SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

ALVOGYL
IODO PENGHA

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Butamben 25.70 g
Iodoform 15.80 g
Eugenol 13.70 g

3 PHARMACEUTICAL FORM
Paste

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

 Treatment of dry socket,
 Post-extraction dressing following a difficult or traumatic extraction in
patients with history of dry sockets.

4.2 Posology and method of administration

Route of administration: Local.
Using a pair of sterilised tweezers, apply a sufficient quantity of ALVOGYL
(about 0.20 g) to adequately cover the bottom of the socket and pack gently
into place.

4.3 Contraindications
ALVOGYL is not to be used on patients having a history of allergic reactions
to procaine-type anaesthetics or sensitivity to iodine or iodine compounds.

4.4 Special warnings and precautions for use

Contents should be used within two years of opening. The cap should always
be replaced immediately after use and the jar kept in a cool dry place.

4.5 Interactions with other medicinal products and other forms of interaction
None stated.

4.6 Pregnancy and lactation

No data available.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None reported.

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4.9 Overdose
None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ALVOGYL is an antiseptic and analgesic paste used for the local treatment of
dry socket.
The butamben (butyl-paraminobenzoate) component provides a moderate
anaesthetic action which is effective for several hours after the paste has been
placed in the socket.
The iodoform ingredient has an effective anti-microbial action.
An analgesic action is provided by the eugenol component which has a
soothing effect on the alveolar tissues and contributes to their normal healing.
Introduced into the socket, ALVOGYL easily adheres to the alveolus due to its
fibrous consistency. Assisted by the patient’s tongue movements, it gradually
self eliminates without an intervention by the practitioner or the patient as the
normal healing of the wound takes place.
ALVOGYL is very easy to apply and requires no special attention from the
practitioner other than observation of the healing process.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Olive oil, spearmint oil, sodium lauryl sulphate, calcium carbonate,
penghawar, purified water.

6.2 Incompatibilities
None stated.

6.3 Shelf life

3 years.
Contents should be used within two years of opening.

6.4 Special precautions for storage

The product should be stored at normal temperature in a room kept free from
dust and insects.
Carefully close after use.

6.5 Nature and contents of container

Opal glass jar with a plastic plug and plastic screw cap.
Contents: 12 g.

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6.6 Special precautions for disposal
see 4.2. "Posology and method of administration"

7 MARKETING AUTHORISATION HOLDER

SEPTODONT Ltd
Units R & S
Orchard Business Centre,
St Barnabas Close,
Allington, Maidstone
Kent ME16 0JZ
ENGLAND

8 MARKETING AUTHORISATION NUMBER

PL 08313/0020

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
02/11/1988 – 19/01/1993 – 19/01/1998

10 DATE OF REVISION OF THE TEXT

August 2002.

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