|-||the treatment of severe, recalcitrant nodular acne, where severe is defined as numerous lesions of at least 5 millimetres in diameter that may be suppurative or haemorrhagic.|
|-||severe, inflammatory acne and acne conglobata.|
|-||pregnancy and lactation (see separate section);|
|-||hypersensitivity to any of the ingredients in the formulation as well as acitretin, tretinoin or vitamin A derivatives;|
|-||patients with liver and kidney impairment, hypervitaminosis A and patients with hyperlipidaemias;|
|-||simultaneous intake of vitamin A or other retinoids and simultaneous administration of tetracyclines.|
|The use of ORATANE is contraindicated in women who are pregnant or who may become pregnant while on therapy. It is also contraindicated in all women of childbearing potential unless an effective contraceptive has been used for one month prior without any interruption. In the event of a pregnancy, severe deformities in the unborn child will be caused. Major deformities, which occur in a high percentage, even if ORATANE has only been taken for short periods of time during pregnancy, include: |
- Central nervous system (CNS) abnormalities, including hydrocephalus, microcephaly and cranial nerve deficit;
- Eye abnormalities, including microphtalmia;
- Heart defects;
- Parathyroid deficiency;
- Skeletal or connective tissue abnormalities, including absence of terminal phalages, alterations of the skull and cervical vertebra, and malformations of the hip, ankle and forearm, facial dysmorphia, cleft or high palate, low-set ears, micropinna and small or absent external auditory canals;
- Meningomyelocele, multiple synostoses and syndactyly;
- Thymus gland abnormality.
It is advisable for female patients to commence using contraceptive measures one month The following precautionary measures must be strictly observed in order to be certain of ruling out the possibility of pregnancy before, during and one month after completion of therapy:
1. Before the treatment with ORATANE begins, the doctor must give the patient specific and detailed advice on the teratogenic risk of the drug, the need for effective and continuous contraception and the possible consequences of a pregnancy, should this occur during the treatment with ORATANE or within 1 month of its completion. It is particularly important here to ensure that the patient is capable of understanding the verbal clarification and can be relied upon to take the necessary steps to prevent conception.
2. The possibility of an already existing pregnancy must be ruled out with certainty by means of a laboratory pregnancy test and, if necessary, a gynaecological examination, before therapy with ORATANE begins. The doctor or an appropriate laboratory should carry out the pregnancy test. It is recommended to start the treatment with ORATANE on the 2nd or 3rd day of menstruation.
3. It is absolutely essential that every women of childbearing age who is treated with ORATANE should practice effective and continuous contraception for 1 month before the treatment, during the treatment and for 1 month after withdrawal of the drug. The efficacy of the chosen method of contraception is to be considered carefully in each individual case, especially in the 1st cycle of hormonal contraception.
4. To guarantee the efficacy of the contraception, a laboratory pregnancy test is to be carried out every month by the doctor.
5. If the treatment is repeated, this kind of continuous and effective contraception must again be practised and prolonged for 1 month after withdrawal of the drug.
6. If, despite these measures, a pregnancy occurs during treatment with ORATANE or during the month following treatment, there is a high risk of very severe deformities in the unborn child. The risk of spontaneous abortion is also increased.
Even women who take no contraceptive measures because of supposed infertility should be urged to observe the above-described precautionary measures for as long as ORATANE is being taken.
The following supportive publications are provided:
- Patient Information Leaflet
- Female Patient Information Leaflet
- Female Patient Consent Form
- Information Guide for Prescriber
ORATANE must not be administered to breast-feeding women.