Syron 80 mg granules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
SYRON 80 mg Granules
Ferrimanitol ovoalbumin
Read the entire 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 personally. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What SYRON 80 mg is and what it is used for
- What you need to know before taking SYRON 80 mg
- How to take SYRON 80 mg
- Possible side effects
- How to store SYRON 80 mg
- Contents of the pack and other information
1. What SYRON 80 mg is and what it is used for
SYRON 80 mg is presented as granules in single-dose sachets. Each package contains 15 or 30 single-dose sachets.
SYRON 80 mg belongs to a group of medicines called oral trivalent iron 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 deficiency states.
2. What you need to know before starting to take SYRON 80 mg
Do not take SYRON 80 mg:
- If you are allergic (hypersensitive) to Ferrimanitol Ovoalbumin or to any of the other components of SYRON 80 mg (listed in section 6).
- If you have hemosiderosis or hemochromatosis (iron storage diseases).
- If you have anemias not related to iron deficiency, such as aplastic anemia, hemolytic anemia, or sideroblastic anemia.
- If you have chronic pancreatitis and hepatic cirrhosis.
- If you have chronic inflammation of the pancreas and liver cirrhosis.
Warnings and precautions
Consult your doctor or pharmacist before starting to take SYRON 80 mg:
If you have or have had gastric or duodenal ulcer, inflammatory bowel diseases, ulcerative colitis, or hepatic insufficiency.
If you are taking or are about to start taking antacids, tetracyclines, quinolones, calcium salts, or levodopa.
Other medicines and SYRON 80 mg:
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine, including those obtained without a prescription.
SYRON 80 mg must not be administered concomitantly with:
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- Tetracyclines or penicillamine, as they may mutually reduce oral absorption.
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- Calcium salts, quinolones (ciprofloxacin, etc.), and levodopa, because iron preparations may reduce the absorption of these medicines.
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- Antacids, as they may reduce the absorption of iron preparations.
Administration of any of these medicines should be separated by at least 2 hours from the administration of SYRON 80 mg.
Taking SYRON 80 mg with food and drinks
SYRON 80 mg must not be administered together with milk or dairy products.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Studies conducted with ferrimanitol ovoalbumin in pregnant women have not revealed problems for the fetus. Data regarding excretion of ferrimanitol ovoalbumin in breast milk are not available.
Driving and using machines:
No signs affecting the ability to drive vehicles or operate machinery have been reported.
SYRON 80 mg contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
SYRON 80 mg contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
SYRON 80 mg contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per granule; hence, it is essentially “sodium-free”.
3. How to take SYRON 80 mg
Follow exactly the administration instructions for Syron 80 mg given by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will indicate how long you should take SYRON 80 mg. Do not stop treatment early, as there is a risk of disease relapse.
The recommended dose is 1 sachet daily, taken after the main meal. Empty the contents of the sachet into 200 ml of water and shake until a uniform solution is obtained. The solution should be taken immediately.
If you feel that the effect 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 Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take SYRON 80 mg:
If you have missed a dose, take it as soon as possible and then continue with your usual schedule. Do not take a double dose to make up for missed doses.
Gastrointestinal irritation symptoms such as nausea and vomiting may occur.
Your doctor will indicate the duration of treatment with Syron 80 mg. Do not stop treatment early, even if you feel better.
4. Possible adverse effects
Like all medicines, SYRON 80 mg may have adverse effects, although not everyone will experience them.
Occasionally, gastrointestinal disturbances (stomach discomfort, nausea, constipation or diarrhea) have been reported, which usually resolve upon reducing the administered dose or, if necessary, after discontinuation of treatment. Black discolouration of stools.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Syron 80 mg
Keep this medicine 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 expiry date stated on the packaging after EXP.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point 
at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Storage of the package and additional information
Composition of Syron 80 mg
The active substance is ferrimanitol ovoalbumin. Each sachet contains 600 mg (approx.) of ferrimanitol ovoalbumin (equivalent to 80 mg of Fe³⁺).
The other components are: banana flavoring, ethyl vanillin, lactose, sodium chloride, and sucrose.
Appearance of the product and contents of the pack
SYRON 80 mg granules are presented in sachets. Each pack contains 15 or 30 sachets.
Marketing Authorization Holder
MABO-FARMA S.A.
Calle Vía de los Poblados, 3,
Edificio 6, 28033 Madrid,
Spain.
Manufacturer responsible
MEIJI PHARMA SPAIN, S.A.
Avda. de Madrid, 94,
28802 Alcalá de Henares, Madrid
Spain
Date of latest revision of this leaflet: October 2010
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/