Alitretinoin 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alitretinoin

Available from:

Ennogen Healthcare Ltd

ATC code:

D11AH04

INN (International Name):

Alitretinoin

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050100; GTIN: 05060254924182

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
250119/5
Ennogen
Alitretinoin Leaflet
UK
English
210 x 510 mm
9 pt
1 of 1
10
07-02-20
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
Alitretinoin is not recommended for people aged under 18 years old. It
is not
known how well it works in this age group.
!
IF YOU HAVE HIGH BLOOD SUGAR (DIABETES), your blood sugar levels may
need to be checked more often and your doctor may start you on a lower
dose of Alitretinoin.
TELL YOUR DOCTOR OR PHARMACIST if you are taking, have recently taken
or might
take any other medicines. This includes medicines obtained without a
prescription, and herbal medicines.
!
IF YOU HAVE HIGH BLOOD FATS, you may need blood tests more often.
Alitretinoin commonly increases blood fats, such as cholesterol or
triglycerides. If your blood fats stay high, your doctor may lower
your dose
or take you off Alitretinoin.
YOU NEED TO TAKE CARE DURING TREATMENT:
!
IF YOU EXPERIENCE ANY PROBLEMS WITH YOUR SIGHT, TELL YOUR DOCTOR
IMMEDIATELY. Alitretinoin may need to be stopped and your sight
monitored.
!
MINIMISE YOUR EXPOSURE TO SUNLIGHT and avoid sun lamps. Your skin may
become more sensitive to sunlight. Before you go out in the sun, use a
sun
protection product with a high protection factor (SPF 15 or higher).
IF YOU
GET DRY SKIN AND LIPS during treatment, use a moisturising ointment or
cream and a lip balm.
DO NOT TAKE OTHER RETINOID MEDICINES (e.g. isotretinoin), VITAMIN A
SUPPLEMENTS OR TETRACYCLINES (a type of antibiotic) while taking
Alitretinoin.
This increases the risk of side effects.
OTHER MEDICINES AND ALITRETINOIN
!
you are taking AMIODARONE (a medicine that helps to regulate heart
rate).
Amiodarone is not recommended to be taken together with Alitretinoin.
!
you are taking SIMVASTATIN (a medicine used to lower cholesterol).
Alitretinoin may decrease the amount of this

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 4.8 for how to report
adverse reactions.
1
NAME OF THE MEDICINAL PRODUCT
Alitretinoin 10 mg capsules, soft
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains 10 mg of alitretinoin
Excipients with known effect
Soya-bean oil.
Each 10 mg capsule contains 92.94 mg soya-bean oil.
Sorbitol.
Each 10 mg capsule contains 13.28 mg sorbitol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, soft
Alitretinoin 10 mg capsules are light brown, oval, soft-gelatin
capsules, 10 mm x 6
mm, containing a yellow to orange, opaque, viscous suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alitretinoin 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
Alitretinoin 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 Alitretinoin
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 Alitretinoin should occur on
the same day.
Dispensing of Alitretinoin should occur within a maximum of 7 days of
the
prescription.
Posology
The recommended dose for alitretinoin is 10 mg or 30 mg once daily.
The recommended starting dose for alitretinoin is 30 mg once daily. A
dose reduction
to 10 mg once daily ma