Isotretinoin 10mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Isotretinoin

Mevcut itibaren:

DE Pharmaceuticals

ATC kodu:

D10BA01

INN (International Adı):

Isotretinoin

Doz:

10mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 13060200

Bilgilendirme broşürü

ISOTRETINOIN 10/20 MG CAPSULES (PIL)
UK
180 X 580 MM (FOLDED SIZE: 180 X 35 MM)
0000000 5179440
00000
26.07.2018/ 15.03.2019/ 18.03.2019/ 22.03.2019
REF.
BLUE
It is very common to experience dryness of the skin, especially
of the lips and face. You may get an inflamed skin (dermatitis),
chapped and inflamed lips (cheilitis), a rash, some mild itching
and slight peeling. This dryness can be relieved by the regular
use of a good moisturising cream from the start of treatment.
If you develop a rash or these skin symptoms, stop taking
isotretinoin and contact your doctor immediately.
Serious skin rashes (erythema multiforme, Stevens-Johnson
syndrome, and toxic epidermal necrolysis), which are
potentially life-threatening and require immediate medical
attention. These appear initially as circular patches often with
central blisters usually on arms and hands or legs and feet,
more severe rashes may include blistering of the chest and
back. Additional symptoms such as infection of the eye
(conjunctivitis) or ulcers of the mouth, throat or nose may
occur. Severe forms of rash may progress to widespread
peeling of the skin which can be life threatening. These serious
skin rashes are often preceded by headache, fever, body aches
(flu-like symptoms). These side effects have been reported with
unknown frequency.
SKIN PROBLEMS
CONTACT YOUR DOCTOR STRAIGHT AWAY IF YOU GET SIGNS OF ANY OF
THESE MENTAL PROBLEMS. Your doctor may tell you to stop taking
Isotretinoin Capsules. That may not be enough to stop the
effects: you may need more help and your doctor can arrange
this.
As mental problems can be caused by many different factors, it
is important to tell your doctor if you have ever had any mental
illness including depression, suicidal behaviour or psychosis
(psychosis means a loss of contact with reality, such as hearing
voices or seeing things that are not there). Also tell your doctor
if you take medicines for any of these conditions.
-
Signs of psychosis: a loss of contact with reality, such as
hearing voices or seeing thin

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isotretinoin 10mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains isotretinoin 10 mg.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsules, Soft
Oval shaped, light pink coloured, opaque soft gelatin capsules
imprinted with `RR` in
black edible ink containing orange-yellow coloured oily suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe forms of acne (such as nodular or conglobate acne or acne at
risk of
permanent scarring) resistant to adequate courses of standard therapy
with systemic
antibacterials and topical therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Isotretinoin should only be prescribed by or under the supervision of
physicians with
expertise in the use of systemic retinoids for the treatment of severe
acne and a full
understanding of the risks of isotretinoin therapy and monitoring
requirements.
The capsules should be taken with food once or twice daily.
_Adults including adolescents and the elderly:_
Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily.
The therapeutic
response to isotretinoin and some of the adverse effects are
dose-related and vary
between patients. This necessitates individual dosage adjustment
during therapy. For
most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are more closely related to the
total dose
administered than to either duration of treatment or daily dose. It
has been shown that
no substantial additional benefit is to be expected beyond a
cumulative treatment dose
of 120-150 mg/kg. The duration of treatment will depend on the
individual daily
dose. A treatment course of 16-24 weeks is normally sufficient to
achieve remission.
In the majority of patients, complete clearing of the acne is obtained
with a single
treatment course. In the event of a definite relapse a further course
of isotretinoin
therapy may be considered using the same da