Generic drug of the Therapeutic class: Metabolism and nutrition
Active ingredients: Acid deanol tartrate , Ginseng , Vitamin A , Thiamine , Riboflavin (E101) , Pyridoxine , Cyanocobalamin adsorbed on gelatin :, Cyanocobalamin , Gelatin , Ascorbic acid , Nicotinamide , Ergocalcopherol , Alpha-tociferol (E307) , Copper sulfate,Alpha-tocopherol
Drug withdrawn from the market on 11/22/2004
what is pharmaton vitamin capsules used for?
Used in functional asthenia.
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.
pharmaton vitamin Contraindications
Linked to vitamin D and calcium:
Hypersensitivity to :
- vitamin D
- calcium lithiasis
Linked to iron : Iron
- Severe renal failure.
- Pregnancy: the harmlessness of deanol has not been established, as a precaution, do not administer during pregnancy
- Breast-feeding: not recommended for breast-feeding women (passage in the milk)
- Combinations not recommended : iron salts (injectable route)
How To Store pharmaton ?
- Do not store above 25°C. Keep the container tightly closed.
pharmaton Side Effects
- Possible occurrence of minor digestive disorders.
- Stool black.
pharmaton vitamin Interactions
- 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.
- Interactions of iron with tetracycline antibiotics (tetracycline, doxycline, minocycline) and vitamin B6 and levodopa are known. Patients on any of these medications should seek medical advice before starting this product.
Drive and use machines
- Not applicable.
- Not applicable.
- Not applicable.
Warnings and Precautions
- 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.
Interference with clinical laboratory tests
- Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay.
- The risk of interference is higher in children and patients with renal impairment and increases with higher doses.
- When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves’ disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin).
- Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected. The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
PREGNANCY & FERTILITY
Pregnancy and lactation
- Reproduction studies with animals using the standardized Panax ginseng extract G115 Pharmaton showed no 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.
- No studies on the effect on human fertility have been conducted with Pharmaton Vitality Capsules.
- Reproduction studies with animals using the standardized Panax ginseng extract G115 Pharmaton showed no adverse effects on fertility.
What happens if I overdose from pharmaton ?
- 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 corresponding to 37 capsules for vitamin A and 10 capsules for vitamin D can cause symptoms of chronic toxicity such as vomiting, headache, drowsiness, and diarrhoea. Acute toxic symptoms are only seen at even higher doses.
- The acute toxic dose in adult humans corresponds to about 25,000 to 50,000 IU for vitamin D (contained in 125 to 250 capsules) and about 300,000 to 900,000 IU for vitamin A (contained in 112 to 337 capsules).
- The chronic toxic dose in adult humans corresponds to about 2,000 IU for vitamin D (contained in 10 capsules) and about 100,000 IU (contained in 37 capsules) for vitamin A.
- Zinc: In general the total daily intake should not exceed 15 mg.
- 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).
What is Forms and Composition ?
6.1 List of excipients
Rapeseed oil, refined
Arachis oil (peanut oil)
Triglycerides, medium chain
Silica, colloidal anhydrous
- Glycerol 85%
- Iron oxide red (E172)
- Iron oxide black (E172)
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