SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS

2 1. NAME OF THE MEDICINAL PRODUCT Lipactin gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains: Heparin sodium..175 IU Zinc sulphate heptahydrate 5 mg For the full list of excipients, see section PHARMACEUTICAL FORM Transparent, homogenous and colourless gel. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Lipactin gel is indicated for the early treatment of symptoms of Herpes labialis such as local itching, swelling and sensations of pain and tension. 4.2 Posology and method of administration Posology 3 to 6 times a day It is preferable to continue the treatment for several days after symptoms disappearance. The treatment should be continued for a maximum of 7-10 days. Paediatric population Lipactin gel should not be used in children under 6 years. Method of administration At the onset of signs of infection or symptoms (local itching, tension or pain sensations or vesicle formation), apply a thin layer on the affected areas (3 to 6 times a day). 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant recipients). 4.4 Special warnings and precautions for use

3 Lipactin gel is intended for cutaneous use only. Contact with the eyes should be avoided. The compounds of Lipactin gel may cause local hypersensitivity reactions 4.5 Interaction with other medicinal products and other forms of interaction There are no known interactions resulting from topical administration. 4.6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of Heparin and Zinc sulphate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Lipactin gel is not recommended during pregnancy and in women of childbearing potential not using contraception. However, no effects during pregnancy are anticipated, since systemic exposure to Heparin and Zinc sulphate is negligible (see section 5.2). Breastfeeding Heparin and Zinc sulphate are not excreted in human milk. Lipactin gel can be used during breast-feeding 4.7 Effects on ability to drive and use machines Lipactin gel has no or negligible influence on the ability to drive and use machines. 4.8 Undesirable effects In rare cases (>1/10,000, <1/1000) irritation reactions such as burning sensations upon application may occur which resolve spontaneously. In very rare cases (<1/10,000) skin disorders like local hypersensitivity reactions manifested as itching, erythema, papules, vesicles beyond the contact area (disseminated reactions) have been reported; in such cases the use of the product should be discontinued. 4.9 Overdose No case of overdose has been reported. In cutaneous use at the recommended dose, no risk of overdose exists (see section 5.2). In the case of accidental ingestion, the product is only very slightly absorbed into the systemic circulation. The major part is directly eliminated in the faeces.

4 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Dermatological, virustatic, ATC code: D06BB Mechanism of action Heparin is an anionic, heterogenic sulphated glycosaminoglycan isolated from porcine mucosa. In vitro, it inhibits plaque formation by preventing the attachment of the virus to the cell. In this way, viruses penetration into the cell is delayed. Zinc sulphate is an astringent and weak antiseptic. It is used to improve wound healing. Zinc sulphate releases zinc ions that bind to the surface proteins of the virus particles within few hours. Binding of the zinc ions leads to the inactivation of the herpes simplex virus. In this way, the viruses are completely prevented from penetrating the cell membrane and the proliferation cycle is blocked irreversibly. In vitro experiments have demonstrated a synergistic antiviral effect of heparin sodium and zinc sulphate heptahydrate present in Lipactin gel on cutaneous infections due to Herpes simplex virus (Herpes labialis [e.g. Herpes febrilis, Herpes solaris]). Pharmacodynamic effects This combination has a triple action: it prevents the virus from attaching to the cell membrane, it inactivates the virus and it precludes its cellular replication Clinical efficacy and safety Clinical studies have demonstrated that topical zinc sulphate solutions are useful in the treatment and prevention of Herpes simplex virus infections. In clinical studies, symptoms of Herpes virus infections (crusting, erythema, pain, pruritus, skin-tension, swelling and vesiculation) improved significantly after treatment with Lipactin gel as compared with placebo. It was demonstrated to be superior to treatment with either heparin sodium or zinc sulphate alone in regard to its onset of action, the length of time for healing, and the alleviation of symptoms of infections Pharmacokinetic properties Absorption / Distribution The absorption of heparin across intact human skin has been measured with radioactive labelled heparin. It penetrates the epidermis and corium, whereby its concentration is inversely related to the depth of penetration. In animal testing, zinc sulphate applied topically to open wounds could not be detected in the serum. Zinc sulphate is incompletely absorbed from the gastrointestinal tract. Biotransformation / Elimination Less than 1% enters the subcutaneous tissue or can be recovered in the urine. Heparin is not absorbed from the gastrointestinal tract. 5.3 Preclinical safety data

5 Acute toxicity The compound had practically no acute toxicity in the mouse by this route of administration. No skin reactions or irritations were seen either in the test or control groups. Skin sensitisation studies A test for skin sensitising (contact allergenic) effect in guinea pigs revealed no adverse skin reaction in the test group nor in the placebo treated control group, whilst all animals of the positive control group (PPD or p-phenylenediamine) reacted after the application. No difference between Lipactin gel and vehicle-treated controls were seen. Lipactin gel was found to be devoid of skin-sensitising (contact allergenic) potential in guinea pigs. A repetitive skin irritation test was made with rabbits in which Lipactin gel caused slight transient erythema when applied repeatedly to rabbit skin. No skin reactions were noted after treatment with excipient. Another test of irritation to the rabbit eye after repeated application of Lipactin gel revealed that the product caused practically no irritation when applied repeatedly to rabbit eye mucosa. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Purified water, glycerol, carmellose sodium, 2-phenoxyethanol, polysorbate 60, polysorbate Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life 2 years. 6.4 Special precautions for storage Do not store above 25C. 6.5 Nature and contents of container 3 g of gel in a tube (aluminium) with screw cap (polyethylene) and dispensing nozzle. 6.6 Special precautions for disposal and other handling No special requirements. 7. MARKETING AUTHORISATION HOLDER Louis WIDMER GmbH Grossmattstrasse Rheinfelden Germany

6 8. MARKETING AUTHORISATION NUMBERS Austria: Finland: Germany: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of latest renewal: 11 August DATE OF REVISION OF THE TEXT 08/2012