Prospect: information for the user

PROFER 80 mg powder for oral solution

ferrimanitol ovoalbumin

Read this prospect carefully before starting to take the medicine, because it contains important information for you.

Profer contains the active ingredient ferrimanitol ovoalbumin, and belongs to a group of medications called oral iron trivalent preparations. It is used in adult patients for the treatment of iron deficiency anemia and iron-deficient states. This medication normalizes altered hematological parameters in iron-deficient states.

Do not take Profer 80 mg

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Profer 80 mg

• If you have or have had gastric or duodenal ulcers, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.
• If you are taking or will start taking any antacid, tetracyclines, quinolones, calcium salts, or levodopa.

Other medications and Profer 80 mg

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Profer 80 mg 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 medications.
• Antacids, as they may decrease the absorption of iron preparations.

The administration of any of these medications should be separated from Profer 80 mg administration by at least 2 hours.

Administration of Profer 80 mg with food and beverages

Profer 80 mg should not be administered with milk or dairy products.

Pregnancy and lactation:

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

Your doctor will decide whether to use this medication.

Pregnancy

No problems for the fetus have been detected in studies conducted with ferrimanitol or ovoalbumin in pregnant women.

Lactation

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

Driving and operating machinery:

No signs of impaired ability to drive vehicles and operate machinery have been described.

Profer 80 mg contains lactose:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Profer 80 mg contains saccharose:

This medication contains saccharose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

It may cause tooth decay.

Profer 80 mg contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day after the main meal. Pour the contents of the packet into 200 ml of water and shake until a uniform solution is obtained. The solution must be ingested immediately.

If you estimate that the action of Profer 80 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Profer 80 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Profer 80 mg:

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Profer 80 mg

Your doctor will indicate the duration of treatment with Profer 80 mg. Do not suspend treatment before, even if you are feeling better, as there is a risk of relapse of the disease.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Profer 80 mg may have adverse effects, although not everyone will experience them.

Occasionally, digestive discomfort (stomach pain, nausea, constipation, or diarrhea) have been described, which usually disappear when the administered dose is reduced or, in the case of suspension of treatment. Black deposits.

Reporting Adverse Effects:

If you experience any of these adverse effects, consult your doctor or pharmacist, 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 on the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Profer 80 mg after the expiration date indicated on the box and on the sachet after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Profer 80 mg granulated for oral solution

The active ingredient is ferrimanitol ovoalbumin. Each sachet contains approximately 600 mg of ferrimanitol ovoalbumin (equivalent to 80 mg of Fe3+).

The other components(excipients)are: banana essence, ethyl vanillin, lactose, sodium chloride and sucrose.

Appearance of the product and content of the packaging

Profer 80 mg granulated is presented in the form of granules in sachets. Each package contains 15 or 30 sachets.

Holder of the marketing authorization and responsible for manufacturing:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last review of this leaflet: October 2020

Other sources of information

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