LIGOSAN 140 mg /G Пародонтальный Гель
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Инструкция по применению LIGOSAN
Содержание инструкции
Ligosan 140 mg/g periodontal gel
Use limited to adult patients
Doxycycline
Read this leaflet carefully before using this medicineas 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 others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, ask your dentist or pharmacist. This includes any possible side effects 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 is Ligosan and what is it used for?
Ligosan contains the active ingredient doxycycline, an antibiotic of the tetracycline group.
Ligosan is indicated in the treatment of chronic and aggressive periodontitis in adults, with pocket depth
≥ 5 mm, in addition to conventional non-surgical periodontitis treatment.
Refer to official guidelines on the appropriate use of antibacterial agents.
2. What you need to know before you take 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 used systemic antibiotics (not for exclusive topical use) shortly before or during the treatment of periodontitis with Ligosan. Tell your dentist if you have used antibiotics, but are unsure if they are systemic antibiotics.
- in case of pregnancy or breastfeeding.
- in children and adolescents.
- if you are at high risk of developing an acute disorder of red blood pigment formation (acute porphyria).
- 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 is potentially associated with an increased sensitivity to light and can cause hypersensitivity reactions following exposure to light. If any skin reactions occur, for example redness of the skin, inform your dentist, who will suspend treatment.
- In case of liver impairment or if being treated with hepatotoxic medicinal products, tetracycline antibiotics such as doxycycline must be used with caution.
- In case of kidney impairment, an accumulation of tetracycline antibiotics such as doxycycline may occur, which can cause liver toxicity. These effects are unlikely to occur following treatment with Ligosan, as a very low level of doxycycline has been found in the blood after treatment with this product.
- In patients with a history of previous yeast infection (candida infection), treatment with doxycycline may increase the risk of oral candida infections. As with other antibiotics, the use of Ligosan may create an increase in the resistance of microorganisms (including fungi) to tetracyclines.
- Tetracycline antibiotics can reduce the activity of blood coagulation factor II (plasma prothrombin). Therefore, if you are undergoing concomitant treatment with anticoagulants, the dosage of the anticoagulant may need to be reduced. Although this effect is unlikely to occur with Ligosan due to the low levels of doxycycline in the blood, these patients should be treated with particular care.
Children and adolescents
Do not administer this medicine to children and adolescents under the age of 18 years.
Other medicines and Ligosan
Tell your doctor, dentist or pharmacist if you are taking or have recently taken or might
take any other medicines.
The effects of other medicinal products and those of Ligosan can interact. The following interactions are possible:
- As an interaction with beta-lactam antibiotics is possible, the concomitant administration of doxycycline in patients undergoing treatment with beta-lactam antibiotics is not recommended.
- The concomitant administration of tetracycline antibiotics such as doxycycline and an anaesthesia with methoxyflurane can cause severe kidney failure (fatal).
- Doxycycline may increase the toxic effect of cyclosporine A.
Following treatment with Ligosan, exposure of other body parts, different from those treated, to
doxycycline (systemic exposure to doxycycline) is extremely low. Considering the low
blood levels of doxycycline after treatment with Ligosan, it is unlikely that the aforementioned
interactions, which affect body areas not undergoing treatment, will occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor, dentist or pharmacist for advice before using this medicine.
Pregnancy
The use of Ligosan is contraindicated in case of pregnancy.
The use of tetracycline antibiotics during dental development can cause permanent discoloration
of the teeth and defects of tooth enamel.
Breastfeeding
Tetracycline antibiotics such as doxycycline pass into breast milk, therefore treatment with
Ligosan is not recommended during breastfeeding.
Driving and using machines
Ligosan does not impair the ability to drive vehicles or use machines.
3. How to use Ligosan
Ligosan must be applied exclusively by dental professionals.
Dosage
The dose 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 in the periodontal pockets using the dedicated device.
Duration of treatment
Ligosan is intended for single use.
If more Ligosan than necessary is applied
An acute overdose is not predictable. In case of an overdose of Ligosan, remove the
excess quantity from the periodontal pocket.
It is known that the harmful effects on health (acute toxicity) of medicinal products containing doxycycline
are low, even after taking comparatively high dosages.
