Last updated on September 29, 2023
Tot’hema ampules contain an iron supplement in liquid form with Copper and Manganese enhancing its action.
Tot’hema is indicated in iron deficiency anaemias, iron deficiency prophylaxis in pregnancy, newborns with an iron-deficient mother, and when adequate amounts of iron cannot be supplied by food intake.
Composition. Iron gluconate: quantity equivalent in iron to 50.00 mg. Manganese gluconate: quantity equivalent in Manganese to 1.33 mg. Copper gluconate: quantity equivalent in copper to 0.70 mg. Excipients (glycerol, glucose, sucrose, anhydrous citric acid, sodium citrate, sodium benzoate, polysorbate 80, caramel colouring TPS (E 150 b), tutti frutti aroma, demineralized water) q.s.f. one drinkable ampoule of 10 ml.
LIST OF EXCIPIENTS WHICH EFFECTS SHOULD BE WELL-KNOWN FOR A SAFE USE IN SOME PATIENTS: glucose, sucrose, glycerol, sodium citrate, sodium benzoate.a
HOW TO TAKE Tothema
Oral route, ampoules are drunk after dilution in sweetened water or not, or in any other soft drink. Take preferably the ampoule before meals but sometimes the time of the intake and the dosage must be adapted in accordance with digestive tolerance.
• Curative treatment: • in adults: 100 to 200 mg of metal iron per day that is to say 2 to 4 ampoules of TOT’HEMA • In infants over 1 month and children: 5 to 10 mg of metal iron per kg and per day.
• Preventive treatment: pregnant women: 50 mg of metal iron per day that is to say 1 ampoule of TOT’HEMA during the last two quarters of pregnancy (or from the 4th month).
• Duration of treatment: it must be sufficient to correct anaemia and to restore iron reserves which, in the adult are 600 mg in the woman and 1 200 mg in the man. Anaemia due to iron deficiency: 3 to 6 months depending on the depletion of reserves, but may be prolonged further if the cause of anaemia is not controlled. The control of efficacy is only useful after at least 3 months of treatment: it should consist of determining the correction of anaemia (Hb, MCV) and the restoration of iron stores (seric iron and transferrin saturation). Respect strictly the duration of treatment.
Storage. Do not store at a temperature higher than 25 ºC / 77 °F. Store in the original package in order to protect from moisture. Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Possible side effects and warnings
Normal coloration of stools in black – digestive symptoms : gastric burns, nausea, constipation, diarrhoea.
Drinking large quantities of tea inhibits iron absorption. Take into account the supply of 3 g of sucrose per ampoule in the daily food intake. Prevention of deficiency in infants is based upon diversified food intake. INFORM YOUR PHYSICIAN OR YOUR PHARMACIST SYSTEMATICALLY ABOUT ALL CURRENT TREATMENT.
ALWAYS KEEP OUT OF REACH OF CHILDREN.
Tothema Patient Package Insert – Download HERE
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