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SPC Table of Contents

FAMVIR

500 Milligram Film Coated Tablet

PCO ManufacturingPPA0465/212/002

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/212/002
1 NAME OF THE MEDICINAL PRODUCT

Famvir 500mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coatedtablet contains 500 mg famciclovir.

Forthe full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM

Film-coated tablet

Product as placed on the market in Greece:

White, oval film-coated tablet, biconvex, bevelled edges, debossed with “FV 500” on one side and plain on the reverse side.
4 CLINICAL PARTICULARS As per PA0013/106/006
4.1 Therapeutic Indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5 PHARMACOLOGICAL PROPERTIES

As per PA0013/106/006
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Tablet core:

Hyprolose

Sodium Starch Glycollate

Magnesium Stearate

Tablet coat:

Hypromellose

Titanium Dioxide (E171)

Polyethylene glycol 4000

Polyethylene glycol 6000
6.2 Incompatibilities

Not applicable
6.3 Shelf life

The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin.
6.4 Special precautions for storage

Do not store above 25ºC. Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Famvir is supplied in Aluminium blister packs containing 21 tablets.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18th July 2014
10 DATE OF REVISION OF THE TEXT

August 2015
6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.
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