IT CAN CAUSE SERIOUS HARM TO THE UNBORN BABY

Women should use effective birth control.

Do not use if you are pregnant or think you may be pregnant.

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. You can see the end of chapter 4 to learn how to report side effects.

Excipients: Refined soybean oil, hydrogenated soybean oil, partially hydrogenated soybean oil, yellow beeswax, gelatin (beef gelatin), sorbitol, glycerol, mannitol, hydrogenated hydrolyzed starch, titanium dioxide (E171), red iron oxide (E172), shellac (obtained from the lac secretion substance of the lac beetle (Laccifer Lacca Kerr), black iron oxide (E172), propylene glycol

Detailed information for this product is available in the patient information leaflet.

Always take ROACCUTANE as directed by your doctor. If you are not sure, consult your doctor or pharmacist.

Instructions for proper use and dosage/frequency of administration

Capsules are taken orally on a full stomach. Swallow whole with a drink or meal.

Do not use ROACCUTANE in children under 12 years of age. You should only use it on children over the age of 12 who have reached puberty. There is no special dose adjustment for this group.

No dose adjustment is required in elderly patients.

Like all medicines, side effects may occur in people who are sensitive to the ingredients contained in ROACCUTANE. Some of these side effects can be serious and lead to hospitalization.

If any of the following occur, stop using ROACCUTANE and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital.

These are all very serious side effects. If you have one of these, it means you have a serious allergy to ROACCUTANE. You may need emergency medical attention or hospitalization.

Side effects are classified as shown in the following categories:

Side effects requiring immediate medical attention