Weleda HyperCal Wound Salve Ointment
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-10-2017
Summary of Product characteristics
(SPC)
16-03-2018
Active ingredient:
TINCTURE OF HYPERICUM PERFORATUM L., HERBA; TINCTURE FROM CALENDULA OFFICINALIS L., HERBA
Available from:
Weleda (UK) Limited
INN (International Name):
TINCTURE OF HYPERICUM PERFORATUM L., HERBA; TINCTURE FROM CALENDULA OFFICINALIS L., HERBA
Dosage:
.
Pharmaceutical form:
Ointment
Prescription type:
Product not subject to medical prescription
Authorization status:
Marketed
Authorization date:
2017-07-28
Patient Information leaflet
I/708539/1
PATIENT INFORMATION
CONTINUES
OVER PAGE
Traditional Herbal Medicinal Product
Calendula tincture and St John’s Wort tincture
WELEDA HYPERCAL WOUND SALVE OINTMENT
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
Ask your qualified healthcare practitioner or healthcare professional
eg a doctor
or pharmacist if you need more information or advice.
You must talk to a doctor if you feel worse, or do not feel better
after seven
days. If you get any side effects, talk to your qualified healthcare
practitioner
or healthcare professional eg a doctor or pharmacist. This includes
any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What this product is and what it is used for
2. What you need to know before using this product
3. How to use this product
4. Possible side effects
5. How to store this product
6. Contents of the pack and other information
WELEDA HYPERCAL WOUND SALVE OINTMENT IS A TRADITIONAL HERBAL MEDICINAL
PRODUCT USED FOR THE RELIEF OF PAINFUL CUTS AND MINOR WOUNDS. THIS IS
BASED ON
TRADITIONAL USE ONLY. EXCLUSIVELY BASED ON LONGSTANDING USE. WELEDA
HYPERCAL WOUND
SALVE
OINTMENT
CONTAINS
THE
ACTIVE
SUBSTANCES
CALENDULA TINCTURE AND ST JOHN'S WORT TINCTURE.
• DO NOT USE
if you are allergic to any of the ingredients or to plants of the
Asteraceae
(Compositae) family (see Section 6)
• WARNINGS AND PRECAUTIONS:
avoid contact with the eyes and mucous membranes
in some patients Weleda
HyperCal Wound Salve
Ointment
may cause
irritation to the skin when first applied. If you experience any
redness,
itching or dry skin discontinue use and consult your
qualified healthcare
practitioner or healthcare professional eg a doctor or pharmacist
Weleda
HyperCal Wound Salve Ointment
is for use on the skin only
do not expose affected areas to UV light during treatment e.g.
sunlight,
sunbeds
if you notice any signs of skin infection you should consult your
qualified
he
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Weleda HyperCal Wound Salve Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains:
0.10 ml of tincture from_ Calendula officinalis_ L., herba (Calendula
herb) (equivalent to 50 mg of Calendula herb)
Extraction solvent Ethanol 86% w/w and
0.15 ml of tincture from_ Hypericum perforatum_ L., herba (St John’s
Wort herb) (equivalent to 50mg of St John’s Wort
herb) Extraction solvent Ethanol 86% w/w.
Excipients with known effect:
1 g of ointment contains 324 mg of Wool Fat (Lanolin)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment
A smooth, buff to pale yellow ointment with a faint characteristic
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of painful
cuts and minor wounds. Exclusively based on
longsanding use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
Adults, the elderly and children over 12 years:
Wash hands before and after use.
Clean the affected area and apply directly or on a dry dressing two or
three times daily.
Duration of use
Do not use for more than one week.
If symptoms worsen,
persist or do not improve after one week of use of Weleda HyperCal
Wound Salve Ointment a
qualified healthcare practitioner or health care professional eg a
doctor or pharmacist should be consulted.
The use is not recommended in children under 12 years of age (See
Section 4.4 Special warnings and precautions for
use).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredients,
other species of the Asteraceae (Compositae) family or any of the
other
ingredients of the product listed in section 6.1.
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