Urostemol Men capsules

UROSTEMOL Men capsules

Each 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) (7-13 : 1), extraction solvent ethanol 90% (m/m).

Excipient(s) with known effect: lactose 56.25 mg.

For the full list of excipients, see section 6.1.

Hard capsules.

Brown gelatin hard capsules.

A traditional herbal medicinal product 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 or frequent urination day and night. This is exclusively based on long-standing use.

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

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 use only.

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

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

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.

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

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 are present or develop during use, medical advice must be sought.

A few cases of suspected interactions between saw palmetto extract and warfarin have been reported. Increased INR-values have been described.

Due to the possible risk of saw palmetto extract enhancing the anticoagulant or antiplatelet effect, the combination of Urostemol Men with anticoagulant or antiplatelet medication should be used with caution.

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.

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

Paediatric population

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.

A few cases of suspected interactions with warfarin have been reported. Increased INR-values have been described.

UROSTEMOL Men is not indicated for use by women.

No fertility data available.

UROSTEMOL Men has no influence on the ability to drive and use machines.

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

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, diarrhoea and eructation).

Frequency not known: Hypersensitivity reactions (rash, urticaria, erythema, pruritus, oedema and anaphylactic shock). If these occur, discontinue use.

Nervous system disorders: Headache may occur.

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 16764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

No cases of an overdose were reported.

Supportive and symptomatic treatment should be provided as appropriate

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.

The active substances pumpkin seed powder, pumpkin seed oil and saw palmetto fruit extract are traditionally used in ailments of the bladder-prostate system. The use of this combination is documented for over 30 years.

Urodynamic and antiphlogistic effects were shown for medicinal pumpkin seeds and pumpkin seed oil.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

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

Anhydrous colloidal silica

Lactose monohydrate

Gelatin

Black iron oxide (E 172)

Yellow iron oxide (E 172)

Red iron oxide (E 172)

Not applicable.

3 years

This medicinal product does not require any special storage conditions.

PVC/PVdC-aluminium-blister.

Packs with 30, 60, 120, 150 or 200 hard capsules.

Not all pack sizes may be marketed.

No special requirements.

Chefaro Ireland DAC,

Treasury Building,

Lower Grand Canal Street,

Dublin 2, Ireland

TR 1186/7/1

Date of first registration: 24 March 2016

July 2017