BIOFANAL

BIOFANAL Ointment

Important notes (mandatory information)

Biofanal OintmentActive ingredient: Nystatin. Field of application: Candida infections of the skin and mucous membranes, in particular intertrigo (submammary, inguinal, perineal, perianal), paronychia, interdigital mycosis.

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


Patient information: Information for users
Biofanal 100,000 IU Ointment
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 leaflet or exactly as directed by your doctor or pharmacist.
. Keep the package leaflet. You may want to read it again later.
. Ask your doctor or pharmacist if you need more information or advice.
. If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. If you do not feel better or even worse, talk to your doctor.

What this leaflet contains

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

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

Biofanal Ointment is a specific antifungal agent (Candida albicans and other Candida species) for the treatment of yeast infections of the skin and vaginal mucosa.

Biofanal Ointment is used to treat Candida infections of the skin and vaginal mucosa, in particular intertrigo, paronychia and interdigital mycosis.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BIOFANAL OINTMENT?

Biofanal Ointment must not be used
- if you are allergic to nystatin or any of the other ingredients of this medicine listed in section 6
- in fungal infections caused by Trichophyton or Aspergillus species.

Warnings and precautions
If Biofanal Ointment and condoms are used at the same time, the contained auxiliary substance paraffin may reduce the tear resistance and thus impair the safety of condoms.

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 active ingredient nystatin contained in Biofanal Ointment, yellowish discolouration of the underwear is possible. These can be removed by normal washing.

Use of Biofanal Ointment together 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.
None known.

Pregnancy, breastfeeding and fertility
Nystatin, the active ingredient in Biofanal Ointment, is hardly absorbed in therapeutic doses after oral administration, via intact skin or via the mucous membranes. Nystatin does not cross the placental barrier, and passage into breast milk is also not to be expected. Biofanal Ointment can be used during pregnancy and breastfeeding. To avoid an ascending infection in the case of an existing pregnancy, hands must be washed thoroughly before applying the ointment.

Driving and using machines
No special precautions are required.

3. HOW TO USE BIOFANAL OINTMENT?

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

Unless otherwise prescribed by your doctor, the usual dose is

The ointment should be applied thinly to the infected skin areas several times a day.
Please wash your hands thoroughly before applying the ointment.
Biofanal Ointment should be used until completely healed. The average duration of therapy required for this is 2-4 weeks. If necessary, Biofanal Ointment can also be used for longer.

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 Ointment than you should:
Poisoning symptoms are hardly to be expected even in the case of an overdose of Biofanal Ointment, since the active ingredient nystatin contained in Biofanal Ointment is only absorbed into the bloodstream in small amounts when applied to the skin or vaginal mucosa. However, if you suspect an overdose, please contact a doctor immediately!

If you forget to use Biofanal Ointment

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

If you stop using Biofanal Ointment:
To achieve the desired therapeutic success, please adhere to the recommended duration of treatment in the section "How to use Biofanal Ointment?" or to the doctor's prescription. Treatment should not be interrupted or ended 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 have side effects, although not everybody gets them.
Hypersensitivity (rash, dermatitis, itching and burning) to nystatin applied externally is very rare (may affect up to 1 in 10,000 people).
If irritation or hypersensitivity occurs, treatment should be discontinued.

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

5. HOW TO STORE BIOFANAL OINTMENT?

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.

After opening the tube, Biofanal Ointment can be stored at room temperature (15-25°C) for 4 weeks.

Do not store above 25 °C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What 1g Biofanal Ointment contains

The active ingredient is: 100,000 IU nystatin.
The other ingredients are: Polyethylene-thick liquid paraffin (5:95).

What Biofanal Ointment looks like and contents of the pack:
Yellow ointment; Packs of 25 g ointment and 50 g ointment.

Pharmaceutical entrepreneur and manufacturer
Dr. R. Pfleger Chemische Fabrik GmbH,
D-96045 Bamberg,
Telephone: 0951/6043-0,
Fax: 0951/604329
E-Mail: info@dr-pfleger.de

This leaflet was last revised in January 2013.

Source: Information from the package leaflet
Status: 08/2015
Active ingredient: Nystatin. Field of application: Candida infections of the skin and mucous membranes, in particular intertrigo (submammary, inguinal, perineal, perianal), paronychia, interdigital mycosis.