Ligosan

Package leaflet: Information for the user

Ligosan 140 mg/g periodontal gel

Use limited to adult patients
Doxycycline
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your dentist or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, talk to your dentist or pharmacist. This includes possible adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Ligosan is and what it is used for
2. What you need to know before using Ligosan
3. How to use Ligosan
4. Possible side effects
5. How to store Ligosan
6. Contents of the pack and other information

1. What Ligosan is and what it is used for

Ligosan contains the active substance doxycycline, an antibiotic belonging to the tetracycline group.
Ligosan is indicated for the treatment of chronic and aggressive periodontitis in adults, with pocket depths ≥ 5 mm, as an adjunct to conventional non-surgical periodontal therapy.
Refer to official guidelines on the appropriate use of antibacterial agents.

2. What you need to know before taking Ligosan

Do not use Ligosan

• if you are allergic to doxycycline, to other tetracycline antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if you have recently used or are currently using systemic antibiotics (not exclusively topical) for the treatment of periodontitis. Inform your dentist if you have taken antibiotics but are unsure whether they were systemic antibiotics.
• if you are pregnant or breastfeeding.
• in children and adolescents.
• if you are at high risk of developing acute porphyria (an acute disorder in red blood pigment formation).
• in case of severe impairment of liver function.

Warnings and precautions
Talk to your dentist or pharmacist before using Ligosan.

• It is known that treatment with tetracycline antibiotics such as doxycycline may increase sensitivity to light and may cause hypersensitivity reactions following exposure to light. If any skin reactions occur, for example skin redness, inform your dentist, who will discontinue treatment.
• In case of impaired liver function or if you are being treated with hepatotoxic medicinal products, tetracycline antibiotics such as doxycycline should be used with caution.
• In case of impaired renal function, accumulation of tetracycline antibiotics such as doxycycline may occur, which could lead to liver toxicity. These effects are unlikely to occur with Ligosan treatment, as very low levels of doxycycline in the blood have been observed after treatment with this product.
• In patients with a history of previous yeast infections (candida infection), treatment with doxycycline may increase the risk of oral candidiasis. As with other antibiotics, the use of Ligosan may lead to increased resistance of microorganisms (including fungi) to tetracyclines.
• Tetracycline antibiotics may reduce the activity of blood coagulation factor II (plasma prothrombin). Therefore, if you are receiving concomitant anticoagulant therapy, a reduction in the anticoagulant dose may be necessary. Although this effect is unlikely to occur with Ligosan due to the low levels of doxycycline in the blood, such patients should be treated with particular care.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age.
Other medicines and Ligosan
Inform your doctor, dentist, or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of other medicinal products and those of Ligosan may interact. The following interactions are possible:

• As interactions with beta-lactam antibiotics are possible, concomitant administration of doxycycline in patients undergoing treatment with beta-lactam antibiotics is not recommended.
• Concomitant administration of tetracycline antibiotics such as doxycycline and anesthesia with methoxyflurane may cause severe (fatal) renal failure.
• Doxycycline may increase the toxic effect of cyclosporine A.

Following treatment with Ligosan, systemic exposure of doxycycline to body parts other than the treated areas is extremely low. Given the low blood levels of doxycycline after treatment with Ligosan, it is unlikely that the above-mentioned interactions affecting untreated body areas will occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, dentist, or pharmacist before using this medicine.
Pregnancy
The use of Ligosan is contraindicated during pregnancy.
The use of tetracycline antibiotics during tooth development may cause permanent discoloration of teeth and defects in dental enamel.
Breastfeeding
Tetracycline antibiotics such as doxycycline pass into breast milk; therefore, treatment with Ligosan is not recommended during breastfeeding.
Driving and use of machinery
Ligosan does not impair the ability to drive vehicles or operate machinery.

