Package Insert: Information for the User

FERROPROTINA 40 mg Oral Granule for Solution

Ferrimanitol 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 to you alone, and you should not give it to others who 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.

Ferroprotinabelongs to the group of antianemic agents.

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

Do not take Ferroprotina 40 mg granulated:

• if you are allergic to ferrimanitol, ovoalbumin, or any of the other components of this medication (listed in section 6).
• if you are allergic to egg proteins.
• if you have hemolytic anemia or iron overload diseases (Hemochromatosis and Hemosiderosis).
• if you have anemia unrelated to iron deficiency, such as aplastic, hemolytic, or sideroblastic anemia.
• if you have cirrhosis or chronic pancreatitis inflammation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ferroprotina 40 mg granulated for oral solution.

Be especially careful with Ferroprotina:

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

Use of Ferroprotina 40 mg granulated for oral solution with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication, including those purchased without a prescription.

Pay special attention to anti-acids (iron absorption may be reduced), tetracyclines, calcium salts, levodopa, and quinolones, as iron preparations may reduce the absorption of these medications.

The administration of these medications should be spaced at least two hours apart.

You should never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided when taking Ferroprotina.

Taking Ferroprotina with food and beverages

Ferroprotina should not be taken with milk or dairy products.

Pregnancyand lactation

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

Pregnancy

Studies conducted with ferrimanitol or ovoalbumin in pregnant women have not detected any problems with the fetus. However, if you are pregnant or think you may be, consult your doctor before taking this medication.

Lactation

No data are available on the passage of the medication to breast milk and its possible effect on the infant.

Driving and operating machinery

No signs of impairment of the ability to drive vehicles and operate machinery have been described.

Ferroprotina 40 mg granulated for oral solution contains lactose and saccharose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Ferroprotina as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

To properly administer Ferroprotina, open the packet in a medium-sized glass of water and shake until a uniform solution is achieved. The contents of the glass should be ingested immediately. This medication should not be administered simultaneously with milk or dairy products.

Oral administration only.

Adults: 1 packet (300 mg of Ferrimanitol or ovoalbumin) per day,after the main meal.

If taking more Ferroprotina

Even at high doses, no intoxication or gastric irritation has been detected. In case of symptoms of digestive intolerance with nausea and vomiting, consult your doctor or the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Ferroprotina

In case you forget to take a dose, take the next dose as soon as you remember, unless it is very close to the next one, in which case omit the missed dose and continue taking the medication as planned.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Ferroprotina

Your doctor will indicate the duration of your treatment with Ferroprotina.Do not discontinue treatment before, even if you are feeling better.

If you have any other questions 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.

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

The adverse effects that may most frequently appear when taking this medication are digestive alterations, such as stomach irritation, loss of appetite, nausea, vomiting, constipation, or diarrhea.

It is very likely that you will present stools with black pigmentation due to the iron coloration eliminated in the feces, a circumstance that, in principle, is of no importance.

If important symptoms of digestive intolerance appear, it is best to suspend treatment and consult with your doctor.

Rare adverse effects (may affect up to 1 in 10,000 people).

Increased liver enzymes.

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 for 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 out of sight and reach of children.

This medication does not require special conditions for conservation.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ferroprotina 40 mg granulated for oral solution

• The active ingredient is Ferrimanitol ovoalbumin. Each sachet contains 300 mg of Ferrimanitol ovoalbumin (equivalent to 40 mg of iron ferrous).
• The other components aresucrose, lactose, sodium chloride, banana flavor, and ethyl vanillin.

Appearance of the product and contents of the packaging

Ferroprotinais presented as a granulated oral solution in sachets.

Each package contains 30 single-dose sachets.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet: November 2010

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