India Product

Nutro tablets

Nutro tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Nutro tablets contain vitamins, minerals, amino acids, taurine and Ginseng Extract in amounts which suit the body's daily requirements.

The tablets 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.


When you should consult your doctor?

You should consult your doctor if you experience any of the following:

You should consult your doctor if you experience any of the following:
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

Psychiatric disorders
Not known: insomnia


WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Patients with a family history of haemochromatosis should seek medical advice before taking Nutro tablets.
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 tablet contains a small amount of lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Influence on velocity reactions while driving motor transport and operating other mechanisms:

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

What to do if you accidentally take too much (overdose) of the medicine?

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 tablets contains the EU %RDA for vitamins A and D).
Prolonged supply of larger amounts corresponding to 37 tablets for vitamin A and 10 tablets 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 tablets) and about 300,000 to 900,000 IU for vitamin A (contained in 112 to 337 tablets).
The chronic toxic dose in adult humans corresponds to about 2,000 IU for vitamin D (contained in 10 tablets) and about 100,000 IU (contained in 37 tablets) 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 tablets 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).

Is it safe in pregnancy and breast-feeding?

Pregnancy and lactation

Reproduction studies with animals using the Panax ginseng extract Nutro tablets 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 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.

Nutro tablets should not be taken during pregnancy or lactation.

Fertility
No studies on the effect on human fertility have been conducted with Nutro tablets.

Reproduction studies with animals using the Panax ginseng extract Nutro tablets showed no adverse effects on fertility.

Storage Conditions:

Do not store above 25°C. Keep the container tightly closed.

Drug Description

Drug description
Active substances:
Taurine …………………...... 500 mg
Ginseng extract powder …….. 42.5 mg
Vitamin A Palmitate………… 600 mcg
Vitamin D …………………… 5 mcg
Thiamine (Vit.B1)…………… 1 mg
Riboflavin (Vit.B2)…………... 1.4 mg
Niacin (Vit.B3)……………….. 12 mg
Pyridoxine (Vit.B6)…………… 1.5 mg
Cyanocobalamine (Vit.B12)… 500 mcg
Folic acid …………………… 0.15 mg
Biotin ………………………… 30 mcg
Copper ………………………….. 0.5 mg
Iron ………………………………7.5 mg
Magnesium …………………… 7.43 mg
Manganese ………………………1.4 mg
Iodine …………………………….0.1mg
Selenium ……………………… 10 mcg
Zinc ……………………………. 5 mg
Chromium ……………………… 33 mcg

Soya protein hydrolysate 186.5 mg contains approximate amino acids
L- Leucine …………………… 13.45 mg
L- Arginine ………………….. 13.28 mg
L- Lysine …………………….. 11.07 mg
L- Phenylalanine …………….. 9.04 mg
L- Isoleucine ………………… 8.25 mg
L- Valine ……………………... 7.91 mg
L- Threonine ………………….. 6.38 mg
L- Histidine …………………… 4.35 mg
DL- Methionine ………………. 2.2 mg
L- Tryptophan ………………… 2.03 m

Excipients:

Indications and dosage.

Indications:
Nutro tablets contain vitamins, minerals, amino acids, taurine and Ginseng Extract in amounts which suit the body's daily requirements.

The tablets 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.
Dosage:
For situations of short term tiredness and exhaustion, Nutro tablets are recommended for 4 weeks. If symptoms have not shown any improvement after 4 weeks, consult a doctor. Nutro tablets may be taken for periods of up to 12 weeks. For longer term use consult a doctor.

Adults: The recommended daily dosage is one tablet per day .The tablet should preferably be taken in the morning with food.
Children:Not recommended for use in children.
Elderly:There are no special dosage recommendations for the elderly.

Side effects and drug interactions.

Side 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

Psychiatric disorders
Not known: insomnia

Drug 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.

Warnings and precautions

Patients with a family history of haemochromatosis should seek medical advice before taking Nutro tablets.

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 tablet contains a small amount of lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


Overdosage and Contraindications

Overdosage:
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 tablets contains the EU %RDA for vitamins A and D).
Prolonged supply of larger amounts corresponding to 37 tablets for vitamin A and 10 tablets 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 tablets) and about 300,000 to 900,000 IU for vitamin A (contained in 112 to 337 tablets).
The chronic toxic dose in adult humans corresponds to about 2,000 IU for vitamin D (contained in 10 tablets) and about 100,000 IU (contained in 37 tablets) 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 tablets 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).
            
 Contraindications
Nutro tablets 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 and in patients with known hypersensitivity to any of the ingredients in the product.

Nutro tablets contain Soya protein and should not be taken by patients known to be allergic to soya. Patients with soya allergy should also avoid Nutro tablets.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions for use”), the use of the product is contraindicated.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Nutro tablets exert a stimulant effect at physical and psychological levels through the combined action of various substances on the basic metabolic processes.
The ginseng extract 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.
Pharmacokinetic properties
Pharmacokinetic studies of  Nutro tablets 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 ginseng extract 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.

Pharmaceutical characteristics:

General physic-chemical properties:  Tablets.
Shelf-life:
2 years.

Storage:
Do not store above 25°C. Keep the container tightly closed.

Package:
The blister pack (PVC/aluminium) contains 60 tablets.

Conditions of supply.
Without prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575