M0BCore Safety Profile

Transcription

1 M0BCore Safety Profile Active substance: Clindamycin Pharmaceutical form(s)/strength: 300mg/2 ml Ampulle, 600 mg/4 ml Ampulle, 900 mg/6 ml Ampulle, 75 mg/5 ml Granulat für orale Lösung, 150 mg Kapselnn, 300 mg Kapseln, Lösung zur äußerlichen Anwendung, Lotion. Vaginalcreme P-RMS: AT/H/PSUR/0035/001 Date of FAR:

2 EU Core Safety Profile Active Substance: Clindamycin Phosphate (Topical Preparations) Brand Names: CELOCIN T, DALACIN C, DALACIN T, DALACINE, DALACINE T, DALACIN EMULSION, DALACIN TOPICO, DALACIN GEL, DALACIN TOPICAL LOTION, DALACIN LOTION, DALACIN TOPICAL SOLUTION Pharmaceutical form(s)/strength: 1% and 10mg/ml Cutaneous Emulsion, 1% Topical Gel, 1% Cutaneous Lotion, 1% Topical Lotion, 1% and 10mg/ml Cutaneous Solution, 1% and 10mg/ml Topical Solution, P-RMS: Austria Date: 13 December 2012 Supersedes: 4.3 Contraindications Topical clindamycin is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or to any excipient listed in Section 6.1 (List of excipients). Clindamycin topical is contraindicated in individuals with a history of antibiotic-associated colitis. 4.4 Special warnings and precautions for use Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe diarrhea and pseudomembranous colitis (see Section 4.8),. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea and colitis have been reported infrequently with topical clindamycin. Therefore, the physician should be alert to the possible development of antibiotic-associated diarrhea or colitis. If significant or prolonged diarrhea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parental therapy with clindamycin. Topical clindamycin solution contains an alcohol base and can cause burning and of eyes, mucous membranes and abraded skin.

3 4.5 Interaction with other medicinal products and other forms of interaction Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. 4.6 Fertility, pregnancy and lactation Pregnancy Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response. In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Lactation It is not known whether clindamycin is excreted in human milk following use of topical clindamycin. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Fertility Fertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability. 4.7 Effects on ability to drive and use machines Clindamycin has no or negligible influence on the ability to drive and use machines. 4.8 Undesirable effects The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in

4 italics. The frequency grouping is defined using the following convention: common ( 1/10); (0 to <1/10); Uncommon ( 1/1, ); (, to <1/1,); (< 1/10,); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Clindamycin Topical Gel Eye and Subcutaneous Tissue Clindamycin Topical Solution Eye and Subcutaneous Tissue Dry skin 0 0 Uncommon 1/1 Gastrointestin al disorder Uncommon 1/1 Gastrointestina l disorder to <1/1 to <1/1 < 1/10 < 1/10

5 Clindamycin Topical Lotion 0 Uncommo n 1/1 to <1/1 < 1/10 Eye and Subcutaneous Tissue disorder 4.9 Overdose Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic effects. In the event of overdosage, general symptomatic and supportive measures are indicated as required.