This information is intended for use by health professionals

1. Name of the medicinal product

Urostemol Men 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),

75 mg of extract (as dry extract) from Saw palmetto fruit (Serenoa repens (Bartram) Small fructus (Sabal serrulata (Michaux) Nichols fructus)) (7-13 : 1), Extraction solvent ethanol 90% (m/m).

Also contains lactose monohydrate (56.25 mg) (See Section 4.4. 'Special warning and precautions for use')

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 or bladder weakness, such as urgency to urinate, urinary incontinence, frequent urination day and night 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 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.

Hepatic and renal impairment: The safety of Saw Palmetto has not been studied in patients with hepatic and/or renal impairment.

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 watermelon, courgettes etc.), or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Saw palmetto is unlikely to have an effect on levels of serum prostate specific antigen (PSA).

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, 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.

There has been a case report of intra-operative haemorrhage associated with the use of Saw palmetto. The prolonged bleeding time may have been a result of platelet dysfunction caused by cyclooxygenase inhibition by Saw palmetto. As a precaution, Saw palmetto should be discontinued and the platelet function assessed prior to patients undergoing surgery.

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.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

Limited interaction studies with Saw palmetto have identified no clinically important drug interactions. Saw palmetto does not appear to significantly affect the cytochrome P450 linked enzyme system.

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.

Fertility: Non-clinical data on constituents of Saw palmetto indicate a potential effect of reduced sperm motility, viability and sperm concentration. The relevance of these findings to humans is not known (see Section 5.3).

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, diarrhoea and eructation 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. The frequency is not known. If these occur discontinue use.

There has been one case report of intraoperative haemorrhage associated with the use of Saw palmetto.

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 an Ames tests conducted with this product.

Studies on carcinogenicity and reproductive toxicity have not been performed.

6. Pharmaceutical particulars
6.1 List of excipients

Silica, colloidal anhydrous

Lactose monohydrate

Gelatin

Iron oxide black (E172)

Iron oxide yellow (E172)

Iron oxide red (E172)

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 30, 60, 120, 150 or 200 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 02855/0240

9. Date of first authorisation/renewal of the authorisation

24/04/2015

10. Date of revision of the text

29/05/2015