ROSALGIN, vaginal solution, 140 ml

Name of the medical product
Rosalgin®

Qualitative and quantitative composition
Each 100 ml of vaginal solution contains:

Active substance: Benzidamine hydrochloride: 100 mg

Pharmaceutical form and content
Vaginal solution
5 vials of 140 ml.

Pharmacotherapeutic class
Pharmacotherapeutic group: Group VIII-1-b Formulas of topical application in the vagina,
Antiinfecious drugs and gynaecological antiseptic drugs.

ATC code: G02CC03 – Other medicines of gynaecological use; Anti-inflammatory of vaginal use

Market authorisation holder
L.Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés

Therapeutic indications
Vulvovaginitis and exocervicitis of any origin and nature.
Pre- and Post-operation prophylaxis in gynaecological surgery.
Female hygiene during puerpery.

Contraindications and side effects
There are no contraindications to the use of Rosalgin vaginal solution, except in the cases of hypersensitivity to the active substance or any of its excipients.

Drug interactions and other forms of interaction
No drug interactions are referred with Rosalgin

Warnings and special precautions for use
As with any other topical application preparations, the prolonged use may lead to hypersensitivity reactions. In these cases, treatment should be discontinued.

When used in pre- and post-operation cases, Rosalgin should be applied under medical surveillance.

Effects in pregnant women, breast-feeding women, children, elderly patients and patients with special pathologies
The toxicological and clinical studies performed with Benzidamina have demonstrated that Rosalgin is free of toxic effects in the recommended doses; nevertheless, a close monitoring is advised.

Effects on the ability to drive and use machines
Nothing to refer.

List of excipients
p-toluenosulphate of trimethylcetylammonium, Alcohol 95%, Polysorbate 20, rose oil and Purified water

Usual posology, with reference to maximum dose
1-2 vaginal irrigations per day, according to the doctor’s opinion. The solution can be used at room temperature. When warmed up, place the closed vial under a stream of hot water for a few minutes.

1- To open the vial, grab the ring while rotating the cap to break the safety ring

2- Pull the cannula until you feel a rebound. Only the complete extraction of the cannula allows the outflow of the liquid.

3 – Gently introduce the cannula in the vagina and squeeze the vial until it becomes empty. Its emptiness may be gradual and regulated according to the needs; there is a valve that prevents the reflux of the solution into the vial.

When possible, perform the irrigation in the lying down position.

To fully benefit from the therapeutic activity, keep the liquid inside the vagina for a few minutes.

Indication of the most favourable moment for the administration of the medicine
According to the doctor’s indication.

Duration of the average treatment when it should be limited
Treatment should continue until the disappearance of the symptoms.

Instructions about what to do if you forget to apply one or more doses
If you forget to apply one or more doses, treatment must be continued.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
Normally, no special precaution is necessary to suspend the treatment.

Measures to adopt in case of overdosage and/or intoxication, emergency measures and antidotes
Overdosage is not to be considered

Advice to the patient
Contact your doctor or pharmacist if after a short period of treatment there are no significant results.

Check if the product is within the expiry date mentioned in the package. Keep the medicine out of reach and sight of children.

Special precautions for storage
Do not store above 25ºC.

Date of the revision of the leaflet
July 2004

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