SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

PhytoCon SABAL FORTE Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each soft capsule contains 320 mg of extract (as soft extract) from Saw palmetto fruit (Serenoa repens (Bartram) Small) (9-11:1).

Extraction solvent: ethanol 96 % (V/V).

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Soft capsule

Oval-shaped, ochre coloured soft capsule containing a yellow-brown, oily mass.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of urinary tract discomfort in men who have been told that they have an enlarged prostate (benign prostatic hypertrophy or BPH). This is 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

Adults and the elderly 1 capsule daily to be taken with food.

This medicine is not indicated for use in children and adolescents less than 18 years old (see Section 4.4. Special warnings and precautions for use).

There are no studies on the safety of Saw palmetto in patients with hepatic and/or renal impairment.

4.3 Contraindications

Patients with known hypersensitivity to Saw palmetto or any of the excipients of the product.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

PhytoCon SABAL FORTE Capsules are intended for use in men who have had benign prostatic hypertrophy already diagnosed by a doctor.

The patient should contact a doctor or qualified healthcare practitioner if symptoms worsen or persist.

A doctor should be consulted immediately if symptoms include haematuria or pyrexia.

Serum prostate specific antigen (PSA) levels are probably not affected by Saw palmetto.

An intra-operative haemorrhage associated with the intake of Saw palmetto has been reported. 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 this product.

This product is not recommended for use in children and adolescents less than 18 years old since there is no relevant use in this age group.

4.5 Interaction with other medicinal products and other forms of interaction

Limited interaction studies have identified no clinically important drug interactions. The cytochrome P450 linked enzyme system does not appear to be significantly affected by Saw palmetto.

4.6 Pregnancy and lactation

This product is for use in men only.

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:

•    Eructation and gastrointestinal discomfort

•    Allergic reactions The frequency is not known.

If adverse reactions occur, a doctor or pharmacist should be consulted.

4.9 Overdose

There are no data on human overdose with Saw palmetto. Appropriate symptomatic and supportive treatment should be administered as clinically indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

The extract was negative in a test (Ames test) for mutagenicity.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

List of excipients

Gelatin polysuccinate

Glycerol Glycerol 85%

Purified water Titanium dioxide (E 171) Ferric oxide (E 172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life is 3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

The soft capsules are packaged in PVC/Aluminium blister packs. Folding boxes with blisters containing 15, 20 or 30 soft capsules.

Package sizes: 15, 20, 30, 60, 90, or 100 soft capsules.

Not all pack sizes maybe marketed.

Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

PhytoCon GmbH & Co KG Koblenzer Str. 48-56 56626 Andernach Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 34863/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/03/2011

10    DATE OF REVISION OF THE TEXT

17/03/2011

11    DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF

RADIOPHARMACEUTICALS (IF APPLICABLE)