SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Puncto CurbiFemme capsules.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

122.5 mg of extract (as dry extract) (26-31:1) from pumpkin seeds (Cucurbita pepo L.), Extraction solvent: Ethanol 60% m/m.

Also contains: Soya bean oil (108 mg) and sorbitol (6.4 mg).

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Capsules, soft.

Yellow-beige colour capsules with gloss and seams, odourless.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used for the relief of lower urinary tract symptoms such as frequent urge to urinate and/or increased urinary frequency and urgency in women with overactive bladder, based on traditional use only.

4.2    Posology and method of administration

For oral administration.

The capsules should be swallowed whole with 1-2 glasses of water. Do not chew the capsules.

Adults and the elderly

One capsule to be taken three times a day.

Children and adolescents under 18 years of age

This product is not indicated in patients under 18 years of age.

4.3    Contraindications

Hypersensitivity to the active substance or other members of the Cucurbitaceae family.

Hypersensitivity to any of the excipients.

Hypersensitivity to peanut or soya as this product contains soya oil.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen a doctor or qualified healthcare practitioner should be consulted.

If symptoms include haematuria or pyrexia medical advice must be sought immediately.

This product contains soya oil and should not be used by patients who are allergic to peanut or soya.

This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this product.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

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 and use machines have been performed.

4.8    Undesirable effects

Allergic reactions may occur in rare cases. Discontinue immediately if hypersensitivity occurs.

The frequency is not known.

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

4.9    Overdose

No cases of overdose have been reported. Supportive and symptomatic treatment should be provided as appropriate.

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

Extract: maltodextrin Capsule filling: soy-bean oil, palm kernel oil, lecithin, coconut oil, yellow beeswax Capsule shell: gelatin, glycerol, purified water, sorbitol,

titanium dioxide E 171, iron oxide yellow E172

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5    Nature and contents of container

PVC/PVDC-Al blister strips in cardboard carton.

Packs of 40, 60 or 120 capsules per package.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

PlantaPhile Ltd., 18 Hyde Gardens, Eastbourne, East Sussex, BN21 4PT, UK.

8    MARKETING AUTHORISATION NUMBER(S)

THR 32294/0017

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/05/2012

10    DATE OF REVISION OF THE TEXT

23/05/2012