SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

H+care haemorrhoid relief cream Boots Alternatives Haemorrhoid Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains:

2.4% v/w tincture of Horse-chestnut seed (Aesculus hippocastanum L). (1:10) Extraction solvent: Ethanol 87% v/v

2.4% v/w tincture of Calendula flower (Calendula officinalis L.) tincture (1:10) Extraction solvent: Ethanol 33% v/v

2.4% v/w tincture of Witch Hazel bark & root Bark (Hamamelis virginiana L).

(1:10)

Extraction solvent: Ethanol 55% v/v

1.8% v/w tincture of Peony root (Paeonia officinalis L.) (1:10 Extraction solvent: Ethanol 87% 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 then apply cream as required. A nozzle is included in this pack and when attached to the tube will aid rectal application.

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 Asteracaea (Compositae) family) or to any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

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.

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

6.1 List of excipients

White soft paraffin

Polawax GP 200 (cetostearyl alcohol, PEG-20 stearate)

Methyl parahydroxybenzoate E218

Honey

Propyl parahydroxybenzoate E216

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5    Nature and contents of container

Epoxy phenolic lacquered aluminium tube. Polyethylene cap. 30 g.

6.6    Special precautions for disposal

A nozzle is included in the pack and when attached to the tube will aid application.

There are no special instructions

7 MARKETING AUTHORISATION HOLDER

A Nelson & Co Limited 5-9 Endeavour Way Wimbledon London SW19 8UH

Trading style: Nelsons Homeopathy

8    MARKETING AUTHORISATION NUMBER(S)

THR 01175/0403

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/04/2013

10    DATE OF REVISION OF THE TEXT

30/04/2013