Natures Garden Raspberry Leaf Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett Raspberry Leaf Capsules Nature’s Bounty Raspberry Leaf Capsules Nature’s Garden Raspberry Leaf Capsules GNC Live Well Raspberry Leaf Capsules Life cycle Raspberry Leaf Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 424mg of extract (as dry extract) from Raspberry leaf (Rubus idaeus L. ssp. idaeus) (equivalent to 1.7g - 3.4g of Raspberry leaf) Extraction solvent: Ethanol 70%v/v
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Two piece clear hard capsules with greenish brown fill.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of menstrual cramps. This is based on traditional use only
4.2 Posology and method of administration
For oral use only
Women experiencing menstrual cramps:
Take 1 capsule 2 times daily. Swallow the whole capsule with water.
Elderly:
There is no relevant indication
Children and adolescents under 18 years of age:
Not recommended for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use)
Duration of use
If symptoms worsen or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted
4.3 Contraindications
• Hypersensitivity to Raspberry leaf or any of the excipients in this product.
4.4 Special warnings and precautions for use
Do not exceed the stated dose
Do not take this product for at least 2 hours after taking iron, calcium and/or magnesium supplement
If symptoms worsen or persist for more than one week, consult a doctor or a qualified healthcare practitioner.
Not recommended for use in children or adolescents under 18 years of age since data are not sufficient.
4.5 Interaction with other medicinal products and other forms of interaction
Due to high tannin contents, raspberry leaf may decrease absorption of iron, calcium and magnesium.
4.6 Fertility, pregnancy and lactation
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
Gastrointestinal disorders such as, flatulence, bloating, diarrhoea, nausea and vomiting
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.
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.
6.1 List of excipients
Microcrystalline cellulose
Magnesium stearate Silica colloidal hydrated
Excipients in the extract:
Maltodextrin
Silica colloidal anhydrous
Capsule Shell: Hypromellose
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C.
Keep in the original container.
Keep the bottle tightly closed.
6.5 Nature and contents of container
Container.
Green Polyethylene terephthalate (PET) bottles with a chiffon 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 foam, aluminium foil and sealable polyester film
Pack size: 30 capsules
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 21710/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/03/2013
10 DATE OF REVISION OF THE TEXT
13/03/2013