Package Insert: Information for the User

SYRON 80 mg Granule

Ferrimanitol ovotransferrin

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is SYRON 80 mg and what it is used for

2. What you need to know before starting to take SYRON 80 mg

3. How to take SYRON 80 mg

4. Possible adverse effects

5. Storage of SYRON 80 mg

6. Contents of the pack and additional information

SYRON 80 mg is presented in granule form in single-dose sachets. Each package contains 15 or 30 single-dose sachets.

SYRON 80 mg belongs to a group of medications known as oral iron trivalent preparations.

SYRON 80 mg normalizes altered hematological parameters in iron-deficient states.

SYRON 80 mg is used in adult patients for the treatment of iron-deficiency anemia and iron-deficient states.

Do not take SYRON 80 mg :

• If you are allergic (hypersensitive) to Ferrimanitol Ovoalbúmina or to any of the other components of SYRON 80 mg (including those listed in section 6).
• 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.
• If you have chronic pancreatitis and liver cirrhosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take SYRON 80 mg

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

If you are taking or will start taking any antacid, tetracycline, quinolone, calcium salts, or levodopa.

Other medications and SYRON 80 mg:

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

SYRON 80 mg should not be administered concurrently with:

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

The administration of any of these medications should be separated from SYRON 80 mg administration by at least 2 hours.

SYRON 80 mg with food and beverages

SYRON 80 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.

In studies conducted with ferrimanitol ovoalbúmina in pregnant women, no problems were detected for the fetus. There is no data available on 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 80 mgcontains lactose.

If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

SYRON 80 mgcontains saccharose.

If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

SYRON 80 mgcontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per granule; it is essentially "sodium-free".

Follow exactly the administration instructions for Syron 80 mg as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of treatment with SYRON 80 mg. Do not discontinue treatment beforehand, as there is a risk of disease relapse.

The recommended dose is 1 tablet per day after the main meal. Pour the contents of the packet into 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 80 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more SYRON 80 mg than you should:

If you have taken more SYRON 80 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 80 mg:

In the event that 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.

Your doctor will inform you of the duration of treatment with Syron 80 mg. Do not discontinue treatment beforehand, even if you are feeling better.

Like all medications, SYRON 80 mg may have 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 stools.

If you consider that any of the adverse effects you are experiencing is 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 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 for Pharmacovigilance of Medicines 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 80 mg in its original packaging.

Do not use SYRON 80 mg after the expiration date that appears on the packaging after CAD.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Syron 80 mg

The active principle is ferrimanitol ovoalbumin. Each sachet contains approximately 600 mg of ferrimanitol ovoalbumin (equivalent to 80 mg of Fe3+).

The other components are: banana essence, ethyl vanillin, lactose, sodium chloride, and saccharose.

Appearance of the product and contents of the packaging

SYRON 80 mg granulated is presented in the form of sachets. Each package contains 15 or 30 sachets.

Holder of the marketing authorization

MABO -FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada Madrid

Spain

Responsible for manufacturing

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802 Alcalá de Henares Madrid

Spain

Last review date of this leaflet: October 2010

The 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/