BIOFANAL

BIOFANAL combination pack for vaginal yeast infections Vagtab.+Ointment

Important notes (mandatory information)

Biofanal combination pack for vaginal thrush and Candida infection of the external genital area 100,000 IU, ointment + vaginal tablets. Active ingredient: Nystatin. Areas of application: for the treatment of infections of the vagina and external genital area caused by proven yeasts that are sensitive to nystatin (Candida species).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Biofanal combination pack for vaginal thrush and Candida infection of the external genital area 100,000 IU, ointment + vaginal tablets
Active ingredient: Nystatin

Read the entire package leaflet carefully before you start using this medicine, because 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 2 weeks, contact 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 agent against yeasts (Candida albicans and other Candida species) for the treatment of yeast infections of the vagina and external genital area, which consists of 2 different components (vaginal tablets and ointment). Biofanal is used to treat infections of the vagina and external genital area caused by proven yeasts that are sensitive to nystatin (Candida species). Explanation: Candida species are fungi that can be detected on the skin and in the vagina of very many women. Only when they multiply excessively does a fungal disease (mycosis) develop, which usually manifests itself through redness, burning, itching, discharge and painful inflammation. It can only be reliably detected by a gynaecologist or dermatologist.

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 the two components of this medicine (vaginal tablets and ointment) listed in section 6.
• in fungal infections caused by Trichophyton or Aspergillus species.

Warnings and precautions

Children

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

What else do you need to watch out for?
If the ointment component of this medicine is used at the same time as condoms or diaphragms, the tear resistance and thus the safety of these products may be impaired due to the paraffin auxiliary substance it contains. Due to the nystatin active ingredient contained in Biofanal, yellowish discolouration of laundry or underwear is possible. This can be removed by normal washing.

Use of Biofanal with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions with other medicines are not known to date.

Pregnancy, breast-feeding and fertility

Nystatin, the active ingredient in Biofanal, is hardly absorbed into the bloodstream in therapeutic doses via intact skin or mucous membranes. Nystatin does not cross the placental barrier, and passage 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 and applying the ointment.

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, type and duration of use are

Component 1 - Ointment

The ointment should be applied thinly to the infected skin areas of the external genital area twice a day. The ointment should be used until it has healed completely. The average duration of therapy required for this is 2 - 4 weeks. Clinical experience with tolerability is available for up to 2 weeks of use. 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.

Component 2 - Vaginal tablets

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

Please wash your hands thoroughly before inserting the vaginal tablet and applying the ointment. A medical follow-up examination should clarify whether the treatment with the vaginal tablets over 3 or 6 days has been successful or should be continued. In the latter case, it may be advisable to extend the treatment until it has healed. Clinical experience with tolerability is available for up to 2 weeks of use. The treatment should preferably 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 of the components of Biofanal than you should

Symptoms of poisoning are hardly to be expected even in the case of an overdose of the components of Biofanal, since the active ingredient nystatin contained in the ointment and vaginal tablets is only absorbed into the bloodstream in small amounts when used on the external genital area (ointment) or vaginally (vaginal tablets). However, if you suspect an overdose, please contact a doctor immediately!

If you forget to use the components of Biofanal

Component 1 - Ointment

You can make up for the forgotten application in the specified or prescribed dosage on the same day.

Component 2 - Vaginal tablets

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

If you stop using Biofanal

In order 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 ended prematurely without prior consultation with a 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.

Component 1 - Ointment

Very rarely (may affect up to 1 in 10,000 people) skin inflammation, itching and burning occur when used on the external genital area.

Component 2 - Vaginal tablets

Occasionally (affects 1 to 10 in 1,000 people) burning and itching may occur. In these cases, the doctor should be informed.

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 container (blister or tube). The expiry date refers to the last day of the month. Do not store above 25°C. After opening the tube, the ointment can be stored at room temperature (15°C - 25°C) for 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Biofanal contains:

• Component 1 - Ointment: 1 g of ointment contains 100,000 IU of nystatin. The other ingredients are: Polyethylene - Thick liquid paraffin (5:95).
• Component 2 - Vaginal tablets: 1 vaginal tablet contains 100,000 IU of nystatin. The other ingredients are: Microcrystalline cellulose, lactose monohydrate, magnesium stearate (Ph.Eur.), maize starch.

What the components of Biofanal look like and contents of the pack:

• Component 1 - Ointment: Yellow ointment.
• Component 2 - Vaginal tablets: Light yellow, oblong, biconvex tablets.

Pack of 25 g ointment and 6 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 infections of the vagina and external genital area caused by proven yeasts that are sensitive to nystatin (Candida species).