FERO-GRADUMET 105 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FEROGRADUMET 105 mg prolonged-release tablets

Iron (in the form of ferrous sulfate)

Read the entire package leaflet carefully before starting to take the medication

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is FEROGRADUMET and what is it used for
2. Before taking FEROGRADUMET
3. How to take FEROGRADUMET
4. Possible side effects
5. Storage of FEROGRADUMET
6. Additional information

1. What is FEROGRADUMET and what is it used for

FEROGRADUMET belongs to a group of medications called oral iron preparations.

FEROGRADUMET is used in adult patients for the treatment of iron deficiency anemia and iron deficiency states.

2. Before taking FEROGRADUMET

Do not take FEROGRADUMET

• If you are allergic (hypersensitive) to iron or any of the other components of FEROGRADUMET.
• If you have an iron overload (e.g., hemochromatosis, hemosiderosis).
• If you have anemia not related to iron deficiency, such as aplastic anemia, hemolytic anemia, and sideroblastic anemia.
• If you have undergone repeated blood transfusions
• If you are receiving concomitant parenteral therapy with iron.
• If you have chronic pancreatitis or liver cirrhosis.

Be careful with FEROGRADUMET

• If you have an acute intestinal condition or liver problems.
• When taking FEROGRADUMET, the stools turn dark green or black. This effect is harmless.
• Due to the risk of mouth ulcers and tooth discoloration, the tablets should not be sucked, chewed, or left in the mouth, but swallowed whole with water. If you cannot follow this instruction or have difficulty swallowing, contact your doctor.
• If you accidentally choke on a tablet, contact your doctor as soon as possible. This is due to the risk of ulcers and narrowing of the bronchi, which can occur if the tablet enters the airways, resulting in persistent cough, bloody cough, and/or shortness of breath, even if the choking occurred days or months before these symptoms appear. Therefore, you will need to be urgently evaluated to ensure that the tablet has not damaged your airways.

Consult your doctor if any of the above circumstances have ever occurred to you.

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.

FEROGRADUMET should not be administered in combination with:

• iron (salts) (parenterally) due to the risk of collapse and shock attributed to the rapid release of iron complexes and transferrin saturation.
• if you are taking certain antibiotics, such as tetracyclines or quinolones, you should take FEROGRADUMET at an interval of two or three hours before or after the antibiotic.
• if you are taking medications with thyroxine or penicillamine, FEROGRADUMET may decrease the effect of these medications.
• if you are taking antacids, calcium supplements, or medications containing bicarbonate, carbonate, oxalates, or phosphates, these may reduce iron absorption.
• if you are taking medications with ascorbic acid (vitamin C), iron absorption may be altered.
• if you are taking medications with chloramphenicol, the response to iron treatment may be delayed.
• if you are taking medications with methyldopa, FEROGRADUMET may reduce its hypotensive effect.

Taking FEROGRADUMET with food or drinks

FEROGRADUMET should not be administered with milk or dairy products.

Certain foods, such as tea, coffee, milk, cereals, may reduce iron absorption.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

No problems have been reported in pregnant or breastfeeding women with oral iron administration.

Driving and using machines

The influence of FEROGRADUMET on the ability to drive and use machines is zero or insignificant.

Important information about some of the components of FEROGRADUMET

This medication may cause stomach upset and diarrhea because it contains castor oil.

It may cause allergic reactions because it contains the colorant Red cochineal A (Ponceau 4R) (E-124). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take FEROGRADUMET

Follow exactly the administration instructions of FEROGRADUMET indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal recommended dose for mild iron deficiency anemia, iron deficiency states, and increased iron needs is 1 tablet once a day.

For severe iron deficiency anemia, with less than 8-9 g/dl of hemoglobin, the normal recommended dose is 1 tablet in the morning and another in the afternoon.

Swallow the tablets whole with water, preferably 1 hour before or 3 hours after meals. If gastrointestinal problems are observed, the tablets can be taken after meals (lunch or dinner). Do not suck, chew, or leave the tablet in the mouth.

If you think the effect of FEROGRADUMET is too strong or too weak, inform your doctor or pharmacist.

If you take more FEROGRADUMET than you should

If you have taken more FEROGRADUMET than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take FEROGRADUMET

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to make up for the forgotten doses.

Symptoms of gastrointestinal irritation with nausea and vomiting may be observed.

If you interrupt treatment with FEROGRADUMET

Your doctor will indicate the duration of treatment with FEROGRADUMET. To complete the body's iron reserves, treatment should be continued for 3 months after hemoglobin values have normalized. Do not stop treatment before, even if you feel better.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, FEROGRADUMET can have side effects, although not everyone will experience them.

The most frequent side effects are gastrointestinal, especially abdominal pain, stomach acid, nausea, vomiting, constipation, or diarrhea. It is common for stools to turn dark green or black due to iron excretion. This effect is harmless.

Rarely, allergic reactions may occur, such as erythema, skin rash, pruritus, and respiratory difficulties.

Frequency not known (cannot be estimated from available data):

Mouth ulcers (in case of incorrect use, when tablets are chewed, sucked, or left in the mouth).

All patients, but especially the elderly and those with swallowing difficulties, may also be at risk of throat or esophageal ulcers (the tube connecting the mouth to the stomach). If the tablet enters the airways, there may be a risk of bronchial ulcers (the main airway to the lungs), which can cause bronchial narrowing.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of FEROGRADUMET

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use FEROGRADUMET after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of FEROGRADUMET

• The active ingredient is iron in the form of ferrous sulfate. Each tablet contains 325 mg of ferrous sulfate, equivalent to 105 mg of elemental iron.
• The other components are: methacrylic acid-methyl methacrylate copolymer, polyethylene glycol 8000 (Macrogol 8000), magnesium stearate, povidone, castor oil, hydroxypropylmethyl cellulose 2910, ethyl cellulose, polyethylene glycol 400 (Macrogol 400), lacquer, and colorant Red cochineal A (Ponceau 4R) (E124) and titanium dioxide (E171).

Appearance and packaging of the product

Package containing 30 film-coated tablets of red color.

Marketing authorization holder and manufacturer

Teofarma Srl

Via F.lli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

This package leaflet was approved in October 2018.

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