Ferritin Oti
Italy
Table of Contents
Package leaflet: Information for the user
Ferritin Oti 40 mg/8 ml syrup, 62.5 mg/8 ml syrup, 62.5 mg/8 ml syrup
Ferric sodium gluconate complex
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Ferritin Oti is and what it is used for
- What you need to know before taking Ferritin Oti
- How to take Ferritin Oti
- Possible side effects
- How to store Ferritin Oti
- Contents of the pack and other information
1. What Ferritin Oti is and what it is used for
Ferritin Oti is an oral antianaemic medicinal product based on trivalent iron.
This medicine is used for the treatment of the following conditions:
Sideropenic disorders (caused by iron deficiency in the body);
Essential hypochromic anaemia (haemoglobin levels below normal);
Chlorosis (pallor of the skin due to haemoglobin levels below normal);
Anaemias secondary to haemorrhage (due to significant blood loss);
Iron deficiency anaemias (lack of iron in the body);
Oligoemic syndromes (reduced blood volume compared to normal) in infancy and puberty due to toxic-infectious and deficiency causes (protein and iron deficiency);
Anaemias during pregnancy;
Adjunctive treatment in convalescence and during growth.
2. What you should know before taking Ferritin Oti
Do not take Ferritin Oti
- if you are allergic to sodium ferric gluconate complex or to any of the other ingredients of this medicine (listed in section 6);
- if you have hemosiderosis or hemochromatosis (excessive accumulation of iron in the body);
- if you have hemolytic anemia (reduced number of red blood cells).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ferritin Oti.
No special precautions for use are required.
Other medicines and Ferritin Oti
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
When iron or its derivatives are administered concomitantly with tetracyclines (antibiotics), reduced absorption of tetracyclines in the body may occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ferritin Oti does not affect the ability to drive vehicles or operate machinery.
Ferritin Oti contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may be harmful to teeth.
Ferritin Oti contains p-hydroxybenzoates
This medicine contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate and ethyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Ferritin Oti syrup contains ethanol
This medicine contains 1.8 mg of alcohol (ethanol) per bottle or 8 ml dose. This amount is equivalent to 1 ml of wine or 1 ml of beer.
The small amount of alcohol in this medicine will not produce significant effects.
Ferritin Oti syrup contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per bottle or 8 ml dose, i.e. essentially ‘sodium-free’.
3. How to take Ferritin Oti
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
40 mg/8 ml syrup (single-dose bottle for children)
Use in children: one bottle twice daily, with meals.
62.5 mg/8 ml syrup (single-dose bottle for adults)
Adults - one bottle twice daily, with meals.
Use in children - half dose (half container twice daily, with meals).
Ferritin Oti is equipped with a child-resistant cap: to open the bottle, press down firmly on the cap and turn it simultaneously counterclockwise.
62.5 mg/8 ml syrup (240 ml bottle for adults)
Adults - one 8 ml measuring spoonful twice daily, with meals.
Use in children - half dose (4 ml twice daily, with meals).
If you take more Ferritin Oti than you should
In case of accidental ingestion/overdose of Ferritin Oti, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include transient gastrointestinal disturbances, which should be treated symptomatically, if needed.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Similarly to all iron-containing preparations, excessive oral doses may cause stomach and intestinal disturbances such as:
- vomiting,
- nausea,
- diarrhoea,
- stomach burning (pyrosis).
Prolonged administration may cause constipation.
During treatment with iron-containing preparations, a harmless darkening of the stools may occur, which has no pathological significance.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ferritin Oti
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Pack contents and other information
What Ferritin Oti contains
40 mg/8 ml syrup (single-dose vials for children)
- The active substance is sodium ferric gluconate complex. Each vial contains 113.6 mg of sodium ferric gluconate complex (equivalent to 40 mg of Fe+++).
- The other components are: sucrose, glycerine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethyl p- hydroxybenzoate, sodium dehydroacetate, Dutch cream flavour, purified water q.s.
62.5 mg/8 ml syrup (single-dose vials for adults)
- The active substance is sodium ferric gluconate complex. Each vial contains 177.5 mg of sodium ferric gluconate complex (equivalent to 62.5 mg of Fe+++).
