Ferroprotina 40 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

FERROPROTINA 40 mg granules for oral solution

Ferrimanitol ovoalbumin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ferroprotina 40 mg granules for oral solution is and what it is used for
2. What you need to know before taking Ferroprotina 40 mg granules for oral solution
3. How to take Ferroprotina 40 mg granules for oral solution
4. Possible side effects
5. How to store Ferroprotina 40 mg granules for oral solution
6. Contents of the pack and other information

1. What Ferroprotina 40 mg oral solution granules is and what it is used for

Ferroprotina belongs to the group of antianaemics.

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

2. What you need to know before taking Ferroprotina 40 mg oral solution granules

Do not take Ferroprotina 40 mg granules:

• if you are allergic to ferrimanitol ovoalbumin or to any of the other components of this medicine (listed in section 6).
• if you are allergic to egg proteins.
• if you have hemolytic anemia or iron overload disorders (hemochromatosis and hemosiderosis).
• if you have anemias not related to iron deficiency, such as aplastic anemia, hemolytic anemia, or sideroblastic anemia.
• if you have cirrhosis or chronic inflammation of the pancreas.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ferroprotina 40 mg granules for oral solution.

Take special care with Ferroprotina:

• If you have or have had gastric or duodenal ulcer, inflammatory bowel diseases, ulcerative colitis, or hepatic insufficiency.
• If you are taking or are about to start taking any antacids, tetracyclines, quinolones, calcium salts, or levodopa.

Taking Ferroprotina 40 mg granules for oral solution with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to take any other medicines, including those obtained without a prescription.

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

The administration of these medicines together should be spaced by at least two hours.

You should never take another medicine on your own initiative without your doctor's recommendation, since certain combinations should be avoided when taking Ferroprotina.

Taking Ferroprotina with food and drinks

Ferroprotina must not be administered together with milk or dairy products.

Pregnancy and breastfeeding

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

Pregnancy

Studies conducted with ferrimanitol ovoalbumin in pregnant women have not detected fetal problems. However, if you are pregnant or think you might be, consult your doctor before taking this medicine.

Breastfeeding

There are no data available on the passage of this medicine into breast milk and its possible effects on the infant.

Driving and using machines

No symptoms affecting the ability to drive or operate machinery have been reported.

Ferroprotina 40 mg granules for oral solution contains lactose and sucrose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ferroprotina 40 mg granules for oral solution

Follow exactly the administration instructions for Ferroprotina provided by your doctor. If in doubt, consult your doctor or pharmacist again.

To properly administer Ferroprotina, pour the contents of the sachet into half a glass of water and shake until a uniform solution is obtained. The contents of the glass should be ingested immediately. This medicine must not be taken simultaneously with milk or dairy products.

For oral use only.

Adults: 1 sachet (300 mg Ferrimanitol ovoalbumin) daily, after the 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 gastrointestinal intolerance such as nausea and vomiting occur, consult your doctor or the Toxicology Information Service, telephone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Ferroprotina

If you forget to take a dose, take the next dose as soon as you remember, unless it is almost time for the next scheduled dose. In this case, skip the missed 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 advise you on the duration of your treatment with Ferroprotina. Do not stop treatment prematurely, even if you feel better.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1,000 people):

The most common adverse effects when taking this medicine are gastrointestinal disturbances, such as irritation (stomach pain), loss of appetite, nausea, vomiting, constipation, or diarrhea.

You are very likely to experience black-stained stools due to the coloring of iron excreted in feces, a circumstance that is initially of no clinical significance.

If severe symptoms of gastrointestinal intolerance occur, treatment should be discontinued and medical advice sought.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Increase in liver enzymes.

Reporting of adverse effects

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

5. Storage of Ferroprotina 40 mg oral solution granules

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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components are sucrose, lactose, sodium chloride, banana flavor, and ethyl vanillin.

Appearance of the medicinal product and contents of the pack

Ferroprotina is presented as granules for oral solution in unit-dose sachets.

Each pack contains 30 unit-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

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent review of this leaflet: November 2010

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/