Package Insert: Information for the User

Ferroprotina 40 mg Soluble Tablets

ferrimanitol or ovoalbumin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others, 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 not listed in this package insert (see section 4).

1. Contents of the package and additional information

Ferroprotina 40 mg soluble tablets belong to a group of medicines called oral iron trivalent preparations.

This medicine normalizes altered hematological parameters in iron-deficient states.

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

Do not take Ferroprotina40 mg soluble tablets

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ferroprotina 40 mg soluble tablets.

• If you have or have had gastric or duodenal ulcers, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.
• If you are taking or are about to start taking any anti-acid medication, tetracyclines, quinolones, calcium salts, or levodopa.

Other medications and Ferroprotina 40 mg soluble tablets

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

This medication should not be administered concurrently 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 medications.
• Anti-acids, as they may decrease the absorption of iron preparations.

The administration of any of these medications should be separated from Ferroprotina 40 mg soluble tablets by at least 2 hours.

Taking Ferroprotina 40 mg soluble tablets with food and beverages

This medication should not be administered concurrently with milk or dairy products.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Your doctor will decide whether to use this medication during pregnancy or breastfeeding.

Pregnancy

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

Lactation

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

Driving and operating machinery

No signs of impairment in driving vehicles and operating machinery have been described.

Ferroprotina 40 mg soluble tablets contain sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 or 2 tablets per day 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 must be ingested immediately.

If you estimate that the action of this medication is too strong or too weak, inform 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 Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Ferroprotina 40 mg soluble tablets

In case you have forgotten a dose, take another as soon as possible and continue with your regular schedule. Do not take a double dose to compensate for the missed doses. Gastrointestinal irritation symptoms with nausea and vomiting may be observed.

If you interrupt treatment with Ferroprotina 40 mg soluble tablets

Your doctor will indicate the duration of treatment with this medication. Do not suspend treatment before, even if you feel better, as there is a risk of relapse of the disease.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Occasionally, digestive discomfort (stomach pain, nausea, constipation, or diarrhea) have been described, which usually disappear when the administered dose is reduced or, in the case of suspension of treatment. Black deposits.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store Ferroprotina 40 mg soluble tablets in their original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Punto Sigre of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ferroprotina 40 mg soluble tablets composition

• The active ingredient is ferrimanitol ovoalbumin. Each tablet contains approximately 300 mg of ferrimanitol ovoalbumin (equivalent to 40 mg of Fe 3+ ).
• The other components (excipients) are: mannitol, sodium croscarmellose, polyvinyl pyrrolidone, sodium fumarate estearate, magnesium stearate, hydroxypropyl cellulose, coffee essence, glycine, sodium saccharin, and mannitol.

Product appearance and packaging content

Ferroprotina 40 mg soluble tablets are presented in the form of 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

Responsible manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: May 2011

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