Natures Garden Horse Chestnut Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett Horse Chestnut Tablets GNC Live Well Horse Chestnut Tablets Lifecycle Horse Chestnut Tablets Nature’s Garden Horse Chestnut Tablets Nature’s Bounty Horse Chestnut Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro resistant tablet contains 272mg - 332mg of extract (as dry extract) from Horse chestnut seeds (Aesculus hippocastanum L. semen) corresponding to 60mg of Triterpene glycosides calculated as aescin.
Extraction solvent: Ethanol 80% v/v For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Speckled, light brown, clear coated, bi-convex, oval shaped tablet, plain on both sides.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of symptoms associated with minor venous insufficiency and varicose veins, such as tired heavy legs, pain, cramps and swelling. This is based on traditional use only.
4.2
Posology and method of administration
For oral use only.
Adults and the elderly
Take 1 tablet 2 times daily immediately after food. Swallow the whole tablet with water.
Do not exceed the stated dose.
Duration of use:
If symptoms worsen or do not improve after 2 weeks, a Doctor or a qualified Healthcare Practitioner should be consulted.
Not for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use)
4.3 Contraindications
Hypersensitivity to Horse Chestnut seed or any of the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose
Patients who have developed ulcers on their lower limbs due to chronic venous insufficiency should not use this product if they are receiving medical care for their venous ulcers. If a patient develops a venous ulcer while using this product they should seek medical advice for advice for the ulceration immediately
If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs particularly associated with redness and heat, cardiac or renal insufficiency, a doctor should be consulted immediately.
The use in children and adolescents under 18 years if age has not been established due to the need for medical supervision.
If symptoms worsen or do not improve after 2 weeks, a Doctor or a qualified Healthcare Practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
There are limited data available on drug interactions with extracts of horse chestnut seed. The data indicates that horse chestnut seeds extracts are unlikely to interact with other medicinal products.
Fertility, Pregnancy and lactation
4.6
Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.
Studies 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
Undesirable effects associated with the use of horse chestnut seed extracts are generally mild.
The following undesirable effects have been reported in clinical studies:
Gastrointestinal disorders:
Nausea
Abdominal Pain or discomfort
Diarrhoea
Vomiting
Allergic reactions (hypersensitivity of the skin, itching, rash, erythema, eczema) Headache and vertigo
The frequency is not known.
If other adverse reactions not mentioned above occur, a Doctor or qualified Healthcare Practitioner should be consulted.
4.9 Overdose
No case of overdose has been reported.
In the event of an overdose, patients may expect an increased likelihood of experiencing an undesirable effect.
Management of an overdose should include appropriate symptomatic and supportive treatment.
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 and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Excipients in the extract Silica colloidal anhydrous
Tablet core
Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Maize starch Croscarmellose sodium Magnesium Stearate
Tablet Coating:
Hypromellose
Triacetin
Talc
Sodium Alginate Stearic acid Ethylcellulose Ammonium hydroxide Medium chain triglycerides Oleic acid
Purified water (volatile)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
35 months
6.4 Special precautions for storage
Store below 25°C.
Store in the original container Keep the bottle tightly closed
6.5 Nature and contents of container
Container.
Green Polyethylene terephthalate (PET) bottles with a green hinge cap (polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin form, aluminium foil and sealable polyester film
Pack size. 30 tablets
6.6
Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton Warwickshire CV10 7RH United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 21710/0012
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/12/2011
10 DATE OF REVISION OF THE TEXT
04/04/2013