Product Summary

1.    Trade Name of the Medicinal Product Canesten Vaginal Tablets.

2.    Qualitative and Quantitative Composition

As per eCMA No. 52.624 issued by Spain.

3.    Pharmaceutical Form

White convex tablet

Clinical Particulars

4.1.    Therap euti c Indi cati ons As per UK PL 00010/0015.

4.2.    Posology and Method of Administration

As per UK PL 00010/0015.

4.3.    Contra-indications

As per UK PL 00010/0015.

4.4.    Special Warnings and Precautions for Use

As per UK PL 00010/0015.

4.5.    Interactions with other Medicaments and other forms of Interaction

As per UK PL 00010/0015.

4.6.    Pregnancy and Lactation

As per UK PL 00010/0015.

4.7.    Effects on Ability to Drive and Use Machines

As per UK PL 00010/0015.

4.8.    Undesirable Effects

As per UK PL 00010/0015.

4.9.    Overdose

As per UK PL 00010/0015.

Pharmacological Properties

5.1.    Pharmacodynamic Properties As per UK PL 00010/0015.

5.2.    Pharmacokinetic Properties

As per UK PL 00010/0015.

5.3.    Preclinical Safety Data

None stated.

6.1.    List of Excipients

As per ECMA No. 52.624 issued by Spain.

6.2.    Incompatibilities

As per UK PL 00010/0015.

6.3.    Shelf Life

60 months unopened.

60 months opened.

6.4.    Special Precautions for Storage

No special precautions.

6.5.    Nature and Contents of Container

Cardboard outer. Tablets sealed in foil.

6.6.    Instruction for Use/Handling As per UK PL 00010/0015.

Administrative Data

7. Marketing Authorisation Holder

Pharmaceutical Identity Ltd Kirk Sandall Industrial Estate Doncaster DN3 1QR

PLPI12998/0047.

9.    Date of First Authorisation/Renewal of Authorisation

None stated.

10.    Date of (Partial) Revision of the Text

None stated.