Zidoval Douche 140,0 mg SOLUTION
PDF Leaflet Revision Date: 13 September 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of mild to moderate non-specific vulvovaginitis.
Dosage (summary)
1-2 vaginal irrigations per day for 7 days.
Pregnancy & Breastfeeding
Safety in pregnancy has not been proven.
Contraindications
- Hypersensitivity to benzydamine or excipients.
Common side effects
- Skin irritation.
Counselling Points
- Contact doctor if vaginal bleeding occurs.
- Use only for vaginal application.
Serious warnings
- Prolonged use may cause sensitisation.
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
Zidoval Douche is indicated for the treatment of mild to moderate non-specific vulvovaginitis featuring small vaginal discharges, itching, irritation, burning and vulvar pain or can be used for personal hygiene after giving birth. Zidoval Douche is for use in patients 18 years of age and older.
4.2 Posology and method of administration
Posology
1-2 vaginal irrigations per day for seven days consecutively. If not resolved within 7 days, further investigation is necessary. The solution can be used at room temperature. If you wish to warm it a little, place the closed bottle under hot running water.
Method of administration
For vaginal use only.
4.3 Contraindications
Hypersensitivity to benzydamine, or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
Use of topical products, especially if prolonged, can give rise to sensitisation phenomena, in which case the treatment must be suspended and suitable therapeutic measures must be adopted. The patient should contact her doctor before use in the case of vaginal bleeding and/or leucorrhoea. Zidoval Douche contains benzalkonium chloride which may cause local irritation.
4.5 Interaction with other medicines and other forms of interaction
No negative interactions with other pharmaceutical products commonly used for the conditions in question have been observed.
4.6 Fertility, pregnancy and lactation
Safety in pregnancy has not been proven.
4.7 Effects on ability to drive and use machines
Zidoval Douche has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Skin irritation has been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
Intoxication is only expected in the event of accidental oral ingestion of large amounts of benzidamine (> 300 mg). Symptoms associated with overdose of ingested benzydamine are mainly gastrointestinal symptoms and symptoms of the central nervous system. Most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and oesophageal irritation. Symptoms of the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability. In acute overdose only symptomatic treatment is possible. Patients should be kept under close observation and supportive treatment should be given. Adequate hydration must be maintained.
