When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
1. NAME OF THE MEDICINAL PRODUCT
ISOTREXIN
ISOTREXIN 2% + 0.05%w/w Gel
Patients should wash their hands after application of the gel. The patient should be advised to avoid over-saturation with Isotrexin to the extent that excess medication could run into their eyes, and angles of the nose or other areas where treatment is not intended. Patients should be advised that if ISOTREXIN is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur. If this occurs accidentally, or through over enthusiastic use, application should be discontinued for a few days.
As ISOTREXIN may cause increased sensitivity to sunlight, deliberate or prolonged exposure to sunlight or sunlamps should be avoided or minimised. When exposure to strong sunlight cannot be avoided a sunscreen product and protective clothing should be used. Patients with sunburn should not use ISOTREXIN due to the possibility of increased sensitivity to sunlight. Concomitant topical medication should be used with caution during therapy with ISOTREXIN because of the potential for a cumulative irritant effects may occur (also see section 4.5). The following section has been added: As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin. Although this is unlikely to occur with topically applied erythromycin, if prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment should be discontinued immediately and the patient investigated further, as the symptoms may indicate antibiotic-associated colitis. 4.5 Interaction with other medicinal products and other forms of interaction. The phrase "none known" has been removed and replaced by: Concomitant application of oxidising agents, such as benzoyl peroxide, should be avoided, since they may reduce the efficacy topical isotretinoin. If combination therapy is required, they should be applied at different times of the day, e.g. one in the morning and the other in the evening. If irritancy or dermatitis results, the frequency of application may have to be reduced. 4.6 Pregnancy and lactation The following section has been added: Fertility Isotretinoin, in therapeutic dosages, does not affect the number, motility and morphology of sperm and does not jeopardise the formation and development of the embryo on the part of the men taking isotretinoin The following sections have been changed, as indicated: Pregnancy The safety of ISOTREXIN for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri- and post-natal development. There are no or limited data on the use of ISOTREXIN in pregnant women. Isotretinoin has been associated with teratogenicity in humans when administered systemically. However, Reproduction studies conducted in rabbits using topical isotretinoin applied at up to 60 times the human therapeutic dose have revealed no harm to the foetus. There have been a reports of birth defects among babies born to women exposed to topical tretinoin during pregnancy, but causality has not been proven. The teratogenic blood level of isotretinoin is not clear. In view of the condition for which ISOTREXIN is used and the known association of systemically administered isotretinoin with human foetal abnormalities, ISOTREXIN is contraindicated in pregnant women or those who may become pregnant during treatment. The use of ISOTREXIN should be avoided by women who are pregnant or intending to conceive. Use during lactation
The following sections have been changed, as indicated: Pregnancy The safety of ISOTREXIN for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri- and post-natal development. There are no or limited data on the use of ISOTREXIN in pregnant women. Isotretinoin has been associated with teratogenicity in humans when administered systemically. However, Reproduction studies conducted in rabbits using topical isotretinoin applied at up to 60 times the human therapeutic dose have revealed no harm to the foetus. There have been a reports of birth defects among babies born to women exposed to topical tretinoin during pregnancy, but causality has not been proven. The teratogenic blood level of isotretinoin is not clear. In view of the condition for which ISOTREXIN is used and the known association of systemically administered isotretinoin with human foetal abnormalities, ISOTREXIN is contraindicated in pregnant women or those who may become pregnant during treatment. The use of ISOTREXIN should be avoided by women who are pregnant or intending to conceive. Use during lactation
Use during lactation
Percutaneous absorption of isotretinoin and erythromycin from ISOTREXIN is negligible. However, as it is not known if isotretinoin is excreted in human milk, ISOTREXIN should not be used during lactation. 4.8 Undesirable effects This section has been changed, as follows: ISOTREXIN may cause: Immune System Disorders Allergic reaction Gastrointestinal disorders Diarrhoea Skin and subcutaneous tissue disorders Slight Stinging, burning sensation, pruritus or skin irritation; erythema, dry skin, skin exfoliation; skin thinning, skin hyperpigmentation, skin hypopigmentation and peeling at the site of application photosensitivity reaction. These local effect usually resolve on discontinuation of therapy. If undue irritation occurs, treatment should be interrupted temporarily and resumed once the reaction subsides. If irritation persists, treatment should be discontinued. Reactions will usually resolve on discontinuation of therapy.
4.9 Overdose This section has been changed, as follows: Acute overdosage of ISOTREXIN has not been reported to date. Accidental ingestion of isotretinoin resulting in overdosage of isotretinoin could be expected to induce symptoms of hypervitaminosis A. These include severe headaches, nausea or vomiting, drowsiness, irritability and pruritus. The isotretinoin and Erythromycin components are is not expected to cause problems on ingestion of the topical gel ISOTREXIN. Further management should be as clinically indicated or as recommended by the national poisons centre, where available. 10 DATE OF REVISION OF TEXT This section has been updated to March 2010.
Correction of mispelling of excipient in Section 4.4