FERROCUR 40 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Ferrocur 40 mg Oral Solution

Iron Proteinsuccinylate

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

• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Ferrocur 40 mg Oral Solution is and what it is used for
2. Before taking Ferrocur 40 mg Oral Solution
3. How to take Ferrocur 40 mg Oral Solution
4. Possible side effects
5. Storage of Ferrocur 40 mg Oral Solution
6. Further information

1. What Ferrocur 40 mg Oral Solution is and what it is used for

Ferrocur 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 Ferrocur 40 mg Oral Solution

Do not take Ferrocur:

• If you are allergic (hypersensitive) to Iron Proteinsuccinylate or any of the other components of Ferrocur.
• If you are allergic to milk proteins.
• If you have any 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 especially careful with Ferrocur:

• 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 using, or have recently used, other medicines, including those obtained without a prescription.

Ferrocur 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 (loss and weakening of bones).
• 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.
• Myphenolate mofetil, used to prevent transplant rejection.

The intestinal absorption of iron and therefore the efficacy of Ferrocur 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 Ferrocur:

• 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 feces.

Taking Ferrocur with food and drinks:

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

Ferrocur is particularly indicated in iron deficiency states that occur during pregnancy and breastfeeding, so 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 Ferrocur:

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 recommended daily sodium intake for an adult.

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

3. How to take Ferrocur 40 mg Oral Solution

Follow the administration instructions of Ferrocur 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 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 recommended dose is as follows:

Adults: 1-2 vials per day, according to medical criteria, (equivalent to 40-80 mg of iron) divided into 2 doses.

Children: Administer 1.5 ml of solution/kg/day (equivalent to 4 mg of iron) 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 effect of Ferrocur is too strong or too weak, tell your doctor or pharmacist.

If you take more Ferrocur than you should:

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

If you forget to take Ferrocur

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, Ferrocur can cause side effects, although not everybody 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.

Disorders of the skin and subcutaneous tissue: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 suffering from is serious, or if you notice any side effects not mentioned in this package leaflet, tell your doctor or pharmacist.

5. Storage of Ferrocur 40 mg Oral Solution

Do not store above 30°C.

Keep out of the reach and sight of children.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Ferrocur:

The active substance is Iron Proteinsuccinylate (Contains milk protein).

Each 15 ml vial of oral solution contains 800 mg of iron proteinsuccinylate, equivalent to 40 mg of iron. The other components are: sorbitol (E-420), propylene glycol (E-1520), propyl parahydroxybenzoate, sodium salt (E-217), methyl parahydroxybenzoate, sodium salt (E-219), sodium saccharin, blackcurrant flavor, sodium hydroxide, and purified water.

Appearance of the product and packaging contents

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

Each pack contains 20 vials.

Marketing authorization holder and manufacturer

Holder:

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Manufacturer

ITALFARMACO, S.A.

C/ San Rafael, 3

28108 Alcobendas - Madrid (SPAIN)

LACER, S.A.

Boters, 5

08290 Cerdanyola del Vallès - Barcelona (Spain)

Date of the last revision of this package leaflet:August 2020

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