Leaflet: information for the user

Kilor 40 mg soluble tablets

ferrimanitol ovoalbumin

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Kilor belongs to a group of medications known as oral iron trivalent preparations.

Kilor normalizes altered hematological parameters in states of iron deficiency.

Kilor is used for the prophylaxis of iron-deficiency anemia and iron-carence states.

Do not take Kilor

• If you are allergic to Ferrimanitol Ovoalbúmina or 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 Kilor.

-If you have or have had stomach ulcers or duodenal ulcers, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.

-If you are taking or will start taking any anti-acid medication, tetracyclines, quinolones, calcium salts, or levodopa.

Other medications and Kilor

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

Kilor should not be administered 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 Kilor administration by at least 2 hours.

Taking Kilor with food and drinks

Kilor 40 mg should not be administered with milk or dairy products.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become 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. Studies conducted with ferrimanitol ovoalbúmina in pregnant women have not detected any problems for the fetus.

No data are available on the excretion of ferrimanitol ovoalbúmina in breast milk.

Driving and operating machinery

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

Kilor contains sodium

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

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

Your doctor will inform you of the duration of treatment with Kilor. Do not discontinue treatment beforehand, as there is a risk of disease relapse.

The recommended dose in adults 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.

In children, use Kilor 40 mg granulated powder for oral solution.

If you estimate that the action of Kilor is too strong or too weak, inform your doctor or pharmacist.

If you take more Kilor than you should

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

If you forgot to take Kilor

In the event that 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 Kilor

Your doctor will inform you of the duration of treatment with Kilor. Do not discontinue treatment beforehand, even if you are feeling better.

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

Like all medications, this medication may produce adverse effects, although not all people 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 Medicines 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original packaging.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Kilor Composition

The active principle is ferrimanitol ovoalbumin. Each tablet contains approximately 300 mg of ferrimanitol ovoalbumin (equivalent to 40 mg of Fe3+).

The other components are: mannitol, sodium croscarmellose, polyvinyl pyrrolidone, sodium fumarate estearate, magnesium stearate, hydroxypropyl cellulose, coffee essence (contains corn maltodextrin), glycine, sodium saccharin, and pearlitol 200 SD.

Product appearance and packaging contents

Kilor is presented in the form of oblong white tablets with brown spots.

Each package contains 30 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

GUIDOTTI FARMA, S.L.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

Manufacturer:

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid

Spain

Last review date of this prospectus:September 2021

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