Ligosan

Package Leaflet: Information for the User

Ligosan, 140 mg/g, Periodontal Gel

For adults only
Doxycycline

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your dentist or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your dentist or pharmacist. This includes any possible side effects not listed in this leaflet. See section
• 4.

Contents of the Package Leaflet

• 1. What is Ligosan and what is it used for
• 2. Important information 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 is Ligosan and what is it used for

Ligosan contains the active substance doxycycline, which is an antibiotic belonging to the group of
tetracyclines.
Ligosan is intended for the treatment of chronic and aggressive periodontitis, where the periodontal pocket has a depth of ≥ 5 mm and is intended for use in adults as a supplementary method to conventional non-surgical periodontal treatment.
Official guidelines on the proper use of antibacterial agents should be taken into account.

2. Important information before using Ligosan

When not to use Ligosan

• in patients treated with antibiotics that act not only locally (systemic) shortly before or during the treatment of periodontitis with Ligosan; the dentist should be informed if the patient has taken antibiotics, but is not sure if they were systemic antibiotics;
• during pregnancy and breastfeeding;
• in children and adolescents;
• in patients at increased risk of developing acute porphyria;
• in patients with acute liver failure.

Warnings and precautions

Before starting treatment with Ligosan, discuss it with your dentist or pharmacist.

• Treatment with tetracycline antibiotics, including doxycycline, may cause increased sensitivity to light and lead to hypersensitivity reactions due to exposure to light. In case of visible skin changes, such as redness, inform your dentist, who will discontinue treatment.

In case of liver failure or treatment with hepatotoxic drugs, caution should be exercised when using tetracycline antibiotics, including doxycycline.

• In case of kidney failure, accumulation of tetracycline antibiotics, such as doxycycline, may occur, which may lead to liver dysfunction or damage. Since the concentration of doxycycline in the blood after using Ligosan is very low, the occurrence of these symptoms due to the use of Ligosan is unlikely.
• In patients with a history of fungal infections (candidiasis), treatment with doxycycline may increase the risk of oral candidiasis. Like other antibiotics, the use of Ligosan may lead to increased resistance of microorganisms (including fungi) to tetracyclines.
• Tetracycline antibiotics may reduce the activity of factor II of blood coagulation (prothrombin). Therefore, if the patient is also being treated with anticoagulant drugs, it may be necessary to reduce their dose. Although the occurrence of such symptoms is unlikely in the case of Ligosan, due to the low concentration of doxycycline in the blood, caution should be exercised in these patients.

Children and adolescents

The medicine should not be given to children and adolescents under 18 years of age.

Ligosan and other medicines

Tell your doctor, dentist, or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Some medicines may interact with Ligosan. The following interactions are possible:

• with beta-lactam antibiotics, therefore concurrent administration of doxycycline to patients taking beta-lactam antibiotics is not recommended;
• concomitant use of tetracycline antibiotics, such as doxycycline, and methoxyflurane anesthesia may cause (leading to death) kidney failure;
• doxycycline may enhance the toxic effects of cyclosporin A.

Exposure of other areas of the body to doxycycline, outside the site of treatment (systemic exposure to doxycycline) after using Ligosan is very low.
It is unlikely that the mentioned interactions regarding non-treated sites will occur, due to the low concentration of doxycycline in the blood after using Ligosan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, dentist, or pharmacist for advice before taking this medicine.
Pregnancy
Use of Ligosan during pregnancy is contraindicated.
Use of tetracycline antibiotics during tooth development may cause permanent discoloration of teeth and enamel damage.
Breastfeeding
Tetracycline antibiotics, such as doxycycline, pass into breast milk, therefore, the use of Ligosan during breastfeeding is not recommended.

Driving and using machines

Ligosan has no influence on the ability to drive and use machines.

3. How to use Ligosan

Ligosan should only be applied by dentists.

Recommended dose

The dose of Ligosan used varies depending on the size, shape, and depth of the periodontal pockets.

