Package leaflet: information for the user

TOT’HEMA, 5 mg, 0.133 mg, 0.07 mg/ml oral solution

Iron(II) gluconate, manganese gluconate, copper gluconate

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1. What TOT’HEMA is and what it is used for
2. What you need to know before you use TOT’HEMA
3. How to take TOT’HEMA
4. Possible side effects
5. How to store TOT’HEMA
6. Contents of the pack and other information

1. What TOT’HEMA is and what it is used for

The medicinal product contains iron gluconate, an effective agent for treatment and prevention of
anaemia due to iron deficiency. The medicine includes the recommended daily dose of copper
and manganese. Copper promotes iron absorption in the gastrointestinal tract and uptake in
erythroblasts. Manganese facilitates haemoglobin synthesis. The product is also suitable for
children after 1 month of age and for pregnant women.

Indications
Prevention and treatment of anaemia due to iron deficiency.

2. What you need to know before you use TOT’HEMA

Do not take TOT’HEMA:

- if you are allergic to the active substances or any of the other ingredients of this medicine
(listed in section 6);
- if you have too much iron in your body;
- if you have thalassemia;
- if you have refractory anaemia;
- if you have bone marrow deficiency.
Warnings and precautions
Talk to your doctor or pharmacist before taking TOT’HEMA.

Caution should be exercised when treating children, as they are more susceptible to iron
poisoning.
One ampoule of TOT’HEMA oral solution contains 3 g of sucrose and 0.08 g of glucose. If you
have been told by your doctor that you have an intolerance to some sugars, talk to your doctor
before taking this medicine.

Other medicines and TOT’HEMA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Inadvisable combinations Parenteral administration of iron salts:

 Parenteral administration of iron salts in combination with orally administered iron can
cause lipothymia or even shock due to the rapid release of iron from its complex form
and transferrin saturation.

Combinations to take into account:

 Acetohydroxamic acid: may reduce absorption of both medicines in the gastrointestinal
tract as a result of iron chelation.

Combinations that require special caution:

 Tetracyclines (oral route): reduced gastrointestinal absorption of tetracyclines (formation
of complexes). Leave sufficient interval (e.g. 2 hours) between taking iron salts and
tetracyclines.
 Magnesium, aluminium and calcium salts, oxides and hydroxides (locally in the
gastrointestinal tract): reduced absorption of iron salts. Leave sufficient interval (e.g. 2
hours) between taking iron salts and local antacids.
 Bisphosphonates (oral route): reduced absorption of bisphosphonates. Leave sufficient
interval (e.g. 2 hours) between taking iron salts and bisphosphonates.
 Fluoroquinolones (norfloxacin, ofloxacin, ciprofloxacin and penicillamine): iron salts
reduce absorption of these medicines.
 Methyldopa: iron products may reduce the effectiveness of orally administered
methyldopa. Decreased effectiveness of methyldopa in lowering blood pressure.
 Thyroxine: iron products reduce thyroxine absorption in the intestinal tract. Leave
sufficient interval (e.g. 2 hours) between taking iron salts and thyroxine.
 Levodopa: iron products may reduce the effectiveness of orally administered levodopa.
Leave sufficient interval (e.g. 2 hours) between taking iron salts and thyroxine.
 Penicillamine: reduced absorption of penicillamine. Leave sufficient interval (e.g. 2
hours) between taking iron salts and penicillamine.
 Strontium: reduced absorption of strontium. Leave sufficient interval (e.g. 2 hours)
between taking iron salts and strontium.
 Entacapone: reduced absorption of entacapone due to the formation of chelates with iron.
Leave sufficient interval (e.g. 2 hours) between taking iron salts and entacapone.

TOT’HEMA with food and drink

Drinking large quantities of tea reduces iron absorption. Take iron preparations when you are not
drinking tea.
Open both ends of the ampoule with your fingers and add the contents to water (sweetened or
not) or non-alcoholic drink (but not milk).
Pregnancy, breast-feeding and fertility
Talk to your doctor or pharmacist before taking this medicine if you are pregnant or breast-
feeding, think you may be pregnant or are planning to have a baby.
TOT’HEMA is suitable for use during the second and third trimester of pregnancy.
Data collected on a large number of pregnancies indicate no adverse effect on pregnancy, the
foetus or the new-born child.

Driving and using machines

There are no known effects.

TOT’HEMA contains sucrose and ethanol.

If you have been told by your doctor that you have an intolerance to some sugars, consult your
doctor before taking this medicine.
Patients on a low-carbohydrate diet should remember that one dose contains 3 g of sucrose and
0.08 g of glucose.
This medicine contains small amount of ethanol (alcohol), less than 100 mg per dose (10 mL).

3. How to take TOT’HEMA

Always take TOT’HEMA exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

Standard dosage:

Treatment: adults 100-200 mg of iron (2-4 ampoules) per day before meals, children after 1
month of age 5-10 mg of iron per kg per day (1-2 mL/kg, the dose can be measured with a
syringe, for instance).
Prevention in case of pregnancy: 50 mg of iron (1 ampoule) per day in the last two trimesters of
pregnancy.

Instructions for use

Shake the ampoule before use.
Open both ends of the ampoule with your fingers and add the contents to water (sweetened
or not) or non-alcoholic drink (but not milk).

If you feel that the effect of TOT’HEMA is too strong or too weak, talk to your doctor or
pharmacist.

If you take more TOT’HEMA than you should

Overdose is possible in case of administration of very large quantities, mainly in children under 2
years of age. Symptoms of overdose include gastrointestinal problems: nausea, vomiting and state
of shock.
Sever iron poisoning can cause a sudden drop of blood pressure, restlessness, confusion and
finally coma, associated with liver damage.
Immediately contact a doctor if you suspect over-dosage.

If you forget to take TOT’HEMA

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, TOT’HEMA can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 patient in 1,000):

Gastrointestinal problems: nausea, vomiting, heartburn, diarrhoea or constipation. Black stools –
this is a normal phenomenon.
Discoloration of the teeth (unusual brown or black spots that disappear after discontinuation of
treatment). They can be reduced through proper cleaning of the teeth.

Allergic reactions have also been reported (prevalence unknown).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TOT’HEMA

Do not store above 25 °C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “Use by”. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What TOT’HEMA contains

The active substances are ferrous gluconate, manganese gluconate and copper gluconate. 1 ml of
the solution contains 5 mg of iron as ferrous gluconate, 0.133 mg of manganese as manganese
gluconate, and 0.07 mg of copper as copper gluconate.

Excipients include: glycerol, glucose solution, sucrose, anhydrous citric acid, sodium citrate,
sodium benzoate, polysorbate 80, caramel colour* (E 150c), fruit flavour*, purified water.
* Caramel colour: glucose, ammonium hydroxide
** Fruit flavour: isoamyl acetate, isoamyl butyrate, benzaldehyde, ethyl methylphenylglycidate,
gamma undecalactone, ethylvanillin, alcohol, water.

What TOT’HEMA looks like and contents of the pack

Oral solution in a 10-mL ampoule; 20 ampoules per pack.

Marketing Authorisation Holder

LABORATOIRE INNOTECH INTERNATIONAL
22 avenue Aristide Briand
94110 Arcueil
France
Manufacturer
INNOTERA CHOUZY
Rue René Chantereau-Chouzy-sur-cisse
41150 Valloire-sur-cisse
France

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:

OÜ Retlando
Aisa 8
80017 Pärnu
Phone: 5136092

This leaflet was last revised in February 2020.