NYSTADERM

NYSTADERM S Suspension dosing pump

Important notes (mandatory information)

Nystaderm-S 100,000 IU/ml suspension. Active ingredient: Nystatin. Areas of application: for nystatin-sensitive infections of the oral cavity (oral thrush), the throat and oesophagus, as well as for topical intestinal treatment of proven nystatin-sensitive yeast infections and for colonisation prophylaxis of the gastrointestinal tract, especially in children and infants.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nystaderm-S 100,000 IU/ml suspension for oral and ingestion use
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 instructed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact 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 7 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS NYSTADERM-S AND WHAT IS IT USED FOR?

Nystaderm-S contains the active ingredient nystatin, which is indicated for the treatment of fungal infections (antimycotic) of the skin and mucous membranes. Nystaderm-S is used for nystatin-sensitive infections of the oral cavity (oral thrush), the throat and oesophagus, as well as for topical intestinal treatment of proven nystatin-sensitive yeast infections and for colonisation prophylaxis of the gastrointestinal tract, especially in children and infants. If you do not feel better or if you feel worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NYSTADERM-S?

Nystaderm-S must not be used:

• if you are allergic to nystatin or a related active ingredient (amphotericin B, natamycin), methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.
• for the treatment of systemic (affecting the internal organs) fungal infections.

Warnings and precautions

Please talk to your doctor or pharmacist before using Nystaderm-S.

Children

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

Use of Nystaderm-S together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Nystatin, the active ingredient in Nystaderm-S, is hardly absorbed after oral administration via intact skin or via the mucous membranes in therapeutic doses. Nystatin does not pass the placental barrier, and transfer into breast milk is also not to be expected. Nystaderm-S can be used during pregnancy and breast-feeding after a benefit/risk assessment.

Driving and using machines

There is no experience regarding impairment of driving and using machines.

Nystaderm-S contains methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate and sucrose

Methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate can cause hypersensitivity reactions, including delayed reactions. This medicine contains sucrose. Please only take Nystaderm-S after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars. Nystaderm-S can be harmful to the teeth (caries). Note for diabetics: 1 ml of Nystaderm-S has less than 0.05 bread units.

3. HOW TO USE NYSTADERM-S?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: For children (= 2 years) and adults, depending on the severity of the disease, 0.5-1.5 ml of suspension 4 times a day after meals, dripped into the mouth. Newborns (0 to 4 weeks) and toddlers (1 month to 2 years) receive 0.5-1 ml of suspension 4 times a day.

Colonisation prophylaxis of the gastrointestinal tract

150,000 IU 3 to 4 times a day for newborns and toddlers. At least 500,000 IU 4 times a day for adults with risk factors. Note: Nystatin should not be used for so-called intestinal rehabilitation in immunocompetent persons (Candida is part of the normal colon flora).

Oral thrush

Drip Nystaderm-S into the mouth after meals and distribute it in the mouth for at least 1 minute so that the entire oral cavity is well wetted.

Type of use

For oral and ingestion use. This medicine is available with a pipette or dosing pump. Please shake the bottle vigorously before use. Draw up the suspension with the pipette up to the desired marking line (0.5 or 1 ml) or remove it with the dosing pump (1 stroke corresponds to 0.5 ml, 2 strokes correspond to 1 ml). Place the suspension in the oral cavity and leave it in the mouth for a few minutes, then swallow it.

Duration of use

In the case of oral thrush, treatment should be continued for 2-3 days after the visible signs of the disease have disappeared. In the case of yeast infections of the gastrointestinal tract, treatment should generally be carried out for 2 weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of Nystaderm-S is too strong or too weak.

If you have taken more Nystaderm-S than you should

Very little information is available on overdose in oral use of nystatin. Since absorption from the gastrointestinal tract into the body is negligible after oral administration, even at high doses, side effects of nystatin on the organism are not to be expected even in the event of overdose. If necessary, the usual measures to remove medication from the gastrointestinal tract should be taken.

If you forget to take Nystaderm-S

Do not take a double dose to make up for a forgotten dose.

If you stop taking Nystaderm-S

You could jeopardise the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment with Nystaderm-S.

If you have any further questions on 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. The following frequency information is used to assess side effects

The following frequency information is used to assess 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

Common

When taking large amounts: gastrointestinal complaints, nausea, vomiting and diarrhoea

Uncommon

Skin rashes, hives (urticaria), hypersensitivity reactions

Rare

Stevens-Johnson syndrome (fever and painful blistering of the skin and mucous membranes). Methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate can cause hypersensitivity reactions, including delayed reactions.

Special notes

If a hypersensitivity reaction occurs, the medicine should be discontinued and, if necessary, appropriate treatment should be carried out by a doctor.

Reporting of side effects

If you notice any side effects, contact 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 to provide more information on the safety of this medicine.

5. HOW TO STORE NYSTADERM-S?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Note on shelf life after opening or preparation: The shelf life after opening the container is 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nystaderm-S contains

The active ingredient is: 1 ml of suspension contains 100,000 IU of nystatin. The other ingredients are: methyl 4-hydroxybenzoate (Ph.Eur.), propyl 4-hydroxybenzoate (Ph.Eur.) (parabens: E 216, E 218), glycerol, highly dispersed silicon dioxide, sucrose, raspberry flavour, purified water.

What Nystaderm-S looks like and contents of the pack

Nystaderm-S is a light yellow suspension and is available in original packs of 24 ml (with dosing pipette), 24 ml and 48 ml (each with dosing pump) as a suspension for oral and ingestion use.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Tel.: 089 / 641 86-0
Fax: 089 / 641 86-130
E-mail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
(a subsidiary of Dermapharm AG)

This package leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 07/2017
Active ingredient: Nystatin. Areas of application: for nystatin-sensitive infections of the oral cavity (oral thrush), the throat and oesophagus, as well as for topical intestinal treatment of proven nystatin-sensitive yeast infections and for colonisation prophylaxis of the gastrointestinal tract, especially in children and infants.