Active ingredients: Rhubarb (Rhubarb glucosidic extract), Salicylic acid
PYRALVEX 0.5% + 0.1% Gingival solution
Why is Pyralvex used? What is it for?
PYRALVEX is an anti-inflammatory, antibacterial and stomatological analgesic (for inflammations and small localized infections in the mouth).
PYRALVEX contains rhubarb extract (containing anthraquinone glycosides) and salicylic acid. Anthraquinone glycosides relieve inflammation while salicylic acid is an analgesic and helps relieve pain.
Contact your doctor if you do not notice any improvement or if you notice your symptoms worsening after 14 days.
PYRALVEX is indicated for:
- Treatment of gingivitis (inflammation of the gum).
- Treatment of stomatitis (inflammation of the mucous membrane of the mouth).
- Treatment of oropharyngitis (inflammation of the back of the mouth).
- Adjuvant in the therapy of alveolar pyorrhea (disease characterized by the swinging of apparently healthy teeth).
Contraindications When Pyralvex should not be used
Do not use PYRALVEX
- If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
- In children under 12 years. There is a hypothetical risk of inducing Reye's syndrome with the application of salicylic acid to the treated part. Reye's syndrome has been observed after oral administration of higher doses of salicylic acid or acetylsalicylic acid in children.
There have been no confirmed cases of Reye's Syndrome associated with the use of Pyralvex.
Due to the ethanol content the medicine is not suitable for patients with alcoholism.
For hygienic reasons, this pack is to be used by one person only.
Precautions for use What you need to know before taking Pyralvex
Talk to your doctor or pharmacist before using Pyralvex.
Topical products, especially if applied for repeated and prolonged periods of time, can give rise to hypersensitization phenomena (allergy).
In this case, stop the treatment and consult your doctor in order to establish a suitable therapy.
Interactions Which drugs or foods may change the effect of Pyralvex
Other medicines and Pyralvex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Using PYRALVEX with food, drink and alcohol
Avoid rinsing your mouth, eating or drinking immediately after application.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Caution should be exercised in prescribing the medicine to pregnant women.
At therapeutic doses of PYRALVEX, it is not known whether the active substances of the medicinal product are excreted in human milk. A decision should be made whether to continue breastfeeding or to continue PYRALVEX therapy taking into account the benefit of breastfeeding for the child and the benefit of PYRALVEX therapy for the woman.
Driving and using machines
PYRALVEX does not affect the ability to drive or use machines.
PYRALVEX contains ethanol.
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose
Dosage and method of use How to use Pyralvex: Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
PYRALVEX must be applied by brushing on the affected area (after removing any dentures) up to 3-4 times a day using the special brush.
Use for short periods of treatment. The maximum duration of treatment is 14 days.
Warning: do not exceed the indicated doses without medical advice as excessive doses of PYRALVEX can be harmful.
Overdose What to do if you have taken an overdose of Pyralvex
If you use more PYRALVEX than you should
Although there are no known cases of overdose, in case of accidental ingestion / intake of an excessive dose, it is advisable to seek advice from your doctor or possibly the nearest hospital.
If you forget to use PYRALVEX
If you forget to use PYRALVEX use it as soon as you remember. Do not use a double dose to make up for a forgotten dose
If your symptoms do not improve consult your doctor. If you are unsure, if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics, ask your doctor or pharmacist.
Side Effects What are the side effects of Pyralvex
Like all medicines, PYRALVEX can cause side effects, although not everybody gets them.
Some people may experience an allergic reaction. Stop taking PYRALVEX and contact your doctor immediately if you have symptoms of an allergic reaction.
Some people may experience a skin rash or hives at the application site after using PYRALVEX.
When using PYRALVEX, a temporary discoloration of the teeth, dentures and dentures, or of the mouth, can commonly occur, which is easily eliminated by normal cleaning of the teeth.
Very commonly you may experience a transient burning sensation at the application site.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at "www.agenziafarmaco.gov.it/it/responsabili". By reporting side effects you can help provide more information on the safety of this medicine. "
Expiry and Retention
Do not use PYRALVEX after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use PYRALVEX if there are obvious signs of packaging deterioration.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What PYRALVEX contains
The active ingredients are rhubarb extract and salicylic acid. Each ml of solution contains 50 mg of rhubarb extract (corresponding to 0.43 - 0.53% m / v of anthraquinone derivatives) and 10 mg of salicylic acid. The other ingredients are ethanol and purified water (ethanol 59.5% v / v)
What PYRALVEX looks like and contents of the pack
PYRALVEX comes in the form of a gingival solution for topical use. Each box contains a dark glass bottle containing 10 ml of solution and an applicator brush.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PYRALVEX 0.5% + 0.1% GINGIVAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 ml contain:
"Active principles
- Glucosidic extract of rhubarb 0.5 g (corresponding to 0.43-0.53% m / v of anthraquinone derivatives)
- Salicylic acid 0.1 g
Excipient with known effects:
- Ethanol .................. 59.5% v / v
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Solution for topical use (brushing).
