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
Roaccutane® | |  | | Roaccutane® |
10 mg, capsules | | | 20 mg, capsules | Isotretinoin | | |
Isotretinoin |
Composition
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.).
Warnings
Contraindications and precautions
Pregnancy
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:
- 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.
- 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.
- 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
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.
Storage
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
MANUFACTURER
F. Hoffmann-La Roche Ltd, Basel, Switzerland. |
