Toctino 30mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alitretinoin

Available from:

Stiefel Laboratories (UK) Ltd

ATC code:

D11AH04

INN (International Name):

Alitretinoin

Dosage:

30mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050100; GTIN: 7640137530105

Patient Information leaflet

Toctino 10 mg capsules, soft
Toctino 30 mg capsules, soft
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY
Women must use effective contraception
Do not use if you are pregnant or you think you may
be pregnant
This medicine is subject to additional monitoring.
This will allow quick identification of new safety
information. You can help by reporting any side effects
you may get. See the end of section 4 for how to report
side effects.
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 breast-feeding
■ If there is any chance you could become pregnant,
you must follow the precautions under “Pregnancy
and prevention programme”, see section on
“Warnings and precautions”.
■ If you have liver disease.
■ If you have severe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Toctino 30 mg capsules, soft
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains 30 mg of alitretinoin
Excipients with known effect:
Soya-bean oil. Each 30 mg capsule contains 282.40 mg soya-bean oil.
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
Red-brown oval capsule approximately 13 mm in length and 8 mm in width
marked
with “A3”.
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 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
reactions to the 30 mg
dose. In studies investigating 10 mg and 30 mg daily doses, both doses
resulted in clearing of
the disease. The 30 mg dose provided a more rapid response and a
higher response rate. The
10 mg daily dose was associated with fewer adverse events (see section
5.1).
_Duration of treatment _
A treatment cour