TOCTINO 30 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

ALITRETINOIN

Disponibil de la:

GLAXO SMITH KLINE (ISRAEL) LTD

Codul ATC:

D11AX19

Forma farmaceutică:

CAPSULES SOFT

Compoziție:

ALITRETINOIN 30 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

GLAXOSMITHKLINE TRADING SERVICES LIMITED

Grupul Terapeutică:

ALITRETINOIN

Zonă Terapeutică:

ALITRETINOIN

Indicații terapeutice:

For use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids .Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx .

Data de autorizare:

2021-11-30

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
For the list of inactive and allergenic ingredients in the
preparation, see section
2:
Important information about some of the ingredients of the medicine
and
section 6: Additional information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician 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.
The medicine is not intended for children under 18 years of age.
In addition to the leaflet, Toctino has a Patient Pamphlet. This
pamphlet
contains important safety information that you must know and adhere to
before and during the treatment with Toctino. Read the Patient
Pamphlet and
the patient leaflet before starting to use the preparation. Keep the
pamphlet
for further reading, if necessary.
WOMEN OF CHILD-BEARING POTENTIAL MUST AVOID BECOMING PREGNANT FOR
ONE MONTH BEFORE STARTING TREATMENT, DURING THE COURSE OF TREATMENT
AND
FOR
ONE
MONTH
AFTER
DISCONTINUING
TREATMENT.
USE
EFFECTIVE
CONTRACEPTIVES. DURING THE COURSE OF TREATMENT, MONTHLY PREGNANCY
TESTS SHOULD BE PERFORMED. IF YOU DISCOVER THAT YOU ARE PREGNANT
DURING
THE
COURSE
OF
TREATMENT
OR
ONE
MONTH
AFTER
TREATMENT,
STOP
THE
TREATMENT IMMEDIATELY AND REPORT TO THE ATTENDING PHYSICIAN. USE OF
THIS MEDICINE DURING PREGNANCY CAUSES RISK OF DEFECTS IN THE UNBORN
BABY AND INCREASES THE RISK OF MISCARRIAGE. SEE ADDITIONAL INFORMATION
IN SECTION
PREGNANCY PREVENTION PROGRAM AND SECTION
PREGNANCY
AND BREASTFEEDING.
DO NOT USE THE MEDICINE IF YOU ARE PREGNANT OR THINK YOU MIGHT BE
PREGNANT.
TOCTINO 10 MG
SOFT CAPSULES
The active ingredient and its quantity:
EACH CAPSULE CONTAINS:
Alitretinoin 10 mg
TOCTINO 30 MG
SOFT CAPSULES
The active ingredient and its quantity:

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TOCTINO 10 MG
TOCTINO 30 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains 10 mg or 30 mg of alitretinoin
Excipients with known effect:
Soybean oil.
Each 10 mg capsule contains 176.50 mg soya-bean oil.
Each 30 mg capsule contains 282.40 mg soya-bean oil.
Sorbitol.
Each 10 mg capsule contains 20.08 mg sorbitol.
Each 30 mg capsule contains 25.66 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft
The Toctino 10 mg capsule is a brown oval capsule approximately 11 mm
in length and 7 mm in width
marked with “A1”.
The Toctino 30 mg capsule is a red-brown oval capsule approximately 13
mm in length and 8 mm in
width marked with “A3”.
PATIENT SAFETY INFORMATION CARD
The marketing of Toctino is subject to a risk management plan (RMP)
including a ‘Patient safety
information card’. The ‘Patient safety information card’,
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 card before
starting treatment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Toctino is indicated for use in adults who have severe chronic hand
eczema that is unresponsive to
treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly hyperkeratotic features
are more likely to respond to
treatment than in those in whom the eczema predominantly presents as
pompholyx (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
Toctino should only be prescribed by dermatologists, or physicians
with experience in the use of
systemic retinoids who have full understanding of the risks of
systemic retinoid therapy and monitoring
requirements. Prescriptions of Toctino for women of childbearing
potential should be limited to 30 days
of treatment and continuation of treatment requires a new
prescription. Ideally, pregnancy testing,
issuing a prescription and dispens