Dafnegin

Patient Information Leaflet

DAFNEGIN® 0,2% Vaginal Solution
Ciclopiroxolamine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What DAFNEGIN is and what it is used for
2. What you need to know before using DAFNEGIN
3. How to use DAFNEGIN
4. Possible side effects
5. How to store DAFNEGIN
6. Contents of the pack and other information

1. What DAFNEGIN is and what it is used for

DAFNEGIN contains the active substance ciclopiroxolamine, which belongs to the group of antifungal (active against fungi) and antibacterial medicines.
DAFNEGIN is used, in combination with other drugs, in the treatment of vulvovaginal candidiasis.
It may also be used following another vaginal treatment to reduce the risk of recurrence.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before using DAFNEGIN

Do not use DAFNEGIN

• if you are allergic to ciclopiroxolamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using DAFNEGIN.
Irrigation is best performed while lying down or in a semi-seated position, trying to retain the solution in the vagina for a few minutes.
The use, especially if prolonged, of vaginal medications may lead to sensitization reactions. In such cases, treatment must be discontinued and appropriate therapeutic measures should be adopted.
To prevent a new infection after recovery, it would be advisable for your partner to also undergo medical evaluation.
Other medicines and DAFNEGIN
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No negative effects on driving or operating machinery have been observed.

3. How to use DAFNEGIN

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the vaginal solution daily, preferably in the morning, for a period of five days, using the entire bottle according to the following instructions:
A) Hold the bottle by the ring and bend the cap until the safety seal breaks (fig. 1)
B) Pull out the cannula until it stops, feeling a click that confirms correct positioning (fig. 2)
C) Insert the cannula into the vagina and press the sides of the bottle to completely empty it.

It is recommended to perform the irrigation procedure while lying down and slowly.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
Dafnegin vaginal solution is generally well tolerated; however, rarely itching, burning, or local irritation may occur.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please consult your doctor, pharmacist, or nurse. You may also report adverse reactions directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. How to store DAFNEGIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DAFNEGIN contains

• The active substance is Ciclopiroxolamine. 100 ml of vaginal solution contain 200 mg of ciclopiroxolamine.
• The other components are: polyethylene glycol 300, poliglycoleum, undecylenic acid, polysorbate 20, lactic acid, and purified water.

Description of the appearance of DAFNEGIN and contents of the pack
Vaginal solution – 5 bottles with applicator, 150 ml each.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S&R Farmaceutici S.P.A., Via dei Pioppi, 2, 06083 Bastia Umbra (Perugia) - Italy
Manufacturer
New.Fa.Dem. S.r.l, Viale Ferrovie dello Stato – Zona ASI, 80014 Giugliano in Campania (NA)

Package leaflet: Information for the patient

DAFNEGIN® 1% Vaginal Cream
DAFNEGIN® 100 mg Vaginal Ovules
Ciclopiroxolamine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

1. What DAFNEGIN is and what it is used for
2. What you need to know before using DAFNEGIN
3. How to use DAFNEGIN
4. Possible side effects
5. How to store DAFNEGIN
6. Contents of the pack and other information

1. What DAFNEGIN is and what it is used for

DAFNEGIN contains the active substance ciclopiroxolamine, which belongs to the class of antifungal (active against fungi) and antibacterial medicinal products.
Vaginal Cream:
It is used for the treatment of vulvo-vaginal and perianal conditions caused by Candida.
Vaginal Ovules:
They are used for the treatment of vulvo-vaginal conditions caused by Candida.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using DAFNEGIN

Do not use DAFNEGIN

• if you are allergic to ciclopiroxolamine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using DAFNEGIN.
It is advisable to perform the irrigation while lying down or in a semi-sitting position, trying to keep the solution in the vagina for a few minutes.
The use, especially if prolonged, of vaginal medicines may lead to sensitization reactions. In such cases, treatment must be discontinued and appropriate therapeutic measures should be taken.
There may be mutual infection between you and your partner; to prevent a new infection after you have already recovered, it is advisable that your partner also undergoes medical evaluation.
Other medicines and DAFNEGIN
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No negative effects on driving or operating machinery have been observed.
DAFNEGIN Vaginal Cream contains cetyl alcohol and stearyl alcohol. It may cause localized skin reactions (e.g., contact dermatitis).
Contains benzyl alcohol. May cause mild local irritation.
DAFNEGIN Vaginal Suppositories contain benzoic acid, which may cause local irritation.

3. How to use DAFNEGIN

Use this medicine exactly as described in this leaflet or as directed by your
physician or pharmacist. If you have any doubts, consult your physician or pharmacist.

Vaginal cream:
Screw the applicator onto the tube of cream and fill it by gently squeezing the tube.
Insert the applicator deeply into the vagina and administer the contents (5 g) once daily before bedtime for 6 consecutive days, or as directed by the physician, up to a maximum of 14 days.
For application, it is recommended to lie on your back with knees bent slightly.
To prevent reinfection after healing has occurred, it is advisable to treat with a small amount of vaginal cream also the skin around the genital area and anus.

Vaginal ovules:
The recommended dose is 1 ovule of 100 mg for 3-6 days, depending on the severity of the infection and according to the physician's judgment.

If you have any doubts about how to use this medicine, consult your physician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Rarely, itching, burning, or irritation have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DAFNEGIN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DAFNEGIN contains
Vaginal cream:

• The active substance is Ciclopiroxolamine. 1 g of ciclopiroxolamine is contained in 100 g of vaginal cream.
• The other components are: 2-octyldodecanol, liquid paraffin, soft white paraffin, cetyl alcohol, stearyl alcohol, myristyl alcohol, cocofatty acid diethanolamide, polysorbate 60, sorbitan monostearate, benzyl alcohol, lactic acid and deionized water.

Vaginal ovules:

• The active substance is Ciclopiroxolamine. Each 100 mg vaginal ovule contains 100 mg of ciclopiroxolamine.
• The other components are: benzoic acid, glyceryl monoricinoleate and semisynthetic glycerides.

Description of the appearance of DAFNEGIN and contents of the pack
Vaginal cream – 78 g tube
Vaginal ovules – 6 ovules of 100 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S&R Farmaceutici S.P.A. - Via dei Pioppi, 2 - 06083 Bastia Umbra - (Perugia) - Italy
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC).
Fulton Medicinali S.p.A. – Via Marconi, 28/9 – 20020 Arese (MI)
New.Fa.Dem. S.r.l Viale Ferrovie dello Stato – Zona ASI 80014 Giugliano in Campania (NA)