FERPLEX 40 mg ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FERPLEX 40 mg ORAL SOLUTION

Iron Proteinsuccinylate

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 FERPLEX 40 mg oral solution is and what it is used for

1. Before taking FERPLEX 40 mg oral solution.

3. How to take FERPLEX 40 mg oral solution.

1. Possible side effects.
2. Storage of FERPLEX 40 mg oral solution.
3. Additional information.

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

FERPLEX 40 mg oral solution 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 FERPLEX 40 mg oral solution

Do not take FERPLEX 40 mg oral solution

• If you are allergic (hypersensitive) to Iron Proteinsuccinylate or any of the other components of FERPLEX 40.
• 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 FERPLEX 40 mg oral solution:

• 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.

FERPLEX 40 mg oral solution 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 (joint inflammation).
• 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 FERPLEX 40 mg oral solution may be reduced if taken with the following medicines, so it is recommended to wait at least 2 hours between taking any of these medicines and taking FERPLEX:

• antacids, normally used in patients with gastric acidity
• chloramphenicol (antibiotic)
• cholestyramine, 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 FERPLEX 40 mg oral solution with food and drinks:

Some plant-based foods, milk, coffee, and tea reduce iron absorption, so it is recommended not to take FERPLEX during the two 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.

FERPLEX 40 mg oral solution 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 FERPLEX 40 mg oral solution:

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 upset 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.

FERPLEX 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 FERPLEX 40 mg oral solution

Follow the administration instructions of FERPLEX 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 with water.

The normal doses are 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 action of FERPLEX is too strong or too weak, tell your doctor or pharmacist.

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

If you take more FERPLEX 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 FERPLEX 40 mg oral solution

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, FERPLEX 40 mg oral solution 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.

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 FERPLEX 40 mg oral solution

Do not store above 30°C

Keep out of the reach and sight of children.

Do not use FERPLEX 40 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. Deposit the packaging and any unused medicines in the SIGRE collection point at the 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 FERPLEX 40 mg oral solution:

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 iron. The other components are: sorbitol (E-420), propylene glycol, 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 content

Ferplex 40 mg is presented as a transparent oral solution, brown in color and with a characteristic odor.

Each package 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 package leaflet was approved in March 2020

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/