FERROPROTINA 40mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

FERROPROTINA 40 mg Granules for Oral Solution

Ferrimanitol Ovoalbumin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

Contents of the Package Leaflet

1. What is Ferroprotina 40 mg Granules for Oral Solution and what is it used for
2. What you need to know before you take Ferroprotina 40 mg Granules for Oral Solution
3. How to take Ferroprotina 40 mg Granules for Oral Solution
4. Possible side effects
5. Storage of Ferroprotina 40 mg Granules for Oral Solution
6. Contents of the pack and further information

1. What is Ferroprotina 40 mg Granules for Oral Solution and what is it used for

Ferroprotinabelongs to the group of antianemics.

It is used to normalize altered blood parameters in iron deficiency states.

2. What you need to know before you take Ferroprotina 40 mg Granules for Oral Solution

Do not take Ferroprotina 40 mg Granules:

• if you are allergic to ferrimanitol ovoalbumin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to egg proteins.
• if you have hemolytic anemia or iron overload diseases (Hemochromatosis and Hemosiderosis).
• if you have anemias not related to iron deficiency, such as aplastic, hemolytic, or sideroblastic anemia.
• if you have cirrhosis or chronic pancreatitis.

Warnings and precautions

Consult your doctor or pharmacist before taking Ferroprotina 40 mg Granules for Oral Solution.

Be especially careful with Ferroprotina:

• If you have or have had gastric or duodenal ulcers, inflammatory bowel disease, ulcerative colitis, or liver failure.
• If you are taking or are going to start taking any anti-acid medication, tetracyclines, quinolones, calcium salts, or levodopa.

Using Ferroprotina 40 mg Granules for Oral Solution with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought without a prescription.

Special attention should be paid to anti-acids (iron absorption may be reduced), tetracyclines, calcium salts, levodopa, and quinolones, as iron preparations may reduce the absorption of these medicines.

The administration of these medicines should be spaced at least 2 hours apart.

Never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided when taking Ferroprotina.

Taking Ferroprotina with food and drinks

Ferroprotina should not be administered with milk or dairy products.

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.

Pregnancy

Studies in pregnant women with ferrimanitol ovoalbumin have not shown any problems with the fetus. However, if you are pregnant or think you may be pregnant, consult your doctor before taking this medicine.

Breast-feeding

There is no information on the passage of the medicine into breast milk and its possible effect on the baby.

Driving and using machines

No signs of affecting the ability to drive vehicles and use machinery have been described.

Ferroprotina 40 mg Granules for Oral Solution contains lactose and sucrose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Ferroprotina 40 mg Granules for Oral Solution

Follow exactly the administration instructions of Ferroprotina indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For the correct administration of Ferroprotina, pour the contents of the sachet into a half glass of water and shake until a uniform solution is achieved. The contents of the glass should be ingested immediately. This medicine should not be administered simultaneously with milk or dairy products.

Oral use only.

Adults: 1sachet (300 mg of Ferrimanitol ovoalbumin) per day, afterthe main meal.

If you take more Ferroprotina than you should

Even at high doses, no intoxication or gastric irritation has been detected. If symptoms of digestive intolerance with nausea and vomiting appear, consult your doctor or the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Ferroprotina

In case you forget to take a dose, take the next dose as soon as you remember, unless it is close to the next dose, in which case omit the forgotten dose and continue taking the medicine as planned.

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

If you stop taking Ferroprotina

Your doctor will indicate the duration of your treatment with Ferroprotina. Do not stop treatment before, even if you feel better.

If you have any other questions about 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.

Rare side effects (may affect up to 1 in 1,000 people).

The most common side effects that may appear when taking this medicine are digestive disorders, such as irritation (stomach pain), loss of appetite, nausea, vomiting, constipation, or diarrhea.

It is very likely that you will present with black-colored stools due to the iron eliminated in the feces, which, in principle, is of no importance.

If significant symptoms of digestive intolerance appear, it is best to suspend treatment and consult your doctor.

Very rare side effects (may affect up to 1 in 10,000 people).

Increased liver enzymes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ferroprotina 40 mg Granules for Oral Solution

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use Ferroprotina after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ferroprotina 40 mg Granules for Oral Solution

• The active substance is Ferrimanitol ovoalbumin. Each sachet contains 300 mg of Ferrimanitol ovoalbumin (equivalent to 40 mg of ferric iron).
• The other ingredients are sucrose, lactose, sodium chloride, banana flavor, and ethyl vanillin.

Appearance of the product and pack contents

Ferroprotinais presented as granules for oral solution in sachets.

Each pack contains 30 single-dose sachets.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of last revision of this leaflet: November 2010

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):http://www.aemps.gob.es/