Bioginal

BIOGINAL 0.2% vaginal solution (active substance: ciclopiroxolamine)
BIOGINAL 100 mg vaginal ovules (active substance: ciclopiroxolamine)

Package leaflet: information for the patient

BIOGINAL 0.2% vaginal solution, 100 mg vaginal ovules

Ciclopiroxolamine
Generic medicine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or 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 any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What BIOGINAL is and what it is used for
2. What you need to know before using BIOGINAL
Do not take BIOGINAL

• 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 BIOGINAL.
Prolonged use of topical medicines may lead to sensitization. If this occurs,
discontinue treatment and inform your doctor or pharmacist.
To prevent recurrent infections, it is advisable that your partner also undergoes a medical evaluation.
BIOGINAL 0.2% vaginal solution (active ingredient: ciclopiroxolamine)
BIOGINAL 100 mg vaginal ovules (active ingredient: ciclopiroxolamine)
Other medicines and BIOGINAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
BIOGINAL is not systemically absorbed (into the general circulation), however, if you are pregnant or breastfeeding, use BIOGINAL only after consulting your doctor, who will carefully monitor your health during treatment.
Driving and using machines
No effects of BIOGINAL on the ability to drive or operate machinery have been reported.

3. How to take BIOGINAL

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
BIOGINAL 0.2% vaginal solution
The recommended dose of BIOGINAL 0.2% vaginal solution is 1 irrigation per day, preferably in the
morning, for 5 days.
It is advisable to perform the vaginal irrigation in a comfortable position, lying down or semi-seated, trying to
retain the solution in the vagina for a few minutes.

BIOGINAL 100 mg vaginal ovules
The recommended dose of BIOGINAL 100 mg vaginal ovules is 1 ovule per day, for 3–6 days,
depending on the severity of the infection and at the discretion of your doctor.
If you use more BIOGINAL than you should
There are no risks of overdose with this medicine.
BIOGINAL 0.2% vaginal solution (active substance: ciclopiroxolamine)
BIOGINAL 100 mg vaginal ovules (active substance: ciclopiroxolamine)
If you have any questions 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 everyone will experience them.
If you experience any of the following side effects, stop treatment with BIOGINAL and inform your doctor:

• rarely itching, burning or local irritation;
• possible occurrence of hypersensitivity reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store BIOGINAL

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 after {Exp.}. 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 BIOGINAL contains
BIOGINAL 0.2% vaginal solution

• The active substance is ciclopiroxolamine; each bottle contains 300 mg of ciclopiroxolamine.
• The other components are: propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, nonoxynol 9, mixed tocopherols, polysorbate 20, cetyltrimethylammonium bromide, lactic acid, edetate disodium, Salvoderm fragrance, purified water.

BIOGINAL 100 mg vaginal ovules

• The active substance is ciclopiroxolamine; each ovule contains 100 mg of ciclopiroxolamine.
• The other components are: cetyltrimethylammonium bromide, All-rac-α-tocopherols, edetate disodium, glyceryl monostearate, semi-synthetic solid glycerides.

Description of the appearance of BIOGINAL and contents of the pack
BIOGINAL 0.2% vaginal solution
Carton box containing 5 150 ml douche bottles. Each bottle is supplied with an applicator nozzle and a closure cap.
BIOGINAL 100 mg vaginal ovules
BIOGINAL 0.2% vaginal solution (a.s. ciclopiroxolamine)
BIOGINAL 100 mg vaginal ovules (a.s. ciclopiroxolamine)
Carton box containing 6 ovules in blister packs.

Marketing Authorization Holder and Manufacturer
Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22 – 00071 Pomezia (Roma) - Italy
Marketing and Distribution Licensee
DOC Generici S.r.l.
Via Turati 40,
20121 - Milano
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) – Italy
April 2026