Profer 40 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PROFER 40 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Profer 40 mg granules for oral solution is and what it is 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 adverse effects
5. How to store Profer 40 mg granules for oral solution
6. Contents of the pack and other information

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

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

This medicine normalizes altered hematological parameters in iron-deficiency states.

It is used for the prophylaxis 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 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 overload disorders).
• If you have anemias not related to iron deficiency, such as aplastic, hemolytic, or sideroblastic anemia.
• If you have chronic pancreatitis or 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 ulcer, inflammatory bowel diseases, ulcerative colitis, or hepatic insufficiency.

If you are taking or are about to start taking antacids, tetracyclines, quinolones, calcium salts, or levodopa.

Other medicines and Profer 40 mg granules

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

Profer 40 mg granules must not be administered concomitantly 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 this medicine.

Taking Profer 40 mg granules with food and drinks

This medicine must not be administered together with milk or dairy products.

Pregnancy and breastfeeding

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 problems for the fetus.

Breastfeeding

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

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Profer 40 mg granules contain lactose

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

Profer 40 mg granules contain sucrose

This medicine 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 40 mg granules contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially “sodium-free.”

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

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

The recommended dose is 1 sachet daily 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 that the effect of Profer 40 mg granules is too strong or too weak, inform 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Profer 40 mg granules

If you have missed a dose, take it as soon as possible and then continue with your usual schedule. Do not take a double dose to make up for missed doses. Symptoms of gastrointestinal irritation such as nausea and vomiting may occur.

If you stop treatment with Profer 40 mg granules

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

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

4. Possible adverse effects

Like all medicines, Profer 40 mg granules can produce adverse effects, although not everyone will experience them.

Occasionally, gastrointestinal disturbances (stomach discomfort, nausea, constipation, or diarrhea) have been reported, which usually resolve upon reducing the administered dose or, if necessary, after discontinuing treatment. Black discolored stools 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 40 mg oral solution granules

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Profer 40 mg granules after the expiry date stated on the packaging and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Profer 40 mg granules for oral solution

• The active substance is ferrimanitol ovoalbumin. Each sachet contains approximately 300 mg of ferrimanitol ovoalbumin (equivalent to 40 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 container

Profer 40 mg granules are presented as granules in sachets. Each pack 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 most recent review of this leaflet: November 2020

Other sources of information

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