ROTAXIN 10MG CAPSULE, SOFT

Nazione: Cipro

Lingua: greco

Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Principio attivo:

ISOTRETINOIN

Commercializzato da:

HADJICONSTANTINOU BROS LTD, CYPRUS (0000003592) 3 DEMETRI LIBERTI (COTSAPA CENTER), LIMASSOL, 3090

Codice ATC:

D10BA01

INN (Nome Internazionale):

ISOTRETINOIN

Dosaggio:

10MG

Forma farmaceutica:

CAPSULE, SOFT

Composizione:

ISOTRETINOIN (0004759482) 10MG

Via di somministrazione:

ORAL USE

Tipo di ricetta:

Εθνική Διαδικασία

Area terapeutica:

ISOTRETINOIN

Dettagli prodotto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 30 CAPS IN BLISTER(S) (300002601) 30 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή

Foglio illustrativo

PATIENT PRODUCT INFORMATION
ROTAXIN 10 MG AND 20 MG, SOFT CAPSULES
Isotretinoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. Keep the leaflet.
You may need to read it again. If you have more questions, ask your
doctor or your
pharmacist (chemist).
Remember this medicine is for you. Only a doctor can prescribe it for
you. Never give it to
other people. It could harm them, even if their symptoms seem the same
as yours.
1. WHAT ROTAXIN IS USED FOR
Rotaxin contains _isotretinoin _– a substance related to vitamin A,
and one of a group of
medicines called _retinoids. _
ROTAXIN IS USED TO TREAT SEVERE TYPES OF ACNE (such as _nodular _or
_conglobate _acne, or
acne that is at risk of causing permanent scarring). You will use
Rotaxin when your acne
has not got better with anti-acne treatments, including antibiotics
and skin treatments.
ROTAXIN TREATMENT MUST BE SUPERVISED BY A DERMATOLOGIST (a doctor
specialised in the
treatment of skin problems).
2. BEFORE YOU TAKE ROTAXIN
DO NOT TAKE ROTAXIN…
0
• IF YOU ARE ALLERGIC TO PEANUT OR SOYA OR ANY OTHER INGREDIENT of
Rotaxin. This
medicine contains soya oil, as well as isotretinoin. See section 6
_Further information _at
the end of this leaflet for a full list of ingredients.
1
• IF YOU ARE PREGNANT or think you may be
2
• IF YOU ARE BREASTFEEDING
3
• IF YOU HAVE LIVER DISEASE
4
• IF YOU HAVE VERY HIGH LEVELS OF BLOOD FATS (e.g. high cholesterol
or triglycerides)
5
• IF YOU HAVE VERY HIGH LEVELS OF VITAMIN A in your body
(_hypervitaminosis A_)
6
• IF YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE AN INTOLERANCE to the
sugars fructose or
sorbitol.
2
IF ANY OF THESE APPLY TO YOU, go back to your doctor before taking any
Rotaxin.
DO NOT USE IN CHILDREN UNDER 12.
USE IN CHILDREN OVER 12 ONLY AFTER PUBERTY.
SPECIAL PRECAUTIONS WITH ROTAXIN
NOT TO BE TAKEN WHEN PREGNANT
1/ 8
IMPORTANT ADVICE FOR WOMEN
ROTAXIN IS LIKELY TO DAMAGE AN UNBORN BABY (in medical language it is
_teratogenic_). IT
ALSO INCREASES THE RISK OF MISCARRIAGE.
1
• YOU MUST NO