Ligoslo, PIL - Common

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ligoslo 140 mg/g Periodontal gel

Doxycycline

In this leaflet:

1.    What Ligoslo is and what it is used for

2.    What you need to know before you use Ligoslo

3.    How to use Ligoslo

4.    Possible side effects

5.    How to store Ligoslo

6.    Contents of the pack and other information

1. What Ligoslo is and what it is used for

Ligoslo is a medicinal product for the treatment of periodontitis and contains doxycycline, an antibiotic from the tetracycline group.

Ligoslo is for the treatment of the chronic and aggressive form of periodontitis with a pocket depth of > 5 mm in adults as an adjunct to conventional non-surgical treatment of periodontitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

2. What you need to know before you use Ligoslo

Do not use Ligoslo

•    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 did receive beta-lactam antibiotics shortly before or during your periodontitis is treated with Ligoslo. Please inform your dentist, if you have received antibiotics, but are not sure, whether these are beta-lactam antibiotics.

•    during tooth development (odontogenesis).

•    if you are pregnant.

•    if you are at a higher risk for developing an acute disorder of the generation of the red blood pigment (acute porphyria).

•    if your liver function is severely impaired.

Warnings and precautions

Talk to your dentist before using Ligoslo

•    The treatment with tetracycline antibiotics like doxycycline is known to be potentially associated with increased light sensitivity and can result in hypersensitivity reactions following light exposure. In case of any apparent skin reactions, e.g. reddening of skin, you should inform your dentist, who will discontinue the treatment.

•    If you suffer from hepatic impairment or if you are treated with hepatotoxic medicinal products, tetracycline antibiotics such as doxycycline should be used with caution.

•    If you suffer from renal impairment, accumulation of tetracycline antibiotics such as doxycycline can occur, which may lead to hepatic toxicity. It appears unlikely that these effects occur following treatment with Ligoslo, since the levels of doxycycline in the blood were found to be very low following treatment with Ligoslo.

•    In patients with a previous history of yeast infection (candida infection), treatment with doxycycline might increase the risk of oral candida infections. As with other antibiotics, the use of Ligoslo may result in an increase of resistance of micro-organisms (including fungi) to tetracyclines.

•    Tetracycline antibiotics can cause a decreased activity of blood clotting factor II (plasma prothrombin). Therefore, if you are simultaneously being treated with anticoagulants, a dose reduction of the anticoagulant may be necessary. Although this effect is unlikely to occur with Ligoslo due to the low levels of doxycycline in the blood, these patients need to be treated with special caution.

Children and adolescents

Ligoslo is not for patients who are under 18 years.

Other medicines and Ligoslo

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 the effect of Ligoslo may influence each other. The following interactions are possible:

•    Since an interaction with beta-lactam antibiotics is possible, simultaneous administration of doxycycline to patients receiving beta-lactam antibiotics is not recommended.

•    Simultaneous administration of tetracycline antibiotics such as doxycycline and an anaesthesia with methoxyflurane can cause severe (fatal) kidney failure.

•    Doxycycline can increase the toxic effect of cyclosporine A.

The doxycycline exposure of other regions of the body except the treated region (systemic doxycycline exposure) after treatment with Ligoslo is very low. It appears unlikely that the above-mentioned interactions, which are affecting untreated regions of the body, occur, taken into consideration the low blood levels of doxycycline after administration of Ligoslo.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, dentist or pharmacist for advice before using this medicine.

Pregnancy

The use of Ligoslo is contraindicated, if you are pregnant.

The use of tetracycline antibiotics during tooth development can cause permanent discoloration of the teeth and defects of the dental enamel.

Breast-feeding

Since tetracycline antibiotics such as doxycycline pass into breast milk, administration of Ligoslo is not recommended, if you are breastfeeding.

Driving and using machines

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

3. How to use Ligoslo

Ligoslo should only be administered by dental care professionals into periodontal pockets using a designated device (periodontal use).

Posology

The usual dosage of Ligoslo depends on the size, shape and depth of the periodontal pockets.

Method of administration

For periodontal use.

Instructions on use

Ligoslo is to be administered exclusively using the prefilled cylinder cartridge with Ligoslo in connection with the cartridge gun.

-    Remove the laminated bag from the refrigerator 20 minutes prior to the start of treatment. Let the laminated bag closed for proper adaption to room temperatur and to avoid moisture by condensation of water.