- The other components are: sucrose, glycerine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethyl p- hydroxybenzoate, sodium dehydroacetate, Dutch cream flavour, purified water q.s.
62.5 mg/8 ml syrup (240 ml bottle)
- The active substance is sodium ferric gluconate complex. 100 ml contains 2218.7 mg of sodium ferric gluconate complex (equivalent to 781.2 mg of Fe+++).
- The other components are: sucrose, glycerine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethyl p- hydroxybenzoate, sodium dehydroacetate, Dutch cream flavour, purified water q.s.
Description of the appearance of Ferritin Oti and pack contents
40 mg/8 ml syrup (children): box of 10 single-dose vials.
62.5 mg/8 ml syrup (adults): box of 10 single-dose vials.
62.5 mg/8 ml syrup: 1 bottle of 240 ml.
Marketing Authorisation Holder and Manufacturer
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72 – 10121 Turin
Exclusive distributor for sale in Italy
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
ABC Farmaceutici S.p.A.
Canton Moretti, 29- 10015 San Bernardo d’Ivrea – Turin
Package leaflet: Information for the user
Ferritin Oti 62.5 mg hard capsules
Ferric sodium gluconate complex
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Ferritin Oti is and what it is used for
- What you need to know before taking Ferritin Oti
- How to take Ferritin Oti
- Possible side effects
- How to store Ferritin Oti
- Contents of the pack and other information
1. What Ferritin Oti is and what it is used for
Ferritin Oti is an oral antianemic medicinal product based on trivalent iron.
This medicine is used for the treatment of the following conditions:
Sideropenic disorders (caused by iron deficiency in the body);
Essential hypochromic anemia (hemoglobin levels below normal);
Chlorosis (pale skin color due to reduced hemoglobin levels);
Anemias secondary to hemorrhage (caused by significant blood loss);
Iron deficiency anemias (lack of iron in the body);
Oligoemic syndromes (reduced blood volume compared to normal) in childhood and puberty due to toxic-infectious and deficiency causes (protein and iron deficiency);
Anemias during pregnancy;
Adjunctive treatment in convalescence and growth.
2. What you need to know before taking Ferritin Oti
Do not take Ferritin Oti
- if you are allergic to sodium ferric gluconate complex or to any of the other ingredients of this medicine (listed in section 6);
- if you have hemosiderosis or hemochromatosis (excessive accumulation of iron in the body);
- if you suffer from hemolytic anemia (reduced number of red blood cells).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ferritin Oti.
No special precautions for use are required.
Other medicines and Ferritin Oti
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If iron or its derivatives are administered concomitantly with tetracyclines (antibiotics), reduced absorption of tetracyclines in the body may occur.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ferritin Oti does not affect the ability to drive or use machinery.
Ferritin Oti contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.
3. How to take Ferritin Oti
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Recommended doses are:
Adults - one capsule twice daily, with meals.
Use in children - half dose (one capsule once daily).
If you take more Ferritin Oti than you should
In case of accidental ingestion/overdose of Ferritin Oti, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include transient intestinal disturbances, which should be treated symptomatically, if necessary.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Similarly to all iron-containing preparations, excessive oral doses may cause stomach and intestinal disturbances such as:
- vomiting,
- nausea,
- diarrhoea,
- stomach burning (pyrosis).
Prolonged administration may cause constipation.
During treatment with iron-containing formulations, harmless dark discoloration of stools may occur, which has no pathological significance.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ferritin Oti
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Pack contents and other information
What Ferritin Oti contains
- The active substance is sodium ferric gluconate complex. Each capsule contains 177.5 mg of sodium ferric gluconate complex (equivalent to 62.5 mg of Fe+++).
- The other components are: talc, magnesium stearate, colloidal silicon dioxide, maize starch, levilite, titanium dioxide, gelatin.
Description of the appearance of Ferritin Oti and pack contents
Box of 20 hard capsules.
Marketing Authorization Holder and Manufacturer
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72 – 10121 Turin
Exclusive distributor for sale in Italy
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
ABC Farmaceutici S.p.A.
Canton Moretti, 29 - 10015 San Bernardo d'Ivrea – Turin