Summary of Product Characteristics (SmPC) - Lifecycle Nettle Leaf capsules,Natures Bounty Nettle Leaf capsules,Holland & Barrett Nettle Leaf capsules,GNC Live Well Nettle Leaf capsules,Natures Garden Nettle Leaf capsules
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett Nettle Leaf Capsules
GNC Live Well Nettle Leaf Capsules
Lifecycle Nettle Leaf Capsules
Nature’s Garden Nettle Leaf Capsules
Nature’s Bounty Nettle Leaf Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 455mg of extract (as dry extract) from Nettle leaf
(Urtica dioica L.) (equivalent to 3636mg – 4545 mg of Nettle leaf).
Extraction solvent: Ethanol 50% 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 relief of minor aches and pains in the joints. This is based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the elderly
Take 1 capsule 2 times daily. Swallow the whole capsule with water.
This product is not for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use)
Duration of use
This product is not to be used for more than 4 weeks
If symptoms worsen or persist after using the product for 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
- Hypersensitivity to the active ingredient or to any of the excipients in this product.
- Conditions where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease)
4.4 Special warnings and precautions for use
- Do not exceed the stated dose
Not recommended for children or adolescents under 18 years of age because data are not sufficient and medicinal advice should be sought.
If symptoms worsen or persist after using the product for 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.
Consult a Doctor or a qualified Healthcare Practitioner if joint pain is accompanied by swelling of the joint, redness or fever.
4.5 Interaction with other medicinal products and other forms of interaction
None known
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 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
Mild gastrointestinal complaints (e.g. nausea, vomiting, diarrhoea)
Allergic skin reactions (e.g. itching, exanthema, hives) may occur. 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 PHARMACEUTICAL PARTICULARS
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
36 months
6.4 Special precautions for storage
Do not store above 25ºC.
Store in the original container.
6.5 Nature and contents of 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: 50 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 21710/0032
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/01/2012
10 DATE OF REVISION OF THE TEXT
02/09/2013