PATIENT INFORMATION LEAFLET

FERPLEX 40 mg ORAL SOLUTION

Iron Proteinsuccinylate

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. Storage of FERPLEX 40 mg oral solution.

6. Additional information.

FERPLEX 40 mg oral solution 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 FERPLEX 40 mg oral solution

• If you are allergic (hypersensitive) to Iron protosuccinylate or to 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 (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 FERPLEX 40 mg oral solution:

• 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, including those purchased without a prescription.

FERPLEX 40 mg oral solution 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 effectiveness of FERPLEX 40 mg oral solution may be reduced if taken with the following medications, so wait at least 2 hours between taking one of these medications and taking FERPLEX:

• Antacids, usually 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 FERPLEX 40 mg oral solution with food and beverages:

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

The simultaneous ingestion of freshly squeezed citrus juices (orange, lemon, etc.) may favor the absorption of iron derivatives.

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

FERPLEX 40 mg oral solution is particularly indicated in iron deficiency states that occur during pregnancy and lactation, therefore no special precautions are necessary.

Driving and operating machinery:

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

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

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 causes intolerance 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.

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

Follow exactly the administration instructions for FERPLEX 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 normal doses are as follows:

Adults: 1-2 vials per day, as prescribed 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 prescribed 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 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 you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service: Telephone 91 562 04 20.

If you forgot to take FERPLEX 40 mg oral solution:

Do not take a double dose to compensate for the 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 other questions about the use of this product, ask your doctor or pharmacist.

Like all medications,FERPLEX 40 mg oral solutionmay cause adverse effects, although not everyone 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 30°C

Keep out of reach and sight of children.

Do not useFERPLEX 40after 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 drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of FERPLEX 40 mg oral solution:

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

Appearance of the product and contents of the packaging

Ferplex 40 mg is presented in the form of a transparent, brown-colored oral solution with a characteristic odor.

Each package contains 20 vials.

Holder of the marketing authorization

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

Telephone:+34 91 657 23 23

Fax:+34 91 657 23 61

Responsible for manufacturing:

ITALFARMACO S.A.

San Rafael, 3

28108 Alcobendas (Madrid)

LACER, S.A.

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

This leaflet was approved in March 2020

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