SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Prostamen soft capsules

Healthspan Saw Palmetto ProstAid Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One soft capsule contains 160 mg of extract (as soft extract) from Saw palmetto fruit (Serenoa repens (Bartram) Small fructus (Sabal serrulata (Michaux) Nichols fructus)) (10-14:1).

Extraction solvent: Ethanol 90 % (m/m)

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Soft capsule.

Oval soft capsule, black-coloured

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men who have a confirmed diagnosis of benign prostatic hypertrophy (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

Adults and the elderly: one capsule twice daily (in the morning and evening).

Children and adolescents less than 18 years old: This product is not indicated in patients less than 18 years.

This product is not for use in women.

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

4.3 Contraindications

This product should not be used:

•    in cases of hypersensitivity to Saw palmetto fruits or any of the other ingredients

•    by patients who are under 18 years of age

4.4 Special warnings and precautions for use

Do not exceed stated dose.

This product is intended for use in men who have had benign prostatic hypertrophy already diagnosed by a medical practitioner. If symptoms worsen consult a healthcare practitioner.

If symptoms include haematuria or pyrexia medical advice must be sought immediately.

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

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 taking medication for Benign Prostatic Hypertrophy should consult their doctor before using the product.

4.5 Interaction with other medicinal products and other forms of interaction

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

4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation should be avoided.

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 effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

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

Based on post-marketing data other adverse events that have been reported are:

Rare (>1/10,000 to <1/1,000):

•    Eructation and gastrointestinal discomfort

•    Allergic reactions

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

None reported.

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, genotoxicity and carcinogenicity have not been performed.

There is some evidence from in vitro experiments to suggest that at very high doses, Saw Palmetto extracts may give rise to a reduction in sperm motility and viability. The relevance of these findings to humans is not known but it is considered that this product is unlikely to have an effect on human fertility.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Succinylated gelatine, glycerol, purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life ofproduct as packaged for sale 3 years.

6.4 Special precautions for storage

None.

6.5    Nature and contents of container

The capsules are packed in PVC/PVdC-aluminium blisters. Pack sizes: 50, 90 or 100 capsules.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Swiss Caps GmbH GrassingerstraBe 9 D-83043 Bad Aibling Germany

tel:    +49 (0) 80 61 / 9 31 01

fax:    +49 (0) 80 61 / 9 01 200

8    MARKETING AUTHORISATION NUMBER(S)

THR 18397/0008

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/03/2010

10    DATE OF REVISION OF THE TEXT

13/04/2011