Isotretinoin 20mg capsules

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Isotretinoin

Disponible desde:

DE Pharmaceuticals

Código ATC:

D10BA01

Designación común internacional (DCI):

Isotretinoin

Dosis:

20mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 13060200

Información para el usuario

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

Ficha técnica

OBJECT 1
ISOTRETINOIN 20MG CAPSULES
Summary of Product Characteristics Updated 30-Apr-2019 | Alliance
Pharmaceuticals
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
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3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
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
Isotretinoin 20mg Capsules
Rizuderm 20mg Capsules
2. Qualitative and quantitative composition
Each capsule contains 20mg isotretinoin.
Excipients with known effect:
Contains soya bean oil (refined, hydrogenated and partially
hydrogenated) maltitol and sorbitol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules, soft.
Red/orange soft capsules marked 'P20'.
4. Clinical particulars
Some of the side effects associated with the use of isotretinoin are
related to the dose. The side effects are
generally reversible after changing the