s syndrome is a very
rare disease which affects the brain and liver and can be fatal.
Do not use Pyralvex if you are allergic (hypersensitive) to rhubarb extract or
salicylic acid or any of the other ingredients of Pyralvex.
For hygiene reasons, this pack must only be used by one person.
Taking/using 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.
Using Pyralvex with food and drink
Avoid rinsing your mouth or eating for 15 minutes after use.
Pregnancy and breast-feeding
Talk to your doctor before you use Pyralvex if you are pregnant
or ­ reast-feeding. Ask your doctor or pharmacist for advice
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before taking any medicine.

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Important information about some of the ingredients of Pyralvex
This medicinal product contains small amounts of ethanol (alcohol) less than
100 mg per dose.
3. How to use Pyralvex
Always use Pyralvex exactly as your doctor had told you.
In adults and the elderly Pyralvex should be applied liberally to the ulcer or
irritated denture area (after dentures have been removed) 3 to 4 times a day
using the brush provided.
Do not exceed the stated frequency of application as excess Pyralvex
may be harmful.
Do not use for more than 7 days.
If you forget to use Pyralvex use it as soon as you remember. If your next
dose is due only use that dose and do not use extra to make up for the
m
­ issed dose.
If your symptoms do not improve consult your doctor. If you have any
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­ uestions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Pyralvex can cause side effects, although not everybody
gets them.
Some people may have an allergic reaction which may include an itchy skin
rash (nettle rash or hives.) If this occurs stop the treatment and contact your
doctor.
Very commonly, a short-term burning feeling can occur when Pyralvex is used.
When using Pyralvex, a temporary discolouration of the teeth, denture and
dental protheses (an artificial device that replaces one or more missing
teeth), or mouth can also commonly occur, but this is easily removed during
normal cleaning of the teeth.
If any of the side effects become serious, or you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Pyralvex
Keep all medicines out of the reach and sight of children.
Store below 25 °C.
Do not use Pyralvex after the expiry date which is stated on the bottle as
month/year. The expiry date refers to the last day of the month.
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 Pyralvex contains
The active substances are Rhubarb extract and Salicylic acid. Each 1 ml of
solution contains 50 mg rhubarb extract (equivalent to 5 mg anthraquinone
glycosides) and 10 mg salicylic acid.
The other ingredients are ethanol and water.
What Pyralvex looks like and contents of the pack
Each carton contains an amber glass bottle containing 10 ml of liquid and an
applicator brush.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Meda Pharmaceuticals Ltd, Skyway
House, Parsonage Road, Takeley, CM22 6PU. It is made by Norgine Pharma,
28102 Dreux, France.
The leaflet was last approved in March 2011.
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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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