SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nelsons Hypercal Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g cream contains:

4.5    mg tincture of St. John’s Wort herb (Hypericum perforatum L.) (1:10), equivalent to 0.45 mg St. John’s Wort herb

Extraction solvent: Ethanol 33% v/v

4.5    mg tincture of Calendula flowers (Calendula officinalis L.) (1:10), equivalent to 0.45 mg Calendula flowers

Extraction solvent: Ethanol 33% 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 relief of minor cuts and wounds, based on traditional use only.

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 if required.

Apply gently to cover the affected area up to three times a day. Cover with a plaster or dry dressing & bandage lightly if required.

Duration of use:

Do not use for more than one week.

If symptoms worsen or persist for more than one week, a doctor or a qualified healthcare practitioner 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 any of the active ingredients 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.

This cream should not be swallowed.

Since no data on the safe use in children are available, the use in children under 12 years of age is not recommended.

If symptoms worsen or persist after one week, a doctor or qualified healthcare practitioner should be consulted.

If signs of skin infection are observed, a doctor or a qualified healthcare practitioner should be consulted.

Discontinue use if redness, irritation or dry skin occurs.

Avoid contact with the eyes and mucous membranes.

During the treatment intense UV-exposure of the respective skin areas should be avoided

Contains Methyl parahydroxybenzoate and Propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).

Contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6    Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7    Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

Skin sensitization and skin reactions may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No case of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity or carcinogenicity have not been performed.

For Calendula officinalis - Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.

For Hypericum perforatum - Studies on acute toxicity and repeated dose toxicity did not show signs of toxic effects.

The weak positive results of an ethanolic extract in the AMES-test (Salmonella typhimurium TA 98 and TA 100, with and without metabolic activation) could be assigned to quercetin and are irrelevant to human safety. No signs of mutagenicity could be detected in further in-vitro and in-vivo test systems.

Tests on reproductive toxicity revealed equivocal results.

Tests on the carcinogenic potential have not been performed

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water

DATE OF REVISION OF THE TEXT

18/05/2016