PERIOCHIP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

Dexcel-Pharma Limited

ATC code:

A01AB03

INN (International Name):

CHLORHEXIDINE GLUCONATE

Dosage:

2.5 Milligram

Pharmaceutical form:

Dental Insert

Prescription type:

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

Therapeutic area:

chlorhexidine

Authorization status:

Not Marketed

Authorization date:

1998-03-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERIOCHIP
®
2.5MG DENTAL 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.
2. WHAT YOU

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Periochip 2.5 mg Dental Insert
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dental insert contains chlorhexidine digluconate 2.5 mg.
Excipient(s):
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Dental insert.
Bullet-shaped, orange brown dental 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
_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 dental 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 dental
insert with a pair of forceps so that the rounded end points away from
the forceps.
Rapidly insert the dental insert into
the pocket to its maximum depth and release.
The dental insert can be further manoeuvred into position using the
tips
of the forceps or a flat
plastic instrument.
Periochip insertion into periodontal
pockets is rapid.
The dental
insert’s
consistency allows placement into the pocket with little discomfort to
the patient.
4.3 CONTRAINDICATIONS
Hypersensitivity to chlor