Prospecto: Information for the User

GLUTAFERRO170 mg/ml oral drops in solution

(Ferroglicina sulfate)

Glutaferro is presented in oral drop form in solution.

This medication belongs to the group of medications known as iron supplements.

Glutaferro is used for the treatment of iron deficiency states.

Do not use Glutaferro

• If you are allergic to ferrous glycinate sulfate or any of the other ingredients of this medication (listed in section 6).
• If you have esophageal stenosis (narrowing) due to any type of gastrointestinal alteration.
• If you have iron overload (excess iron in the blood).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medication.

Iron supplements can cause poisoning, especially in children.

This medication 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 disorders that alter oxygen transport), myelodysplasia (inadequate functioning of the spinal cord), or alterations in iron absorption or storage.

Other medications and Glutaferro

Use of Glutaferro with other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The treatment effect may be affected if Glutaferro is administered simultaneously with other medications.

The intravenous administration of iron salts and doxycycline should be avoided.

Glutaferro should not be administered until at least two to four hours have passed since the administration of any of the following therapeutic agents:

• Antacids: the therapeutic effect of Glutaferro may be impaired if administered concurrently with antacids. The minimum time interval between antacid and iron administration is two hours.
• Thyroid hormones: Glutaferro reduces the effect of medications containing thyroid hormones if administered concurrently. The minimum time interval between thyroid hormone and iron administration is two hours.
• Antibiotics: Glutaferro reduces the effect of certain antibiotics (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 medications: other medications may be affected by Glutaferro treatment: methyldopa (administer with the widest possible interval), penicillamine (administer at least two hours before Glutaferro), bisphosphonates (administer with a two-hour interval), levodopa (administer with the widest possible interval), or nonsteroidal anti-inflammatory drugs (may increase the irritating effect on the gastric mucosa of these drugs).

Use of Glutaferro with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

No effects of this medication on driving or operating machinery have been reported.

Glutaferro contains sorbitol.

This medication contains 300 mg of sorbitol per ml.

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

Glutaferro contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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 for adults is 1.5-2.5 ml three times a day.

Use in children and adolescents:

Up to 1 year and premature infants: ………….. 0.3-0.5 ml per day distributed with food.

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 be continued until normal iron levels in the blood are reached or until iron reserves in the body are restored.

If side effects occur, consult your doctor. If you estimate that the action of Glutaferro is too strong or too weak, inform your doctor or pharmacist.

If you use more Glutaferro than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 91 562.04.20 indicating the medication and the amount ingested. Bring the leaflet with you.

If you forgot to use Glutaferro

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Abdominal discomfort, stomach burning, vomiting, diarrhea, constipation, dark stools, and rash (temporary skin eruption).

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

Reporting Adverse Effects

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require any special storage temperature.

Expiration Date:

Do not use this medication after the expiration date that appears on the packaging after - CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging or closure is damaged.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Glutaferro

The active principle of this medication is the ferroglycine sulfate complex 170 mg equivalent to 30 mg of Iron(II).

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

Appearance of the product and contents of the packaging

Glutaferro is presented in the form of oral drops in a solution in containers that contain 25 ml of solution and a dosing dropper.

Holder of the marketing authorization

MEDIX, S.A

Calle del Plástico, nº 5 nave 9

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Responsible for manufacturing

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/La Laguna 66-68-70, Polígono Industrial Urtinsa II Alcorcón, 28923 (Madrid)

Last review of this leaflet was in 07/2021

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/