Profer 40 mg soluble tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PROFER 40 mg effervescent tablets

ferrimanitol ovoalbumin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Profer 40 mg effervescent tablets are and what they are used for
2. What you need to know before taking Profer 40 mg effervescent tablets
3. How to take Profer 40 mg effervescent tablets
4. Possible adverse effects
5. How to store Profer 40 mg effervescent tablets
6. Contents of the pack and other information

1. What Profer 40 mg effervescent tablets are and what they are used for

Profer 40 mg effervescent tablets belong to a group of medicines known as oral trivalent iron preparations.

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

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

2. What you need to know before taking Profer 40 mg soluble tablets

Do not take Profer 40 mg soluble tablets

• If you are allergic (hypersensitive) to ferrimanitol ovoalbumin or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to egg proteins
• If you have hemosiderosis or hemochromatosis (iron storage diseases)
• If you have types of anemia 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

Consult your doctor or pharmacist before starting to take PROFER 40 mg soluble tablets

• 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 any antacids, tetracyclines, quinolones, calcium salts, or levodopa

Other medicines and Profer 40 mg soluble tablets

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

This medicine must not be administered at the same time as:

• 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 soluble tablets with food and drinks

This medicine must not be administered at the same time as 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 using 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 shown any problems for the fetus.

Breastfeeding

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

Driving and using machines

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

Profer 40 mg soluble tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Profer 40 mg dispersible tablets

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 or 2 tablets daily after the main meal. Dissolve the tablet in 100 ml or 200 ml of water and shake until a uniform solution is obtained. The solution should be taken immediately.

If you feel that the effect of Profer 40 mg dispersible tablets is too strong or too weak, inform your doctor or pharmacist.

If you take more Profer 40 mg dispersible tablets than you should

If you have taken more Profer 40 mg dispersible tablets 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 dispersible tablets

If you have missed a dose, take it as soon as possible and then continue with your regular dosing 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 taking Profer 40 mg dispersible tablets

Your doctor will determine the duration of treatment with this medicine. Do not discontinue 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 effervescent tablets may produce adverse effects, although not everyone will experience them.

Occasionally, gastrointestinal disturbances (stomach pain, nausea, constipation, or diarrhea) have been reported, which usually disappear when the administered dose is reduced or, if necessary, after discontinuation of 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 Medicines: 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 effervescent tablets

Keep out of sight and reach of children.

No special storage conditions required.

Do not use Profer 40 mg effervescent tablets after the expiry date stated on the packaging 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. Dispose of containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Profer 40 mg dispersible tablets

• The active substance is ferrimanitol ovoalbumin. Each tablet contains 300 mg (approx.) of ferrimanitol ovoalbumin (equivalent to 40 mg of Fe3+).
• The other components (excipients) are: mannitol, sodium croscarmellose, polyvinylpyrrolidone, sodium stearyl fumarate, magnesium stearate, hydroxypropyl cellulose, coffee flavour, glycine, sodium saccharin and pearlitol 200 SD.

Appearance of the product and contents of the pack

Profer 40 mg dispersible tablets are presented as white, oval-shaped tablets with brown specks. Each pack contains 30 tablets.

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 revision of this leaflet: October 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