FERROPROTINA 80 MG ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Ferroprotina 80 mg Granules for Oral Solution

ferrimanitol ovoalbúmina

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 Ferroprotina 80 mg Granules for Oral Solution is and what it is used for.
2. What you need to know before you take Ferroprotina 80 mg Granules for Oral Solution.
3. How to take Ferroprotina 80 mg Granules for Oral Solution.
4. Possible side effects.
5. Storage of Ferroprotina 80 mg Granules for Oral Solution.

1. Contents of the Pack and Further Information

1. What Ferroprotina 80 mg Granules for Oral Solution is and what it is used for

Ferroprotina contains the active substance ferrimanitol ovoalbúmina and belongs to a group of medicines called oral iron preparations. It is used in adult patients for the treatment of iron deficiency anemia and iron deficiency conditions. This medicine normalizes the altered hematological parameters in iron deficiency conditions.

2. What you need to know before you take Ferroprotina 80 mg Granules for Oral Solution

Do not takeFerroprotina 80 mg Granulesif:

• You are allergic to ferrimanitol ovoalbúmina or any of the other ingredients of this medicine (listed in section 6). Do not take this medicine if you are allergic to egg or egg proteins.
• You have hemosiderosis and hemochromatosis (iron deposit diseases).
• You have anemia not related to iron deficiency, such as aplastic anemia, hemolytic anemia, and sideroblastic anemia.
• You have chronic pancreatitis or liver cirrhosis.

Warnings and Precautions

Consult your doctor or pharmacist before taking Ferroprotina 80 mg

Other Medicines and Ferroprotina 80 mg Granules

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Ferroprotina 80 mg should not be administered together with:

• Tetracyclines or penicillamine because they can decrease each other's oral absorption.
• Calcium salts, quinolones (ciprofloxacin, etc.), and levodopa, because iron preparations can decrease the absorption of these medicines.
• Anti-acids, because they can decrease the absorption of iron preparations.

The intake of any of these medicines should be spaced at least 2 hours from the administration of Ferroprotina 80 mg.

Taking Ferroprotina 80 mg Granules with Food and Drinks

Ferroprotina 80 mg should not be administered together with milk or dairy products.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

In case you are pregnant or breastfeeding, your doctor will decide whether to use this medicine.

Pregnancy

In studies conducted with ferrimanitol ovoalbúmina in pregnant women, no problems for the fetus have been detected.

Breastfeeding

No data are available on the excretion of ferrimanitol ovoalbúmina in breast milk.

Driving and Using Machines

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

Ferroprotina 80 mg contains Lactose, Sucrose, and Sodium

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

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

It may cause cavities.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially sodium-free.

3. How to Take Ferroprotina 80 mg Granules for Oral Solution

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

The recommended dose is 1 sachet daily after the main meal. Pour the contents of the sachet into 200 ml of water and shake until a uniform solution is obtained. The solution should be ingested immediately.

If you think the action of Ferroprotina 80 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Ferroprotina 80 mg Granules than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ferroprotina 80 mg Granules

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to make up for the forgotten doses.

If you stop taking Ferroprotina 80 mg Granules

Your doctor will indicate the duration of treatment with Ferroprotina 80 mg. Do not stop treatment before, even if you feel better, as there is a risk of relapse of the disease.

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.

Occasionally, gastrointestinal disorders (stomach pain, nausea, constipation, or diarrhea) have been described, which usually disappear when the administered dose is decreased or, if necessary, after treatment is suspended. Black pigmentation of stools.

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 side effects 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 80 mg Granules for Oral Solution

Keep this medicine out of the sight and reach of children.

Do not use Ferroprotina 80 mg after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required. Keep Ferroprotina 80 mg in its original package.

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

6. Contents of the Pack and Further Information

Composition of Ferroprotina 80 mg Granules for Oral Solution

• The active substance is ferrimanitol ovoalbúmina. Each sachet contains approximately 600 mg of ferrimanitol ovoalbúmina (equivalent to 80 mg of Fe3+).
• The other ingredients (excipients) are: banana flavor, ethyl vanillin, lactose, sodium chloride, and sucrose.

Appearance of the Product and Contents of the Pack

Ferroprotina 80 mg is presented as granules in sachets. Each pack contains 15 or 30 sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid)

Spain

Date of Last Revision of this Leaflet:June 2009

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