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SPC Table of Contents

FAMVIR

250 Milligram Film Coated Tablet

PCO ManufacturingPPA0465/212/001

Summary of Product Characteristics

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath
8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/212/001
1 NAME OF THE MEDICINAL PRODUCT

Famvir 250mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet 250 mg of famciclovir.

Excipient with known effects:contains anhydrous lactose.

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

Film-Coated Tablet

Product imported from Greece and Italy:

White, round, film-coated, biconvex, bevelled edges, debossed with FV on one side and ‘250’ on the reverse side.
4 CLINICAL PARTICULARS As per PA0013/106/002
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 PA0013/106/002
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Hydroxypropyl cellulose

Lactose anhydrous

Sodium starch glycollate

Magnesium stearate (E572)

Hypromellose

Titanium dioxide (E171)

Macrogol 4000

Macrogol 6000
6.2 Incompatibilities

Not applicable
6.3 Shelf life

The shelf-life expiry date of this product is 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 25°C.

Store in the original package in order to protect from moisture.
6.5 Nature and contents of container

Blister packs containing 21 tablets in an over-labelled outer carton.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26th September 2008
10 DATE OF REVISION OF THE TEXT

June 2016
6.6 Special precautions for disposal and other handling

No special requirements.
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