Label: Information for the User

LACTOFERRINA 40 mg ORAL SOLUTION

Iron Proteinsuccinylate (Fe3+)

Lactoferrinis a medication that provides iron to red blood cells, treating states of iron deficiency and curing anemia (reduction of hemoglobin levels and the number and size of red blood cells) due to this lack of iron.

Do not take Lactoferrina

-If you are allergic (hypersensitive) to Iron proteinsuccinate or any of the other components of Lactoferrina.

-If you are allergic to milk proteins.

-If you have a disease that causes iron accumulation in the body (hemochromatosis, hemosiderosis).

-If you have pancreatitis (inflammation of the pancreas) or liver cirrhosis (chronic liver disease characterized by the formation of fibrosis or "scars" in the liver tissue that alter its structure and normal functioning) due to iron accumulation.

-If you have anemia due to causes other than iron deficiency.

Be especially careful with Lactoferrina

• Before starting treatment with this medication, if you have anemia or iron deficiency, you must consult your doctor.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

Lactoferrinamay reduce intestinal absorption and, therefore, the effect of some medications, such as:

-Antibiotics, such as quinolones and tetracyclines.

-Bisphosphonates, used in patients with osteoporosis (bone loss and weakening).

-Penicillamine, used to treat arthritis (inflammation of the joints).

-Alfa-metildopa, used to treat high blood pressure.

-Thyroxine, used to treat hypothyroidism (underactive thyroid gland).

-Levodopa and carbidopa, used to treat Parkinson's disease.

-Micofenolato mofetilo, used to prevent transplant rejection.

The intestinal absorption of iron and, therefore, the effectiveness ofLactoferrinamay be reduced if taken with the medications listed below, so you should wait at least 2 hours between taking one of these medications and takingLactoferrina:

-Antacids, usually used in patients with acid reflux.

-Chloramphenicol (antibiotic).

-Colestiramina, used in patients with high cholesterol.

-Medications for the treatment of stomach ulcers or gastroesophageal reflux, such as omeprazole, lansoprazole, and pantoprazole.

Interference with diagnostic tests:

This medication may interfere with laboratory tests for occult blood in stool.

Taking Lactoferrina with food and beverages

Some plant-based foods, milk, coffee, and tea reduce iron absorption, so it is recommended not to takeLactoferrinawithin two hours of consuming any of these foods.

The simultaneous ingestion of freshly squeezed citrus juices (orange, lemon, etc.) may enhance the absorption of iron derivatives.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Lactoferrinais particularly indicated in iron deficiency states that occur during pregnancy and lactation; therefore, no special precautions need to be taken.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

Important information about some of the components of Lactoferrina

This medication contains 1400 mg of sorbitol per vial. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a condition of intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 61.1 mg of propylene glycol in each vial, equivalent to 4.1 mg/ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

This medication contains 38.4 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.9% of the maximum daily sodium intake recommended for an adult.

Lactoferrina may cause allergic reactions (possibly delayed) because it contains propylparaben sodium salt (E-217) and methylparaben sodium salt (E-219).

Follow exactly the administration instructions for Lactoferrina as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will inform you of the duration of your treatment. Do not discontinue treatment beforehand, as the desired effect will not be achieved.

Take this medication preferably one hour before meals.

The contents of the vial can be taken directly or diluted in water.

The normal doses are as follows:

Adults:

1-2 vials per day, as prescribed by your doctor (equivalent to 40-80 mg of Fe3+), divided into 2 doses.

Children:

Administer 1.5 ml of solution/Kg/day (equivalent to 4 mg of Fe3+), or as prescribed by your doctor, divided into 2 doses.

The duration of treatment depends on the nature and severity of the iron deficiency. Treatment should continue until iron reserves are replenished.

If you estimate that the action of Lactoferrina is too strong or too weak, inform your doctor or pharmacist.

If you take more Lactoferrina than you should

If you take more Lactoferrina than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Lactoferrina

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, take the next one as soon as possible and continue as before.

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

Like all medications,Lactoferrinamay cause adverse effects, although not all people will experience them.

The following adverse effects (of unknown frequency) have been reported:

Gastrointestinal Disorders: stomach pain, nausea, constipation, or diarrhea, which usually disappear quickly after reducing the dose or, if necessary, after suspending treatment.

Dermatological and Subcutaneous Tissue Disorders:allergic reactions.

Appearance of green or black stools, due to iron elimination. This adverse effect is harmless.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

No requires special storage conditions.

Keep out of reach and sight of children.

Do not useLactoferrinafter the expiration date indicated on the packaging. 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 packaging and medicines that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines that you no longer need. In this way, you will help protect the environment.

Lactoferrin Composition

The active principle is Iron Proteinsuccinylate (contains milk protein). Each vial of 15 ml oral solution contains 800 mg of Iron Proteinsuccinylate, equivalent to 40 mg of Fe3+.

The other components are: sorbitol (E-420), propylene glycol (E-1520), propylparaben sodium salt (E-217), methylparaben sodium salt (E-219); sodium saccharin, blackberry flavor, sodium hydroxide, and purified water.

Product Appearance and Packaging Content

LACTOFERRINA is presented as a transparent, brown-colored oral solution with a characteristic odor.

Each package contains 20 vials.

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th Floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Under license from Italfarmaco S.p.A. (Italy)

Responsible Manufacturer

Italfarmaco S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Spain

or

LACER, S.A.

Boters, 5

08290 Cerdanyola del Vallès (Barcelona)

Spain

This leaflet was approved in May 2022.

The 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.es.