Napiers Damiana Plus Herbal Elixir
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
English Herbal Medicines Damiana & Cola Plus Mixture Napiers Damiana Plus Herbal Elixir
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral liquid contains:
0.65 ml of liquid extract from Damiana leaf (Turnera diffusa) (1:1).
Extraction solvent: ethanol 30% v/v
1.25 ml of liquid extract from Cola seeds (Cola nitida (Vent.) Schott et Endl.) (1:1). Extraction solvent: ethanol 30% v/v
0.25 ml of liquid extract from Lucerne herb* (Medicago sativa) (1:1).
Extraction solvent: ethanol 30% v/v
0.25 ml of liquid extract from Saw palmetto fruit (Serenoa repens (Bartram) (1:1). Extraction solvent: ethanol 30% v/v
0.150 ml of liquid extract from Uva ursi leaf (Arctostaphylos uva-ursi) (1:1). Extraction solvent: ethanol 30% v/v
*Certified organically produced herbal ingredient
Each 5 ml of oral liquid also contains approximately 900mg ethanol (alcohol) , 0.217 ml glucose, and 1g sucrose (see Section 4.4. "Special warnings and precautions for use").
For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral liquid.
Dark brown liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to help relieve symptoms of fatigue and weakness, particularly in older men, based on traditional use only.
4.2 Posology and method of administration
For oral use only
Adults (over 18) and the elderly
Take one 5ml teaspoon every three hours with water or fruit juice if desired. Maximum daily dose: 25 ml (5 doses).
If symptoms worsen or persist after using the product for one week, a doctor or a qualified healthcare care practitioner should be consulted.
Not recommended for children or adolescents below the age of 18 years. (See section
4.4 ‘Special warnings and precautions for use’.)
Hepatic and renal impairment:
The safety of Saw Palmetto has not been studied in patients with hepatic and /or renal impairment.
4.3 Contraindications
Patients with a known hypersensitivity to any of the active ingredients or any of the excipients.
Gastric and duodenal ulcers, cardiovascular disorders such as hypertension and arrhythmia, hyperthyroidism.
Kidney disorders
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.
Uva ursi leaf may cause a greenish-brown colouration of the urine.
This medicinal product contains 22.5% v/v ethanol; up to 900 mg ethanol per dose (equivalent to 22.5 ml of beer or 9.4 ml of wine).
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Contains glucose and sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Contains Lucerne (Alfalfa). Potentially harmful for individuals with a history of systematic lupus erythematosus.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
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.
Lucerne may affect hormone therapies (hormone replacement therapy, oral contraceptive pill) if taken in excessive quantities.
Lucerne may affect blood-sugar concentrations in patients with diabetes due to the manganese content.
Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. metronidazole).
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 of this product on the ability to drive or use machinery have been performed.
This product contains alcohol (see Section 2).
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
Nausea, vomiting, stomach ache have been reported with Uva ursi leaf. The frequency is not known.
If other adverse reactions occur, a doctor or a qualified health care practitioner should be consulted
4.9 Overdose
No case of overdose has been reported.
Overdose of this product may result in alcohol intoxication and should be treated accordingly. Amount of ethanol in a full bottle:
18 g in 100 ml equivalent to 0.75 large glasses of wine; 36 g in 200 ml equivalent to
1.5 large glasses of wine
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.
Available tests on genotoxicity of water and ethanolic extracts of Uva ursi leaf are inadequate. Reproductive toxicity has not been studied. Available carcinogenicity studies have been negative.
Arbutin, the principal component of Uva ursi leaf, displayed some maternal and fetal toxicity in rats after subcutaneous administration of 400 mg/kg/day. No effect on reproduction has been observed at doses of 100 mg/kg/day.
Toxicity tests with hydroquinone, a hydrolysis product of arbutin, have demonstrated some evidence of genotoxicity and carcinogenicity. Risks posed by the exposure of hydroquinone during the short-term treatment with Uva ursi leaf preparations are considered minimal.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose (Syrup)
Caramel E150 Clove Oil,
Ceylon Cinnamon Bark Oil
Compound Cardamom Tincture (water, cinnamon bark, caraway seed, cardamon pods, ethanol, glycerol, cochineal E120)
Glycerol
Liquorice Liquid Extract (liquorice root, sorbitol, ethanol, water)
Nutmeg Oil
Ethanol
Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Glass bottle with polypropylene screw-cap: 100ml and 200ml.
6.6 Special precautions for disposal
There are no special requirements.
7 MARKETING AUTHORISATION HOLDER
Rutland Biodynamics Ltd,
Town Park Farm,
Brooke, Rutland,
LE15 8DG.
8 MARKETING AUTHORISATION NUMBER(S)
THR 28255/0025
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/04/2013
10 DATE OF REVISION OF THE TEXT
29/04/2013