Package Leaflet: Information for the User

Ferrocur 40 mg Oral Solution

Iron Proteinsuccinylate

Read this 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 others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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. Additional Informationl

Ferrocur is a medication 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 lack of iron.

Do not take Ferrocur :

• If you are allergic (hypersensitive) to Iron succinylate or to any of the other components of Ferrocur.
• 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 Ferrocur :

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

Use of other medications :

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

Ferrocur may 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).
• 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
• Mycophenolate mofetil, used to prevent transplant rejection

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

• Antacids, normally used in patients with acid reflux
• Chloramphenicol (antibiotic)
• Colestiramine, used in patients with high cholesterol
• Medications for the treatment of stomach ulcers or gastroesophageal reflux, such as omeprazole, lansoprazole, pantoprazole

Interference with diagnostic tests :

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

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 two 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 medication.

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

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 that makes you intolerant 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 that contain 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.

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

Follow exactly the administration instructions for Ferrocur 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 recommended dose is as follows:

Adults: 1-2 vials per day, as recommended by your doctor (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 as recommended 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 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service: Phone 91 562 04 20.

If you forgot to take Ferrocur:

Do not take a double dose to compensate for the missed dose. 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, Ferrocurmay produce 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 prospectus, inform your doctor or pharmacist.

Do not store above 86°F (30°C).

Keep out of the reach and sight of children.

Do not use Ferrocur after 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 the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition ofFerrocur:

The active ingredient is Iron proteinsuccinate (Contains milk protein).

Each vial of 15 ml oral solution contains 800 mg of iron proteinsuccinate, 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 package

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

Each package contains 20 vials.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Laboratorios Effik, S.A

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Responsible for manufacturing

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 review of this leaflet:August 2020

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