Read this leaflet carefully before taking the medicine

• Keep this leaflet. You may need to read it again.
• If you have any doubts, ask your doctor or pharmacist.
• This medicine was prescribed to you. You should not give it to others; the medicine may be harmful to them, even if they have the same symptoms.

NAME OF THE MEDICAL PRODUCT
Dafnegil, 500 mg Nifuratel and 200.000 I.U. Nistatine, vaginal ovule

Dafnegil consists in the association of Nifuratel with Nistatine.

Nifuratel is a synthetic drug, developed by the research laboratories POLI, endowed with an intense and effective trichomonocidal, antibacterial and mycostatic action.

Its polyvalent effect allows the treatment of vaginitis of mixed ethyology, as well as the prevention of mycosis, derived from specific treatments against trichomoniasis.

Nistatine is a well known antibiotic with a fungicidal action and it is particularly active against fungi of Candida species.

The association of Nifuratel-Nistatine allows to achieve “a total fungicidal effect” and develop a polyvalent therapy for vaginitis while ensuring the elimination of pathogenic agents, responsible by the infection (Candida a.,Trichomonas v. and bacteria) and restoring the physiological conditions of the vaginal flora.
This is a way to prevent recurrences after an apparent recovery of the primary infection.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal ovule contains:

Nifuratel ...................................................... 500 mg

Nistatine ...................................................... 200.000 U.I.

PHARMACEUTICAL FORM
Vaginal ovule.

PHARMACOTHERAPEUTIC CLASS
Group VIII-1-b) Genitourinary system; Formulas of topical application in the Vagina; Antiinfectious drugs and gynaecological antiseptic drugs.

NAME OR DESIGNATION OF THE RESPONSIBLE FOR THE M.A
L. Lepori, Lda
Rua João Chagas, 53, Piso 3
1495-072 Algés

THERAPEUTIC INDICATIONS
Treatment of vulvovaginal infections due to Candida, Trichomonas and bacteria.

CONTRAINDICATIONS AND SIDE EFFECTS
The product is contraindicated in patients with hypersensitivity to Nistatine or Nifuratel, or to any of the excipients present in the formulation.

No undesirable effects were reported, due to the use of Dafnegil, vaginal ovules.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
No pharmacological interactions were reported with Dafnegil components.

SPECIAL PRECAUTIONS FOR USE
The prolonged use of the product may cause sensitivity phenomena.
In this case, treatment should be discontinued.

Sexual intercourse should be avoided during treatment.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
There are no contraindications.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
No effects on the ability to drive and use machines were observed.

LIST OF EXCIPIENTS
Each ovule contains:
Dimethylpolysiloxane

Components of the gelatine ovule:
Gelatine, glycerin, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide (E171) and yellow iron oxide (E172).

USUAL POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE
Apply 1 vaginal ovule of 500 mg per day or according to the doctor’s indication.

In order to obtain an effective therapeutic result, place the ovule as deep as possible inside the vagina.

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
The duration of the treatment depends on the clinical situation and its evolution.

INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL EFFECTS

If you forget to administer one or more doses, treatment must be continued.

No special precaution is necessary to suspend the treatment.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS AND ANTIDOTES
It can be excluded considering the administration route.

ADVICE TO THE PATIENT
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

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 AND INDICATION OF VISIBLE SIGNS OF DETERIORATION, IF THEY EXIST

Keep in a dry place.
Do not store above 25ºC.

DATE OF THE REVISION OF THE LEAFLET: February 2004.

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