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Nutrition Warehouse Herbal Pile Tablets

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nutrition Warehouse Herbal Pile Tablets Holland & Barrett Herbal Pile Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

6 mg of extract (as dry extract) from Witch Hazel bark (Hamamelis virginiana L.) (5-7.7:1)

Extraction solvent: Ethanol 30% v/v For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet

Dark brown round biconvex tablet.

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 oral use only.

Adults and the elderly

One to two tablets to be taken after each meal.

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

The use in children or adolescents under 18 years of age is not recommended (see section 4.4 Special warnings and precautions for use.’)

Contraindications

4.3


Hypersensitivity to the active substance or any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

If rectal bleeding occurs a doctor should be consulted.

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

The use in children and adolescents under 18 years of age is not recommended due to the lack of data on safety and efficacy.

4.5    Interaction with other medicinal products and other forms of interaction

None reported

4.6 Fertility, pregnancy and lactation

Safety 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

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Allergic contact dermatitis has been reported. The frequency is not known.

If other adverse reactions occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

No cases have been reported with this product.

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

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Gum Acacia

Calcium Phosphate Tribasic Sago Flour

Magnesium Trisilicate Stearic Acid Capsicum Oleoresin Ethylcellulose N100

6.2    Incompatibilities

None known

6.3    Shelf life

3 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

High density polyethylene tampertainer. Pack size: 100 tablets.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Nutrition Warehouse Limited

Samuel Ryder House

Barling Way

Eliot Park

Nuneaton

Warwickshire

CV10 7RH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 14010/0039

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/04/2013

10    DATE OF REVISION OF THE TEXT

22/04/2013