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1. Potters Strength
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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Potter’s Strength

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains: -

45 mg Cola seed (Cola nitida (Vent.)(Schott et Endl.)

80.5 mg of extract (as dry extract) from Damiana leaf (Turnera diffusa Will.) (100:35) (equivalent to 230 mg Damiana leaf)

Extraction solvent: Water

11.3 mg of extract (as soft extract) from Saw Palmetto fruit (Serenoa repens (Bartram) Small) (4:1) (equivalent to 45.2 mg Saw Palmetto berry) Extraction solvent: Water

Each tablet contains 45.2 mg sucrose and 45 mg lactose. (See section 4.4 Special warnings and precautions for use.)

See Section 6.1 for full list of excipients

3 PHARMACEUTICAL FORM

Tablet.

A brownish red round sugar coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to help relieve symptoms of fatigue and weakness , based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Take two tablets three times a day.

Not recommended for children and adolescents under 18 years of age. (See section 4.4 ‘Special warnings and precautions for use’.)

If the symptoms worsen or persist after using the product for one week, a doctor or a qualified healthcare practitioner should be consulted.

Hepatic and renal impairment:

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

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients.

Gastric and duodenal ulcers, cardiovascular disorders such as hypertension and arrhythmia, hyperthyroidism.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.

Not recommended before bedtime as it may cause sleep disturbances.

If the symptoms worsen or persist after using the product for one week, a doctor or a qualified healthcare practitioner should be consulted.

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.

This product contains sucrose and lactose.

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

4.5 Interaction with other medicinal products and other forms of interaction

Patients taking MAO-inhibitor drugs should use Cola seed preparations with caution.

Cola seed preparations like other caffeine containing preparations reduce action of sedative drugs and increase side effects caused by sympathomimetic drugs.

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 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.

Studies on the effects on fertility have not been performed.

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

There has been one case report of intra operative 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 occur, a doctor or a qualified health care practitioner 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

No case of overdose has been 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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

P-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 P-sitosterol in this product are unlikely to have an effect on human fertility.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Lactose

Sodium Starch Glycolate Talc

Pre-gelatinised Starch Magnesium Stearate Shellac Kaolin Light Titanium Dioxide (E171) Red Iron Oxide(E172) Carmine lake (E120) Maltodextrin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

10 DATE OF REVISION OF THE TEXT

28/09/2015