1. Name Of The Medicinal Product
Pharmaton Vitality Capsules
2. Qualitative And Quantitative Composition
Each capsule contains:
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3. Pharmaceutical Form
Soft gelatin capsules for oral use.
4. Clinical Particulars
4.1 Therapeutic Indications
Pharmaton Vitality Capsules contain vitamins, minerals and standardised Ginseng Extract G115 in amounts which suit the body's daily requirements.
The capsules are indicated for relief of temporary periods of:
States of exhaustion (e.g. caused by stress), tiredness, feeling of weakness, vitality deficiency.
Prevention and treatment of symptoms caused by ill-balanced or deficient nutrition.
4.2 Posology And Method Of Administration
For situations of short term tiredness and exhaustion, Pharmaton Vitality Capsules are recommended for 4 weeks. If symptoms have not shown any improvement after 4 weeks, consult a doctor. Pharmaton Vitality Capsules may be taken for periods of up to 12 weeks. For longer term use consult a doctor.
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4.3 Contraindications
Pharmaton Vitality Capsules are contraindicated in patients with disturbances of calcium (e.g. hypercalcaemia and hypercalciuria), hypervitaminosis A or D, renal insufficiency, concomitant retinoid (e.g. for acne) or vitamin D therapy, haemochromatosis, iron overload syndrome and in patients with known hypersensitivity to any of the ingredients in the product.
Pharmaton Vitality Capsules contain arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Pharmaton Vitality Capsules.
4.4 Special Warnings And Precautions For Use
Patients with a family history of haemochromatosis should seek medical advice before taking Pharmaton Vitality Capsules.
An allowance should be made for vitamins or minerals obtained from other sources.
In states of exhaustion (e.g. caused by stress), clinical trials have shown that improvement starts usually within 4 weeks of treatment. If symptoms have not shown any improvement during that time, or you are concerned, please consult your doctor.
The label will state “Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal”. This will appear on the labelling within a rectangle in which there is no other information.
Patients taking warfarin (or other coumarin anticoagulants) should have increased monitoring of their INR levels when starting or stopping treatment with ginseng containing products.
Each capsule contains a small amount of lactose (26 mg). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Panax ginseng may reduce the effect of warfarin (or other coumarin anticoagulants).
4.6 Pregnancy And Lactation
Reproduction studies with animals using the standardized Panax ginseng extract G115 Pharmaton showed no adverse effects on fertility, nor any teratogenic effects. However, controlled studies with pregnant women are not available.
Controlled studies with women using multivitamin-mineral preparations at the usual dosage during the course of the first trimester resulted in no fetal risks. There are no signs indicating a risk if this type of preparation is taken during the second and third trimesters, and the probability of injuring the fetus appears to be very low.
Large doses of vitamin A (10,000 IU per day) have been found to be teratogenic if administered during the first trimester of pregnancy. Vitamin D given during the last trimester of pregnancy may cause hypercalcaemia in infants. As with many other medicines an assessment of benefits versus risks should be made before this product is administered during this period.
Pharmaton Vitality Capsules should not be taken during pregnancy or lactation.
4.7 Effects On Ability To Drive And Use Machines
None known
4.8 Undesirable Effects
Cases of headache, dizziness, insomnia, gastrointestinal reactions (such as nausea, stomach pain, vomiting and diarrhoea) and hypersensitivity reactions (such as rash, pruritus) have been observed.
4.9 Overdose
Nervousness may occur following an overdose of the product.
The toxicity of the product in large overdoses is caused by the toxicity of the liposoluble vitamins A and D. A safe dose for both vitamins is considered to be 5-10 x RDA (each capsule contains the EU %RDA for vitamins A and D).
Prolonged supply of larger amounts (40-55 x RDA for Vitamin A; 10-25 x RDA for Vitamin D) can cause symptoms of chronic toxicity. Acute toxic symptoms are only seen at even higher doses.
Iron: Severe acute toxicity in man has been reported from doses of iron ranging from 12-1500 x RDA (each capsule contains the UK %RDA for iron). Most incidents of acute iron toxicity have resulted from accidental oral ingestion of iron pills by children. Longer-term doses of iron up to 6-7 x RDA have been reported to have no toxic effect.
Symptoms: Initial symptoms include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may also occur.
Treatment: To minimise or prevent further absorption of the medication, as follows:
Induce vomiting e.g. by administration of an emetic.
Gastric lavage with desferrioxamine solution (2g/l). Then desferrioxamine (5 - 10g in 50-100ml water) should be introduced into the stomach to be retained.
