Leaflet: information for the user

PROFER 40 mg powder for oral solution

ferrimanitol ovoalbúmina

Read this leaflet carefully before you start taking the medicine, because 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 prescribedonlyfor you and should not be given to others, even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects,consultyour doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1. What Profer 40 mg powder for oral solution is and what it is used for

2. Before taking Profer 40 mg powder for oral solution

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

4. Possible side effects

5. Storage of Profer 40 mg powder for oral solution

6. Contents of the pack and additional information

Profer 40 mg granulated belongs to a group of medications known as oral iron trivalent preparations.

This medication normalizes altered hematological parameters in states of iron deficiency.

It is used for the prophylaxis and treatment of iron deficiency anemia and iron-deficient states.

Do not take Profer 40 mg granulated

• If you are allergic (hypersensitive) to ferrimanitol or ovoalbumin orto any of the other components ofthis medication (including 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 and liver cirrhosis.

Warnings and precautions

Consult your doctor before starting to take Profer 40 mg granulated

• 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 40 mg granulated

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

Profer 40 mg granulated should not be administered with:

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

The intake of any of these medications should be separated by at least 2 hours from the administration of this medication.

Profer 40 mg granulated with food and beverages

This medication 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

Studies conducted with ferrimanitol or ovoalbumin in pregnant women have not detected any problems for the fetus.

Lactation

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

Driving and operating machinery

No signs of impairment of driving ability and operating machinery have been described.

Profer 40 mg granulatedcontains lactose

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

Profer 40 mg granulatedcontains saccharose

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

It may cause tooth decay.

Profer 40 mg granulatedcontains 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. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is 1 tablet per day after the main meal. Pour the contents of the packet into 100 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 40 mg oral powder is too strong or too weak, inform your doctor or pharmacist.

If you take more Profer 40 mg oral powder than you should

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

If you forget to take Profer 40 mg oral powder

In case you have forgotten a dose, take another as soon as possible and continue with your usual schedule. Do not take a double dose to compensate for the missed doses. Gastrointestinal irritation symptoms with nausea and vomiting may be observed.

If you interrupt treatment with Profer 40 mg oral powder

Your doctor will indicate the duration of treatment with Profer 40 mg oral powder. Do not discontinue treatment before, even if you are feeling better, as there is a risk of disease relapse.

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

Like all medications, Profer 40 mg granule may cause 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 type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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 out of sight and reach of children.

No special storage conditions are required.

Do not use Profer 40 mg powder after the expiration date indicated 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 through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Profer 40 mg granulated for oral solution

• The active ingredient is ferrimanitol ovoalbumin. Each sachet contains approximately 300 mg of ferrimanitol ovoalbumin (equivalent to 40 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 40 mg granulated is presented in the form of granules in sachets. Each package contains 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)

Last review date of this leaflet: November 2020

Other sources of information

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