This information is intended for use by health professionals

1. Name of the medicinal product

Urostemol capsules

2. Qualitative and quantitative composition

Each hard capsule contains:

400 mg of Pumpkin seed, crushed (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb), 340 mg of Pumpkin seed oil (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Capsule, hard.

Red-brown gelatin capsules, hard.

4. Clinical particulars
4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of lower urinary tract symptoms related to an overactive bladder or bladder weakness, such as urgency to urinate, urinary incontinence, frequent urination, based on traditional use only.

4.2 Posology and method of administration

For oral use only

Adults and the elderly

One capsule to be taken three to five times a day.

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

Method of administration

The capsules should be taken with water, ideally before meals.

Long term use is possible on the advice of a doctor or qualified healthcare practitioner (see section 4.4 'Special warnings and precautions for use').

4.3 Contraindications

Hypersensitivity to the active substances, to other members of the Cucurbitaceae family (such as water melon, courgettes etc.) or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen after 7 days of use, or persist after 4 weeks of use, the patient should consult a doctor or a qualified healthcare practitioner.

If symptoms such as fever, spasms, blood in the urine, urinary retention, painful urination, loin pain, abdominal or back pain or vaginal discharge are present or develop during the use of this medicinal product, the patient should consult a doctor or a qualified healthcare practitioner, in order to exclude any underlying serious medical condition.

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

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

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.

No studies on the effects on fertility have 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

The following convention has been used for the classification of the adverse reactions

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)

Mild gastrointestinal complaints such as abdominal pain, dyspepsia, nausea, vomiting, stomach discomfort, dysphagia, oesophageal pain and diarrhoea have been reported. The frequency is common (4%).

There have been post marketing reports of allergic reactions such as rash, urticaria, erythema, pruritus, oedema and anaphylactic shock. The frequency is not known. If these occur, discontinue use.

If other adverse reactions not mentioned above occur, the patient should consult a doctor or pharmacist.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after registration 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of an overdose were 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

No mutagenicity was observed in Ames tests conducted with this product.

Studies on carcinogenicity and reproductive toxicity have not been performed.

6. Pharmaceutical particulars
6.1 List of excipients

Gelatin

Titanium dioxide (E 171)

Iron oxide red (E 172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions. Store in the original package.

6.5 Nature and contents of container

PVC-aluminium-blister.

Packs of 50, 100 or 160 hard capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorisation holder

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

THR 02855/0239

9. Date of first authorisation/renewal of the authorisation

24/04/2015

10. Date of revision of the text

29/05/2015