Tot'hema Composition, Use, Dose, Side Effect

Tot'hema is a blood tonic package as oral solutions in ampoules. It is one of the most effective blood tonic in Nigeria.

Tot'hema

Tothema is manufactured by innothera chouzy in France with marketing authorisation holder as laboratoire innotech international, France.

Tothema Used And Indication

Tot'hema belongs to a class of medicines called antianemics (Iron supplement).

This medicine is an iron supplement. It is prescribed as:

1. a curative treatment of iron deficiency anemia in adults, children and infants

2. a preventive or curative treatment of iron deficiency in pregnant women, infants and children when the dietary intake of iron is inadequate.

Composition Of Tot'hema

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 colorant E150c (glucose, ammonium hydroxide), tutti frutti flavoring (isoamyl acetate, isoamyl butyrate, benzaldehyde, ethyl methylphenylglycidate, gamma undecalactone, ethyl vanillin, alcohol, water) and demineralised water.

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Warnings And Precautions

Do not take Tot'hema:

1. 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).

2. If you have an excess of iron, non-iron deficiency anemia (such as thalassemia, refractory anemia. anemia due to medullary insufficiency and inflammatory anemia).

Take Special Care With Tot'hema

1. The prevention of infantile deficiency is based on the early introduction of a diversified diet.

2. 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-isomaltase insufficiency (rare hereditary diseases).

3. This medicine contains 0.08g 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.

4. 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).

5. The medicine contains small amounts of alcohol, less than 100 mg per ampoule.

Taking Other Medicines

You must wait for at least 2 hours between taking Tot'hema and one of the following medicines:

1. antibiotics in the family of cyclones or fluoroquinolones (medicines used to treat certain infections).

2. Diphosphonates (medicines used to treat bone diseases).

3. Penicillamine (medicine used to treat rheumatoid arthritis and Wilson's disease).

4. Thyroxine containing medicines (medicines used for thyroid treatment).

5. Topical gastrointestinal medicines such as salts, oxides and hydroxides of magnesium, aluminum and calcium.

Please tell your pharmacist or medical doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Excessive consumption of tea inhibits the absorption of iron. This is why you should avoid taking tot'hema at the same time as tea.

Tot'hema Effect On Pregnancy And Breast-feeding

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.

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Ask your doctor or pharmacist for advice before taking any medicine.

Dosage Of Tot'hema

The usual dose is:

• As a curative treatment of iron deficiency and iron deficiency anemia:

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: 50mg of element iron per day. i.e. 1 ampoule per day during the last 2 trimesters of pregnancy (or from the 4th month).

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

Method And Route Of Administration

This medicine is taken orally.

Take the ampoules diluted in water, sweetened or not, or any other non-alcoholic drink.

Hold the body of the ampoule with one hand. Bend the tip for the ampoule with the other hand.

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 anemia 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 anemia is not controlled.

Respect the duration of treatment.

Overdose Of Tot'hema

The following symptoms may develop following massive ingestion of iron salts, particularly in children less than two years old: signs of irritation and gastrointestinal necrosis, with, in most cases, nausea, vomiting and state of shock.

Treatment should be given as soon as possible through gastric lavage using a 1% solution of sodium bicarbonate.

Use of a chelating agent is efficient, the most specific being deferoxamine, mainly when the serum iron concentration is higher than 5 pg/ml. A state of shock, concentration is higher than 5 ug/ml. A state of shock. dehydration and acid-base balance disturbance are treated in the standard practice.

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Side Effects Of Tot'hema

Like all medicines, Tot'hema can cause side effects, although not everybody gets them:

- Uncommon side effects (affecting 1 to 10 patients in 1 000):

• Digestive disorders: gastric burning, nausea, vomiting, constipation, diarrhea.

• Stools normally black.

• Brown or black marks on the teeth, reversible on stopping treatment. They can also be attenuated by brushing the teeth.

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.

How To Store Tothema

Do not store above 25°C.