BIOGINAL 100 mg Pessary

Treść ulotki

1. BIOGINAL 0.2% vaginal solution, 100 mg vaginal suppositories
   1. What is BIOGINAL and what is it used for
   2. What you need to know before taking BIOGINAL
   3. How to take BIOGINAL
   4. Possible side effects
   5. How to store BIOGINAL
   6. Contents of the pack and other information

BIOGINAL 0.2% vaginal solution, 100 mg vaginal suppositories

Ciclopiroxolamine
Generic medicine

Read this leaflet carefully before taking 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 BIOGINAL is and what it is used for
• 2. What you need to know before you take BIOGINAL
• 3. How to take BIOGINAL
• 4. Possible side effects
• 5. How to store BIOGINAL
• 6. Contents of the pack and other information

1. What is BIOGINAL and what is it used for

BIOGINAL contains “ciclopiroxolamine” as its active ingredient.
Ciclopiroxolamine, belonging to a category of antifungal and antimicrobial drugs, is
able to kill many types of pathogenic fungi and bacteria (such as dermatophytes, Candida albicans,
Gram-positive and Gram-negative bacteria).
BIOGINAL therefore inhibits the growth of pathogenic fungi and bacteria that cause problems in
women, leading to a rapid resolution of symptoms.
BIOGINAL is mainly useful as an adjunct therapy for inflammation of the vagina that
also involves the vulva, i.e. the external female genitalia (vulvo-vaginitis), caused by
the microorganism Candida albicans.
See your doctor if you do not feel better or if you feel worse after a week of therapy.

2. What you need to know before taking BIOGINAL

Do not take BIOGINAL

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

Warnings and precautions
Talk to your doctor or pharmacist before taking BIOGINAL.
Prolonged use of topical medications can lead to sensitization reactions. In such
cases, stop treatment and inform your doctor or pharmacist.
To prevent recurrence of infection, it is advisable that your partner also undergo a
medical check-up.

Other medicines and BIOGINAL
Tell 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, 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.
BIOGINAL is not absorbed systemically (into the general body), however if you are
pregnant or breastfeeding, take BIOGINAL only after consulting your doctor
who will carefully monitor your health during the period of taking the medicine.

Driving and operating machinery
No effects of BIOGINAL on the ability to drive and operate
machinery have been reported.

3. How to take BIOGINAL

Take this medicine following exactly as indicated 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 douche daily, preferably in the morning, for 5 days.
It is advisable to perform the irrigation in the vagina in a comfortable position, lying down or semi-recumbent, trying to keep the solution in the vagina for a few minutes.

BIOGINAL 100 mg vaginal suppositories
The recommended dose of BIOGINAL 100 mg vaginal suppositories is 1 suppository daily, for 3-6 days, depending on the severity of the infection and at the discretion of your doctor.

If you take more BIOGINAL than you should
There is no risk of overdose with this medicine.

If you stop taking BIOGINAL
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.
If you experience any of the following side effects, stop treatment with
BIOGINAL and inform your doctor:

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more 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 reported on the label after {Scad}. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain 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 BIOGINAL contains
BIOGINAL 0.2% vaginal solution

• The active ingredient is ciclopiroxolamine, each bottle contains 300 mg of ciclopiroxolamine.
• The other ingredients are: propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, nonoxynol 9, mixed tocopherols, polysorbate 20, cetrimide, lactic acid, sodium edetate, salvoderm fragrance, purified water.

BIOGINAL 100 mg vaginal pessaries

• The active ingredient is ciclopiroxolamine, each pessary contains 100 mg of ciclopiroxolamine.
• The other ingredients are: cetrimide, mixed tocopherols, sodium edetate, glyceryl monostearate, solid semi-synthetic glycerides.

Description of the appearance of BIOGINAL and contents of the pack
BIOGINAL 0.2% vaginal solution
Cardboard box containing 5 wash bottles of 150 ml. Each bottle is equipped with a
dispensing cannula and a closing cap.
BIOGINAL 100 mg vaginal pessaries
Cardboard box containing 6 pessaries in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22

• 00040 - Pomezia (RM) Italy

Manufacturer
Special Product’s Line S.p.A.
Strada Paduni, 240

• 03012- Anagni (FR) Italy