SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Waterfall Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each soft capsule contains:

66 mg of extract (as dry extract) from Boldo leaf (Peumus boldus Molina) (5:1) Extraction solvents: Ethanol 30% v/v

25 mg of extract (as dry extract) from Celery seed (Apium graveolens L.) (4:1) Extraction solvents: Ethanol 50 %v/v

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, soft.

Dark purple oblong soft gel capsule

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve bloating associated with premenstrual water retention, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

Adults: The recommended dose is 2 capsules in the morning, preferably before meals.

The capsules should be swallowed whole with some water or other liquid.

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

Use in the elderly is not relevant for this indication.

If symptoms worsen or persist after using the product for one week, a doctor or a qualified healthcare practitioner should be consulted

4.3 Contraindications

Hypersensitivity to the active ingredients or to plants of the Apiaceae (Umbelliferae) family or to carrots, mugwort, birch or dandelion or to any of the excipients.

Conditions where a reduced fluid intake is recommended (e.g. cardiac or renal disease).

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist after one week or if symptoms such as fever, spasms, dysuria or blood in the urine occur, a doctor or a quailed healthcare practitioner should be consulted.

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Additive effects with diuretics cannot be excluded and therefore concomitant treatment is not recommended.

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 effects on the ability to drive or operate machines have been performed

4.8 Undesirable effects

Gastric irritation including mild colic, nausea and vomiting may occur. Hypersensitivity (anaphylaxis) has been reported with Boldo leaf.

Allergic reaction to Celery seed in individuals sensitive to certain plants and species including wild carrots, mugwort, birch and dandelion have been reported. Also inflammation in individuals with renal disease has been reported and skin inflammation and sensitivity to sunlight.

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

No cases of overdose have 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, carcinogenicity and genotoxicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Safflower Oil

Lecithin thin (light)

Hydrogenated vegetable oil

Beeswax Yellow

Juniper Berry Flavouring

Glycerin

Gelatin

6.2 Incompatibilities

None known.

6.3 Shelf life

18 months.

6.4 Special precautions for storage

Store below 25°C. Store in the original container.

6.5 Nature and contents of container

PVC I PVdC blisters of 10, 20, 24 or 30 capsules.

Amber glass bottles with screw cap closures containing aluminium back liners of 30, 60, 66, 72, 80, 100 or 125 capsules.

Not all pack sizes are marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Bee Health Ltd Carnaby Bridlington East Yorkshire YO15 3QY

8    MARKETING AUTHORISATION NUMBER(S)

THR 37056/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/03/2013

10    DATE OF REVISION OF THE TEXT

27/03/2013