SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

H+care haemorrhoid relief cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g cream contains:

2.4    mg tincture of Horse-chestnut seed (Aesculus hippocastanum L.) (1:10), equivalent to 0.24 mg Horse-chestnut seed

Extraction solvent: Ethanol 85% v/v

2.4    mg tincture of Calendula flowers (Calendula officinalis L.) (1:10), equivalent to 0.24 mg Calendula flowers

Extraction solvent: Ethanol 33% v/v

2.4    mg tincture of Witch Hazel Bark (Hamamelis virginiana L.) (1:10), equivalent to 0.24 mg Witch Hazel Bark

Extraction solvent: Ethanol 55% v/v

1.8 mg tincture of Peony Root (Paeonia officinalis L.) (1:10), equivalent to 0.18 mg Peony Root

Extraction solvent: Ethanol 84% 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 to relieve the itching and burning associated with haemorrhoids, based on traditional use only.

4.2 Posology and method of administration

For rectal use only

Wash hands before and after use

Adults and the elderly:

Clean affected area with a hygienic wipe or with warm water, dry the area gently and then apply cream up to 3 times a day, as required. A nozzle is included in this pack and when attached to the tube will aid rectal application. Wash the nozzle before and after each use.

Application is particularly recommended after a bowel movement.

Duration of use:

Do not use for more than two weeks

If symptoms worsen or persist for more than two weeks, a doctor or a qualified healthcare practitioner should be consulted.

The use is not recommended in children or adolescents under 18 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.

The cream should not be swallowed.

Since no data on the safe use in children are available, the use in children and adolescents under 18 years of age is not recommended.

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

Avoid contact with eyes and mucous membranes

If rectal bleeding occurs, a doctor should be consulted.

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

Contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).

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, allergic contact dermatitis 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 reports of overdose.

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified Water White soft paraffin

Cetostearyl alcohol & PEG-20 Stearate Methyl parahydroxybenzoate E218 Honey

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