CANDIO HERMAL

CANDIO HERMAL Soft Paste

Important notes (mandatory information)

Candio-Hermal Softpaste. Active ingredient: Nystatin. Areas of application: for the treatment of weeping yeast fungal infections of the skin in nappy rash (nappy thrush on sore skin).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Candio-Hermal Softpaste
Active ingredient: Nystatin

Read the entire package leaflet carefully because it contains important information for you. This medicine is also available without a prescription. However, in order to achieve the best possible treatment results, Candio-Hermal Softpaste must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after two to three weeks, you must definitely see a doctor.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

This package leaflet contains

1. WHAT IS CANDIO–HERMAL SOFTPASTE AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING CANDIO–HERMAL SOFTPASTE?
3. HOW IS CANDIO–HERMAL SOFTPASTE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CANDIO–HERMAL SOFTPASTE BE STORED?
6. FURTHER INFORMATION

1. WHAT IS CANDIO-HERMAL SOFTPASTE AND WHAT IS IT USED FOR?

Candio-Hermal Softpaste is a remedy for yeast fungal infections of the skin. Candio-Hermal Softpaste is used for the treatment of weeping yeast fungal infections of the skin in nappy rash (nappy thrush on sore skin).

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING CANDIO-HERMAL SOFTPASTE?

Candio-Hermal Softpaste must not be used if you are hypersensitive (allergic) to nystatin or any of the other ingredients of Candio-Hermal Softpaste.

When using Candio-Hermal Softpaste with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Interactions with other medicines are not known to date. If Candio-Hermal Softpaste is used at the same time in the genital or anal area and latex products (e.g. condoms, diaphragms) are used, the functionality of these products may be reduced and thus their safety may be impaired due to the contained other ingredient "liquid paraffin".

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicines. Nystatin, the active ingredient in Candio-Hermal Softpaste, is considered to be safe for use during pregnancy and breast-feeding.

Driving and using machines

No special precautions are necessary.

3. HOW IS CANDIO-HERMAL SOFTPASTE USED?

Always use Candio-Hermal Softpaste exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not quite sure. Unless otherwise prescribed by your doctor, the usual dose is: Apply Candio-Hermal Softpaste thinly and evenly to the affected areas of skin three to five times a day. The average duration of treatment is two to three weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of Candio-Hermal Softpaste is too strong or too weak.

If you have used more Candio-Hermal Ointment than you should

In cases of overdose, the side effects known for the active ingredient nystatin may occur. Symptoms of poisoning are not known.

If you forget to use Candio-Hermal Softpaste

Do not use double the amount if you have forgotten the previous application.

If you stop using Candio-Hermal Softpaste

When treating fungal infections, all fungal foci on the skin and mucous membranes must be eliminated in order to avoid relapses that originate from untreated fungal foci. Always contact your doctor if you want to stop treatment.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Candio-Hermal Softpaste can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

In very rare cases, burning and redness in the sense of irritant contact reactions may occur, or in very rare cases, hypersensitivity reactions in the sense of allergic contact dermatitis, which can manifest themselves through itching, redness, and blisters even beyond the contact area (so-called spreading reaction). If hypersensitivity occurs (e.g. itching, burning), the medication must be discontinued and a doctor must be consulted.

Reporting of side effects

If you get 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, Department 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 SHOULD CANDIO-HERMAL SOFTPASTE BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and tube after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C. Note on shelf life after opening: Do not use Candio-Hermal Softpaste for longer than 6 months after first opening the tube.

6. FURTHER INFORMATION

What Candio-Hermal Softpaste contains

The active ingredient is: Nystatin. 100 g of paste contain 10 million IU (International Units) of nystatin (equivalent to 2 g of nystatin). The other ingredients are: Polyethylene - Liquid paraffin (5:95); Poly(O-methyl)rice starch; Titanium dioxide; Polyethylene glycol-200 dioleate; Highly dispersed silicon dioxide; Sorbitan sesquioleate; Sorbitan stearate; Sodium chloride.

What Candio-Hermal Softpaste looks like and contents of the pack

Candio-Hermal Softpaste is an off-white paste. Candio-Hermal Softpaste is available in packs of 20 g and 50 g of paste for application to the skin.

Pharmaceutical entrepreneur and manufacturer

Almirall Hermal GmbH
Scholtzstraße 3, 21465 Reinbek
Telephone: (040) 727 04-0
Telefax: (040) 722 92 96
info@almirall.de
www.almirall.de

This package leaflet was last revised in February 2015.

Source: Information from the package leaflet
Status: 12/2016
Active ingredient: Nystatin. Areas of application: for the treatment of weeping yeast fungal infections of the skin in nappy rash (nappy thrush on sore skin).