Profer 80 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PROFER 80 mg granules for oral solution

ferrimanitol ovoalbumin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Profer 80 mg granules for oral solution is and what it is used for
2. What you need to know before taking Profer 80 mg granules for oral solution
3. How to take Profer 80 mg granules for oral solution
4. Possible adverse effects
5. How to store Profer 80 mg granules for oral solution
6. Contents of the pack and other information

1. What Profer 80 mg oral solution granules is and what it is used for

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

2. What you need to know before taking Profer 80 mg granules for oral solution

Do not take Profer 80 mg

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

Warnings and precautions:

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

• if you have or have had gastric or duodenal ulcer, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.
• if you are taking or are about to start taking antacids, tetracyclines, quinolones, calcium salts, or levodopa.

Other medicines and Profer 80 mg

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

Profer 80 mg must not be administered concurrently with:

• Tetracyclines or penicillamine, as they may mutually reduce oral absorption.
• Calcium salts, quinolones (e.g., ciprofloxacin), and levodopa, because iron preparations may reduce the absorption of these medicines.
• Antacids, as they may reduce the absorption of iron preparations.

Administration of any of these medicines should be separated by at least 2 hours from the administration of Profer 80 mg.

Taking Profer 80 mg with food and drinks

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

Pregnancy and lactation:

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

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

Pregnancy

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

Breastfeeding

There are no data available regarding the excretion of ferrimanitol ovoalbumin in breast milk.

Driving and use of machines:

No signs affecting the ability to drive vehicles or operate machinery have been reported.

Profer 80 mg contains lactose:

This medicinal product contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Profer 80 mg contains sucrose:

This medicinal product contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

May cause dental caries.

Profer 80 mg contains sodium:

This medicinal product contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Profer 80 mg granules for oral solution

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 sachet daily after the main meal. Pour the contents of the sachet into 200 ml of water and shake until a uniform solution is obtained. The solution should be taken immediately.

If you think that the effect 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Profer 80 mg:

If you have missed a dose, take it as soon as possible and then continue with your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop treatment with Profer 80 mg:

Your doctor will indicate the duration of treatment with Profer 80 mg. Do not stop treatment earlier, even if you feel better, as there is a risk of disease relapse.

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

4. Possible adverse effects

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

Occasionally, gastrointestinal disturbances (stomach pain, nausea, constipation, or diarrhoea) have been reported, which usually resolve when the administered dose is reduced or, if necessary, after discontinuation of treatment. Black discolouration of faeces may occur.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Profer 80 mg granules for oral solution

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Profer 80 mg after the expiry date stated on the box and sachet after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Profer 80 mg oral solution granules

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

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

Appearance of the product and contents of the pack

Profer 80 mg granules for oral solution is presented as granules in sachets. Each pack contains 15 or 30 sachets.

Marketing Authorisation Holder and Manufacturer:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the most recent review of this leaflet: October 2020

Other sources of information

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