ROACCUTAN

Generic Name/API: isotretinoin

Manufacturer: Roche Pharma

Dosage Forms & Strength & Pack Size:
Soft capsules, 10 mg and 20 mg, 30’s

Storage:
How to store Roaccutane
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the pack and blister.
Do not store above 25° C.
Store in the original package and keep blister in the outer carton in order to protect from moisture and light.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
What Roaccutane is and what it is used for
Roaccutane contains isotretinoin – a substance related to vitamin A, and one of a group of medicines called retinoids (for treatment of acne).
Roaccutane is used to treat severe forms of acne (such as nodular or conglobate acne, or acne that is at risk of causing permanent scarring) in adults and adolescents. You will use Roaccutane when your acne has not got better with anti-acne treatments, including antibiotics and skin treatments. Roaccutane should not be used to treat prepubertal acne and not in children aged less than 12 years of age.
Roaccutane treatment must be supervised by a dermatologist (a doctor specialised in the treatment of skin problems).

Warnings and precautions
Talk to your doctor or pharmacist before taking Roaccutane:
If you have ever had any kind of mental health problems. This includes depression, aggressive tendencies or mood changes. It also includes thoughts about hurting yourself or ending your
life. This is because your mood may be affected while taking Roaccutane Talk to your doctor if you experience persistent pain in your lower back or buttocks during treatment with Roaccutane. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue treatment with Roaccutane and refer you to a specialist for treatment of inflammatory back pain. Further evaluation may be needed including imaging modalities such as MRI.

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