Patient Information Leaflet

PERIOCHIP

2.5 mg Periodontal Insert
(chlorhexidine digluconate)
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your dentist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your dentist. See section 4.

Contents of this leaflet:

What PerioChip is and what it is used for
What you need to know before using PerioChip
How to use PerioChip
Possible side effects
How to store PerioChip
Package contents and other information

1. What PerioChip is and what it is used for

What PerioChip is
PerioChip is a small chip containing the antimicrobial agent chlorhexidine digluconate.

What PerioChip is used for
Most of us experience gingivitis, an inflammation of the gums, at some point in our lives.
Untreated gingivitis may progress to periodontitis, which can result in tooth loss. Periodontitis is a disease characterized by inflammation and deterioration of the tissues supporting the teeth. To prevent it, gingivitis must be treated at an early stage. If left untreated, the gums become infected by a bacterial buildup known as plaque, causing them to pull away from the tooth and form a periodontal pocket. Once a pocket forms, plaque accumulation may increase and the disease worsens. When placed by a dentist into the periodontal pocket, PerioChip eliminates most of the bacteria responsible for the disease and reduces inflammation, thereby decreasing pocket depth.

PerioChip is applied in combination with mechanical plaque removal for the treatment of chronic periodontal inflammation in adults.

2. What you need to know before using PerioChip

Do not use PerioChip if you are allergic (hypersensitive) to chlorhexidine gluconate or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
In rare cases, PerioChip may cause severe allergic reactions, which can lead to a sudden drop in blood pressure and even loss of consciousness. Early signs of a severe allergic reaction may include skin rash, difficulty breathing, itching, generalized swelling, feeling lightheaded, rapid heartbeat, stomach discomfort or diarrhea.
If you experience any of these symptoms, contact your dentist or doctor immediately (see section 4: "Possible side effects").
Children and adolescents:
PerioChip is not recommended for use in children and adolescents.
Other medicines and PerioChip
Tell your dentist if you are taking nystatin (used to treat fungal infections), as it may reduce the effectiveness of PerioChip. Inform your dentist if you are currently taking, have recently taken, or might take any other medicines, including over-the-counter medicines, even though it is unlikely that problems may arise from taking other medicines.
PerioChip with food, beverages and alcohol
No changes to your diet are necessary while undergoing treatment with PerioChip.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breast-feeding, you must inform your dentist. PerioChip should be avoided during pregnancy and breast-feeding.

3. How to use PerioChip

After mechanically cleaning your teeth and removing as much plaque as possible, your dentist will insert PerioChip devices into all the dental pockets requiring treatment. The chips dissolve slowly over approximately 7 days and do not need to be removed.
Your dentist may ask you to return within three months to assess the effectiveness of the treatment and, if necessary, continue treatment with the insertion of additional PerioChips.
Your dentist will advise you on any other medications that may be needed during treatment with PerioChip.
During treatment, continue to brush your teeth as usual.

4. Possible side effects

Like all medicines, PerioChip can cause side effects, although not everyone experiences them.
If you experience any of the following reactions, consult a doctor immediately:
swelling, e.g. of the face, lips, tongue or throat; skin irritation; itching; wheezing or difficulty breathing; dizziness and feeling faint; rapid heartbeat; stomach upset or diarrhoea. You may be experiencing a severe allergic reaction.

In the first few days after insertion of the PerioChip, you may temporarily experience pain or discomfort in the gums and teeth, or swelling and redness of the gums. These discomforts may be due to scaling or the physical insertion of the chip.

The following side effects have been reported:

Very common side effects (may affect more than 1 in 10 people)

toothache

Common side effects (may affect up to 1 in 10 people)

swelling, pain and/or bleeding of the gums

Uncommon side effects (may affect less than 1 in 100 people)

upper respiratory tract infection (e.g. throat infection)
swelling of the lymph glands
dizziness
enlargement, recession and itching of the gums
mouth ulcers
tooth sensitivity
neuralgia (nerve pain)
flu-like illness
general feeling of fatigue
fever

Frequency not known (frequency cannot be estimated from the available data)

skin allergic reactions such as dermatitis (skin inflammation), itching, skin redness, hives, skin irritation and blistering

Other side effects reported include:

dental abscess
more serious tissue damage and infection spreading from the site of chip insertion
loss of taste
discoloration of the gums

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your dentist or doctor.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PerioChip

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use PerioChip after the expiry date stated on the packaging.

6. Contents of the pack and other information

What PerioChip contains
The active substance is chlorhexidine digluconate. Each brown-orange, dome-shaped periodontal insert contains 2.5 mg of chlorhexidine digluconate.
The excipients are hydrolyzed gelatin (cross-linked with glutaraldehyde), glycerol, and water.
PerioChip is available in blister packs containing: 2, 10 or 20 tablets.
Marketing Authorization Holder and Manufacturer:
Dexcel Pharma GmbH
Carl-Zeiss-Straße, 2
63755 Alzenau
Germany
This summary of product characteristics was last approved on