Nystatin Pessaries 100 000 Units
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NYSPES/Nystatin Pessaries 100,000 Units
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nystatin BP 105,000 Units (approx. 18.00 mg)
3 PHARMACEUTICAL FORM
Pessaries
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of candidal vaginitis.
4.2 Posology and method of administration
Pessaries:
Adults including the elderly:
1 or 2 pessaries should be inserted high into the vagina for 14 consecutive nights or longer, regardless of any intervening menstrual period.
Children:
Not recommended.
Route of administration: Vagina
4.3 Contraindications
There are no known contraindications to use of NYSPES, except hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
In pregnancy, care should be taken when using an applicator to prevent the possibility of mechanical trauma.
4.5 Interaction with other medicinal products and other forms of interaction
Not known.
4.6 Pregnancy and lactation
In pregnancy, care should be taken when using the applicator provided to prevent the possibility of mechanical trauma.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
None stated.
4.9 Overdose
None.
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. Nystatin has both fungistatic and fungicidal effects.
5.2 Pharmacokinetic properties
Nystatin is an antifungal 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
Lactose, povidone, purified water, industrial methylated spirit 99%, maize starch, sodium starch glycolate, magnesium stearate.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
Special precautions for storage
6.4
Store below 25°C in a 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 foam sponge wads.
Pack sizes: 100 and 500.
6.6 Special precautions for disposal
No special precautions. Use as directed by the physician.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
Boumpoulinas 11, 3 Floor
NICOSIA
CYPRUS
PC. 1060
CYPRUS
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0071
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 21/11/2008
10 DATE OF REVISION OF THE TEXT
21/11/2008