3. How to use Ligosan

Ligosan must be applied exclusively by dental professionals.
Dosage
The amount of Ligosan used depends on the size, shape, and depth of the periodontal pockets.
Method of administration
Medicinal product for periodontal use.
It must be applied by dental professionals into the periodontal pockets using the dedicated device.
Duration of treatment
Ligosan is intended for single use only.
If more Ligosan is applied than required
Acute overdose is not expected. In case of Ligosan overdose, remove the excess amount from the periodontal pocket.
It is known that medicinal products containing doxycycline have low health-damaging effects (acute toxicity), even after ingestion of comparatively high doses.
In case of accidental overdose, gastrointestinal absorption can be prevented by administering medicinal products that neutralize excess gastric acid (antacids) or salts containing magnesium or calcium. This is based on the binding of the active substance doxycycline to compounds that cannot be absorbed by the body (non-absorbable chelate complexes). If necessary, undertake other general supportive measures. Doxycycline cannot be removed from the bloodstream by dialysis.
If you have any doubts about the use of this product, consult your doctor, dentist, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Uncommon (may affect up to 1 in 100 people)

• swelling of the gums
• taste resembling chewing gum

Frequency not known (cannot be estimated based on available data)

• urticaria with formation of wheals, transient localized swelling of the skin and mucous membranes (angioneurotic edema), hypersensitivity reactions (anaphylaxis), red skin spots (allergic purpura)

Cross-allergy within the tetracycline group is possible.
Adverse reactions reported following oral administration of doxycycline are not listed here.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your dentist or pharmacist.
You can also report adverse reactions via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Ligosan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the laminated pouch after "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
After first opening of the laminated pouch: use immediately.
Signs indicating unsuitability for use: do not use this medicine if the laminated pouch containing the cylindrical cartridge is damaged.
After first use, discard any remaining gel.

6. Package Contents and Other Information

What Ligosan Contains

• The active substance is doxycycline. 1 g of periodontal gel contains 140 mg of doxycycline (as doxycycline hyclate). One pre-filled cylindrical cartridge containing 260 mg of periodontal gel contains 36.40 mg of doxycycline.
• The other ingredients are: polyglycolide, polyethylene glycol-DL-lactide/glycolide copolymer (high viscosity), polyethylene glycol-DL-lactide/glycolide copolymer (low viscosity).

Description of the Appearance of Ligosan and Package Contents
Ligosan is a yellow, non-transparent periodontal gel.
Packages containing 2, 4, 8, 10 or 16 pre-filled cylindrical cartridges are available, each containing 260 mg of periodontal gel.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Kulzer GmbH
Leipziger Straße 2
63450 Hanau
Germany

Manufacturer responsible for batch release
Artesan Pharma GmbH & Co. KG
Wendlandstr. 1
29439 Lüchow (Germany)

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Liechtenstein, Italy, Poland, Spain: Ligosan
Germany, Finland: Ligoslo
Belgium, Netherlands, United Kingdom: Adjusan

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for Use
Ligosan must be administered exclusively using the pre-filled cylindrical cartridge supplied with the product and the appropriate applicator gun.

• Remove the foil pouch from the refrigerator 20 minutes before starting treatment. Do not open the foil pouch, to allow proper temperature acclimatization and to prevent moisture due to condensation.
• Immediately before use, open the sealed foil pouch and remove the cylindrical cartridge containing the gel.
• Insert the cylindrical cartridge into the appropriate applicator gun and remove the cap from the cartridge nozzle.
• Squeeze the handle of the cartridge gun until gel appears at the tip of the nozzle.
• The medicine is now ready for application.
• Clean and dry the periodontal pocket as usual.
• Carefully insert the cartridge nozzle tip into the periodontal pocket. Position the nozzle tip at the base of the pocket and press the cartridge gun handle to dispense the gel. Slowly withdraw the nozzle tip from the periodontal pocket while continuing to dispense the gel.

Application should continue until excess gel becomes visible along the gingival margin, indicating that the pocket has been completely filled. Excess gel may be removed with a gauze pad or a moistened cotton swab.

For 7 days following treatment with Ligosan, any mechanical dental cleaning in the treated area must be avoided, except for brushing the occlusal surfaces of the teeth and the tongue.