Syron 40 mg soluble tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYRON 40 mg Soluble Tablets
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 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 40 mg is and what it is used for
- What you need to know before taking SYRON 40 mg
- How to take SYRON 40 mg
- Possible side effects
- How to store SYRON 40 mg
- Contents of the pack and other information
1. What SYRON 40 mg is and what it is used for
SYRON 40 mg belongs to a group of medicines called oral trivalent iron preparations.
SYRON 40 mg normalizes altered hematological parameters in iron-deficiency states.
SYRON 40 mg is used for the prophylaxis of iron deficiency anemia and iron deficiency states.
2. What you need to know before taking SYRON 40 mg
Do not take SYRON 40 mg
- If you are allergic (hypersensitive) to Ferrimanitol Ovoalbumin 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 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 inflammation of the pancreas or liver cirrhosis.
Warnings and precautions
Talk to your doctor or pharmacist before starting this medicine if:
- You have or have had gastric or duodenal ulcer, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.
- You are taking or are about to start taking antacids, tetracyclines, quinolones, calcium salts, or levodopa.
Please consult your doctor if any of the above conditions have ever applied to you.
Other medicines and SYRON 40 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
SYRON 40 mg must not be administered concomitantly with:
- Tetracyclines or penicillamine, as they may mutually reduce oral absorption.
- Calcium salts, quinolones (e.g., ciprofloxacin), and levodopa, because iron preparations may reduce the absorption of these medicines.
- Antacids, as they may reduce the absorption of iron preparations.
Administration of any of these medicines should be spaced at least 2 hours apart from the administration of SYRON 40 mg.
Taking SYRON 40 mg with food and drink
SYRON 40 mg should not be administered together with milk or dairy products.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Studies conducted with Ferrimanitol Ovoalbumin in pregnant women have not shown any problems for the fetus.
There are no data available regarding the excretion of Ferrimanitol Ovoalbumin in breast milk.
Driving and using machines
No symptoms affecting the ability to drive or operate machinery have been reported.
SYRON 40 mg contains sodium.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".
3. How to TAKE SYRON 40 mg
Follow exactly the administration instructions for SYRON 40 mg provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the duration of treatment with SYRON 40 mg. Do not stop treatment prematurely, as there is a risk of disease relapse.
The recommended dose is 1 or 2 tablets daily, taken 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 should be taken immediately.
If you feel that the effect 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 Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take SYRON 40 mg
If you have missed a dose, take it as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for missed doses. Symptoms of gastrointestinal irritation such as nausea and vomiting may occur.
If you stop taking SYRON 40 mg
Your doctor will determine the duration of treatment with SYRON 40 mg. Do not stop treatment early, even if you feel better.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, SYRON 40 mg may produce adverse effects, although not everyone will experience them.
Occasionally, gastrointestinal disturbances (stomach pain, nausea, constipation or diarrhoea) have been reported, which usually disappear when the administered dose is reduced or, if necessary, after discontinuation of treatment. Black discolouration of stools.
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 listed 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 40 mg
Keep this medicine 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of SYRON 40 mg
The active substance is ferrimanitol ovoalbumin. Each tablet contains 300 mg (approx.) of ferrimanitol ovoalbumin (equivalent to 40 mg of Fe3+).
- The other components are: mannitol, sodium croscarmellose, polyvinylpyrrolidone, sodium stearyl fumarate, magnesium stearate, hydroxypropyl cellulose, coffee flavoring, glycine, sodium saccharin, and pearlitol 200 SD.
Appearance of the product and contents of the pack
SYRON 40 mg is presented as oval, white tablets with brown specks. Each pack contains 30 tablets.
Marketing Authorization Holder
MABO-FARMA S.A.
Calle Vía de los Poblados, 3,
Building 6, 28033 Madrid,
Spain.
Manufacturer
MEIJI PHARMA SPAIN, S.A.
Avda. de Madrid, 94,
28802 Alcalá de Henares
Madrid, Spain
Date of the most recent revision of this leaflet: April 2011
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es