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The Leaflet (Text version)

Patient package insert in accordance with the Pharmacists' Regulations
(Medicinal Preparations) - 1986
The dispensing of this medicine requires a doctor's prescription
Read this package insert carefully in its entirety before using this medicine



10 mg, capsules

20 mg, capsules




Each capsule contains:
Isotretinoin 10 mg

Each capsule contains:
Isotretinoin 20 mg

Therapeutic activity
For severe cystic acne that does not respond to other treatments.

When should the preparation not be used?

Do not use this medicine if you are pregrant or breast-feeding (see below).
Do not use this medicine if you are sensitive to any of its ingredients.
Do not use this medicine if you suffer from disfunction of the liver or kidneys, high blood lipid levels or an excess of vitamin A.
Do not use if you are taking medicines from the tetracycline group (antibiotics).

Do not take this medicine without consulting a doctor before starting treatment:

If you are suffering or have suffered in the past from diabetes, obesity.
If you are suffering or come from a familly that has a history of high blood lipid levels.
If you are on any sort of diet.

How will this medicine affect your daily life?
Use of this drug will likely result, at distant intervals, in vision problems, especially at night. Therefore, caution when driving must be excercised (see below in Side effects).
Do not drink wine or alcoholic beverages while under treatment with this medicine.
This medicine may cause a special sensitivity when the patient is exposed to the sun (and to excessive suntan); therefore, avoid exposure to the sun and take appropriate precautions (long clothes, a hat, protective creams, etc.).

Contraindications and precautions


Roaccutane is a teratogenic drug, and therefore, it must not be used in women who are of child-bearing age.
Despite this, for severe cases of acne that are destroying facial skin, and when there is no alternative treatment, a doctor may prescribe Roaccutane for women of child-bearing age.
However, the patient must obey all of the precautionary measures written below and weigh the known risks against the positive potential of the treatment:
  1. It is incmbent on all women of child-bearing age, who undergo treatment with Roaccutane, to consistently use an effective method of contraception a month before begining treatment, throughout treatment, and up to four weeks after treatment is finished. One must thoroughly examine the effectiveness of the contraception, in all female patients, especially during the menstrual period when a hormonal contraceptive preparation is taken for the first time.
  2. In the same way, consistent use of effective contraception must be continued if the treatment is prolonged (relapse of the disease) until four weeks after treatment is completed.
  3. But, if despite all precautions, pregnancy occurs while undergoing treatment with Roaccutane, and until four weeks after treatment is completed, there is a hightened danger of fatal abnormalities (especially in the central nervous system, the heart and the major blood vessels).
Before any treatment with Roaccutane, the doctor must check all women of child-bearing age and make sure that they are not pregnant. For the same reason, information must be given to the women avout effective means of contraception and about the potential dangers should a pregnancy occur during treatment with Roaccutane and until four weeks after treatment is completed.

Before begining treatment and throughout treatment with this medicine, liver function and blood lipid levels should be tested.
If you are sensitive to any food or drug, especially to Vitamin A or retinoids, you must inform your doctor of this before begining treatment with this medicine.
Do not donate blood until thirty days after finishing treatment.

Drug interactions
If you are taking another drug concomitantly or if you have just finished treatment with another medicine, inform the attending doctor in order to prevent hazards or lack of efficacy arising from drug interactions, especially regarding medicines belonging to the following groups: tetracyclines (antibiotics), Vitamin A, other acne preparations or any other preparation or cosmetic product that could dry up the skin, preparations that contain alcohol.

Side effects
In addition to the desired effect of the medicine, adverse reactions may occur during the course of taking this medicine, for example: dryness of the mouth and nose, muscle pains, joint pains, thinning or shedding hair, sensitivity to the sun (see above), dryness in the eyes which may make it difficult to wear contact lenses, skin peeling, hoarseness, blurring and dizziness, falling asleep during the day.

Effects that require special attention
Peeling or inflammation of the lips, eye inflammation, nose bleeds: stop treatment and consult your doctor.
Visual changes, strong headaches, skin rash (rare): stop treatment and consult your doctor.
Depression (rare): consult your doctor.
In the event that you experience side effects not mentioned in this leaflet, or if there is a change in your general health, consult your doctor immediately.

Dosage is according to doctor's instructions only.
Do not exceed the recommended dosage. This medicine is not be taken at specific time intervals as determined by the attending doctor.

Directions for use
Do not chew! Swallow the medicine with water. Take this medicine with a meal.

How can you contribute to the success of the treatment?

Complete the full course of treatment as instructed by the doctor.
Even if there is an improvement in your health, do not discontinue use of this medicine before consulting your doctor.

Avoid poisoning!
This medicine, and all other medicines, must be stored in a safe place out of the reach of children and/or infants, to avoid poisoning. If you have taken an overdose, or if a child has accidentally swallowed the medicine, proceed immediately to a hospital emergency room and bring the package of the medicine with you.
Do not induce vomiting unless explicitly instructed to do so by a doctor!
This medicine has been prescribed for the treatment of your ailment; in another patient it may cause harm.
Do not give this medicine to your relatives, neighbours or acquaintances.
Do not take medicines in the dark!
Check the label and the dose each time you take your medicine. Wear glasses if you need them.

Store in a cool place.
Even if kept in their original container and stored as recommended, medicines may be kept for a limited period only. Please note the expiry date of the medicine! In case of doubt, consult the pharmacist who dispensed the medicine to you.
Do not store different medications in the same package.

License number
Roaccutane 10 mg: 692222903
Roaccutane 20 mg: 692122904

F. Hoffmann-La Roche Ltd, Basel, Switzerland.