Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Chlorhexidine digluconate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
e PerioChip Do not use PerioChip if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of PerioChip (see section 6). Warnings and precautions PerioChip may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash, breathing difficulties, itch, generalised swelling, light headedness, rapid heart rate, upset stomach or diarrhoea. If you notice these symptoms, contact your dentist or doctor immediately (see under 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 (for the treatment of fungal infections) as it may reduce the effectiveness of PerioChip. Please tell your dentist if you are taking, have recently taken or might take any other medicines including medicines obtained without prescription, although it is unlikely that any problems will arise if you take any other medicines.
PerioChip with food, drink and alcohol No change in your diet is necessary while being treated with PerioChip. Pregnancy, breast-feeding and fertility You should inform your dentist if you are pregnant, think you may be pregnant or are planning to have a baby or breast-feeding. PerioChip should be avoided during pregnancy and breastfeeding.
PerioChip After cleaning your teeth mechanically to remove as much plaque as possible, your dentist will put PerioChips into all those tooth pockets, which need to be treated. The chips will then dissolve slowly over about 7 days and do not need to be removed. Your dentist may ask you to return within about three months to check how your treatment is working and perhaps to continue your treatment with more PerioChips. Your dentist will advise you if any other medication is needed while you are receiving treatment with PerioChip. You should continue to clean your teeth as normal.
Like all medicines, PerioChip can cause side effects, although not everybody gets them. If you experience any of the following reactions, get immediate medical help: swelling e.g. of the face, lips, tongue or throat; skin rash; itch; wheezing or difficulty breathing; feeling faint and dizzy; rapid heart rate, upset stomach or diarrhoea. You may be having a severe allergic reaction. During the first few days following PerioChip insertion, you may temporarily experience pain or discomfort of the gum and teeth and swelling and/or redness of the gums, this may be due to the scaling procedure or the physical placement of the chip. The following side effects have been reported: Very common side effects (may affect more than 1 in10 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 fewer than 1 in 100 people) • upper respiratory tract infection (e.g. throat infection) • swelling of the lymph glands • dizziness • enlargement, shrinkage and itching of the gums • mouth ulcers • sensitivity of teeth • neuralgia (pain from irritation of the nerve) • flu like illness • general tiredness • fever
Not known (frequency cannot be estimated from the available data) • allergic skin reactions such as dermatitis (inflammation of the skin), itch, redness of the skin, hives, skin irritation and blisters
The following side effects have also been reported: • tooth abscess • more severe tissue damage and infection spreading from where the chip is placed • loss of taste • discoloration of gums Reporting of side effects If you get any side effects, talk to your dentist or doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.
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, which is stated on the pack.
What PerioChip contains The active substance is chlorhexidine digluconate. Each orange-brown, bullet shaped periodontal insert contains 2.5 mg of chlorhexidine digluconate. The other ingredients are hydrolysed gelatin (cross-linked with glutaraldehyde), glycerol and water. PerioChip is available in blister packs of: 2, 10 or 20 chips. Manufacturer/ Marketing Authorisation Holder Dexcel"'Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK. This leaflet was revised in June 2020.
The active substance in Periochip 2.5 mg Dental Insert is chlorhexidine digluconate.
This leaflet reproduces the patient information leaflet approved for Periochip 2.5 mg Dental Insert, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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 periodontal 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 periodontal pockets is rapid. The periodontal insert's consistency allows placement into the pocket with little discomfort to the patient.
Hypersensitivity to chlorhexidine digluconate or to any of the excipients listed in section 6.1.
There have been individual reports of systemic hypersensitivity following placement of PerioChip. Local hypersensitivity reactions such as gingival swelling are common.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving products containing chlorhexidine. These usually occur from within minutes to a few hours of dosing. Patients should therefore be instructed to seek immediate medical attention if they develop allergic symptoms such as skin rash, itch, generalised swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhoea after exposure to chlorhexidine (see section 4.8).
Chlorhexidine is known to be incompatible with anionic agents which may be present in some toothpastes and with sucrose in the diet. Such interactions do not impact significantly on the efficacy of PerioChip. Treatment remained effective with PerioChip during clinical studies in which patients continued with regular toothbrushing and their normal diet.
Nystatin is known to be antagonistic to the efficacy of chlorhexidine. Concomitant use of medicinal products containing this active substance should be avoided.
Pregnancy
There are no data or limited data (less than 300 pregnancies) on the use of chlorhexidine in pregnant women.
Studies in animals have not shown any direct or indirect harmful effects (under normal conditions of use) on reproduction (see section 5.3).
As a precaution PerioChip should be avoided during pregnancy.
Breast-feeding
It is not known if chlorhexidine is excreted in human milk.
A risk for newborns/infants cannot be excluded.
PerioChip should not be administered to nursing women.
Fertility
Studies in animals have not shown any effect on fertility (within normal conditions of use).
Not relevant.
Approximately one third of patients experience adverse reactions, usually transient, during the first few days after chip insertion. These may also be due to the mechanical placement of the periodontal insert in the periodontal pocket or as a result of the preceding scaling procedure. The most commonly reported are gastrointestinal system disorders: dental, gingival or oral soft tissue reactions or are otherwise described as application site reactions.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); frequency not known (cannot be estimated from the available data):
System Organ Class
Very Common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Not Known (cannot be estimated from the available data)
Infections and infestations
Upper respiratory tract infection
Blood and lymphatic system disorders
Lymphadenopathy
Immune disorders
Hypersensitivity including anaphylactic shock* (see sections 4.3 and 4.4.)
Nervous system disorders
Dizziness, neuralgia
Gastrointestinal disorders
Toothache
Gingival swelling, gingival pain, gingival bleeding
Gingival hyperplasia, gingival recession, gingival pruritus, mouth ulceration, sensitivity of teeth
Skin disorders
Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters
General disorders and administration site conditions
Malaise, influenza like illness, pyrexia
* Patients should be instructed to seek immediate medical attention if they develop allergic symptoms such as skin rash, itch, generalised swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhoea after exposure to chlorhexidine.
The following adverse reactions have been derived from post-marketing reports on PerioChip: systemic hypersensitivity, anaphylactoid reaction, soft tissue necrosis, cellulitis and abscess related to the application site, loss of taste and gingival discoloration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
No case of overdose has been reported.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Chlorhexidine digluconate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Ask anything about Periochip 2.5 mg Dental Insert. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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