NEOTIGASON 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACITRETIN

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

D05BB02

Pharmaceutical form:

CAPSULES

Composition:

ACITRETIN 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ACTAVIS GROUP PTC EHF, ICELAND

Therapeutic area:

ACITRETIN

Therapeutic indications:

Severe disorders of keratinization such as erythrodermic psoriasis local or generalized pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier's disease.

Authorization date:

2019-12-12

Patient Information leaflet

PATIENT SAFETY INFORMATION CARD
DOCTOR’S NAME:
TELEPHONE:
Neotigason is used TO TREAT SEVERE SKIN PROBLEMS including psoriasis,
ichthyosis and keratosis.
Treatment of the drug in a patient of childbearing age is for severe
disease which is resistant to
standard treatments.
NEOTIGASON )ACITRETIN( MUST NOT BE TAKEN DURING PREGNANCY.
NEOTIGASON )acitretin(, when taken by a pregnant woman, can cause
severe malformation of
the unborn baby such as skull, facial, cardiovascular, brain, skeletal
and thymus defects.
IF YOU BECOME PREGNANT OR THINK YOU MIGHT BE PREGNANT, STOP TAKING
NEOTIGASON )ACITRETIN(
IMMEDIATELY AND CONTACT YOUR DOCTOR.
Read the package leaflet carefully before you start treatment.
WHAT YOU HAVE TO DO IF YOU COULD BECOME PREGNANT:
• YOU MUST USE AT LEAST 1 HIGHLY EFFECTIVE METHOD OF CONTRACEPTION
)SUCH AS AN INTRA-UTERINE
DEVICE OR AN IMPLANT( OR CORRECTLY USE 2 EFFECTIVE METHODS OF BIRTH
CONTROL THAT WORK IN
DIFFERENT WAYS )SUCH AS AN ORAL CONTRACEPTIVE TOGETHER WITH A CONDOM(
BEFORE, DURING AND
FOR 3 YEARS AFTER STOPPING TREATMENT.
• YOU MUST NOT BECOME PREGNANT while taking NEOTIGASON )acitretin(,
or for 3 years after
stopping treatment.
• YOU MUST ATTEND REGULAR FOLLOW-UP VISITS.
• YOU MUST HAVE REGULAR PREGNANCY TESTS TO ENSURE YOU ARE NOT
PREGNANT PRIOR TREATMENT,
ONCE A MONTH DURING TREATMENT AND EVERY 1-3 MONTHS FROM STOPPING
TREATMENT UNTIL 3
YEARS AFTERWARDS.
This medication has been prescribed to you only, DO NOT SHARE IT WITH
ANYBODY AND RETURN ANY
UNUSED CAPSULES BACK TO THE PHARMACY.
FOR YOUR CONVENIENCE, AN APPOINTMENT TABLE TO RECORD THE DATES OF YOUR
VISITS TO THE
ATTENDING DOCTOR IS AVAILABLE IN THE ISRAELI DRUG REGISTRY - ON THE
MINISTRY OF HEALTH WEBSITE
AND ON THE SITE OF THE DEPARTMENT OF RISKS MANAGEMENT UNDER MATERIALS
FOR THE PATIENT.
The format of this card and its contents were checked and approved by
the Ministry of Health on
February 2019.
."باصخلإا نس يف ءاسنلل ة
ّ
مهم تامولعم"
تانيكاملا لامعتساو ةقايسلا
ءا�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
▼THIS MEDICINAL PRODUCT IS SUBJECT TO ADDITIONAL MONITORING. THIS
WILL ALLOW QUICK
IDENTIFICATION OF NEW SAFETY INFORMATION. HEALTHCARE PROFESSIONALS ARE
ASKED TO
REPORT ANY SUSPECTED ADVERSE REACTIONS. SEE SECTION “UNDESIRABLE
EFFECTS” FOR HOW TO
REPORT ADVERSE REACTIONS.
NEOTIGASON 10MG AND 25MG CAPSULES
*************************************************************************************
1
NAME OF THE MEDICINAL PRODUCT
Neotigason 10mg Capsules
Neotigason25mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg Capsules:
Each capsule, contains Acitretin 10 mg
25 mg Capsules:
Each capsule, contains Acitretin 25 mg
Excipients with known affect: Glucose (see section _4.3
Contraindications_).
This medicine contains less than 1 mmol sodium (23 mg) per capsule,
that is to say
essentially ‘sodium-free’.
For a full list of excipients, see section _6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Capsules for oral administration
10 mg Capsules:
Hard gelatin capsules with white body and brown cap with “10”
printed in black on the
body, containing 10 mg acitretin.
25mg Capsules:
Hard gelatin capsules with yellow body and brown cap with “25”
printed in black on the
body, containing 25 mg acitretin.
Neotigason Capsules 10mg, 25mg, SPC, 02-2020, HH, Notification
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe disorders of keratinization such as erythrodermic psoriasis
local or generalized or
pustular psoriasis congenital ichthyosis pityriasis rubra pilaris
darier's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Neotigason should only be prescribed by physicians who are experienced
in the use of
systemic retinoids and understand the risk of teratogenicity
associated with acitretin
therapy (see Section 4.6).
The capsules should be taken once daily with meals or with milk.
There is a wide variation in the absorption and rate of metabolism of
Neotigason. This
necessitates individual adjustment of dosage. For this reason the
following dosage
recommendations can