PYRALVEX FL 10ML 0.5%+0.1% GEN

PYRALVEX 50 MG/ML + 10 MG/ML GENGIVAL FUTURE

active ingredients

10 ml contain: • Active ingredients - glucose extract 500 mg (0.5 g) (corresponding to 0,43-0,53% m/v of anthraquinonic derivatives) - Salicylic acid 100 mg (0.1 g) Excipient with known effects: - Ethanol 59.5% v/v For full list of excipients, see paragraph 6.1

Excellent

Ethanol, purified water

Therapeutic indications

Pargivitis, stomatitis, oropharyngitis, coadjuvant in alveolar piorrea therapy.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. It should not be used in children under 12 years of age. With the topical application of salicylic acid, there is a hypothetical risk of inducing Reye Syndrome. Reye syndrome was observed after oral administration of higher doses of salicylic acid or acetylsalicylic acid in children. There were no confirmed cases of Reye Syndrome associated with the use of Pyralvex. Due to the content of ethanol the drug is not suitable for patients with alcoholism.

Population

Do not exceed the recommended doses. Adults and children aged 12 and over: apply locally by brushing (after removing any teeth) 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 the age of 12 (see paragraph 4.3).

Conservation

This medicine does not require any special condition of conservation.

Warnings

Do not exceed the frequency of recommended applications. The toxicity of salicylates may occur if the recommended frequency of application is exceeded. Coloring of teeth, teethers and tooth prostheses (see paragraph 4.8). Topical products, especially when applied for repeated and prolonged periods of time, can give rise to hypersensitivity phenomena. In this case, stop the treatment and consult the doctor in order to establish suitable therapy. After a short period of treatment without appreciable results, consult your doctor.

Interactions

Salicylates are highly linked to plasma proteins and can spy on other drugs from binding sites. Clinically important interactions can occur with heparine and oral anticoagulants, but these are mainly due to an effect on the pyastrinic function, rather than on pharmacokinetic parameters.

Effects

In the classification by organs and systems, the unwanted effects are listed by frequency order (number of patients expected to manifest the reaction), using the following convention: Very common (≥1/10) Common (≥1/100, immune system disorders: Notable: Allergic reactions Gastrointestinal diseases: City: Temporary coloring of teeth or oral mucosa. Skin and subcutaneous tissue disorders: Notable: rash and hives Systemic pathologies and conditions for administration: Very common: Local transitional burning sensation on the application site Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The toxicity of salicylates may occur if the frequency of application is exceeded. Overdose associated with local applications are not likely, although the extent of systemic absorption of salicylic acid and anthraquinonic derivatives is unknown. A systemic overdose following ingestion could lead to abdominal cramps, diarrhea and possible salicylism (which occurs with hyperventilation, tinnitus, deafness, vasodilation, sweating).

Animal studies are not enough to demonstrate the effects on pregnancy and/or embryo/fetal development. Potential risks for man are unknown. It is necessary to be cautious in prescribing the medicine to pregnant women. Inhibition of prostaglandin synthesis could negatively affect pregnancy and/or embryo/fetal development. Therefore, PIRALVEX should be used only in the first and second trimester of pregnancy after carefully assessing the risk-benefit ratio. If PYRALVEX is used by a woman who tries to conceive, or during the first or second trimester of pregnancy, the dose must be kept low and the duration of treatment as short as possible. The use of PYRALVEX should be avoided in the third trimester of pregnancy. During the last three months of pregnancy, the mechanism of action of these medicines can involve the suppression of labor, the prolongation of gestation and a prolonged labor. Moreover, it can cause cardiovascular diseases (with premature closure of arterial duct and pulmonary hypertension) and kidney toxicity (with oliguresis and oligoamnios) in the newborn, increased tendency to bleeding in the mother and newborn as well as edema formation risk in the mother. Anthraquinan glucosides derived from rhubarb may be excreted in breast milk. However, at the therapeutic doses of PYRALVEX, it is not known whether these or salicylic acid are excreted in breast milk. It is appropriate to decide whether to continue breastfeeding or continue therapy with PYRALVEX taking into consideration the benefit of breastfeeding for the child and the benefit of PYRALVEX therapy for the woman.

Source: Farmadati