Napiers Pro-Vitality Max Strength Herbal Elixir
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Pro-Vitality Max Strength Herbal Elixir
Box's Herbals Damiana and Saw Palmetto Restorative Elixir
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral liquid contains: -
0.30 ml of extract (as liquid extract) from Corn Silk Herb (Zea mays L.) (1:1) Extraction Solvent: Ethanol 45% v/v
0.38 ml of extract (as liquid extract) from Damiana Leaf (Turnera diffusa Will.) (1:1)
Extraction Solvent: Ethanol 45 % v/v
1.53 ml of extract (as liquid extract) from Saw Palmento Fruit (Serenoa repens (Bartram)) (1:1)
Extraction Solvent: Ethanol: Ethanol 45% v/v
5 ml of oral liquid contains approximately 1.04 g of ethanol, 0.7 g of sucrose. (See section 4.4 ‘Special warnings and precautions for use’.)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Elixir.
A dark brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve fatigue, exhaustion and debility, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the Elderly: Take two 5 ml teaspoonfuls (10ml) three times a day. The use in children or adolescents under 18 years of age is not recommended (See Section 4.4. ‘Special warnings and precautions for use’.)
If symptoms worsen or persist after one week, a doctor or 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 to any of the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist after one week, a doctor or qualified healthcare practitioner should be consulted.
The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
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. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 26 % v/v of alcohol i.e. up to 2.1g per 10 ml dose, equivalent to 52 ml of beer and 22 ml of wine per dose.
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.
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.
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
The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.
Studies on the effect of this product 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
This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section 4.4 “Special warnings and precautions for use”.)
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 reaction occurs, a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (31 g in 150 ml; 52 g in 250 ml: 104 g in 500 ml: equivalent to 1.3,2.2 or 4.3 large glasses of wine) may result in intoxication and should be treated accordingly.
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
Syrup (sucrose)
Cinnamon oil Glycerol oil Orange oil Beetroot Powder Water
6.2 Incompatibilities
None
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25oC. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle with child-resistant polypropylene cap packed in a cardboard box: 150ml, 250ml and 500ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
HIGHLAND HERBS LTD
10 PAYNE STREET, GLASGOW G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2013
10 DATE OF REVISION OF THE TEXT
20/01/2015