This information is intended for use by health professionals

1. Name of the medicinal product

Urostemol Prosta capsules

2. Qualitative and quantitative composition

Each hard capsule contains:

500 mg of Pumpkin seed soft extract (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb) (15-25 : 1), Extraction solvent: ethanol 92% (m/m).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Capsule, hard.

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 in men related to an overactive bladder, such as urgency to urinate and frequent urination, or who have a confirmed diagnosis of benign prostatic hyperplasia (BPH), based on traditional use only.

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

4.2 Posology and method of administration

For oral use only.

Adults and the elderly:

One capsule to be taken twice 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.

Duration of use

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 substance, to other members of the Cucurbitaceae family (such as watermelon, 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, or if symptoms such as fever, spasms, blood in urine, painful urination, urinary retention, loin pain, abdominal or back pain occur during the use of the medicinal product, the patient should consult a doctor or qualified healthcare practitioner.

Patients with confirmed benign prostatic hyperplasia (BPH)

This product is intended for men who have had benign prostatic hyperplasia (BPH) already diagnosed by a medical practitioner. Patients taking medication for benign prostatic hyperplasia (BPH) should consult their doctor before taking this product.

The use in children and adolescents under 18 years of age 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

Tests on reproductive toxicity, carcinogenicity and genotoxicity have not been performed.

6. Pharmaceutical particulars
6.1 List of excipients

Silica, hydrophobic colloidal

Gelatin

Iron oxide, black (E 172)

Iron oxide, red (E 172)

Iron oxide, yellow (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/PVdC-aluminium-blister.

Packs of 20, 40, 80 or 140 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 02855/0241

9. Date of first authorisation/renewal of the authorisation

24/04/2015

10. Date of revision of the text

29/05/2015