Method of administration

The medicinal product is intended for periodontal use only.
It should be applied by dentists into the periodontal pockets using a device intended for this purpose.

Duration of treatment

Ligosan is intended for single use.

Use of a higher than recommended dose of Ligosan

There is no risk of acute overdose. If too much Ligosan is administered, it should be removed from the periodontal pocket.
Harmful effects on health (acute toxicity) in the case of doxycycline-containing medicines are negligible, even after taking relatively high doses. In case of accidental overdose, administration of medicinal products that neutralize excess hydrochloric acid in the stomach (antacids) or magnesium or calcium salts will prevent absorption from the gastrointestinal tract. This involves converting the active substance, doxycycline, into compounds that cannot be absorbed by the body (non-absorbable chelate complexes). If necessary, further symptomatic and supportive treatment should be initiated. Doxycycline cannot be removed from the bloodstream by dialysis.
Any additional questions about this medicinal product should be directed to the dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (affects up to 1 in 100 people)

• gingival swelling
• taste like chewing gum

Unknown (frequency cannot be estimated from the available data)

• hives with blisters, transient local subcutaneous swelling, and swelling of mucous membranes (angioedema), hypersensitivity reactions (anaphylaxis), purple spots on the skin (allergic purpura).

Complete cross-resistance occurs within the tetracycline antibiotic group.
Side effects that occur when doxycycline is taken orally have not been listed in this leaflet.

Reporting side effects

If you get any side effects, talk to your dentist or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, PL-02-222 Warsaw
phone: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ligosan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the laminated pouch and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
After opening the laminated pouch: use immediately.
Signs of deterioration: Do not use this medicine if you notice that the laminated pouch containing the cylindrical insert is damaged.
Any unused gel should be discarded after first use.

6. Contents of the pack and other information

What Ligosan contains

• The active substance is doxycycline. 1 g of periodontal gel contains 140 mg of doxycycline (as doxycycline hyclate). 1 filled cylindrical insert containing 260 mg of periodontal gel contains 36.40 mg of doxycycline.
• The other ingredients are: polyglycol, macrogol-DL-lactide and glycolide copolymer (high viscosity), macrogol-DL-lactide and glycolide copolymer (low viscosity).

What Ligosan looks like and contents of the pack

Ligosan is a non-transparent, yellow periodontal gel.
Available in packs containing 2, 4, 8, 10, or 16 filled cylindrical inserts, 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

Artesan Pharma GmbH & Co. KG
Wendlandstr. 1
29439 Lüchow (Germany)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany, Austria, Liechtenstein, Poland, Italy
Ligosan

Date of last revision of the package leaflet: 05/2025

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Information intended for healthcare professionals only:

Method of use

The medicinal product Ligosan should only be administered using the ready-to-use, filled cylindrical insert Ligosan attached to the dosing gun.

• Remove the laminated pouch from the refrigerator 20 minutes before starting the application. Leave the pouch closed to allow the product to adjust to room temperature, which will prevent moisture from accumulating due to condensation.
• Open the sealed laminated pouch just before use and remove the cylindrical insert containing the gel.
• Insert the cylindrical insert into the gun and remove the cap from the end of the insert.
• Press the gun handle until the gel starts to come out of the end of the insert.
• The medicinal product is ready for application.
• Wash and dry the periodontal pocket as usual.
• Gently place the tip of the insert into the periodontal pocket. Position the tip of the insert at the base of the pocket and press the gun handle to express the gel. Slowly withdraw the insert from the pocket while continuing to express the gel.

Continue applying the gel until excess gel appears on the gum line, indicating that the pocket has been completely filled with gel. Excess gel can be removed using a moistened dental cotton roll or paper point.
For 7 days after application, avoid mechanical cleaning of the teeth treated with Ligosan gel, except for brushing the chewing surfaces of the teeth (occlusal surface) and the tongue.