TOT'HEMA oral solution in ampoule
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 have 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, oral solution in ampoule is and what it is used for?
2. What you need to know before you take TOT'HEMA, oral solution in ampoule?
3. How to take TOT'HEMA, oral solution in ampoule.
4. Possible side effects.
5. How to store TOT'HEMA, oral solution in ampoule.
6. Contents of the pack and other information.
1. WHAT TOT'HEMA, oral solution in ampoule IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic class: COMBINATION, ANTIANAEMIC, MINERAL SUPPLEMENT, TRACE ELEMENT - ATC code: B03AE10: ANTIANAEMIC PREPARATIONS, VARIOUS IRON COMBINATIONS. TOTHEMA belongs to a class of medicines called antianaemics (Iron supplement).
This medicine is an iron supplement. It is indicated for:
a curative treatment of iron deficiency anaemia in adults, children and infants
a preventive or curative treatment of iron deficiency in pregnant women, infants and children when the dietary intake of iron is inadequate.
2. WHAT YOU NEED TO KNOW BEFORE TAKING TOTHEMA, oral solution in ampoule.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Do not take TOT'HEMA, oral solution in ampoule:
If you are allergic (hypersensitive) to the active substances (ferrous gluconate, manganese gluconate and copper gluconate) or any of the other ingredients of this medicine (listed in section 6).
If you have an excess of iron, non-iron deficiency anaemia (such as thalassemia, refractory anaemia, anaemia due to medullary insufficiency and inflammatory anaemia).
Warnings and precautions
Talk to your doctor or pharmacist before taking TOTHEMA.
- The prevention of infantile deficiency is based on the early at introduction of a diversified diet.
- This medicine contains 3 g of sucrose per ampoule. This should be taken into account in the daily ration in the event of a low-sugar diet or diabetes. This medicine is not recommended in patients with fructose intolerance, glucose- galactose malabsorption syndrome or sucrase-isomaltose insufficiency (rare hereditary diseases).
- This medicine contains 0.08 g of glucose per ampoule. This should be taken into account in the daily ration in the event of a low-sugar diet or diabetes. This medicine is not recommended in patients with glucose-galactose malabsorption syndrome.
- The presence of glucose and sucrose in this medicinal product may be harmful to teeth when taken over an extended period (e.g. for 2 weeks or more).
- The medicine contains small amounts of ethanol (alcohol), less than 100 mg per ampoule.
Other medicines and TOT'HEMA, oral solution in ampoule.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You must wait for at least 2 hours between administration of TOTHEMA and one of the following medicines:
- Antibiotics such as cyclins or fluoroquinolones (medicines used to treat some infections).
- Diphosphonates (medicines used to treat bone diseases). Penicillamine (medicine used to treat rheumatoid arthritis and Wilson's disease).
- Medicines containing thyroxin (medicines used for thyroid treatment).
- Local gastrointestinal medicines such as salts, oxides and hydroxides of magnesium, aluminium and calcium.
TOT'HEMA, oral solution in ampoule with food and drink Excessive consumption of tea inhibits the absorption of iron. This is why you should avoid taking TOT'HEMA at the same time as tea.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Under normal conditions of use, this medicine can be taken during pregnancy.
If you are breast-feeding, talk to your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
TOT'HEMA, oral solution in ampoule contains glucose, sucrose and ethanol (see section: Warnings and precautions).
3. HOW TO TAKE TOT'HEMA, oral solution in ampoule
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is:
As a curative treatment of iron deficiency and iron deficiency anaemia:
For adults: 100 to 200 mg of elemental iron per day, i.e. 2 to 4 ampoules per day.
For infants from 1 month and children: 5 to 10 mg of elemental iron/kg/day.
As a preventive treatment for iron deficiency:
For pregnant women: 50 mg of elemental iron per day, i.e. 1 ampoule per day during the last 2 trimesters of pregnancy (or from 4th month).
Method and route of administration
This medicine is taken orally. Shake the ampoule before use. Take the ampoules diluted in water, sweetened or not, or any other non-alcoholic drink.
Frequency of administration
Take preferably before meals, but the time of administration and sometimes the dose can be adapted according to digestive tolerance.
Duration of treatment
It must be adequate to correct the anaemia and replenish iron stores, which, for adults, are 600 mg for women and 1200 mg for men.
Anemia due to iron deficiency: 3 to 6 months depending on the depletion of the stores, to be prolonged if the cause of anaemia is not controlled. Respect the duration of treatment.
If you take more TOT'HEMA, oral solution in ampoule than you should,
Inform your doctor or pharmacist.
The following symptoms may develop following massive ingestion of iron salts, particularly in children less than two years old: signs of irritation and gastro-intestinal necrosis associated with nausea, vomiting and a state of shock, in most cases.
Treatment should be provided as early as possible by pumping stomach using a 1% solution of sodium bicarbonate.
The use of a chelating agent is efficient, the most specific being deferoxamine, mainly when the serum iron concentration is higher than 5 μg/ml. State of shock, dehydration and acid- basic disturbances are treated following the standard practice.
If you forget to take TOTHEMA, oral solution in ampoule,
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, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects (affecting 1 to 10 patients in 1 000):
- Digestive disorders: heartburn, nausea, constipation, diarrhea.
- Usual, black-colored stools.
- Brown or black stains on the teeth, stains disappear once treatment is ended. They can also be decreased by toothbrushing.
Side effects with unknown frequency:
- Potential allergic reactions.
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 to the Competent Authority for pharmacovigilance in your country.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE TOT'HEMA, oral solution in ampoule
- 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 box. The expiry date refers to the last day of that month.
- Do not store above 30°C.
- 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, oral solution in ampoule contains
The active substances are:
Iron...........50.00 mg
Corresponding to ferrous gluconate......................399.73 mg
Manganese...........1.33 mg
Corresponding to manganese gluconate............10.78 mg
Copper............0.70 mg
Corresponding to copper gluconate..................5.00 mg
For a 10 ml ampoule.
The other ingredients are Glycerol, liquid glucose, sucrose, anhydrous citric acid, sodium citrate, sodium benzoate, polysorbate 80, caramel coloring E150c (glucose, ammonium hydroxide), tutti Frutti flavoring (isoamyl acetate, isoamyl butyrate, benzaldehyde, ethyl methylphenylglycidatate, gamma undeclaration, ethylvanillin, alcohol, water) and demineralized water.
What TOT'HEMA, oral solution in ampoule looks like and contents of the pack
This medicine is in the form of oral ampoule.
Each box contains 20 ampoules.
Marketing authorization holder
LABORATOIRE INNOTECH INTERNATIONAL
22 AVENUE ARISTIDE BRIAND 94110 ARCUEIL
FRANCE
Manufacturer
INNOTHERA CHOUZY
RUE RENE CHANTEREAU, CHOUZY-SUR-CISSE
41150 VALLOIRE-SUR CISSE
FRANCE
This leaflet was last revised in September 2019.