Leaflet: information for the user

PROFER 40 mg soluble tablets

ferrimanitol ovoalbumin

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.

• Ifyou experienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Profer 40 mg soluble tablets and what it is used for

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

3. How to take Profer 40 mg soluble tablets

4. Possible side effects

5. Storage of Profer 40 mg soluble tablets

6. Contents of the pack andadditional information

Profer 40 mg soluble tablets belongs to a group of medicines called oral iron trivalent preparations.

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

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

Do not take Profer 40 mg soluble tablets

• If you are allergic (hypersensitive) to ferrimanitol or ovoalbumin or to any of the other components of this medication (listed in section 6)
• If you are allergic to 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 or pharmacist before starting to take PROFER 40 mg soluble tablets

• If you have or have had gastric or duodenal ulcers, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency
• If you are taking or are about to start taking any anti-acid medication, tetracyclines, quinolones, calcium salts, or levodopa

Other medications and Profer 40 mg soluble tablets

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

This medication should not be administered concurrently 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
• Anti-acids, as they may decrease the absorption of iron preparations

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

Taking Profer 40 mg soluble tablets with food and beverages

This medication should not be administered concurrently 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 using this medication

Your doctor will decide whether it is advisable to use this medication if you are pregnant or breastfeeding

Pregnancy

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

Lactation

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

Driving and operating machinery

No signs of impairment of the ability to drive vehicles and operate machinery have been described

Profer 40 mg soluble tablets contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free"

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

The recommended dose is 1 or 2 tablets per day 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 must be ingested immediately.

If you estimate that the action of Profer 40 mg soluble tablets is too strong or too weak, inform your doctor or pharmacist.

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

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

If you forgot to take Profer 40 mg soluble tablets

In case you have forgotten a dose, take another as soon as possible and continue with your regular 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 soluble tablets

Your doctor will indicate the duration of treatment with this medication. 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Profer 40 mg soluble tablets may produce 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 stools.

Communication of 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 communicate 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 the sight and reach of children.

No special storage conditions are required.

Do not use Profer 40 mg soluble tablets after the expiration date that appears on the packaging 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.Deposit the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Profer 40 mg soluble tablets

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

Appearance of the product and contents of the packaging

Profer 40 mg soluble tablets are presented in the form of oblong white tablets with brown spots. Each package contains 30 tablets.

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: October 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