CURATANE 40 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

ISOTRETINOIN

Disponible desde:

TARO INTERNATIONAL LTD, ISRAEL

Código ATC:

D10AD04

formulario farmacéutico:

CAPSULES SOFT GELATIN

Composición:

ISOTRETINOIN 40 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

DOUGLAS PHARMACEUTICALS LTD, NEW ZEALAND

Grupo terapéutico:

ISOTRETINOIN

Área terapéutica:

ISOTRETINOIN

indicaciones terapéuticas:

For the treatment of severe cystic acne that does not respond to other treatment.

Fecha de autorización:

2020-11-30

Información para el usuario

Page_ _1 of
12
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
CURATANE
5 MG
SOFT GELATIN
CAPSULES
CURATANE
10 MG
SOFT GELATIN
CAPSULES
CURATANE
20 MG
SOFT GELATIN
CAPSULES
CURATANE
30 MG
SOFT GELATIN
CAPSULES
CURATANE
40 MG
SOFT GELATIN
CAPSULES
COMPOSITION:
Each capsule
contains:
5 mg
isotretinoin
Each capsule
contains:
10 mg
isotretinoin
Each capsule
contains:
20 mg
isotretinoin
Each capsule
contains:
30 mg
isotretinoin
Each capsule
contains:
40 mg
isotretinoin
Inactive ingredients and allergens in this medicine: See section 2
'Important information
about some of this medicine's ingredients' and section 6 'Additional
information'.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them
even if it seems to you that their medical condition is similar to
yours.
In addition to the patient information leaflet, Curatane has a patient
information
brochure. This brochure contains important safety information that you
need to know
before starting treatment with Curatane, and which you must follow.
Read the patient
information brochure and patient information leaflet before using this
medicine. Keep
the brochure in case you need to read it again.
_ _
Important information that you should read:
SPECIAL WARNINGS FOR WOMEN/TEENAGE GIRLS
CURATANE IS HIGHLY LIKELY TO HARM AN UNBORN BABY (IN MEDICAL LANGUAGE:
THE
MEDICINE IS TERATOGENIC) – IT CAN CAUSE SERIOUS ABNORMALITIES OF THE
UNBORN
BABY'S BRAIN, FACE, EAR, EYE, HEART AND CERTAIN GLANDS (THE THYMUS
GLAND AND THE
PARATHYROID GLAND). IT ALSO INCREASES THE RISK OF MISCARRIAGE. THIS
MAY HAPPEN
EVEN IF CURATANE IS TAKEN ONLY FOR A SHORT TIME DURING PREGNANCY.
THEREFORE:
1.
YOU MUST NOT TAKE CURATANE IF YOU ARE PREGNANT OR THINK YOU MIGHT BE
PR

Ficha técnica

Page 1 of 16
CURATANE (ISOTRETINOIN) CAPSULES
PATIENT SAFETY INFORMATION GUIDE
The marketing of Curatane is subject to a risk management plan (RMP)
including a 'Patient
Safety Information Guide'. The 'Patient Safety Information Guide',
emphasizes important
safety information that the patient should be aware of before and
during treatment.
Please explain to the patient the need to review the guide before
starting treatment.
PRESCRIBER GUIDE
This product is marketed with prescriber guide providing important
safety information.
Please ensure you are familiar with this material as it contains
important safety information.
PRESCRIBER CHECKLIST
Physician checklist for prescribing to female patients is to be
completed by the Physician
for all female patients prescribed Curatane and kept with patient
notes to document
compliance with the Curatane Pregnancy Prevention Programme.
1. NAME OF THE MEDICINAL PRODUCT
Curatane 5 mg, 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg soft gelatin capsule contains: 5 mg isotretinoin.
Each 10 mg soft gelatin capsule contains: 10 mg isotretinoin.
Each 20 mg soft gelatin capsule contains: 20 mg isotretinoin.
Each 30 mg soft gelatin capsule contains: 30 mg isotretinoin.
Each 40 mg soft gelatin capsule contains: 40 mg isotretinoin.
Excipients with known effect:
Contain soya bean oil (refined, hydrogenated and partially
hydrogenated) and sorbitol.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Each 5 mg capsule has a faint pinkish-cream to cream coloured oblong
soft gelatin shell
with a yellow/orange opaque liquid.
Each 10 mg capsule has a light violet coloured oblong soft gelatin
shell with a yellow/orange
opaque liquid.
Each 20 mg capsule has a maroon coloured oblong soft gelatin shell
with a yellow/orange
opaque liquid.
Each 30 mg capsule has a pink coloured oval soft gelatin shell with a
yellow/orange opaque
viscous liquid.
Each 40 mg capsule has a light orange coloured oval soft gelatin shell
with a yell