GLUTAFERRO 170 mg/ml ORAL SOLUTION DROPS

Introduction

Package Leaflet: Information for the User

GLUTAFERRO170 mg/ml oral drops in solution

(Ferroglycine sulfate)

Contents of the package leaflet:

1. What is Glutaferro and what is it used for
2. What you need to know before you take Glutaferro
3. How to take Glutaferro
4. Possible side effects
5. Storage of Glutaferro
6. Contents of the pack and further information

1. What is Glutaferro and what is it used for

Glutaferro is presented as oral drops in solution.

This medicinal product belongs to the group of medicinal products called iron supplements.

Glutaferro is used for the treatment of iron deficiency conditions.

2. What you need to know before you take Glutaferro

Do not take Glutaferro

• If you are allergic to ferroglycine sulfate or any of the other ingredients of this medicinal product (listed in section 6).
• If you have esophageal stenosis (narrowing) due to any type of gastrointestinal disorder.
• If you have iron overload (increased amount of iron in the blood).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicinal product.

Iron preparations can cause poisoning, especially in children.

This medicinal product should be administered with caution.

• If you are taking another iron supplement in your diet and/or iron salts.

• If you have any of these diseases: hemolytic anemia, hemoglobinopathies (blood diseases that alter oxygen transport), myelodysplasia (inadequate functioning of the bone marrow) or alterations in iron absorption or storage.

Other medicines and Glutaferro

Use of Glutaferro with other medicines. Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of 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:

• Antacids: the therapeutic effect of Glutaferro may be impaired if administered concomitantly with antacids. The minimum time interval between the administration of antacids and iron is two hours.
• Thyroid hormones: Glutaferro decreases the effect of medicines containing thyroid hormones if administered concomitantly. The minimum time interval between the administration of thyroid hormones and iron is two hours.
• Anti-infectious medicines: Glutaferro decreases the effect of certain anti-infectious medicines (tetracyclines and fluoroquinolones) if administered simultaneously. In the case of fluoroquinolones, they should be administered at least two hours before or four hours after Glutaferro. In the case of tetracyclines other than doxycycline, the interval between administration 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), or non-steroidal anti-inflammatory drugs (may increase the irritating effect on the gastric mucosa of these drugs).

Use of Glutaferro with food, beverages, and alcohol

It is advisable to take the medicine at least 2 hours away from meals, as absorption may be reduced. Do not take the medicine with food, vegetable foods, milk or derivatives, coffee, tea, or beverages containing calcium. Iron absorption is decreased with calcium and with 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 have a baby, ask your doctor or pharmacist for advice before taking any medicine.

No known risks have been described with iron intake during pregnancy and breastfeeding.

Driving and using machines

No effects of this medicine on the ability to drive or use machines have been observed.

Glutaferro contains sorbitol.

This medicinal product contains 300 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Glutaferro contains sodium

This medicinal product contains less than 23 mg of sodium (1 mmol) per daily dose, which is essentially "sodium-free".

3. How to take Glutaferro

Follow exactly the administration instructions of this medicinal product 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 side effects are observed, they should be administered during or after meals. In the case of children, Glutaferro can be administered mixed with water, juices, and even milk.

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

Use in children and adolescents:

Up to 1 year and premature: ………….. 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.

Treatment should continue until normal iron values are reached in the blood or until body iron reserves are restored.

If you experience side effects, consult your doctor. If you think the action of Glutaferro is too strong or too weak, tell 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. Telephone 91 562.04.20 indicating the medicine and the amount ingested. Bring 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the administration of Glutaferro, the following adverse reactions may occur:

Abdominal discomfort, heartburn, vomiting, diarrhea, constipation, dark stools, and exanthema (temporary skin rash).

These adverse reactions appear very rarely (affect less than 1 in 10,000 people).

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glutaferro

Keep this medicinal product out of the sight and reach of children.

This medicinal product does not require any special storage temperature.

Expiry date:

Do not use this medicinal product after the expiry date stated on the packaging after - EXP. The expiry date is the last day of the month indicated.

Do not use this medicinal product if you notice that the packaging or closure is damaged.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Glutaferro

The active substance of this medicinal product is ferroglycine sulfate 170 mg equivalent to 30 mg of Iron(II).

The other ingredients (excipients) are: sorbitol (E-420), sodium saccharin, orange essence, caramel. See section 2.

Appearance of the product and pack contents

Glutaferro is presented as oral drops in solution in packs containing 25 ml of solution and 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)

This leaflet was last revised in 07/2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/