PATIENT INFORMATION LEAFLET

SYRON 40 mg Soluble Tablets

Ferrimanitol ovotransferrin

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 you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

SYRON 40 mg belongs to a group of medications known as oral iron trivalent preparations.

SYRON 40 mg normalizes altered hematological parameters in states of iron deficiency.

SYRON 40 mg is used for the prophylaxis of iron deficiency anemia and states of iron deficiency.

Do not take SYRON 40 mg

• If you are allergic (hypersensitive) to Ferrimanitol Ovoalbúmina or to any of the other components of SYRON 40 mg (listed in section 6).
• If you are allergic to egg proteins.
• If you have hemosiderosis and hemochromatosis (iron storage diseases).
• If you have anemia not related to iron deficiency, such as aplastic, hemolytic, and sideroblastic anemia.
• If you have chronic pancreatitis and liver cirrhosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

-If you have or have had a stomach ulcer or duodenal ulcer, inflammatory bowel disease, ulcerative colitis, or liver insufficiency.

-If you are taking or will start taking any anti-acid medication, tetracyclines, quinolones, calcium salts, or levodopa.

Consult your doctor if any of the aforementioned circumstances have occurred at any time.

Other medications and SYRON 40 mg

Inform your doctor or pharmacist if you are using, have used, or may need to take any other medication, including those purchased without a prescription.

SYRON 40 mg should not be administered concurrently with:

• Tetracyclines or penicillamine, as they may decrease each other's oral absorption.
• Calcium salts, quinolones (ciprofloxacin, etc.), and levodopa, as iron preparations may decrease the absorption of these medications.
• Anti-acids, as they may decrease the absorption of iron preparations.

The administration of any of these medications should be separated from SYRON 40 mg administration by at least 2 hours.

Use of SYRON 40 mg with food and beverages

SYRON 40 mg should not be administered concurrently with milk or dairy products.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Studies conducted with ferrimanitol ovoalbúmina in pregnant women have not detected any problems for the fetus.

No data are available regarding the excretion of ferrimanitol ovoalbúmina in breast milk.

Driving and operating machinery

No signs of impairment of the ability to drive vehicles and operate machinery have been described.

SYRON 40 mg contains sodium.

This medication contains less than 23 mg of sodium (1mmol) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for SYRON 40 mg as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of treatment with SYRON 40 mg. Do not discontinue treatment beforehand, as there is a risk of disease relapse.

The recommended dose is 1 or 2 tablets daily after the main meal. Dissolve the tablet in 100 ml or 200 ml of water and shake until a uniform solution is obtained. The solution must be ingested immediately.

If you estimate that the action of SYRON 40 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more SYRON 40 mg than you should

If you have taken more SYRON 40 mg than recommended, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take SYRON 40 mg

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 SYRON 40 mg

Your doctor will inform you of the duration of treatment with SYRON 40 mg. Do not discontinue treatment beforehand, even if you feel better.

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

Like all medications, SYRON 40 mg may produce adverse effects, although not everyone will experience them.

Occasionally, digestive discomfort (stomach pain, nausea, constipation, or diarrhea) have been described, which usually disappear when the administered dose is reduced or, in the case of suspension of treatment. Black deposits.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

No special storage conditions are required. Store SYRON 40 mg in its original packaging.

Do not use SYRON 40 mg after the expiration date indicated 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. Dispose of the packaging and medicines you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask 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 SYRON 40 mg

The active ingredient is ferrimanitol ovoalbumin. Each tablet contains approximately 300 mg of ferrimanitol ovoalbumin (equivalent to 40 mg of Fe3+).

• The other components are: mannitol, sodium croscarmellose, polyvinyl pyrrolidone, sodium fumarate stearate, magnesium stearate, hydroxypropyl cellulose, coffee essence, glycine, sodium saccharin, and pearlitol 200 SD.

Appearance of the Product and Container Content

SYRON 40 mg is presented in the form of oblong white tablets with brown spots. Each container contains 30 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada

MadridSpain

Responsible for Manufacturing

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802 Alcalá de Henares

MadridSpain

Last Review Date of this Leaflet: April 2011

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.gob.es