Severe poisoning: Shock and/or coma with high iron levels (serum iron>90µmol/l in children,>142µmol/l in adults); immediate supportive measures plus i.v. infusion of desferrioxamine should be instituted.
Less severe poisoning: i.m. desferrioxamine is recommended (1g 4-6 hourly in children; 50mg/kg up to a maximum dose of 4g in adults).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmaton Vitality Capsules exert a stimulant effect at physical and psychological levels through the combined action of various substances on the basic metabolic processes.
The standardised ginseng extract G115 raises the general level of cellular activity, which is expressed by a pronounced increase in the physical and mental capacity.
In animal experiments, it caused a reduction of lactic acid concentration in muscles during exercise. An increase in the dopamine and noradrenaline content and a reduction in the serotonin content in the brain stem could be observed.
Vitamins, minerals and trace elements correct and prevent impairment of the cell metabolism in situations with increased demands. Low supply of vitamins, minerals, and trace elements may cause disturbances, such as debility, tiredness, decrease in vitality, reduced force of resistance, and decelerated convalescence. The composition and dosages of the preparation were chosen according to the European RDA-requirements for food supplements.
Choline, inositol, linoleic acid and linolenic acid, in the form of lecithin, improve energy output and lipid metabolism.
5.2 Pharmacokinetic Properties
Pharmacokinetic studies of Pharmaton Vitality Capsules have not been carried out, because of the complex composition of the product and the small quantities of the active ingredients contained. Moreover, these substances are well known.
Pharmacokinetic studies of the standardised ginseng extract G115 are not possible, because it is a complex extract. In the ginseng root more than 200 substances have been identified to date. Pharmacokinetic studies of individual purified ginsenosides have been carried out in various animal species:
Using radioactively labelled (14C) Ginsenoside Rgl, originated from the standardized Panax ginseng extract G115 Pharmaton, a bioavailability of 30% was determined in mice.
With intraperitoneal application, depending on the tested animal species and the Ginsenoside type, a half-life of between 27 minutes and 14.5 hours was measured.
5.3 Preclinical Safety Data
Acute toxicity
The oral LD50 of the standardized Panax ginseng extract G115 Pharmaton is more than 5 g/kg of body weight in the mouse and the rat, and more than 2 g/kg in the mini-pig.
Reproduction toxicity
The effect of standardized Panax ginseng extract G115 Pharmaton on reproductive performance was studied in two generations of Sprague-Dawley rats. Animals of both sexes were fed either control diet or diet supplemented with the standardized Panax ginseng extract G115 Pharmaton at dose levels of 1.5, 5 or 15 mg/kg body weight/day. Parameters of reproduction and lactation in the treated groups were comparable to those of the controls for two generations of dams and pups. No treatment-related effects were seen in weekly body weights and food consumption, haematological and blood chemistry parameters, and ophthalmic, macroscopic and histopathological examinations.
Fetal toxicity
The standardized Panax ginseng extract G115 Pharmaton, administered to pregnant Wistar rats and pregnant New Zealand rabbits, caused no abnormality in the foetal development.
The rats were treated with 40 mg/kg/day from the 1st to the 15th day after mating.
The rabbits were treated with 20 mg/kg/day from the 7th to the 16th day after mating.
The fetuses were removed by caesarean section on the 21st day in the rats and on the 27th day in the rabbits.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Capsule:
Rapeseed oil, refined
Hard fat
Ethyl vanillin
Arachis oil (peanut oil)
Triglycerides, medium chain
Gelatin
Lactose monohydrate
Silica, colloidal anhydrous
Capsule shell:
Gelatin
Glycerol 85%
Iron oxide red (E172)
Iron oxide black (E172)
6.2 Incompatibilities
None stated.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Do not store above 25°C. Keep the container tightly closed.
6.5 Nature And Contents Of Container
Brown glass bottles (hydrolytical class III, Ph.Eur) with pilfer proof aluminium caps (with rubber inserts) containing either 30, 40, 60, 90 or 100 capsules. Or Aluminium foil/polyvinylchloride/polyvinylidenchloride blister packs of 4, 30, 40, 60, 90 and 100 capsules.
Current Marketed Packs
Brown glass bottles (hydrolytical class m, Ph.Eur) with pilfer proof aluminium caps (with rubber inserts) containing either 30, 60, or 100 capsules.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Boehringer Ingelheim Limited (Self Medication Division)
Trading as Pharmaton Natural Health Products
Ellesfield Avenue
Bracknell
Berkshire
RG12 8YS
8. Marketing Authorisation Number(S)
PL 00015/0250
9. Date Of First Authorisation/Renewal Of The Authorisation
03/12/2008
10. Date Of Revision Of The Text
October 2009
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