Periochip 2.5 mg Dental Insert

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine gluconate

Available from:

Dexcel Pharma GmbH

ATC code:

A01AB; A01AB03

INN (International Name):

Chlorhexidine gluconate

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Periodontal insert

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiinfectives and antiseptics for local oral treatment; chlorhexidine

Authorization status:

Not marketed

Authorization date:

1998-03-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERIOCHIP
®
2.5MG PERIODONTAL INSERT
(Chlorhexidine digluconate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
‐
Keep this leaflet. You may need to read it again.
‐
If you have any further questions, ask your dentist.
‐
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
‐
If you get any side effects, talk to your dentist. This includes any
possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What PerioChip is and what it is used for
2. What you need to know before you use PerioChip
3. How to use PerioChip
4. Possible side effects
5. How to store PerioChip
6. Contents of the pack and other information
1. WHAT PERIOCHIP IS AND WHAT IT IS USED FOR
WHAT IS PERIOCHIP
PerioChip is a small chip containing the antimicrobial agent
chlorhexidine digluconate.
WHAT IS PERIOCHIP FOR
Most people will at some stage of their lives suffer from gingivitis,
which is inflammation of
the gums. If gingivitis is left untreated, it may lead to
periodontitis which can result in tooth
loss. Periodontitis is a disease in which the tissues that support the
teeth become inflamed and
degenerate. This disease can be prevented by treating gingivitis in
the early stages. If,
however, gingivitis is not treated, the gums will be attacked by
bacterial build-up known as
plaque, causing the gum to become separated from the tooth and
resulting in the formation of
a periodontal pocket. Once a pocket has formed, plaque can build up
and the disease can
become worse.
PerioChip is inserted by a dentist into the periodontal pocket to
eliminate most of the disease-
causing bacteria, to reduce the pocket inflammation and to decrease
the depth of the pocket.
PERIOCHIP IS USED IN COMBINATION WITH THE MECHANICAL REMOVAL OF PLAQUE
IN THE
TREATMENT OF CHRONIC INFLAMMATORY PERIODONTAL DISEASE IN ADULTS

Summary of Product characteristics

Health Products Regulatory Authority
03 March 2023
CRN00DDCY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Periochip 2.5 mg Dental Insert
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each periodontal insert contains chlorhexidine digluconate 2.5 mg.
Excipient(s): with known effect:
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Periodontal insert.
Bullet-shaped, orange brown periodontal insert.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PerioChip with scaling and root planing is indicated as an adjunctive
antimicrobial treatment for moderate to severe chronic
periodontal disease in adults with pocketing. PerioChip may be used as
part of a periodontal treatment programme.
PerioChip is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults including the elderly: _
Following mechanical debridement, a PerioChip is placed in each of the
periodontal pockets to be
treated. Retreatment with PerioChip following mechanical plaque
removal at 3 month intervals may provide additional benefit
if pocket depth remains ≥ 5mm.
The PerioChip biodegrades in the periodontal pocket over about a 7-day
period and no return visit to the dental clinic to
remove the peridontal insert is necessary. The patient should be
instructed to continue normal oral hygiene procedures. No
restrictions on dietary habits are needed.
_Children _
_and adolescents : _
PerioChip is not indicated in children and adolescents, since data on
safety and efficacy in this age
group have not been established.
Method of administration
Isolate and dry the periodontal pocket. Open an aluminium blister
cavity containing one PerioChip. Pick up the periodontal
insert with a pair of forceps so that the rounded end points away from
the forceps. Rapidly insert the periodontal insert into
the pocket to its maximum depth and release. The periodontal insert
can be further manoeuvred into position using the tips of
the forceps or a flat plastic instrument. PerioChip insertion into
periodont