Ferroprotina 80 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ferroprotina 80 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could 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.

Leaflet contents

1. What Ferroprotina 80 mg granules for oral solution is and what it is used for.

2. What you need to know before taking Ferroprotina 80 mg granules for oral solution.

3. How to take Ferroprotina 80 mg granules for oral solution.

4. Possible adverse effects.

5. How to store Ferroprotina 80 mg granules for oral solution.

6. Contents of the container and other information

1. What Ferroprotina 80 mg granules for oral solution is and what it is used for

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

2. What you need to know before taking Ferroprotina 80 mg oral solution granules

Do not take Ferroprotina 80 mg granules:

• If you are allergic to ferrimanitol ovoalbumin 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.
• If you have hemosiderosis or hemochromatosis (iron overload diseases).
• If you have anemias not related to iron deficiency, such as aplastic, hemolytic, or sideroblastic anemia.
• If you have chronic inflammation of the pancreas or liver cirrhosis.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ferroprotina 80 mg:

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

Other medicines and Ferroprotina 80 mg granules

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

Ferroprotina 80 mg must not be administered at the same time as:

• Tetracyclines or penicillamine, as they may mutually reduce oral absorption.
• Calcium salts, quinolones (e.g. ciprofloxacin), and levodopa, because iron preparations may reduce the absorption of these medicines.
• Antacids, as they may reduce the absorption of iron preparations.

When taking any of these medicines, administer them at least 2 hours apart from Ferroprotina 80 mg.

Taking Ferroprotina 80 mg granules with food and drinks

Ferroprotina 80 mg 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

If you are pregnant or breastfeeding, your doctor will decide whether it is appropriate to use this medicine.

Pregnancy

Studies conducted with ferrimanitol ovoalbumin in pregnant women have not shown any problems for the fetus.

Breastfeeding

There are no data available regarding the excretion of ferrimanitol ovoalbumin in breast milk.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Ferroprotina 80 mg contains lactose, sucrose, and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

May cause dental caries.

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

3. How to take Ferroprotina 80 mg granules for oral solution

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 taken immediately.

If you think that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ferroprotina 80 mg granules

If you have missed a dose, take it as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Ferroprotina 80 mg granules

Your doctor will indicate how long you should continue treatment with Ferroprotina 80 mg. Do not discontinue treatment prematurely, even if you feel better, as there is a risk of relapse of the disease.

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 may cause adverse effects, although not everybody will experience them.

Occasionally, gastrointestinal discomfort (stomach pain, nausea, constipation or diarrhoea) has been reported, which usually resolves upon reducing the administered dose or, if necessary, after discontinuation of treatment. Black discolouration of stools may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 80 mg oral solution granules

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

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

No special storage conditions are required. Store Ferroprotina 80 mg in its original packaging.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging at the SIGRE Point in your usual pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ferroprotina 80 mg granules for oral solution

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

Nature of the product and pack contents

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 latest review of this leaflet: June 2009

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