PROFER 40 mg ORAL SOLUTION GRANULES

Introduction

Leaflet: information for the user

PROFER 40 mg granulesfor oral solution

ferrimanitol ovoalbúmina

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Profer 40 mg granules for oral solution are and what they are used for
2. Before taking Profer 40 mg granules for oral solution
3. How to take Profer 40 mg granules for oral solution
4. Possible side effects
5. Storage of Profer 40 mg granules for oral solution
6. Package contents and additional information

1. What Profer 40 mg granules for oral solution are and what they are used for

Profer 40 mg granules belong to a group of medicines called oral iron preparations.

This medicine normalizes altered hematological parameters in iron deficiency states.

It is used for the prevention and treatment of iron deficiency anemia and iron deficiency states.

2. What you need to know before taking Profer 40 mg granules for oral solution

Do not take Profer 40 mg granules

• If you are allergic (hypersensitive) to ferrimanitol ovoalbúmina or any of the other components of this medicine (listed in section 6). Do not take this medicine if you are allergic to eggs or egg proteins.
• If you have hemosiderosis and hemochromatosis (iron deposition diseases).
• If you have anemia not related to iron deficiency, such as aplastic anemia, hemolytic anemia, and sideroblastic anemia.
• If you have chronic pancreatitis and liver cirrhosis.

Warnings and precautions

Consult your doctor before starting to take Profer 40 mg granules

• If you have or have had gastric or duodenal ulcers, inflammatory bowel disease, ulcerative colitis, or liver failure.

If you are taking or are about to start taking any anti-acid medicine, tetracyclines, quinolones, calcium salts, or levodopa.

Other medicines and Profer 40 mg granules

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Profer 40 mg granules should not be administered with:

• Tetracyclines or penicillamine, as they may decrease each other's oral absorption.
• Calcium salts, quinolones (ciprofloxacin, etc.), and levodopa, as iron preparations may decrease the absorption of these medicines.
• Anti-acids, as they may decrease the absorption of iron preparations.

Take any of these medicines at least 2 hours apart from the administration of this medicine.

Taking Profer 40 mg granules with food and drinks

This medicine should not be taken with milk or dairy products.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

If you are pregnant or breastfeeding, your doctor will decide whether to use this medicine.

Pregnancy

Studies conducted with ferrimanitol ovoalbúmina in pregnant women have not detected problems for the fetus.

Breastfeeding

No data are available on the excretion of ferrimanitol ovoalbúmina in breast milk.

Driving and using machines

No signs of impaired ability to drive vehicles or use machinery have been reported.

Profer 40 mg granulescontain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Profer 40 mg granulescontain sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may cause tooth decay.

Profer 40 mg granulescontain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free"

3. How to take Profer 40 mg granules for oral solution

Follow the administration instructions for this medicine exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

The recommended dose is 1 sachet per day after the main meal. Pour the contents of the sachet into 100 ml of water and shake until a uniform solution is obtained. The solution should be taken immediately.

If you think the effect of Profer 40 mg granules is too strong or too weak, tell your doctor or pharmacist.

If you take more Profer 40 mg granules than you should

If you have taken more Profer 40 mg granules than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Profer 40 mg granules

If you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to make up for the missed doses. You may experience symptoms of gastrointestinal irritation with nausea and vomiting.

If you stop taking Profer 40 mg granules

Your doctor will indicate the duration of treatment with Profer 40 mg granules. Do not stop treatment before, even if you feel better, as there is a risk of relapse of the disease.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Profer 40 mg granules can cause side effects, although not everyone gets them.

Occasionally, gastrointestinal disorders (stomach pain, nausea, constipation, or diarrhea) have been reported, which usually disappear when the administered dose is reduced or, if necessary, after treatment is discontinued. Black pigmentation of stools.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Profer 40 mg granules for oral solution

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Profer 40 mg granules after the expiration date stated on the packaging and on the sachet after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Profer 40 mg granules for oral solution

• The active ingredient is ferrimanitol ovoalbúmina. Each sachet contains approximately 300 mg of ferrimanitol ovoalbúmina (equivalent to 40 mg of Fe3+).
• The other ingredients (excipients) are: banana flavor, ethyl vanillin, lactose, sodium chloride, and sucrose.

Appearance of the product and package contents

Profer 40 mg granules are presented in sachet form. Each package contains 30 sachets.

Marketing authorization holder and manufacturer:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last revision of this leaflet: November 2020

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es