Ferplex 40 mg oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FERPLEX 40 mg ORAL SOLUTION

Iron Protein Succinylate

Read the entire leaflet carefully before you start taking this medicine.

• 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 may harm them.
• If you consider any of the side effects you experience to be severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What FERPLEX 40 mg oral solution is and what it is used for

2. Before taking FERPLEX 40 mg oral solution

3. How to take FERPLEX 40 mg oral solution

4. Possible side effects

5. How to store FERPLEX 40 mg oral solution

6. Further information

1. What FERPLEX 40 mg oral solution is and what it is used for

FERPLEX 40 mg oral solution is a medicine that supplies iron to the red blood cells, treating iron deficiency states 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 FERPLEX 40 mg oral solution

Do not take FERPLEX 40 mg oral solution

• If you are allergic (hypersensitive) to iron proteinsuccinilate or to any of the other ingredients of FERPLEX 40.
• If you are allergic to milk proteins.
• If you have a 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 caused by conditions other than iron deficiency.

Take special care with FERPLEX 40 mg oral solution:

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

FERPLEX 40 mg oral solution may reduce intestinal absorption, and therefore the effectiveness, 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 thus the effectiveness of FERPLEX 40 mg oral solution, may be reduced when taken together with the following medicines. Therefore, at least 2 hours should be left between taking any of these medicines and taking FERPLEX:

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

Interference with diagnostic tests:

This medicine may interfere with laboratory tests for the detection of occult blood in stools.

Taking FERPLEX 40 mg oral solution with food and drinks:

Certain plant-based foods, milk, coffee, and tea reduce iron absorption. Therefore, it is recommended not to take FERPLEX within 2 hours after consuming any of these foods.

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

FERPLEX 40 mg oral solution is particularly indicated in iron deficiency states occurring during pregnancy and breastfeeding; therefore, no special precautions are required.

Driving and operating machinery:

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

Important information about some of the ingredients of FERPLEX 40 mg oral solution:

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 (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize 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 per 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 given other medicines containing propylene glycol or alcohol.

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

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

3. How to take FERPLEX 40 mg oral solution

Follow exactly the administration instructions for FERPLEX given by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take your medicine.

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

Take this medicine preferably a few hours before meals.

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

The usual 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/kg/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 be continued until iron stores are replenished.

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

If you take more FERPLEX 40 mg oral solution than you should:

If you take more FERPLEX than prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service: Telephone 91 562 04 20.

If you forget to take FERPLEX 40 mg oral solution:

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

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

4. Possible adverse effects

Like all medicines, FERPLEX 40 mg oral solution may produce adverse effects, although not everyone will experience them.

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

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

Skin and subcutaneous tissue disorders: allergic reactions.

Appearance 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 FERPLEX 40mg oral solution

Do not store above 30°C.

Keep out of the reach and sight of children.

Do not use FERPLEX 40 after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

6. ADDITIONAL INFORMATION

Composition of FERPLEX 40 mg oral solution:

The active substance is iron protein succinylate (contains milk protein). Each 15 ml vial of oral solution contains 800 mg of iron protein succinylate, equivalent to 40 mg of iron. The other components are: sorbitol (E-420), propylene glycol, sodium propylparahydroxybenzoate (E-217), sodium methylparahydroxybenzoate (E-219), sodium saccharin, blackberry flavour, sodium hydroxide and purified water.

Appearance of the medicinal product and contents of the container

Ferplex 40 mg is presented as a transparent, brown oral solution with a characteristic odour.

Each pack contains 20 vials.

Marketing Authorization Holder

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Telephone: +34 91 657 23 23

Fax: +34 91 657 23 61

Manufacturer:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

LACER, S.A.

Boters, 5, 08290 Cerdanyola del Vallès-Barcelona- Spain

This patient information leaflet was approved in March 2020

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