SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ginsana

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

G115 Panax Ginseng Extract 100mg [dry extract ethanolic 40%: 1.3-3:1].

3    PHARMACEUTICAL FORM

Soft capsule.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

States of exhaustion (e.g. caused by stress), tiredness, feeling of weakness, vitality deficiency.

4.2 Posology and method of administration

Adults:    For situations of short term tiredness and exhaustion, Ginsana is recommended

for 2 to 3 weeks.

For longer term use, consult a doctor. Ginsana may be taken in periods of up to 12 weeks.

The recommended dose is one or, if required, two capsules per day taken during the morning, the first capsule preferably with breakfast and the second with lunch.

4.3 Contraindications

Ginsana Capsules are contraindicated in patients with known hypersensitivity to any of the ingredients in the product

Ginsana Capsules contain soya and should not be taken by patients known to be allergic to soya. As there is a possible relationship between allergy to soya and allergy to peanut, patients with peanut allergy should also avoid Ginsana Capsules.

In case of intolerance to lactose, an excipient of the product, the use of the product is contraindicated (see section “Special warnings and precautions for use.”

4.4 Special warnings and precautions for use

If symptoms persist patients are advised to seek medical advice.

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 (65 mg). Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency or glucose 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).

Ginsana may be taken with multivitamin and mineral supplements.

4.6 Fertility, Pregnancy and lactation

Reproduction studies with animals using G115 Panax Ginseng extract showed no adverse effects on fertility, nor any teratogenic effects, but in view of the limitations of these studies the findings must be interpreted with caution. As

controlled studies with pregnant women are not available, Ginsana is not recommended for use during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

In rare cases gastrointestinal reactions (such as nausea, stomach pain and diarrhoea) and insomnia have been reported as possibly drug related. In addition, allergic reactions have been reported rarely.

4.9 Overdose

Signs of nervousness may occur following an overdose of the product. General supportive measures should be taken if necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

GINSANA is a preparation containing the standardised Panax ginseng extract G115 from the roots of the plant Panax ginseng C.A. Meyer. The pharmacological actions of the standardised Panax ginseng extract G115 are considered to be attributed not only to the ginsenosides, but also to the glycans, polysaccharides, and probably to the polyacethylenes and other not yet identified substances contained in the root of the plant Panax ginseng C.A. Meyer.

The standardised Panax ginseng extract G115 raises the general level of cellular activity, which is expressed by a pronounced increase in the physical and mental capacity of the patient. No human data are available. Results of studies carried out in animals are discussed in section 5.3.

5.2 Pharmacokinetic properties

Since the standardised Panax ginseng extract G115 is a complex extract containing more than 200 different identified substances, it is very difficult to perform pharmacokinetic studies. No human data are available. Results of studies carried out in animals are discussed in section 5.3.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

In animal experiments, standardised Panax ginseng extract G115 has caused a reduction of lactic acid concentration in muscles during exercise. An increase of the dopamine and noradrenaline content and a reduction of the serotonin content in the brain stem has also been observed.

Pharmacokinetic studies of individual purified ginsenosides have been carried out in various animal species.

Using radioactively labelled (¹⁴C) Ginsenoside Rg1, originated from the standardised Panax ginseng extract G115, a bioavailability of 30% was determined in mice.

With intraperitoneal application, depending on the animal species tested and the type of Ginsenoside, half-lifes of 27 minutes (Ginsenoside Rg1) and 14.5 hours (Ginsenoside Rb1) were measured.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose Silicon dioxide Lecithin Soya lecithin

Mixture of yellow beeswax, hydrogenated soya-bean oil, and partially hydrogenated vegetable oil.

Rape oil

Ethylvanillin

Gelatin

Glycerol

Iron oxide black (E172)

Iron oxide red (E172)

Anidrisorb (a mixture of sorbitol, mannitol, and sorbitan).

6.2 Incompatibilities

None stated.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Blister(s) of Aluminium foil/PVC/PVDC, in cardboard container of 4, 10, 12, 20, 24, 30, 50, 60, 90, or 100 capsules, or

Blister(s) of Aluminium foil/P VC/P VDC, in pouch container of 4, 8, or 12

capsules,

or

Bottle (glass) with cap (aluminium) containing 30, 50, 60, 90, or 100 capsules.

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

Alston Garrard & Co Ltd,

Modbury House,

New Mills Business Park,

Modbury,

Devon PL21 0TO

IK

8    MARKETING AUTHORISATION NUMBER(S)

PL 20677/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17^th November 1999

10 DATE OF REVISION OF THE TEXT

28/01/2013