Summary of medicine characteristics - PROSTASAN SAW PALMETTO CAPSULES
Prostasan Saw palmetto Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains 320mg of extract (as soft extract) from Saw palmetto fruit (Serenoa repens (Bartram) Small fructus (Sabal serrulata (Michaux) Nichols fructus)) (9–12 :1).
Extraction solvent : Ethanol 96% V/V.
One capsule contains 6.93 – 8.47 mg sorbitol.
For a full list of excipients, see section 6.1
Soft capsule.
It is an oval-shaped, dark brown coloured capsule containing a clear, greenish-brown coloured oil.
4.1 Therapeutic indications
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 daily to be taken with food.
Children and adolescents less than 18 years old: This product is not indicated in patients less than 18 years.
Hepatic and renal impairment: The safety of Saw palmetto has not been studied in patients with hepatic and/or renal impairment.
Duration of use
Long term use is possible (see section 4.4. ‘Special warnings and precautions for use.’)
If symptoms worsen or if no improvement in symptoms is seen after 8 weeks of treatment, consult a doctor or qualified health care practitioner.
4.3 Contraindications
This product should not be used:
In patients who have a known hypersensitivity to Saw palmetto or any of the other ingredients used in this product.
By patients who are under 18 years of age.
By women who are pregnant or breastfeeding.
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 or if haematuria or pyrexia occur, medical advice must be sought immediately.
If no improvement in symptoms is seen after 8 weeks of treatment, consult a doctor or qualified health care practitioner.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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 Prostasan Capsules.
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:
Gastrointestinal disorders
Eructation and gastrointestinal discomfort
Skin disorders
Allergic reactions such as rash, pruritis
The frequency is not known.
If other adverse effects not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
4.9 OverdoseThere are no data on human overdose with Saw palmetto. Appropriate symptomatic and supportive treatment should be administered as clinically indicated.
5.1 Pharmacodynamic properties
The active constituents of Saw palmetto have not been established definitively, however the fatty acid and phytosterol (such as P-sitosteroi) components are considered to play a role in its activity.
5.2 Pharmacokinetic properties
No definitive pharmacokinetic data are available.
5.3 Preclinical safety data
5.3 Preclinical safety dataData on reproductive toxicity are limited. Carcinogenicity studies have not been performed. An Ames test conducted with the extract to investigate genotoxic potential was negative.
□ -sitosterol (5mg/kg) given subcutaneously for 32 or 48 days had an antifertility effect on male rats by reducing sperm motility, viability and sperm concentration. The relevance of these findings to humans is not known, but it is considered that the low levels of □-sitosterol in this product are unlikely to have an effect on human fertility.
6.1
Gelatin
Glycerol
Sorbitol
Ferric oxide red
Ferric oxide black
Ferric oxide yellow
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened 60 months.
Use within 5 months of opening.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
Keep out of the sight and reach of children.
6.5 Nature and contents of container
Amber glass bottles (Type III glass) with aluminium pilfer proof closure with a polyethylene liner.
Pack sizes: 30 capsules
60 capsules
90 capsules
Amber glass bottles (Type III glass) with coated aluminium foil sealing and aluminium pilfer proof closure with a polyethylene liner.
Pack sizes: 30 capsules
60 capsules
90 capsules
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.