POLYGYNAX Vaginal capsule Ref.[28309] Active ingredients: Neomycin Nystatin Polymyxin B

Warnings

In the event of local intolerance or allergic reaction, the treatment must be interrupted.

The sensitisation to antibiotics by local route may compromise its later use of the same antibiotic or related antibiotics using the systemic route.

Precautions for use

The duration of treatment must be limited because of the risk of selecting resistant germs and superinfection by these germs.

In the absence of data on the importance of neomycin and polymyxin B fractions resorbed by the mucosa, the risk of systemic effects, especially increased with renal insufficiency, cannot be excluded.

This medicinal product contains soybean oil and may cause hypersensitivity reactions (urticaria, anaphylactic shock).

Contraindicated combinations

+ Condoms and Diaphragms (latex)

Risk of rupture.

Combinations not recommended:

+ Spermicide

Any local vaginal treatment is likely to inactivate a spermicidal local contraception.

Ph3. regnancy

Due to the presence of an aminoside, neomycin, causing an ototoxic risk, and the possibility of systemic absorption, the use of this medicinal product is not recommended during pregnancy.

Lactation

Due to the digestive immaturity of the newborn and the pharmacokinetic properties of this medicinal product, its prescription is not recommended during lactation.

Not relevant.

Adverse reactions are classified by system organ class.

For adverse reactions reported from spontaneous notifications, their frequency is not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.

Not applicable.