PATIENT INFORMATION LEAFLET

FEROGRADUMET 105 mg prolonged-release tablets

Iron (in the form of ferrous sulfate)

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

FEROGRADUMET belongs to a group of medications known as oral iron preparations.

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

Do not take FEROGRADUMET

Be especially careful with FEROGRADUMET

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

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 concurrently:

• with iron (salts) (parenteral route) due to the risk of collapse and shock attributed to the rapid release of iron complexes and saturation of transferrin.
• if you are taking some antibiotics, such as tetracyclines or quinolones, take FEROGRADUMET two or three hours before or after the antibiotic.
• if you are taking medications with thyroxine or penicillamine, FEROGRADUMET may reduce 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 beverages

FEROGRADUMET should not be administered concurrently with milk or dairy products.

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery:

The influence of FEROGRADUMET on the ability to drive and operate machinery is negligible or insignificant.

Important information about some of the components of FEROGRADUMET

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

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

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

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

For severe iron-deficiency anemias, with less than 8 to 9 g/dl of hemoglobin, the recommended normal 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 a meal (lunch or dinner). Do not chew, crush, or leave the tablet in the mouth.

If you estimate that the action 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 Toxicological 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 your regular schedule. Do not take a double dose to compensate for the missed doses.

Gastrointestinal irritation symptoms, including 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 iron reserves in the body, treatment should continue for 3 months after hemoglobin values have normalized in iron-deficiency anemias.Do not discontinue treatment before, even if you feel better.

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

Like all medications, FEROGRADUMET may have adverse effects, although not everyone will experience them.

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

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

Unknown frequency (cannot be estimated from available data):

Mouth ulcers(in the case ofincorrect use,whenthe tablets are chewed, sucked, or left inthemouth).

All patients, but especially older patients, and patients with difficulty swallowing may also be at risk of esophageal or throat ulcers (the tube that connects their mouth to their stomach). If the pill enters the airways, there may be a risk of bronchial ulcers (the main air passage of the lungs), which can cause bronchial constriction.

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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

Do not store at a temperature above 25° C. Store in the original packaging.

Do not use FEROGRADUMET after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medicines at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

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: methylmethacrylate copolymer, polyethylene glycol 8000 (Macrogol 8000), magnesium stearate, povidone, ricin oil, hydroxypropylmethyl cellulose 2910, ethylcellulose, polyethylene glycol 400 (Macrogol 400), lacquer, and red cochineal A (Ponceau 4R) (E124) and titanium dioxide (E171).

Appearance of the product and contents of the package

Package containing 30 red-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Teofarma Srl

Via F.lli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

This leaflet was approved in October 2018.

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