Boehringer Ingelheim Ltd Consumer Healthcare

Pharmaton Capsules

Each capsule contains:

Excipients: Each capsule contains arachis oil (1.32 mg) and lactose monohydrate.

For a full list of excipients, see section 6.1.

Capsules, soft (short term: capsule)

Dark brown, opaque, oblong, soft gelatin capsules.

In the management of fatigue and weakness associated with stress, convalescence, or the symptoms of ageing, impaired general health.

As a vitamin and mineral supplement for persons requiring dietary adjuncts, as in convalescence, etc. in the correction of specific vitamin deficiencies.

Adults: The recommended dose is one capsule daily.

The capsule should preferably be taken in the morning with food.

The usual course of treatment with Ginseng lasts 8 to 12 weeks.

Children: Not recommended

Pharmaton 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 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 Capsules.

In case of intolerance to lactose, an excipient of the product, the use of the product is contraindicated. (See section 4.4).

Patients with a family history of haemochromatosis should seek medical advice before taking Pharmaton Capsules.

Patients receiving any other medication or those under the care of a doctor should consult a physician before taking this product.

Excessive doses of vitamin A or D may lead to hypervitaminoses. An allowance should always be made for intake of these vitamins from other sources.

There is insufficient information on the safety of the product to recommend prolonged use.

If symptoms have not shown any improvement within 4 weeks, patients should consult a doctor.

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.

Ginseng may affect the activity of depressants or stimulants which act on the central nervous system.

Ginseng may potentiate the action of antihypertensives.

Pyridoxine may increase the peripheral metabolism of levodopa thereby reducing the therapeutic efficacy in patients with Parkinson's disease.

If you are taking warfarin (or other coumarin anticoagulants), consult a doctor before starting or stopping treatment with Pharmaton Capsules.

Pharmaton Capsules are not recommended for use during pregnancy and lactation.

There is no report of experience in human pregnancy.

Large doses of vitamin A 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.

WARNING: Do not take Vitamin A supplements if you are pregnant or likely to become pregnant except on the advice of a doctor or ante-natal clinic.

None stated.

Cases of headache, dizziness, gastrointestinal reactions (such as nausea, stomach pain, vomiting and diarrhoea) and hypersensitivity reactions (such as rash and pruritis) have been observed.

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. (Oberritter H., Vitaminspur 3, 40-44, 1988; Council for Responsible Nutrition, Safety of Vitamins and Minerals, Washington 1986).

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. Doses which cause acute toxic symptoms are still higher.

Iron: Severe acute toxicity in man has been reported from doses of iron ranging from 12-1500 x RDA (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 in some reports (Council for Responsible Nutrition, Safety of Vitamins and Minerals, Washington 1986).

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.

- Administration of an emetic

- Gastric lavage with desferrioxamine solution (2 g/l). Then desferrioxamine (5 g in 50-100 ml 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 (1 g 4-6 hourly in children; 50 mg/kg up to a maximum dose of 4 g in adults).

Pharmacotherapeutic group: Other combinations of nutrients, ATC code: V06D X

Pharmaton Capsules exert a stimulant effect at physical and psychic 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.

The vitamins and minerals play a role in all basic metabolic processes of the organism. As essential substances, the daily intake of appropriate quantities to supply the daily requirements is very important.

Choline, inositol, linoleic acid and linolenic acid, in the form of lecithin, improve energy output and lipid metabolism.

Pharmacokinetic studies on Pharmaton 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 100 substances have been identified to date. Pharmacokinetic studies of individual purified ginsenosides, carried out in various animal species, show that already in the stomach numerous metabolites are formed.

Not applicable.

Capsule

Rapeseed oil, refined

Hard fat

Ethyl vanillin

Arachis oil, refined (peanut oil)

Triglycerides, medium chain

Gelatin

Lactose monohydrate

Silica, colloidal anhydrous

Capsule shell

Gelatin

Glycerol 85 %

Iron oxide red (E172)

Iron oxide black (E172)

Not applicable

Bottles: 3 years

Blisters: 18 months

Do not store above 25^oC.

Bottle: Keep the bottle tightly closed to protect from moisture.

Brown glass bottles (hydrolytical class III, Ph.Eur.) with pilfer proof aluminium caps (with rubber inserts) containing either 4, 30, 60, 90 or 100 capsules.

Aluminium blister packs of 4, 30, 60, 90 and 100 capsules.

Not all pack sizes may be marketed

No special requirements.

United Pharmacist Co-Op Ltd.,

Belgard Road,

Tallaght

Dublin 24.

PA 337/5/1

Date of first authorisation: 04 January 1984

Date of last renewal: 17 January 2009

April 2009