Arnicare arnica cream

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Arnica tincture

から入手可能:

Nelsons

ATCコード:

n/a

INN（国際名）:

Arnica tincture

投薬量:

9microlitre/1gram

医薬品形態:

Cutaneous cream

投与経路:

Cutaneous

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 19020300; GTIN: 5000488104400 5000488201352

情報リーフレット

®
®
Please read all of this leaflet carefully before
using this medicine, it contains important
information. Please keep this leaflet; you
might need to read it again.
1. What is this medicine used for
A traditional herbal medicinal product used for the
symptomatic relief of bruises, based on traditional
use only.
2. Before using this medicine
Do not use this medicine if:
• you are allergic to any of the ingredients or to
plants of the Asteraceae (Compositae) family (such
as daisies, marigolds or artichokes) (see section 6).
• you are pregnant or breastfeeding.
Important information about some of the
ingredients
• Contains cetostearyl alcohol which may cause skin
reactions (e.g. contact dermatitis). Methyl
parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) in this medicine may
cause allergic reactions (possibly delayed).
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everyone gets them. Some
people experience itching, rash, dry skin or skin
reactions (e.g. contact dermatitis), if you experience
any of these, discontinue use and consult your
doctor, pharmacist or qualified healthcare
practitioner.
Reporting of side effects
If you have any side effects including those not
listed on this leaflet, consult your doctor or
pharmacist. You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store this medicine
• Keep this medicine out of the reach and sight of
children.
• Do not use after expiry date on the carton & tube.
• Do not store above 25ºC. Store in original
container.
6. Further information
What is in this medicine
Active ingredient
1 g cream contains 9.0 mg tincture of Arnica whole
plant (
_Arnica montana_
L.) (1:10), equivalent to
0.9 mg Arnica whole plant.
Extraction solvent: Ethanol 57% v/v.
Also contains:
Purified water, Glyceryl
monostearate & Macrogol stearate, Apricot kernel
oil

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nelsons Arnicare Arnica Cream
Boots Pharmaceuticals Bruise Relief Arnica Cream to the licence.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains:
9.0 mg tincture of Arnica Whole Plant (_Arnica montana_ L.) (1:10),
equivalent to 0.9
mg Arnica Whole Plant
Extraction solvent: Ethanol 57% v/v
Also contains Cetostearyl alcohol, propyl parahydroxybenzoate (E216)
and methyl
parahydroxybenzoate (E218). (See section 4.4. Special warnings and
precautions for
use)
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream
A smooth white to off-white cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the symptomatic relief
of bruises,
based on traditional use only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only
Wash hands before and after use.
ADULTS, THE ELDERLY AND CHILDREN:
Apply to the affected area 4 times a day as required.
If symptoms worsen or persist after using the product for 2 weeks, a
doctor or
qualified healthcare practitioner should be consulted.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to plants of the
Asteraceae (Compositae)
family or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose
Avoid contact with eyes and mucous membranes.
Not to be applied to broken or irritated skin.
Discontinue use if skin becomes red,
dry or irritated.
This product contains Cetostearyl alcohol, which may cause local skin
reactions (e.g.
contact dermatitis).
This product contains propyl parahydroxybenzoate (E216) and methyl
parahydroxybenzoate (E218), which may cause allergic reactions
(possibly delayed).
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None reported
4.6
FERTILITY, PREGNANCY AND LACTATION
Safety during pregnancy and lactation has not been established. In the
absence of
sufficient data, the use during pregnancy and lactation is not
recommended.
Studi