It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Chefaro Ireland Ltd

Chefaro Ireland Ltd

Summary of Product Characteristics last updated on medicines.ie: 11/4/2016

Urostemol Femina

1. NAME OF THE MEDICINAL PRODUCT

Urostemol femina capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains: 227.3 mg of pumpkin seed oil (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb); 56 mg of extract (as dry extract) of fragrant sumach bark (Rhus aromatica Aiton) (5-7 : 1), extraction solvent water; 18 mg of extract (as dry extract) of hop strobile (Humulus lupulus L.) (5.5-6.5 : 1), extraction solvent water.

Excipients with known effect:

Each capsule contains 47 mg of soya-bean oil, 24 mg of glucose syrup, 17.7 mg of soya-bean lecithin and 7 mg of glycerol.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Hard capsules.

Red-brown gelatin hard capsules.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of lower urinary tract symptoms in women related to an overactive bladder or bladder weakness, such as urgency to urinate, urinary incontinence or frequent urination. This is exclusively based on long-standing use.

Prior to treatment, other serious conditions should have been ruled out by a doctor.

4.2 Posology and method of administration

Posology

Adults and elderly patients

One capsule to be taken three times a day.

Paediatric population

The use in children and adolescents under 18 years of age is not recommended (see section 4.4).

Method of administration

For oral only.

The capsules should be taken with sufficient fluids, ideally before meals.

Due to a lack of data, the safety of this product for long term use has not been established.

If symptoms worsen during use or persist after 4 weeks of use a qualified healthcare professional e.g. a doctor or pharmacist should be consulted.

4.3 Contraindications

Hypersensitivity to the active substances, to other members of the Cucurbitaceae family (such as watermelon, courgettes etc.), soya, peanuts, or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

It is strongly advised that you see a doctor before taking this product as urinary symptoms may be due to a serious underlying condition which only your doctor can diagnose.

If symptoms worsen during use or persist after 4 weeks of use a qualified healthcare professional e.g. a doctor or pharmacist should be consulted.

If symptoms such as pyrexia, spasms, haematuria, urinary retention, painful urination, loin pain, abdominal or back pain or vaginal discharge are present or develop during use, medical advice must be sought.

The use in children and adolescents under 18 years of age or pregnant women (see section 4.6) is not recommended, because lower urinary tract symptoms in these populations require medical supervision.

Patients with rare glucose-galactose malabsorption should not take this medicine.

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

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

There are no known interactions.

4.6 Fertility, pregnancy and lactation

Pregnancy

The use in pregnant women is not recommended, because lower urinary tract symptoms in this population require medical supervision.

The safety during pregnancy has not been established. In the absence of sufficient data, the use during pregnancy is not recommended.

Breastfeeding

The safety during lactation has not been established. In the absence of sufficient data, the use during lactation is not recommended.

Fertility

No data are available.

4.7 Effects on ability to drive and use machines

Urostemol Femina may impair ability to drive and use machines. Affected patients should not drive or operate machinery.

4.8 Undesirable effects

The assessment of the frequency of undesirable effects is based on the following definitions: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Common: Mild gastrointestinal complaints (abdominal pain, dyspepsia, nausea, vomiting, stomach discomfort, dysphagia, oesophageal pain and diarrhoea).

Frequency not known: hypersensitivity reactions (rash, urticaria, erythema, pruritus, oedema and anaphylactic shock).

If other adverse reactions not mentioned above occur a qualified healthcare professional e.g. a doctor or pharmacist should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

No cases of an overdose were reported.

Supportive and symptomatic treatment should be provided as appropriate.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The active constituents of pumpkin seed have not been finally substantiated. Seeds from specifically cultivated medicinal pumpkin species C. pepo L. convar. citrullina I. Greb. var. styriaca I. Greb contain fatty oil with specific non-ubiquitous phytosterols (delta-7-sterols) which are suggested to contribute to its activity. Urodynamic and antiphlogistic effects were shown for medicinal pumpkin seeds and pumpkin seed oil.

This combination as well as the singular drugs pumpkin seed, hop strobile and fragrant sumach bark have been used to treat irritative bladder complaints for decades. From non-clinical studies anti-inflammatory, antimicrobial, diuretic, spasmolytic effects and soothing effects on overactive bladder and bladder weakness have been reported.

There are no specific pharmacodynamic studies for Urostemol femina.

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

No genotoxic potential was observed in the AMES test for this specific product formulation.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

All-rac-α-tocopheryl acetate

Soya-bean lecithin

Partially hydrogenated soya-bean oil

Yellow beeswax

Gelatin

Glycerol

Spray-dried liquid glucose

Maltodextrin

Titanium dioxide (E 171)

Iron oxide (E 172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

27 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

PVC/PE/PVdC-aluminium-blister.

Packs with 30, 60 or 120 hard capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Chefaro Ireland Limited

First Floor, Block A,

The Crescent Building,

Northwood Office Park

Dublin 9, Ireland

8. MARKETING AUTHORISATION NUMBER(S)

TR 1186/6/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first registration: 24 March 2016

10. DATE OF REVISION OF THE TEXT

03/2016

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.