FERROPROTINA 40 mg SOLUBLE TABLETS

Introduction

Package Leaflet: Information for the User

Ferroprotina 40 mg Soluble Tablets

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 symptoms 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 40 mg Soluble Tablets are and what they are used for
2. What you need to know before you take Ferroprotina 40 mg Soluble Tablets
3. How to take Ferroprotina 40 mg Soluble Tablets
4. Possible side effects
5. Storage of Ferroprotina 40 mg Soluble Tablets

1. Package Contents and Additional Information

1. What Ferroprotina 40 mg Soluble Tablets are and what they are used for

Ferroprotina 40 mg Soluble Tablets belong to a group of medicines called oral iron trivalent preparations.

This medicine normalizes altered hematological parameters in iron deficiency states.

It is used for the prophylaxis of iron deficiency anemia and iron deficiency states.

2. What you need to know before you take Ferroprotina 40 mg Soluble Tablets

Do not take Ferroprotina 40 mg Soluble Tablets

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

Warnings and Precautions

Consult your doctor or pharmacist before taking Ferroprotina 40 mg Soluble Tablets

• 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 medicine, tetracyclines, quinolones, calcium salts, or levodopa.

Other Medicines and Ferroprotina 40 mg Soluble Tablets

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

This medicine should not be administered together with:

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

Take any of these medicines at least 2 hours apart from the administration of Ferroprotina 40 mg Soluble Tablets.

Taking Ferroprotina 40 mg Soluble Tablets with Food and Drinks

This medicine should not be administered with milk or dairy products.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will decide whether you should take this medicine if you are pregnant or breastfeeding.

Pregnancy

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

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 or use machinery have been described.

Ferroprotina 40 mg Soluble Tablets contain Sodium

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

3. How to take Ferroprotina 40 mg Soluble Tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 or 2 tablets daily after the main meal. Dissolve the tablet in 100 ml or 200 ml of water and shake until a uniform solution is obtained. The solution should be taken immediately.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ferroprotina 40 mg Soluble Tablets than you should

If you have taken more Ferroprotina 40 mg than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Ferroprotina 40 mg Soluble Tablets

If you have missed 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 missed doses. Symptoms of gastrointestinal irritation with nausea and vomiting may be observed.

If you stop taking Ferroprotina 40 mg Soluble Tablets

Your doctor will indicate the duration of treatment with this medicine. 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 Medicines and Healthcare Products Agency (AEMPS) website: 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 Soluble Tablets

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required. Store Ferroprotina 40 mg Soluble Tablets in the original package.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the Sigre Point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ferroprotina 40 mg Soluble Tablets

• The active ingredient is ferrimanitol ovoalbúmina. Each tablet contains approximately 300 mg of ferrimanitol ovoalbúmina (equivalent to 40 mg of Fe3+).
• The other ingredients (excipients) are: mannitol, croscarmellose sodium, povidone, sodium stearyl fumarate, magnesium stearate, hydroxypropyl cellulose, coffee flavor, glycine, sodium saccharin, and mannitol.

Appearance and Package Contents

Ferroprotina 40 mg Soluble Tablets are presented as oblong, white tablets with brown spots. Each package contains 30 tablets.

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: May 2011

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