Alitretinoin 30mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Alitretinoin

Saatavilla:

Ennogen Healthcare Ltd

ATC-koodi:

D11AH04

INN (Kansainvälinen yleisnimi):

Alitretinoin

Annos:

30mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 13050100; GTIN: 05060254924199

Pakkausseloste

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
250119/6
Ennogen
Alitretinoin 30mg Leaflet
UK
English
210 x 510 mm
9 pt
1 of 1
11
07-02-20
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
YOU NEED TO TAKE CARE DURING TREATMENT:
!
IF YOU DEVELOP ANY MENTAL HEALTH PROBLEMS including depression,
aggressive tendencies, mood changes, thoughts about hurting yourself
or
ending your life, YOU MUST STOP TAKING ALITRETINOIN IMMEDIATELY and
contact your doctor as soon as possible.
YOU SHOULD NEVER GIVE THIS MEDICINAL PRODUCT TO ANOTHER PERSON. PLEASE
TAKE ANY UNUSED CAPSULES TO YOUR PHARMACIST AT THE END OF TREATMENT.
TELL YOUR DOCTOR OR PHARMACIST IF:
!
you are taking SIMVASTATIN (a medicine used to lower cholesterol).
Alitretinoin may decrease the amount of this medicine in your body.
ADDITIONAL PRECAUTIONS
!
IF YOU HAVE BEEN SUFFERING FROM THYROID DISEASE. Alitretinoin may
lower
your thyroid hormone levels. If your thyroid hormone level is low,
your
doctor may prescribe supplements.
!
IF YOU DEVELOP DRY EYES, lubricating eye ointment or tear replacement
drops can help. If you wear contact lenses, you may need to wear
glasses
during alitretinoin treatment. Dry eyes and sight problems normally
return
to normal once treatment is stopped.
!
you are taking KETOCONAZOLE, FLUCONAZOLE, MICONAZOLE (medicines used
to treat infections). Your doctor may decide to reduce your dose of
Alitretinoin.
!
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.
!
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

Valmisteyhteenveto

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 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 278.94 mg soya-bean oil.
Sorbitol.
Each 30 mg capsule contains 25.55 mg sorbitol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, soft
Alitretinoin 30 mg capsules are yellow, oval, soft-gelatin capsules,
13 mm x 8 mm,
containing a yellow to orange, opaque, viscous suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alitretinoin capsules 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 dai