Contents of the leaflet:

1.What GLUTAFERRO is and what it is used for
2.What you need to know before you start using GLUTAFERRO
3.How to use GLUTAFERRO
4.Possible side effects
5.How to store GLUTAFERRO
6.Contents of the package and additional information

1. What GLUTAFERRO is and what it is used for

GLUTAFERRO is available as oral drops in solution form.
This medicine belongs to the group of medications known as iron supplements.
GLUTAFERRO is used for the treatment of iron deficiency conditions.

2. What you need to know before you start using Glutaferro

Do not take GLUTAFERRO
•If you are allergic to ferroglycine sulfate or any of the other ingredients of this medicine (listed in section 6).
•If you have esophageal stenosis (narrowing) caused by any gastrointestinal condition.
•If you have iron overload (an increase in the amount of iron in your blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine. Iron preparations can cause intoxication, especially in children.

This medicine should be used with caution:
•If you are taking other dietary iron supplements and/or iron salts.
•If you have any of the following conditions: hemolytic anemia, hemoglobinopathies (blood disorders that affect oxygen transport), myelodysplasia (impaired functioning of the spinal cord), or disorders in iron absorption or storage.

Interaction of GLUTAFERRO with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines. The effectiveness of the treatment may be affected if GLUTAFERRO is administered simultaneously with other medicines.

Intravenous administration of iron salts and doxycycline should be avoided. GLUTAFERRO should not be administered until at least two to four hours after the administration of any of the following therapeutic agents:
•Antacid medications: The therapeutic effect of GLUTAFERRO may be impaired if administered concurrently with antacid medications. The minimum interval between the administration of antacids and iron is two hours.
•Thyroid hormones: GLUTAFERRO reduces the effect of medicines containing thyroid hormones when administered together. The minimum interval between the administration of thyroid hormones and iron is two hours.
•Anti-infective medications: GLUTAFERRO reduces the effect of certain anti-infective medicines (tetracyclines and fluoroquinolones) when administered simultaneously.
•Fluoroquinolones: Should be administered at least two hours before or four hours after GLUTAFERRO.
•Tetracyclines (other than doxycycline): The interval between administrations should be at least three hours.
•Other medicines: Other medicines may be affected by treatment with GLUTAFERRO:
•Methyldopa: Administer with the widest possible interval.
•Penicillamine: Administer at least two hours before GLUTAFERRO.
•Bisphosphonates: Administer with an interval of at least two hours.
•Levodopa: Administer with the widest possible interval.
•Non-steroidal anti-inflammatory drugs (NSAIDs): These drugs may increase their irritating effect on the gastric mucosa when taken with GLUTAFERRO.

GLUTAFERRO with food and drinks

It is advisable to take the medicine at least 2 hours apart from meals, as absorption may be reduced. The medicine should not be taken with food, vegetables, milk or dairy products, coffee, tea, or calcium-containing beverages. Iron absorption is decreased by calcium and other agents present in certain foods that form complexes with iron.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
No known risks have been described with the intake of iron during pregnancy and breastfeeding.

Driving and using machines

No known effects of this medicine on the ability to drive or operate machines.
GLUTAFERRO contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Glutaferro

Follow exactly the dosing instructions provided by your doctor or pharmacist. If you have any doubts, consult your doctor again.
Iron salts should be taken between meals for maximum absorption. If gastrointestinal side effects are observed, they should be taken during or after meals. For children, GLUTAFERRO can be mixed with water, juices, or even milk.

The recommended dose for adults is 1.5-2.5 ml three times a day.

Use in children:
•Up to 1 year and premature infants: 0.3-0.5 ml per day, distributed with food.
•From 1 to 6 years: 0.2-0.7 ml three times a day.
•Over 6 years: 0.7 ml three times a day.

The treatment should continue until normal iron levels in the blood are reached or until the body’s iron stores are replenished. If side effects occur, consult your doctor. If you feel that the action 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 +34 91 562 04 20, stating the medicine and the amount ingested. Bring the leaflet with you.

If you forget to take GLUTAFERRO:
Do not take a double dose to make up for a missed dose.

4. Possible side effects

As with all medicines, GLUTAFERRO may cause side effects, although not everyone experiences them.

The following side effects may occur during the administration of GLUTAFERRO:
•Abdominal discomfort, heartburn, vomiting, diarrhea, constipation, dark stools, and rash (temporary skin eruption).

These side effects are very rare, affecting fewer than 1 in 10,000 people.

If you experience any side effects, consult your doctor or pharmacist, even if they are not mentioned in this leaflet.

5. How to store Glutaferro

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.

Expiration:
Do not use this medicine after the expiration date stated on the packaging after “EXP.” The expiration date refers to the last day of the month indicated.
Do not use this medicine if you notice that the packaging or seal is damaged.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and packaging at a medicine waste collection point at the pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and additional information

The active ingredient of this medicine is the ferroglycine sulfate complex 170 mg, equivalent to 30 mg of Iron (II). The other ingredients (excipients) are: sorbitol (E-420), sodium saccharin, orange essence, and caramel. See section 2.

Product appearance and package contents
GLUTAFERRO is presented as oral drops in solution form in containers containing 25 ml of solution and a dosing dropper.

Marketing authorization holder and manufacturer
LABORATORIOS MEDIX, S.A
Calle del Plástico, no 5 nave 9
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
The last revision of this leaflet was in March 2012.
Detailed and updated information about this medicine is available on the Spanish Agency of Medicines and Health Products (AEMPS) website: http://www.aemps.es/