We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Boehringer Ingelheim Ltd Consumer Healthcare

Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, UK
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 399
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com
Customer Care direct line: +44 (0)1344 741 186
Medical Information Facsimile: +44 (0)1344 741 298


Summary of Product Characteristics last updated on medicines.ie: 13/08/2013
SPC Pharmaton Capsules



Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Pharmaton Capsules


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

(G115) Panax Ginseng extract

40.0 mg

[dry extract ethanolic 40%:1.3-3:1]

 

Vitamin A concentrate (oily form) synthetic (for Vitamin A)

2667.0 IU

Cholecalciferol concentrate (oily form) [Vitamin D3]

200.0 IU

all-rac--tocopheryl acetate [Vitamin E]

10.0 mg

L-Ascorbic acid [Vitamin C]

60.0 mg

Thiamine nitrate [Vitamin B1 mononitrate]

1.4 mg

Riboflavin [Vitamin B2]

1.6 mg

Nicotinamide

18.0 mg

Pyridoxine hydrochloride [Vitamin B6]

2.0 mg

Folic acid

100.0 micrograms

Cyanocobalamin [Vitamin B12]

1.0 micrograms

Biotin

150.0 micrograms

Calcium (as anhydrous dibasic calcium phosphate)

100.0 mg

Iron (as dried ferrous sulphate)

10.0 mg

Magnesium (as dried magnesium sulphate)

10.0 mg

Zinc (as zinc sulphate monohydrate)

1.0 mg

Copper (as dried copper sulphate)

2.0 mg

Selenium (as dried sodium selenite)

50.0 micrograms

Lecithin (containing choline, inositol, linoleic acid, linolenic acid)

100.0 mg

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

For a full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Capsules, soft (short term: capsule)

Dark brown, opaque, oblong, soft gelatin capsules.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

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.


Go to top of the page
4.2 Posology and method of administration

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


Go to top of the page
4.3 Contraindications

Pharmaton Capsules are contraindicated in patients with disturbances of calcium metabolism (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, pregnancy and lactation (see section 4.6) 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.


Go to top of the page
4.4 Special warnings and precautions for use

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.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

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

Ginseng may potentiate the action of antihypertensives.

Interactions of iron with tetracycline antibiotics (tetracycline, doxycycline, minocycline) and vitamin B6 with levodopa are known. Vitamin B6 may increase the peripheral metabolism of levodopa thereby reducing the therapeutic efficacy in patients with Parkinson's disease. Patients on any of these medications should seek medical advice before starting this product.

In case of concomitant intake of ginseng preparations and anticoagulants, the effect of oral blood thinning medication (e.g. warfarin) may potentially be reduced. Patients on blood thinning medications should seek medical advice before starting this product.


Go to top of the page
4.6 Fertility, pregnancy and lactation

Pregnancy

Pharmaton Capsules are not recommended for use during pregnancy and lactation (see section 4.3). 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.

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.

Fertility

No studies on the effect on human fertility have been conducted with Pharmaton Capsules.


Go to top of the page
4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.


Go to top of the page
4.8 Undesirable effects

Adverse events have been ranked under headings of frequency using the following convention:

Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000); not known – cannot be estimated from the available data.

Immune system disorders:

Not known: hypersensitivity

Nervous system disorders:

Common: headache

Not known: dizziness

Gastro-intestinal disorders:

Common: nausea, vomiting

Uncommon: diarrhoea

Not known: abdominal pain

Skin and subcutaneous tissue disorders:

Not known: rash, pruritus

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via 'freepost', in addition to the traditional post-paid 'yellow card' option.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: http://www.imb.ie

e-mail: imbpharmacovigilance@imb.ie


Go to top of the page
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. (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).


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

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.


Go to top of the page
5.2 Pharmacokinetic properties

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.


Go to top of the page
5.3 Preclinical safety data

Not applicable.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

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)


Go to top of the page
6.2 Incompatibilities

Not applicable


Go to top of the page
6.3 Shelf life

Bottles: 36 months

Blisters: 18 months


Go to top of the page
6.4 Special precautions for storage

Do not store above 25°C.

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


Go to top of the page
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 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


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 7/66/1


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

04 January 1984

Date of last renewal:

17 January 2009


Go to top of the page
10. DATE OF REVISION OF THE TEXT

August 2013



Link to this document from your website:
http://www.medicines.ie/medicine/14338/SPC/Pharmaton+Capsules/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share