Tot'Hema oral solution in ampoules (iron, manganese, copper) – iron-deficiency anaemia

Tot'Hema is a medicine in the form of an oral solution in ampoules containing three active substances: iron(II) gluconate, manganese gluconate and copper gluconate. It belongs to the group of antianaemic preparations (iron in other combinations, ATC B03AE10). One 10 mL ampoule contains 50 mg of elemental iron, 1.33 mg of manganese and 0.70 mg of copper.

It is used to treat iron-deficiency anaemia in adults, children and infants, and to prevent and treat iron deficiency in pregnant women and certain groups of infants. The dose and duration of treatment are decided by the doctor.

What is Tot'Hema used for and how should it be taken correctly?

Key facts about the medicine

What is Tot'Hema used for?

• treatment of iron-deficiency anaemia in adults, children and infants
• prevention and treatment of iron deficiency in pregnant women, premature newborns, twins or infants whose mothers had iron deficiency, when dietary iron intake is insufficient

How is it used and dosed?

• Shake the ampoule before use, break it at both ends and pour the contents into a glass of water (sweetened or unsweetened) or another non-alcoholic drink.
• The medicine is usually taken before meals; the timing, and sometimes the dose, can be adjusted to individual tolerance.
• Treatment of anaemia usually lasts 3 to 6 months, until the anaemia is corrected and iron stores are replenished; haemoglobin is checked as decided by the doctor.

These values are the general dosing from the leaflet and are not an individual recommendation. The dose and duration of treatment are decided by the doctor.

Special patient groups

• Children: the medicine is intended for infants older than 1 month and children; the dose is calculated by body weight. Sodium benzoate in the medicine may increase jaundice in newborns up to 4 weeks of age.
• Kidney or liver impairment: according to the SmPC, dose adjustment is generally not necessary.
• People who have been told they cannot tolerate some sugars should talk to their doctor before taking the medicine.

Contraindications – when the medicine must not be used

• hypersensitivity to iron, manganese, copper or any of the excipients
• iron overload or disturbed iron metabolism (haemochromatosis, thalassaemia, refractory, aplastic or sideroblastic anaemia) and excessive parenteral iron intake (e.g. repeated transfusions)
• anaemia not caused by iron deficiency (e.g. haemolytic or megaloblastic anaemia, or anaemia of inflammation)
• Wilson's disease

Precautions and warnings

• The cause of iron deficiency must be identified and treated; if the deficiency is linked to an inflammatory disease, the medicine will not be effective.
• Risk of inhalation: incorrect use can lead to the solution entering the airways and causing damage (necrosis, inflammation and narrowing of the bronchi). Persistent cough, coughing up blood or shortness of breath, even weeks after such an event, require urgent medical assessment.
• The medicine must not be given intravenously.
• Glucose and sucrose may harm the teeth with prolonged use (at least 2 weeks).
• The lining of the stomach and intestine may become pigmented during iron therapy, which may interfere with surgery.
• Contains 108 mg alcohol per ampoule (less than 3 mL of beer) and sodium benzoate; it is essentially “sodium-free”.

Interactions with other medicines, food and drink

• Concomitant use with intravenous iron preparations is not recommended.
• Tell your doctor if you take acetohydroxamic acid.
• Colestyramine: take iron 1–2 hours before or 4 hours after colestyramine.
• Leave at least 2 hours between Tot'Hema and: tetracycline or fluoroquinolone antibiotics, bisphosphonates, penicillamine, thyroid hormones, preparations containing zinc, calcium or strontium, medicines for Parkinson's disease (entacapone, carbidopa, levodopa), HIV medicines (bictegravir, integrase inhibitors), trientine, methyldopa, and antacids and adsorbents (magnesium, aluminium and calcium salts).
• Whole grains, vegetables, tea, coffee, red wine, milk, dairy products and eggs reduce iron absorption – leave at least 2 hours.

Pregnancy and breastfeeding

The medicine can be used during pregnancy if needed; for the prevention of iron deficiency in pregnant women it is intended for the last two trimesters. Small amounts of iron pass into breast milk; if you are breastfeeding, talk to your doctor before use.

Driving and using machines

Tot'Hema has no or negligible influence on the ability to drive and use machines.

Possible side effects

• Common (up to 1 in 10 patients): constipation, diarrhoea, heartburn, nausea, vomiting, black stools, bloating and abdominal pain.
• Frequency not known: hypersensitivity and anaphylactic reaction, gastrointestinal irritation, gastritis, intestinal pseudomelanosis, tooth discoloration (brown or black stains that disappear when use stops), rash, itching, hives, angioedema and allergic dermatitis.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: cases of iron poisoning have been reported, especially in children. Symptoms include vomiting and diarrhoea, low blood pressure and shock, metabolic acidosis (rapid breathing, fast heartbeat, confusion, drowsiness), and signs of kidney and liver damage. Contact a doctor or emergency service immediately.
• Missed dose: continue treatment at the prescribed dose; do not take a double dose.
• Duration and stopping: follow your doctor’s instructions – treatment continues until the anaemia is corrected and iron stores are replenished.

Related information

• What reduces iron in the blood and what are the symptoms of iron deficiency?

Composition, packaging and manufacturer

• Active substances per ampoule (10 mL): iron 50.00 mg (as iron(II) gluconate, hydrate 399.73 mg), manganese 1.33 mg (as manganese gluconate 10.78 mg), copper 0.70 mg (as copper gluconate 5.00 mg).
• Excipients: glycerol, liquid glucose, sucrose, citric acid, sodium citrate, sodium benzoate (E211), polysorbate 80, caramel colour (E150c), tutti-frutti flavour (contains alcohol), purified water.
• Appearance: clear dark brown solution; a fine deposit may be present.
• Pack: box of 20 dark glass ampoules of 10 mL.
• Marketing authorisation holder: Representative office of Laboratoire Innotech International Belgrade, Milentija Popovića 5v, New Belgrade.
• Manufacturer: Innothera Chouzy, Chouzy-sur-Cisse, France.

Storage

• Store below 30 °C.
• Shelf life: 2 years.
• Keep out of the sight and reach of children; do not use after the expiry date on the pack.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

How do I take Tot'Hema?

Shake the ampoule, break it at both ends and pour the contents into a glass of water or another non-alcoholic drink. It is usually taken before meals and is not taken undiluted straight from the ampoule.

How long is Tot'Hema taken?

In iron-deficiency anaemia, treatment usually lasts 3 to 6 months, because iron stores must be replenished in addition to normalising haemoglobin. The duration is decided by the doctor based on follow-up tests.

Is it normal for stools to turn black while taking Tot'Hema?

Yes, black stools are a common and expected effect of iron preparations. If stools are black and tarry with weakness or abdominal pain, or you vomit blood, contact a doctor immediately.

Can Tot'Hema be taken during pregnancy?

Yes, the medicine can be used during pregnancy if needed. For the prevention and treatment of iron deficiency in pregnant women the leaflet states 1 ampoule per day during the last two trimesters, but the dose is always decided by the doctor.

Sources

• ALIMS – Patient leaflet, Tot'Hema® oral solution (April 2024, Serbian)
• ALIMS – Summary of Product Characteristics, Tot'Hema® oral solution (Serbian)
• ALIMS – New authorisations and renewals 16 March – 31 May 2024 (Serbian)
• ALIMS – National Register of Medicines 2021 (Serbian)

Sources checked on: 23 October 2026.