|
Section Number
|
Subject
|
Change
|
2
|
Qualitative and Quantitative Composition
|
New text:
Active substance:
Tazarotene ....................................................... 0.1 g
Excipients with a well known effect:
Butylhydroxyanisole.......................................... 0.05 g
Butylhydroxytoluene......................................... 0.05 g
For 100 g of gel
For a full list of excipients, see section 6.1.
Replaces:
100 g gel contains: tazarotene 0.1 g
For excipients, see 6.1.
|
|
3
|
Pharmaceutical Form
|
Zorac is a Colourlesss to light yellow, translucent to homogeneous cloudy, gel.
|
|
4.2
|
Posology and method of administration
|
see sections 4.8 Undesirable effects and 5 Pharmacological Properties
|
|
4.3
|
Contraindications
|
(see section 4.6 Pregnancy and lactation)
|
|
4.4
|
Special warnings and precautions for use
|
(see section 5.3 Preclinical safety data)
|
|
4.6
|
Pregnancy and lactation
|
Zorac gel is contraindicated in women who are or may become pregnant (see 4.3). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the foetus. Women of child-bearing potential should be informed warned of the potential risk and use adequate birthcontrol measures when Zorac gel is used. The possibility that a woman of childbearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to Zorac gel therapy, which should begin during a normal menstrual period.
Although in animals no malformations were observed after dermal application, skeletal alterations were seen in the foetuses, which may be attributable to systemic retinoid effects. Teratogenic effects were observed after oral administration.
In view of these findings Zorac gel must not be used by pregnant women or women planning a pregnancy.
|
|
4.8
|
Undesirable effects
|
Furthermore skin discoloration might occur.
|
|
5.1
|
Pharmacodynamic properties
|
Pharmacotherapeutic group: {group TOPICAL ANTIPSORIATIC AGENT, ATC-code: D05AX05}
Topical antipsoriatic agent ; ATC-code: D05AX05
|
|
6.5
|
Nature and contents of container
|
10 g, 15 g, 30 g, 50 g, 60 g and 100 g in tube (aluminium, internally lacquered epoxyphenolic) with white polypropylene cap.
Aluminium tube, internally lacquered, epoxyphenolic, with white polypropylene cap.
Pack sizes : 10 g, 15 g, 30 g, 50 g, 60 g, and 100 g gel.
|
|
9
|
Date of first authorization/renewal of the authorization
|
30th July 1997 / 3rd December 2001 2006
|
|
10
|
Date of revision of text
|
21st May 2009
20th January 2003
|