Glutaferrro 170 mg/ml oral solution drops
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
GLUTAFERRO 170 mg/ml oral solution drops in solution
(Ferroglycine sulfate)
Read the entire patient information leaflet carefully before you start using this medicine, as it contains important information for you.
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Package leaflet contents:
- What Glutaferro is and what it is used for
- What you need to know before using Glutaferro
- How to use Glutaferro
- Possible side effects
- Storage of Glutaferro
- Contents of the pack and other information
1. What Glutaferro is and what it is used for
Glutaferro is presented in the form of oral drops in solution.
This medicine belongs to the group of medicines called iron supplements.
Glutaferro is used for the treatment of iron deficiency states.
2. What you need to know before using Glutaferro
Do not use Glutaferro
- If you are allergic to ferroglycine sulfate or to any of the other ingredients of this medicine (listed in section 6).
- If you have esophageal stenosis (narrowing) due to any gastrointestinal disorder.
- If you have iron overload (increased iron levels in the blood).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use this medicine.
Iron-containing preparations may cause poisoning, especially in children.
This medicine should be used with caution:
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If you are taking additional dietary iron supplements and/or iron salts.
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If you have any of the following conditions: hemolytic anemia, hemoglobinopathies (blood disorders affecting oxygen transport), myelodysplasia (impaired bone marrow function), or disorders affecting iron absorption or storage.
Other medicines and Glutaferro
Use of Glutaferro with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The effectiveness of treatment may be affected if Glutaferro is administered simultaneously with other medicines.
Concomitant intravenous administration of iron salts and doxycycline must be avoided.
Glutaferro should not be administered until at least two to four hours after administration of any of the following therapeutic agents:
- Antacids: The therapeutic effect of Glutaferro may be reduced if taken together with antacids. The minimum time interval between administration of antacids and iron should be two hours.
- Thyroid hormones: Glutaferro reduces the effect of thyroid hormone-containing medicines when administered together. The minimum time interval between administration of thyroid hormones and iron should be two hours.
- Anti-infective medicines: Glutaferro reduces the effect of certain anti-infective medicines (tetracyclines and fluoroquinolones) when administered simultaneously. For fluoroquinolones, they should be administered at least two hours before or four hours after Glutaferro. For tetracyclines other than doxycycline, the interval between administrations should be at least three hours.
- Other medicines: Other medicines may be affected by Glutaferro treatment: methyldopa (administer with as long an interval as possible), penicillamine (administer at least two hours before Glutaferro), bisphosphonates (administer with an interval of at least two hours), levodopa (administer with as long an interval as possible), or non-steroidal anti-inflammatory drugs (NSAIDs) (may increase the gastric mucosal irritant effect of these drugs).
Use of Glutaferro with food, drinks, and alcohol
It is advisable to separate the intake of this medicine from meals by at least two hours, as absorption may be reduced. This medicine should not be taken with food, plant-based foods, milk or dairy products, coffee, tea, or beverages containing calcium. Iron absorption is reduced by calcium and other agents present in certain foods that form complexes with iron.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
No known risks have been reported with iron intake during pregnancy and breastfeeding.
Driving and using machines
No effects of this medicine on the ability to drive or operate machinery are known.
Glutaferro contains sorbitol
This medicine contains 300 mg of sorbitol per ml.
Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.
Glutaferro contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per daily dose, which is essentially “sodium-free”.
3. How to use Glutaferro
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Iron salts should be taken between meals for maximum absorption. If gastrointestinal adverse effects occur, they should be administered during or after meals. In children, Glutaferro may be administered mixed with water, fruit juices, or even milk.
The recommended dose for adults is 1.5–2.5 mL three times daily.
Use in children and adolescents:
Up to 1 year and premature infants: ………….. 0.3–0.5 mL daily, distributed with food.
From 1 to 6 years: ……………………………….. 0.2–0.7 mL three times daily.
Over 6 years: …………………………………….. 0.7 mL three times daily.
Treatment should continue until normal blood iron levels are reached or until body iron stores are replenished.
If side effects occur, consult your doctor. If you think the effect of Glutaferro is too strong or too weak, inform your doctor or pharmacist.
If you take more Glutaferro than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take the package leaflet with you.
If you forget to take Glutaferro
Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse reactions may occur during administration of Glutaferro:
Abdominal discomfort, heartburn, vomiting, diarrhoea, constipation, dark stools, and rash (temporary skin eruption).
These adverse reactions occur very rarely (affecting less than 1 in 10,000 people).
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Glutaferro
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage temperature.
Expiry:
Do not use this medicine after the expiry date stated on the packaging after - EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice that the packaging or closure is damaged.
Medicines must not be disposed of via wastewater or household waste. Unwanted medicines and their containers should be taken to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the package and other information
Composition of Glutaferro
The active substance in this medicine is ferroglycine sulfate complex 170 mg, equivalent to 30 mg of Iron(II).
The other components (excipients) are: sorbitol (E-420), sodium saccharin, orange flavor, caramel. See section 2.
Appearance of the product and contents of the container
Glutaferro is available as an oral solution in dropper bottles containing 25 ml of solution, with a dosing dropper.
Marketing Authorization Holder
MEDIX, S.A.
Calle del Plástico, nº 5 nave 9
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Manufacturer
INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
C/La Laguna 66-68-70, Polígono Industrial Urtinsa II Alcorcón, 28923 (Madrid)
The most recent revision of this leaflet was in 07/2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/