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Gingivitis, stomatitis, oropharyngitis, adjuvant in the therapy of alveolar pyorrhea.
04.2 Posology and method of administration
Do not exceed the recommended dose.
Adults and children aged 12 and over: apply locally by brushing (after removing any dentures) on the affected area up to 3-4 times a day. Do not rinse your mouth, eat or drink immediately after application.
The patient should contact the doctor if the symptoms do not improve. The maximum duration of treatment is 14 days.
Children under 12 years: contraindicated in children under 12 years of age.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
It should not be used in children below 12 years of age. There is a hypothetical risk of inducing Reye's syndrome with topical application of salicylic acid. Reye's syndrome has been observed after oral administration of higher doses of salicylic acid or acetylsalicylic acid in children.
There have been no confirmed cases of Reye's Syndrome associated with the use of Pyralvex.
Due to the ethanol content the medicine is not suitable for patients with alcoholism.
04.4 Special warnings and appropriate precautions for use
Do not exceed the recommended application frequency. Salicylate toxicity can occur if the recommended frequency of application is exceeded.
Discolouration of teeth, dentures and dental prostheses (see section 4.8).
Topical products, especially if applied for repeated and prolonged periods of time, can give rise to hypersensitization phenomena.
In this case, stop the treatment and consult your doctor in order to establish a suitable therapy.
After a short period of treatment without noticeable results, consult your doctor.
04.5 Interactions with other medicinal products and other forms of interaction
Salicylates are highly bound to plasma proteins and can displace other drugs from binding sites. Clinically important interactions may occur with heparin and oral anticoagulants, but these are mainly due to an effect on platelet function rather than pharmacokinetic parameters.
04.6 Pregnancy and lactation
Animal studies are insufficient to demonstrate effects on pregnancy and / or embryonal / fetal development. The potential risks to men are unknown. Care should be taken when prescribing the medicine to pregnant women.
Anthraquinone glycosides derived from rhubarb may be excreted in breast milk. However, at therapeutic doses of PYRALVEX, it is not known whether these or salicylic acid are excreted in human milk. A decision should be made whether to continue breastfeeding or to continue therapy with PYRALVEX taking into account the benefit of breastfeeding for the baby. and the benefit of PYRALVEX therapy for women.
04.7 Effects on ability to drive and use machines
PYRALVEX does not affect the ability to drive or use machines.
04.8 Undesirable effects
In the organ system classification, undesirable effects are listed in order of frequency (number of patients expected to experience the reaction), using the following convention: very common (≥1 / 10); common (≥1 / 100,
Disorders of the immune system.
Not known: allergic reactions
Gastrointestinal disorders.
Common: temporary discoloration of the teeth or oral mucosa.
Disorders of the skin and subcutaneous tissue.
Not known: rash and urticaria.
General disorders and administration site conditions.
Very common: transient local burning sensation at the application site
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
04.9 Overdose
Salicylate toxicity can occur if the frequency of application is exceeded.
Overdose associated with local applications are unlikely, although the extent of systemic absorption of salicylic acid and anthraquinone derivatives is not known. A systemic overdose following ingestion could lead to abdominal cramps, diarrhea and possible salicilism (which occurs with hyperventilation, tinnitus, deafness, vasodilation, sweating).
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antimicrobials for local oral treatment.
ATC code: A01AB11.
Salicylic acid has antibacterial properties.
The purified rhubarb extract has a buccal and gingival anti-inflammatory and analgesic activity. In vitro tests have shown that it is also characterized by antibacterial activity against a number of microorganisms including: staphylococcus, streptococcus, proteus and candida albicans.
The presence of salicylic acid favors the penetration of the constituents of the purified rhubarb extract into the intercellular spaces.
05.2 Pharmacokinetic properties
The systemic bioavailability of Pyralvex is not significant as the amount of the active substance absorbed is very low.
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ethanol, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
10ml dark glass bottle;
30 ml dark glass bottle.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Close the bottle tightly after use.
07.0 MARKETING AUTHORIZATION HOLDER
Meda Pharma S.p.A. - Viale Brenta, 18 - 20139 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 005268038 "0.5% + 0.1% gingival solution" 1 bottle of 10 ml
A.I.C. n. 005268040 "0.5% + 0.1% gingival solution" 1 bottle of 30 ml
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
November 2009.
10.0 DATE OF REVISION OF THE TEXT
06/2014.
