Ferroprotina 40 mg soluble tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ferroprotina 40 mg effervescent tablets

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; do not pass it on to other people, even if they have the same symptoms as you, as 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 effervescent tablets are and what they are used for

2. What you need to know before taking Ferroprotina 40 mg effervescent tablets

3. How to take Ferroprotina 40 mg effervescent tablets

4. Possible side effects

5. How to store Ferroprotina 40 mg effervescent tablets

6. Contents of the pack and other information

1. What Ferroprotina 40 mg effervescent tablets is and what it is used for

Ferroprotina 40 mg effervescent tablets belongs to a group of medicines called oral trivalent iron 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 taking Ferroprotina 40 mg soluble tablets

Do not take Ferroprotina 40 mg soluble tablets

• If you are allergic to ferrimanitol ovoalbumin or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to egg proteins.
• If you have hemosiderosis or hemochromatosis (iron overload disorders).
• If you have anemias unrelated to iron deficiency, such as aplastic, hemolytic, or sideroblastic anemia.
• If you have chronic inflammation of the pancreas or 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 ulcer, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.
• If you are taking or are about to start taking any antacids, tetracyclines, quinolones, calcium salts, or levodopa.

Other medicines and Ferroprotina 40 mg soluble tablets

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

This medicine must not be administered concomitantly with:

• 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.

Administration of any of these medicines should be separated by at least 2 hours from the administration of Ferroprotina 40 mg soluble tablets.

Taking Ferroprotina 40 mg soluble tablets with food and drink

This medicine 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.

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 40 mg soluble tablets contain sodium

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

3. How to take Ferroprotina 40 mg effervescent tablets

Follow exactly the instructions for use of this medicine provided 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 that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ferroprotina 40 mg effervescent 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 at telephone number 91 562 04 20.

If you forget to take Ferroprotina 40 mg effervescent tablets

If you have missed a dose, take it as soon as possible and continue with your usual schedule. Do not take a double dose to make up for missed doses. Symptoms of gastrointestinal irritation such as nausea and vomiting may occur.

If you stop taking Ferroprotina 40 mg effervescent tablets

Your doctor will advise you on the duration of treatment with this medicine. 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 everyone 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 discontinuing 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 Medicinal Products: 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 effervescent tablets

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

Do not use this medicine after the expiry date 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 40 mg effervescent tablets in their original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Punto Sigre collection point at your usual pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ferroprotina 40 mg effervescent tablets

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

Appearance of the medicine and contents of the pack

Ferroprotina 40 mg effervescent tablets are presented as white, oblong tablets with brown specks. Each pack 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 the most recent revision of this leaflet: May 2011

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