Ferrocúr 40 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ferrocur 40 mg oral solution

iron protein succinylate

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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. How to store 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 medication that supplies iron to the blood red blood cells, treating conditions of iron deficiency and curing anemia (reduction in hemoglobin levels and in the number and size of red blood cells) due to this lack of iron.

2. Before taking Ferrocur 40 mg oral solution

Do not take Ferrocur:

• If you are allergic (hypersensitive) to iron protein succinylate or to any of the other components of Ferrocur.
• If you are allergic to milk proteins.
• If you have any disease causing iron accumulation in the body (hemochromatosis, hemosiderosis).
• If you have pancreatitis (inflammation of the pancreas) or hepatic cirrhosis (chronic liver disease characterized by the formation of fibrosis or "scarring" in the liver tissue, altering its structure and normal function) due to iron accumulation.
• If you have anemia due to causes other than iron deficiency.

Take special care with Ferrocur:

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

Use of other medicines:

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

Ferrocur may reduce intestinal absorption, and therefore the effect, of certain 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 arterial hypertension (high blood pressure).
• Thyroxine, used to treat hypothyroidism (underactive thyroid gland).
• Levodopa and carbidopa, used to treat Parkinson's disease.
• Mycophenolate mofetil, used to prevent transplant rejection.

The intestinal absorption of iron, and therefore the effectiveness of Ferrocur, may be reduced if taken together with the following medicines. Therefore, you should wait at least 2 hours between taking any of these medicines and taking Ferrocur:

• Antacids, commonly used in patients with gastric acidity.
• Chloramphenicol (antibiotic).
• Colestipol, used in patients with high cholesterol.
• Medicines used to treat stomach ulcer or esophageal reflux, such as omeprazole, lansoprazole, pantoprazole.

Interference with diagnostic tests:

This medicine may interfere with laboratory tests for occult blood in feces.

Taking Ferrocur with food and drinks:

Certain plant-based foods, milk, coffee, and tea reduce iron absorption. Therefore, it is recommended not to take Ferrocur within two hours after consuming any of these foods.

Concomitant intake of freshly squeezed citrus juices (orange, lemon, etc.) may enhance the absorption of iron compounds.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Ferrocur is particularly indicated for iron deficiency states occurring during pregnancy and breastfeeding; therefore, no special precautions are required.

Driving and use of machines:

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

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 informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor (or your child's 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, particularly if the baby has been administered other medicines containing propylene glycol or alcohol.

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

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

3. How to take Ferrocur 40 mg oral solution

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

Your doctor will determine the duration of your treatment. Do not stop the treatment earlier, as the desired effect would 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 doses are as follows:

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

Children: Administer 1.5 mL of solution per kg per day (equivalent to 4 mg of iron), or as directed by the physician, divided into two doses.

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

If you feel that the effect of Ferrocur is too strong or too weak, inform your doctor or pharmacist.

If you take more Ferrocur than you should:

If you take more Ferrocur than you should, contact 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 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ferrocur may cause adverse effects, although not everyone experiences them.

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

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

Skin and subcutaneous tissue disorders: allergic reactions.

Passage of green or black stools, due to iron excretion. This adverse effect is harmless.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform 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 container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Ferrocur:

The active substance is iron protein succinate (Contains milk protein).

Each 15 ml vial of oral solution contains 800 mg of iron protein succinate, equivalent to 40 mg of iron. 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.

Appearance of the product and contents of the container

Ferrocur is presented as a clear, brown oral solution with a characteristic odor.

Each package 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 most recent revision of this leaflet: August 2020

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