SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

NYSTABS/Nystatin Tablets 500,000 Units

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Nystatin BP 525,000 Units (approximately 90.00 mg)

3    PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Candidiasis

4.2    Posology and method of administration

Adults, including the Elderly:

1 tablet four times daily. This dose may be doubled. For prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of C. albicans in patients receiving broad-spectrum antibiotic therapy.

Administration should be continued for 48 hours after clinical cure to prevent relapse.

Children: Not recommended.

Route of administration: Oral

4.3 Contraindications

There are no known contra-indications to the use of Nystatin, except hypersensitivity to the ingredients in the product.

4.4 Special warnings and precautions for use

None stated

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Pregnancy and lactation

None stated

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Nausea, vomiting and diarrhoea have occasionally been reported with doses of Nystatin exceeding 4 to 5 million units daily. Non systemic effects or allergic reactions have been associated with its oral use.

4.9 Overdose

Since the absorption of Nystatin from the gastro-intestinal tract is negligible, overdosage causes no systemic toxicity.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Nystatin exerts its effect by interaction with cell walls and cell membranes. Sterols present in the cell membrane are necessary for this effect. It has both fungistatic and fungicidal effects.

5.2 Pharmacokinetic properties

Nystatin is an anti-fungal antibiotic active against Candida albicans and a wide range of yeast-like fungi.

5.3 Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Pregelatinised maize starch, maize starch, lactose, sodium starch glycollate, magnesium stearate.

Shellac, povidone, talc, sucrose, E171, E124, E128 E110, E172.

Incompatibilities

None stated.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

Store in a cool, dry place in well closed containers.

Protect from light.

6.5    Nature and contents of container

High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts.

Pack sizes: 28 and 100.

6.6    Special precautions for disposal

Use as directed by the physician.

7    MARKETING AUTHORISATION HOLDER

Chelonia Healthcare Limited

Boumpoulinas 11, 3 ^rd Floor

NICOSIA

CYPRUS

PC. 1060

CYPRUS

8    MARKETING AUTHORISATION NUMBER(S)

PL 33414/0072

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/11/2008

10    DATE OF REVISION OF THE TEXT

21/11/2008