DAFNEGIN 1% Cream

Зміст інструкції

1. What is DAFNEGIN and what is it 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
7. What is DAFNEGIN and what is it used for
8. What you need to know before using DAFNEGIN
9. How to use DAFNEGIN
10. Possible side effects
11. How to store DAFNEGIN
12. Contents of the pack and other information

DAFNEGIN® 0,2% Vaginal Solution
Ciclopiroxolamine

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is DAFNEGIN and what is it used for

DAFNEGIN contains the active ingredient ciclopiroxolamine, which belongs to the category of antifungal (active against fungi) and antibacterial medicinal products.
DAFNEGIN is used, together with other medications, in the therapy of vulvo-vaginal pathologies caused by Candida.
It can also be used after another vaginal therapy, in order to reduce the risk of recurrence.
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 cyclopiroxolamine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using DAFNEGIN.
It is advisable to perform the irrigation while lying down or semi-reclined, trying to keep the solution in the
vagina for a few minutes.
The use, especially if prolonged, of medicines for vaginal use may lead to sensitization phenomena. In
such a case, treatment should be discontinued and appropriate therapeutic measures adopted.
To prevent re-infection after you have already recovered, it would be advisable for your partner to also
undergo a medical check-up.

Other medicines and DAFNEGIN
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
No adverse effects on driving and operating machinery have been reported.

3. How to use DAFNEGIN

Use this medicine following exactly as stated in this leaflet or as instructed 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 is broken (fig. 1)
B) Pull the cannula until it stops, so you can feel the click of correct positioning (fig. 2)
C) Insert the cannula into the vagina and press the walls of the bottle to allow complete emptying.

It is recommended to perform the irrigation in a lying position and slowly.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dafnegin vaginal solution is generally well tolerated, however, itching,
burning or local irritation may rarely occur.

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

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 which is stated on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DAFNEGIN contains

• The active ingredient is Ciclopiroxolamine. 100 ml of vaginal solution contains 200 mg of ciclopiroxolamine.
• The other ingredients are: polyethylene glycol 300, polyglycolum, undecylenoyl phenylpropionate, polysorbate 20, lactic acid, and purified water.

Description of the appearance of DAFNEGIN and contents of the pack
Vaginal solution – 5 vials with cannula of 150 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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)

DAFNEGIN® 1% Vaginal Cream
DAFNEGIN® 100 mg Vaginal Ovules
Ciclopiroxolamine

Read this leaflet carefully before you use 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, see your doctor.

Contents of this leaflet:

• 1. What DAFNEGIN is and what it is used for
• 2. What you need to know before you use 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 is DAFNEGIN and what is it used for

DAFNEGIN contains the active ingredient ciclopiroxolamine, which belongs to the category of antifungal (active against fungi) and antibacterial medicinal products.

Vaginal Cream:
It is used for the treatment of vulvo-vaginal and peri-anal pathologies caused by Candida.

Vaginal Suppositories:
They are used for the treatment of vulvo-vaginal pathologies 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using DAFNEGIN.
It is advisable to perform the irrigation while lying down or semi-reclined, trying to keep the solution in the
vagina for a few minutes.
The use, especially if prolonged, of medicines for vaginal use may lead to sensitization phenomena. In
this case, it is necessary to stop the treatment and adopt appropriate therapeutic measures.
There is a possibility of reciprocal infection between you and your partner; to prevent a new infection after you have
already recovered, it is advisable that your partner also undergo medical examination.

Other medicines and DAFNEGIN
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
No adverse effects on driving and operating machinery have been reported.

DAFNEGIN Vaginal cream contains cetyl alcohol and stearyl alcohol. It may cause localized skin
reactions (e.g. contact dermatitis).
Contains benzyl alcohol. It may cause mild local irritation.

DAFNEGIN Vaginal suppositories contains benzoic acidwhich may cause local irritation.

3. How to use DAFNEGIN

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
.

Vaginal cream:
Screw the applicator onto the tube of cream and fill it by applying slight pressure to the tube.
Insert the applicator deep into the vagina and apply the contents (5 g) daily before bedtime for 6 consecutive days or as directed by the doctor, up to a maximum of 14 days.
A supine position with legs slightly bent is recommended for application.
To prevent a new infection after it has already healed, it is advisable to treat with some vaginal cream also the skin present around the genitals and anus.

Vaginal suppositories:
The recommended dose is 1 suppository of 100 mg for 3-6 days depending on the severity of the infection and at the doctor's discretion.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or
nurse. You can also report side effects directly through 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DAFNEGIN contains

Vaginal cream:

• The active ingredient is Ciclopiroxolamine. 100 g of vaginal cream contains 1 g of ciclopiroxolamine.
• The other ingredients are: 2-octyl-dodecanol, liquid paraffin, soft paraffin, cetyl alcohol, stearyl alcohol, myristyl alcohol, coconut fatty acid diethanolamide, polysorbate 60, sorbitan monostearate, benzyl alcohol, lactic acid and deionised water.

Vaginal ovules:

• The active ingredient is Ciclopiroxolamine. Each 100 mg vaginal ovule contains 100 mg of ciclopiroxolamine.
• The other ingredients are: benzoic acid, glyceryl monoricinoleate and semi-synthetic glycerides.

Description of the appearance of DAFNEGIN and contents of the pack
Vaginal cream – Tube 78 g
Vaginal ovules – 6 ovules of 100 mg.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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)