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PYRALVEX SOLUTION OROMUCOSAL SOLUTION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - PYRALVEX SOLUTION OROMUCOSAL SOLUTION

PYRALVEX™ Oromucosal Solution Rhubarb Extract and Salicylic Acid

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.
  • 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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 salicylic 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.

0117681107 56UK2059110–03

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 breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

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 missed dose.

If your symptoms do not improve consult your doctor. If you have any questions 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 Mylan Products Ltd. Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. It is made by Norgine Pharma, 28102 Dreux, France.

The leaflet was last approved in February 2018.

0117681107

56UK2059110–03


(HO Mylan

06.03.18 16:19

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Pyralvex Solution used for?

Pyralvex Solution is an oromucosal solution commonly used to relieve pain and inflammation in the mouth and throat caused by conditions such as canker sores, gingivitis, and other oral irritations.

How do I apply Pyralvex Solution?

To apply Pyralvex Solution, use a clean cotton swab or your fingertip to gently dab the solution onto the affected area in your mouth or throat. Avoid eating or drinking for at least 30 minutes after application.

Can Pyralvex be used for kids?

Pyralvex Solution is typically recommended for adults and children over 12 years of age. For younger children, consult with a healthcare professional before use.

Are there any side effects of using Pyralvex Solution?

Some possible side effects may include a burning sensation at the application site, dry mouth, or allergic reactions. If you experience severe side effects, seek medical attention immediately.

How often can I use Pyralvex Solution?

You can use Pyralvex Solution up to four times a day. However, it's important to follow the instructions provided by your healthcare provider or those on the packaging.

Is Pyralvex safe during pregnancy?

Pregnant women should consult their doctor before using Pyralvex Solution to ensure it is safe for their specific situation.

Can I drink alcohol while using Pyralvex Solution?

It's best to avoid alcohol consumption while using Pyralvex Solution as it may cause further irritation to your mouth and throat.

How long does it take for Pyralvex Solution to work?

Many patients report relief from pain within minutes of applying Pyralvex Solution; however, individual results may vary.

Will Pyralvex interact with my other medications?

Always inform your doctor about any medications you are currently taking. While there are generally no known major interactions with Pyralvex, it's best to be cautious.

Can I use Pyralvex on open sores or wounds in my mouth?

Yes, Pyralvex can be applied to open sores; however, avoid excessive application as it may cause discomfort. Consult with a healthcare professional for guidance.

What should I do if I accidentally swallow Pyralvex Solution?

If you accidentally swallow a small amount of Pyralvex Solution, don’t panic; however, if you swallow a large quantity or experience any adverse symptoms, seek medical advice immediately.

How do I store Pyralvex Solution?

Store Pyralvex Solution in a cool, dry place away from direct sunlight. Keep out of reach of children.

Is there a sugar-free version of Pyralvex Solution available?

Pyralvex does not contain sugar; however, it's best to check with your pharmacist for specific product variants available in your area.

Can I use mouthwash after applying Pyralvex Solution?

It is recommended to wait at least 30 minutes after applying Pyralvex before using mouthwash or rinsing your mouth to ensure maximum effectiveness.

What are the main ingredients in Pyralvex Solution?

Pyralvex contains active ingredients such as salicylic acid and other antiseptics that help reduce pain and inflammation in the oral cavity.

Is there a limit on how long I should use Pyralvex Solution continuously?

If symptoms persist beyond 7 days while using Pyralvex, it's advisable to consult with a healthcare provider for further evaluation and guidance.

Does Pyralvex have any natural ingredients?

Pyralvex includes herbal extracts along with its medicinal components, specifically designed to soothe oral irritations naturally.

Can I use other topical treatments along with Pyralvex?

While some topical treatments can be used alongside Pylarivx, always consult with your healthcare provider to avoid potential interactions or duplicate therapies.

What should I do if my symptoms worsen after using Pyralvex Solutions?

If your symptoms worsen or do not improve after using Pyralyx as directed, contact your healthcare provider for further advice and potential alternative treatments.