Napiers Pro-Vitality Herbal Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Pro-Vitality Herbal Tablets Box's Herbals Strength Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains: -
45 mg of Cola seed (Cola nitida (Vent.) Schott et Endl.)
80.5 mg of extract (as dry extract) from Damiana leaf (Turnera diffusa Will.) (100:35)
Extraction solvent: Water
11.3 mg of extract (as soft extract) from Saw Palmetto fruit (Serenoa repens (Bartram)) (4:1) Extraction solvent: Water
Each tablet contains approximately 45.2 mg of sucrose and 45 mg of lactose. (See section 4.4 ‘Special warnings and precautions for use’.)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated, pale green biconvex tablet.
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: Two tablets three times a day.
The use in children and 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 to 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 is not recommended because data are insufficient and medical advice should be sought.
Not recommended before bedtime as it may cause sleep disturbances.
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.
If symptoms worsen or persist after one week, a doctor or qualified healthcare practitioner should be consulted.
This product contains lactose and sucrose. Patients with rare hereditary problems of 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
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.
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
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 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
No cases known.
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
Starch pregelatinised Magnesium Stearate Shellac E904 Light Kaolin Chlorophyll E140
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
Glass bottle with Bakelite type screw-cap closure, packed in a cardboard carton: 50, 100 tablets.
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 Limited 10 Payne Street Glasgow G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0015
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2013
20/01/2015