LACTOFERRIN 40 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

LACTOFERRIN 40 mg ORAL SOLUTION

Iron Proteinsuccinylate (Fe3+)

Read the entire package leaflet carefully before starting to take the medicine

• Keep this package leaflet, as 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What is Lactoferrin and what is it used for
2. Before taking Lactoferrin
3. How to take Lactoferrin
4. Possible side effects
5. Storage of Lactoferrin
6. Additional information

1. What is Lactoferrin and what is it used for

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

2. Before taking Lactoferrin

Do not take Lactoferrin

• If you are allergic (hypersensitive) to Iron Proteinsuccinylate or any of the other components of Lactoferrin.
• 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 (a chronic liver disease characterized by the formation of fibrosis or "scars" in liver tissue that alter its structure and normal function) due to iron accumulation.
• If you have anemia due to causes other than iron deficiency.

Be careful with Lactoferrin

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

Use of other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, other medicines, including those obtained without a prescription.

Lactoferrin may reduce the intestinal absorption and, therefore, the effect of some medicines, such as:

• Antibiotics, such as quinolones and tetracyclines.
• Bisphosphonates, used in patients with osteoporosis (bone loss and weakening).
• Penicillamine, used for arthritis (inflammation of the joints).
• Alpha-methyldopa, used to treat high blood pressure.
• Thyroxine, used to treat hypothyroidism (underactive thyroid gland).
• Levodopa and carbidopa, used to treat Parkinson's disease.
• Mycofenolate mofetil, used to prevent transplant rejection.

The intestinal absorption of iron and, therefore, the efficacy of Lactoferrin may be reduced if taken with the following medicines, so you should wait at least 2 hours between taking any of these medicines and taking Lactoferrin:

• Antacids, normally used in patients with gastric acidity.
• Chloramphenicol (antibiotic).
• Colestyramine, used in patients with high cholesterol.
• Medicines for the treatment of stomach ulcers or esophageal reflux, such as omeprazole, lansoprazole, pantoprazole.

Interference with diagnostic tests:

This medicine may interfere with laboratory tests for the investigation of occult blood in stool.

Taking Lactoferrin with food and drinks

Some plant-based foods, milk, coffee, and tea reduce iron absorption, so it is recommended not to take Lactoferrin during the 2 hours following the consumption of 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 medicine.

Lactoferrin is particularly indicated in iron deficiency states that occur during pregnancy and breastfeeding; therefore, no special precautions are necessary.

Driving and using machines

No effects have been observed on the ability to drive and use machines.

Important information about some of the components of Lactoferrin

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

This medicine 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 medicines that contain propylene glycol or alcohol.

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

Lactoferrin may cause allergic reactions (possibly delayed) because it contains propyl hydroxybenzoate sodium salt (E-217) and methyl hydroxybenzoate sodium salt (E-219).

3. How to take Lactoferrin

Follow the administration instructions of Lactoferrin indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medicine.

Your doctor will indicate the duration of your treatment. Do not stop the treatment before, as the desired effect will not be achieved.

Take this medicine preferably a few hours 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, according to medical criteria, (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 according to medical criteria, 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 think the action of Lactoferrin is too strong or too weak, tell your doctor or pharmacist.

If you take more Lactoferrin than you should

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

If you forget to take Lactoferrin

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

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

4. Possible side effects

Like all medicines, Lactoferrin can cause side effects, although not everyone gets them.

The following side effects have been reported (frequency unknown):

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

Skin and subcutaneous tissue disorders:allergic reactions.

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

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

5. Storage of Lactoferrin

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Lactoferrin after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Lactoferrin

The active ingredient is Iron Proteinsuccinylate (contains milk protein). Each 15 ml vial of 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), propyl hydroxybenzoate sodium salt (E-217), methyl hydroxybenzoate sodium salt (E-219); sodium saccharin, blackcurrant flavor, sodium hydroxide, and purified water.

Appearance of the product and packaging contents

LACTOFERRIN is presented as a transparent oral solution, brown in color, and with a characteristic odor.

Each package contains 20 vials.

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

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

Manufacturer

Italfarmaco S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Spain

or

LACER, S.A.

Boters, 5

08290 Cerdanyola del Vallès (Barcelona)

Spain

This package leaflet was approved in May 2022.

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