Nutraplus 10% cream

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Urea

MAH:

Galderma (UK) Ltd

ATC_code:

D02AE01

INN:

Urea

dosage:

100mg/1gram

pharmaceutical_form:

Cutaneous cream

administration_route:

Cutaneous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 13020100; GTIN: 5020465000273

PIL

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C R E A M
N U T R A P L U S
TM 1 0 % W / W C RE A M
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRAPLUS 10% W/W CREAM
Urea
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. What Nutraplus is and what it is used for
2. What you need to know before you use Nutraplus
3. How to use Nutraplus
4. Possible side effects
5. How to store Nutraplus
6. Contents of the pack and other information
1. WHAT NUTRAPLUS IS AND WHAT IT IS USED FOR
•
Nutraplus is an emollient, a moisturising and protective cream for the
treatment of dry or damaged skin.
•
The active substance in this product is urea, a natural substance
found in healthy skin.
•
The presence of urea in the cream moisturises the skin. This helps
bring back soft and supple skin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRAPLUS
DO NOT USE NUTRAPLUS
•
If you are allergic to urea or any of the other ingredients of this
medicine (listed in section 6). An allergic reaction may
include a rash or itching.
•
On large areas of skin if you have renal impairment, talk to your
doctor before using.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Nutraplus.
•
If irritation occurs, discontinue use temporarily and consult your
doctor.
•
Apply carefully only to damaged or inflamed skin or to the face
•
Avoid getting Nutraplus in your eyes, mouth, nose or ears (mucous
membranes). Upon accidental contact, rinse the affected
area with clean water.
•
Nutraplus should only be used under medical supervisi

SPC

OBJECT 1
NUTRAPLUS CREAM
Summary of Product Characteristics Updated 30-Aug-2017 | Galderma
(U.K) Ltd
1. Name of the medicinal product
Nutraplus 10% w/w Cream
2. Qualitative and quantitative composition
Each gram of cream contains 100mg of Urea
Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.8
mg/g, Propyl
parahydroxybenzoate (E216) 0.9 mg/g, Propylene glycol 45mg/g, Cetearyl
alcohol 18.0 mg/g – 22.5 mg/g
For the full list of excipients see section 6.1
3. Pharmaceutical form
Cream
Smooth white, almost odourless cream (water in oil emulsion).
4. Clinical particulars
4.1 Therapeutic indications
An emollient, moisturising and protective cream for the treatment of
dry or damaged skin
4.2 Posology and method of administration
Adults, paediatric population and older people
Apply evenly to the dry skin areas two to three times daily, or as
directed by the physician or pharmacist.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
The product should not be used extensively in patients with severe
renal impairment.
4.4 Special warnings and precautions for use
Avoid contact with the eyes and mucous membranes. If irritation
occurs, discontinue use temporarily and
consult a physician.
Apply with caution only to damaged or inflamed skin or to the face.
The product should be used under medical supervision in babies.
4.5 Interaction with other medicinal products and other forms of
interaction
Urea may enhance the efficacy of topical formulations of
5-fluorouracil and dithranol, and increase the
release and the permeation into the skin of active ingredients from
other topical products such as
corticosteroids.
4.6 Fertility, pregnancy and lactation
There are no clinical data available concerning use in pregnancy.
There are no adequate experimental animal studies available concerning
the effects on pregnancy,
embryonic development, foetal development and/or post-natal
development.
Caution must be exercised for use during pregnancy. However,
indicatio