Девочки, если кто-то принимает этот препарат, возможно, вам эта информация пригодится:
Diane-35 - Safety advisory
Health professionals and consumers are advised that the TGA is continuing to closely monitor Diane-35 and its generics.
Diane-35 is an anti-androgenic progestogen-oestrogen combination, which is approved for the treatment of signs of androgenisation (increased male hormones) in women, such as severe acne and hirsutism (excessive hairiness). It is also an effective oral contraceptive in these patients.
Diane-35 is also available in Australia under the trade names Brenda-35, Juliet-35, Estelle-35 and Laila-35.
The TGA is aware that the French medicines agency (ANSM) has reviewed Diane-35 and has announced that it will suspend the marketing authorisation of the medicine within the next three months. ANSM has found that the risk of venous thromboembolism (VTE, also known as blood clots) outweighs the benefits of Diane-35 in treating acne and hirsutism. The European Medicines Agency also plans to conduct a Europe-wide review.
The TGA is undertaking a review of the safety information available for Diane-35. Once this review has been completed, the TGA will provide updated advice.
If you are taking Diane-35 ED and have any questions or concerns, ask your health professional.
Do not stop taking Diane-35 ED without consulting your doctor.
All oral contraceptives and other hormonal products, such as Diane-35, pose a small risk of blood clots. This risk is influenced by age, family history of blood clots and lifestyle factors, such as weight and smoking.
Contact your doctor immediately or go to the Emergency Department at your nearest hospital if you develop any symptoms of blood clots, such as:
- persistent leg pain or tenderness
- swelling, warmth and redness of the leg
- severe chest pain
- sudden shortness of breath or difficulty breathing.