TOCTINO 30mg soft capsules

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

ALITRETINOIN

Saadav alates:

Glaxo SmithKline UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC kood:

D11AH04

INN (Rahvusvaheline Nimetus):

ALITRETINOIN 30 mg

Ravimvorm:

SOFT CAPSULE

Koostis:

ALITRETINOIN 30 mg

Retsepti tüüp:

POM

Terapeutiline ala:

OTHER DERMATOLOGICAL PREPARATIONS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2009-12-16

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOCTINO
® 10 MG CAPSULES, SOFT
TOCTINO
® 30 MG CAPSULES, SOFT
alitretinoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Toctino is and what it is used for
2.
What you need to know before you take Toctino
3.
How to take Toctino
4.
Possible side effects
5.
How to store Toctino
6.
Contents of the pack and other information
1.
WHAT TOCTINO IS AND WHAT IT IS USED FOR
The active substance in Toctino is alitretinoin. It belongs to a group
of medicines known as _retinoids_
which are related to Vitamin A. Toctino capsules come in two
strengths, containing 10 mg or 30 mg of
alitretinoin.
Toctino is used to treat adults with severe chronic hand eczema that
has not got better after any other
topical treatments, including steroids. Treatment with Toctino must be
supervised by a specialist skin
doctor (a dermatologist).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOCTINO
DO NOT TAKE TOCTINO

IF YOU ARE PREGNANT or if you can become pregnant and are not using
effective birth control
measures
(SEE BELOW, “PREGNANCY AND BREAST-FEEDING”).

If you are breast-feeding.

If you have LIVER DISEASE.

If you have SEVERE KIDNEY DISEASE.

If you have HIGH BLOOD FATS (such as high cholesterol or raised
triglycerides).

If you have UNTREATED THYROID DISEASE.

If you have VERY HIGH LEVELS OF VITAMIN A in your body
(_hypervitaminosis_ A).

If you are ALLERGIC to alitretinoin, to other retinoids (such as
isotretinoin), to peanut or soya or
any of the other ingredi

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Toctino
®
10 mg capsules, soft
Toctino
®
30 mg capsules, soft
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains 10 mg or 30 mg of alitretinoin
Excipients with known effect:
Soya-bean 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”.
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
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 dispensing of Toctino
should occur on the same day.
Dispensing of Toctino should occur within a maximum of 7 days of the
prescription.
The recommended dose for Toctino is 10 mg or 30 mg once daily.
The recommended starting dose for Toctino is 30 mg once daily. A dose
reduction to 10 mg once daily
may be considered in patients with unacceptable adverse r