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