Nelsons Arnicare Arnica Cream

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Arnica montana

제공처:

Pharmaceutical Business Consultants Limited

INN (국제 이름):

Arnica montana

약제 형태:

Cream

승인 상태:

Marketed

승인 날짜:

2018-11-09

환자 정보 전단

®
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 homeopathic medicinal product used within
the homeopathic tradition for the symptomatic
relief of bruises.
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 get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can report any suspected adverse reactions via
HPRA Pharmacovigilance, Website: www.hpra.ie
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 sight and reach of
children.
• Do not store above 25ºC.
• Do not use after expiry date on the carton & tube.
6. Further information
What is in this medicine
Active ingredient
Each gram of cream contains:
Arnica montana tincture 1X (0.9% w/w)
Also contains:
Purified water, Glyceryl
monostearate & Macrogol stearate, Apricot kernel
oil, Cocoa butter, Glycerol (E422), Cetostearyl
alcohol & PEG-20 Stearate, Cetostearyl alcohol,
Cetyl palmitate, G

제품 특성 요약

Health Products Regulatory Authority
06 May 2022
CRN00CXNW
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nelsons Arnicare Arnica Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains:
Arnica montana tincture 1X (0.9% w/w)
Excipients with known effect:
Cetostearyl alcohol 2.75% w/w
Propyl parahydroxybenzoate (E216) 0.15% w/w
Methyl parahydroxybenzoate (E218) 0.30% w/w
For the 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 homeopathic medicinal product used within the homeopathic tradition
for the symptomatic relief of bruises.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only
Wash hands before and after use.
Adults, the elderly and children over 2 years: Apply to the affected
area 4 times a day, as required.
Not recommended for children under 2 years.
If symptoms worsen or persist after using the product for two 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 listed in
6.1.
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 is not recommended for children under 2 years of age and
medical advice should be sought.
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
INTERACTIONS
None reported
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
Health Products Regulatory Authority
06 May 2022
CRN00CXNW
Page