BIOFANAL

BIOFANAL for vaginal yeast infections 100,000 IU vaginal tablets.

Important notes (mandatory information)

Biofanal for vaginal thrush vaginal tablets 100,000 IU Active ingredient: Nystatin. Areas of application: for the treatment of vaginal infections caused by nystatin-sensitive yeasts (Candida albicans, Candida glabrata, etc.) (discharge, vaginitis).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Biofanal for vaginal thrush vaginal tablets 100,000 IU
Active ingredient: Nystatin

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 or 6 days, talk to your doctor.

What this package leaflet contains

1. WHAT IS BIOFANAL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BIOFANAL?
3. HOW TO USE BIOFANAL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BIOFANAL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BIOFANAL AND WHAT IS IT USED FOR?

Biofanal is a specific antifungal agent (Candida albicans and other Candida species) for the treatment of vaginal yeast infections. Biofanal is used to treat vaginal infections caused by nystatin-sensitive yeasts (Candida albicans, Candida glabrata, etc.) (discharge, vaginitis).

2. WHAT SHOULD YOU CONSIDER BEFORE USING BIOFANAL?

Biofanal must not be used if you are allergic to nystatin or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Children

Due to the high osmolarity of nystatin, use in very underweight and immature premature infants is not recommended.

What else do you need to watch out for?
Due to the nystatin contained in Biofanal, yellowish discolouration of the underwear is possible. This can be removed by normal washing.

Use of Biofanal with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. Interactions with other medicines are not known so far.

Pregnancy, breast-feeding and fertility

Nystatin, the active ingredient in Biofanal, is hardly absorbed in therapeutic doses via intact skin or via the mucous membranes. Nystatin does not cross the placental barrier and transfer into breast milk is also not to be expected. Biofanal can be used during pregnancy and breast-feeding. To avoid an ascending infection during pregnancy, hands must be washed thoroughly before inserting the vaginal tablet.

Driving and using machines

No special precautions are required.

3. HOW TO USE BIOFANAL?

Always use this medicine exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

• Short-term therapy: On 3 consecutive days, 2 vaginal tablets should be inserted deep into the vagina before bedtime.
• 6-day therapy: On 6 consecutive days, one vaginal tablet should be inserted deep into the vagina before bedtime.

Please wash your hands thoroughly before inserting the vaginal tablet. A medical follow-up examination should clarify whether the treatment has been successful or should be continued. In the latter case, the treatment can be extended until the final cure. The treatment should not be carried out during menstruation or should be completed before it begins.

Children and adolescents

Since there is insufficient data on the treatment of children and adolescents, treatment should be carried out in consultation with a doctor.

If you have used more Biofanal than you should

Symptoms of poisoning are hardly to be expected even in the case of an overdose of Biofanal, since the active ingredient nystatin contained in Biofanal is only absorbed into the bloodstream in small amounts when used vaginally. In case of suspected overdose, please contact a doctor in any case!

If you forget to use Biofanal

You should continue treatment the next day and extend the duration of treatment by one day accordingly.

If you stop using Biofanal

To achieve the desired therapeutic success, please adhere to the recommended duration of treatment in the section "How to use Biofanal?" or to the doctor's prescription. Treatment should not be interrupted or terminated prematurely without prior consultation with the doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Occasionally (affects 1 to 10 out of 1,000 people treated), burning and itching may occur. If side effects occur, treatment should be discontinued.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE BIOFANAL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container. The expiry date refers to the last day of the month. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What one Biofanal tablet contains

The active ingredient is 100,000 IU nystatin. The other ingredients are: Microcrystalline cellulose, lactose monohydrate, magnesium stearate (Ph.Eur.), corn starch.

What Biofanal looks like and contents of the pack

Light yellow, oblong, biconvex tablets. Packs of 6 and 12 vaginal tablets.

Pharmaceutical entrepreneur and manufacturer

Dr. Pfleger Arzneimittel GmbH
D-96045 Bamberg
Telephone: 0951/6043-0
Telefax: 0951/604329
E-mail: info@dr-pfleger.de

This package leaflet was last revised in July 2020.

Source: Information from the package leaflet
Status: 01/2022
Active ingredient: Nystatin. Areas of application: for the treatment of vaginal infections caused by nystatin-sensitive yeasts (Candida albicans, Candida glabrata, etc.) (discharge, vaginitis).