Ferrofolin

Package leaflet: Information for the patient

FERROFOLIN 40 mg/15 ml + 0.185 mg/15 ml oral solution

Iron + folic acid
Please read all of 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, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ferrofolin is and what it is used for

Ferrofolin is a medicine containing iron and folinic acid, used for the prevention and treatment of iron and folate (vitamin B group) deficiencies in the body.
Ferrofolin is used to treat certain types of anemia:

• anemias characterized by red blood cells containing low levels of haemoglobin (hypochromic anemias);
• anemias characterized by red blood cells with normal haemoglobin content (normochromic anemias);
• childhood anemias due to low levels of iron or folates (macrocytic and megaloblastic anemias due to iron or folate deficiency);
• anemias occurring during pregnancy, the postpartum period, and during breastfeeding.

2. What you need to know before taking Ferrofolin

Do not take Ferrofolin

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have too much iron in your body (haemochromatosis and haemosiderosis) or problems with how iron is used in your body (sideroachrestic anaemia);
• if you have anaemias that are not caused by iron and folate deficiency (aplastic or haemolytic anaemia);
• if you have anaemia due to vitamin B12 deficiency (megaloblastic anaemia secondary to vitamin B12 deficiency). In this case, you may take Ferrofolin only in combination with vitamin B12;
• if you have liver problems (hepatic cirrhosis) or pancreas problems (chronic pancreatitis), as these may be due to excess iron in the body.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferrofolin.

• Consult your doctor and exercise particular caution if you are lactose intolerant, as you may experience an adverse reaction when taking this medicine.
• It is not recommended to take this medicine for more than 6 months unless otherwise decided by your doctor.
• If you are due to have a faecal occult blood test, inform your doctor or nurse that you are taking Ferrofolin, as this medicine may alter the test results.

Children and adolescents
This medicine can be used in children and adolescents.
Other medicines and Ferrofolin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of Ferrofolin or may have their effect altered by Ferrofolin, in particular:

• Ferrofolin may reduce the effectiveness of certain medicines used in the treatment of tumours and leukaemias (aminopterin, methotrexate and other pterin derivatives);
• Ferrofolin may reduce the effectiveness of certain antibacterial medicines (such as sulfonamides, trimethoprim);
• Taking chloramphenicol (a medicine used to treat infections) may delay the effectiveness of iron therapy;
• Taking vitamin C (ascorbic acid) at the same time may increase iron absorption in your body;
• Taking antacids (medicines for stomach acidity) at the same time may decrease iron absorption in your body;
• Take Ferrofolin at least two hours apart from the following medicines, because the iron contained in this medicine may reduce their effectiveness:
• medicines used to treat infections: tetracyclines, quinolones, penicillamine;
• medicines used for bone diseases such as osteoporosis: bisphosphonates;
• medicines used for thyroid disorders: thyroxine;
• medicines used for Parkinson's disease: levodopa, carbidopa, alpha-methyldopa.

Ferrofolin with food, drinks and alcohol
If you consume vegetables, milk, coffee or tea, take Ferrofolin at least two hours apart from these foods, as they may reduce the amount of iron absorbed by your body.
Pregnancy and breastfeeding
This medicine may be used during pregnancy and while breastfeeding.
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine normally does not impair your ability to drive or operate machinery.
Ferrofolin contains sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Ferrofolin contains sodium methyl para-hydroxybenzoate and sodium propyl para-hydroxybenzoate
These may cause allergic reactions (including delayed reactions).

3. How to take Ferrofolin

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Ferrofolin must be taken by mouth.
The recommended dose is:
Adults
1 to 2 containers per day, according to the doctor's instructions, divided into two administrations,
preferably before meals.
Use in children
The recommended dose for children should be calculated based on your child's weight by
multiplying:
child's weight in kg × 1.5 ml
The calculated amount should be divided into two separate administrations, preferably before the two
main meals.
Your doctor may adjust the recommended dose.
Instructions for preparation:
To open the container, remove the overcap and press firmly on the reservoir cap so that the
powder falls into the solution. Shake until the powder dissolves completely.
Remove the reservoir cap and drink the solution directly from the container or mix it with still water.

Once the solution has been prepared, it is recommended to use it on the same day.
The duration of treatment with Ferrofolin will be determined by your doctor.
If you take more Ferrofolin than you should
In case of accidental ingestion/overdose of a large amount of Ferrofolin, inform your doctor immediately
or go to the nearest hospital.
If you have taken more of the medicine than prescribed, you may experience: pain in the central upper abdomen
between the ribs and the navel (epigastralgia), nausea, vomiting, diarrhoea, and vomiting blood. In addition to
these symptoms, drowsiness, pallor, bluish discoloration of the skin (cyanosis), and shock may occur; shock is a condition caused by inadequate blood supply to the body and can lead to coma.
If you forget to take Ferrofolin
Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rarely, and particularly after taking the highest doses, gastrointestinal disturbances may occur, such as diarrhoea, constipation, nausea, and pain in the central abdominal area between the ribs and the navel (epigastralgia).
These symptoms tend to disappear after stopping Ferrofolin or after reducing the dose.
Iron-containing preparations may turn stools black or dark grey; this is not a cause for concern.
Following the instructions contained in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Ferrofolin

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 stated on the packaging after “Exp.”.
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 Ferrofolin contains
Each single-dose container contains:

• in the solution:
• The active substance is Fe 40 mg (as ferriprotinate)
• The other components are sorbitol E420, propylene glycol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, blackcurrant flavour, sodium saccharin, purified water.
• in the reservoir cap:
• The active substance is folinic acid 0.185 mg (as calcium folinate pentahydrate)
• The other component is mannitol E421.

Description of the appearance of Ferrofolin and pack contents
Ferrofolin is supplied as 10 single-dose vials of 15 ml each. Each vial contains the solution and is sealed with a reservoir cap containing the powder.

Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)