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 absorption of the active substance doxycycline by
compounds that cannot be absorbed by the body (non-absorbable chelate complexes). If
necessary, take other general supportive measures. Doxycycline cannot be eliminated from the
bloodstream by dialysis.
If you have any doubts about the use of this product, consult your doctor, dentist or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)
- gum swelling
- taste similar to chewing gum
Frequency not known (cannot be estimated from available data)
- urticaria with wheals, transient localised swelling of the skin and mucous membranes (angioedema), hypersensitivity reactions (anaphylaxis), red skin spots (allergic purpura)
The possibility of cross-allergy between the tetracycline group should be reported.
Side effects reported following oral administration of doxycycline are not indicated here.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
dentist or pharmacist
website: 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 Ligosan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the laminated sachet after “EXP”. The
expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8°C).
After the first opening of the laminated sachet: use immediately
Signs indicating unsuitability for use: do not use this medicine if the laminated sachet containing
the cylinder cartridge is damaged.
After first use, discard any residual gel.
6. Package Contents and Other Information
What Ligosan contains
- The active ingredient is doxycycline. 1 g of periodontal gel contains 140 mg of doxycycline (as doxycycline hyclate). 1 prefilled cylindrical cartridge containing 260 mg of periodontal gel contains 36.40 mg of doxycycline.
- The other ingredients are: polyglycolide, macrogol-DL-lactide/glycolide copolymer (high viscosity), macrogol-DL-lactide/glycolide copolymer (low viscosity).
Description of Ligosan and package contents
Ligosan is a non-transparent yellow periodontal gel.
Packs of 2, 4, 8, 10 or 16 prefilled cylindrical cartridges, each containing 260 mg
of periodontal gel, are available.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Liechtenstein, Italy, Poland, Spain Ligosan
Germany, Finland Ligoslo
Belgium, Netherlands, United Kingdom Adjusan
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The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use
Ligosan must be administered exclusively using the prefilled cylindrical cartridge with the
product and the appropriate applicator.
- Remove the laminated sachet from the refrigerator 20 minutes before starting treatment. Do not open the laminated sachet to allow proper adaptation to room temperature and to avoid moisture due to condensation.
- Open the sealed laminated sachet immediately before use and remove the cylindrical cartridge containing the gel.
- Insert the cylindrical cartridge into the appropriate applicator and remove the cap from the tip of the cartridge nozzle.
- Press the applicator handle until gel emerges from the tip of the cartridge nozzle.
- The medicinal product is now ready for application.
- Clean and dry the periodontal pocket as usual.
- Carefully insert the tip of the cartridge nozzle into the periodontal pocket. Position the tip of the cartridge nozzle at the base of the pocket and press the applicator handle to dispense the gel. Slowly remove the tip of the cartridge nozzle from the periodontal pocket while continuing to dispense the gel.
Application should continue until excess gel appears on the gingival margin, indicating that
the pocket has been completely filled with gel. Excess gel can be removed with the tip of a
paper wipe or a cotton swab moistened with water.
For 7 days after treatment with Ligosan, any mechanical cleaning of the teeth in the treated area must be avoided, other than brushing the chewing surface (occlusal area) of the teeth and the
tongue.
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- Страна регистрации
- Форма выпускаPeriodontal gel, 140 MG/G
- Код АТХA01AB22
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги LIGOSANФорма выпуска: Mouthwash, 150 MLДействующее вещество: ХлоргексидинОтпускается без рецептаФорма выпуска: Mouthwash, 200MG/100MLДействующее вещество: ХлоргексидинПроизводитель: HALEON ITALY S.R.L.Отпускается без рецептаФорма выпуска: Oral gel, 20 MG/GДействующее вещество: miconazoleПроизводитель: KENVUE ITALIA S.P.A.Отпускается без рецепта
Аналоги LIGOSAN в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог LIGOSAN в Польша
Аналог LIGOSAN в Украина
Аналог LIGOSAN в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
LIGOSAN требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество LIGOSAN — Доксициклин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
LIGOSAN производится компанией KULZER GMBH. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения LIGOSAN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить LIGOSAN в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Доксициклин) включают BROXO DIN, KORSODYL, DAKTARIN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