-    Open the sealed laminated bag directly before use and remove the cylinder cartridge which contains the Ligoslo.

-    Insert the cylinder cartridge into the cartridge gun and remove the closure from the tip of the cartridge nozzle.

-    Operate the handle of the cartridge gun until Ligoslo is extruded from the tip of the cartridge nozzle.

-    The product is now ready for administration.

-    Clean and dry the periodontal pocket as usual.

-    Gently insert the tip of the cartridge nozzle into the periodontal pocket. Place the tip of the cartridge nozzle at the basis of the pocket and operate the handle of the cartridge gun to extrude the gel. Slowly remove the tip of the cartridge nozzle from the periodontal pocket whilst continuously extruding the gel.

The administration should be continued until excess gel appears at the gingival line, which shows the entire pocket is completely filled with the gel. Any excess gel can be removed using a paper tip or wetted cotton pellet.

Any mechanical tooth cleaning other than brushing the chewing surface of the teeth (occlusal area) and the tongue should be avoided on any area treated with Ligoslo for the following 7 days after treatment.

Duration of the treatment

Ligoslo is used once.

If you receive more Ligoslo than you should

Acute overdosing is not expected. If Ligoslo has been overdosed, it should be removed from the periodontal pocket.

It is known that the harmful effects for health (acute toxicity) of medicinal products containing doxycycline is low, even after intake of comparatively high doses. In cases of accidental overdose, gastrointestinal absorption can be prevented by administration of medicinal products, which neutralize excess stomach acid (antacids) or by administration of magnesium or calcium containing salts. This is based on the absorption of the active substance doxycycline into compounds, which cannot be absorbed by the body (non-absorbable chelate complexes). If necessary, other general supportive measures should be undertaken. Doxycycline can not be removed from the bloodstream by blood purification (dialysis).

If you have any further questions on the use of this medicine, ask your dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Frequencies of undesirable effects are defined as:

Very common:    may affect more than 1 in 10 people

Common:    may affect up to 1 in 10 people

may affect up to 1 in 100 people

may affect up to 1 in 1,000 people

may affect up to 1 in 10,000 people

frequency cannot be estimated from the available data

Side effects reported in a clinical study:

Uncommon:

-    swelling of the gums (gingiva)

-    a chewing-gum like taste

General disorders and administration site conditions

-    Hypersensitivity reactions

Unknown frequency: Hives with formation of blisters (urticaria), transient local swelling under the skin and mucous membranes (angioneurotic oedema), hypersensitivity reactions (anaphylaxis), purple patches on the skin (allergic purpura)

A complete cross-allergy exists within the group of tetracycline antibiotics.

Undesirable effects reported for orally taken doxycycline are not listed here.

Reporting of side effects

If you get any side effects, talk to your dentist orpharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Ligoslo

Keep out of the reach and sight of children.

Do not use Ligoslo after the expiry date which is stated on the laminated bag and carton after “EXP”. The expiry date refers to the last day of that month.

Store the cylinder cartridge in a refrigerator (2-8 °C) in the original unopened laminated bag.

After first opening of the laminated bag: Use immediately.

Signs of non usability: Do not use Ligoslo if the laminated bag surrounding the cylinder cartridge is damaged.

Discard any remaining gel after first use.

6.    Contents of the pack and other information

What Ligoslo contains

The active substance is doxycycline.

1 g of periodontal gel contains 140 mg doxycycline equivalent to 161.5 mg doxycycline hyclate.

1 pre-filled cylinder cartridge with 260 mg periodontal gel contains 36.40 mg doxycycline.

The other ingredients are:

Polyglycolide, Macrogol-DL-lactide/glycolide copolymer (high viscosity), Macrogol-DL-lactide/glycolide copolymer (low viscosity).

What Ligoslo looks like and contents of the pack

Ligoslo is a yellow gel and packed in prefilled cylinder cartridges.

Pack sizes with 2, 4, 8, 10 or 16 pre-filled cylinder cartridges.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Heraeus Kulzer GmbH Gruner Weg 11 63450 Hanau Germany

Manufacturer

Artesan Pharma GmbH & Co. KG Wendlandstr. 1 29439 Luchow Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Liechtenstein, Italy, Poland, Spain    Ligosan

Germany, Finland    Ligoslo

Belgium, The Netherlands, United Kingdom    Adjusan

This leaflet was last approved in 12/2013.

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