Kilor 40 mg soluble tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Kilor 40 mg effervescent tablets

ferrimanitol ovoalbumin

Read this 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. 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 Kilor is and what it is used for
2. What you need to know before taking Kilor
3. How to take Kilor
4. Possible side effects
5. How to store Kilor
6. Contents of the pack and other information

1. What Kilor is and what it is used for

Kilor belongs to a group of medicines called oral trivalent iron preparations.

Kilor normalizes altered hematological parameters in iron-deficient states.

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

2. What you need to know before starting to take Kilor

Do not take Kilor

• If you are allergic to Ferrimanitol Ovoalbúmina or to any of the other components of this medicine (listed in section 6).
• If you are allergic to 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 or pharmacist before starting to take Kilor.

• 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 any antacid medicines, tetracyclines, quinolones, calcium salts, or levodopa.

Other medicines and Kilor

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

Kilor must not be administered together 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 spaced at least 2 hours apart from the administration of Kilor.

Taking Kilor with food and drinks

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

Pregnancy, breastfeeding and fertility

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 for you to use this medicine. Studies conducted with ferrimanitol ovoalbumin in pregnant women have not detected any problems for the fetus.

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.

Kilor contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially "sodium-free".

3. How to take Kilor

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

Your doctor will indicate how long you should take Kilor. Do not stop treatment prematurely, as there is a risk of disease relapse.

The recommended dose for adults 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.

For children, use Kilor 40 mg granulated sachets for oral solution.

If you think that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20.

If you forget to take Kilor

If you have forgotten 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 interrupt treatment with Kilor

Your doctor will indicate how long you should take Kilor. Do not stop treatment prematurely, even if you feel better.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Occasionally, gastrointestinal disturbances (stomach pain, nausea, constipation or diarrhoea) have been reported, which usually resolve upon reducing the administered dose or, if necessary, after discontinuation of treatment. Black discoloured 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 can also report them directly through 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 Kilor

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kilor

The active substance 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, polyvinylpyrrolidone, sodium stearyl fumarate, magnesium stearate, hydroxypropyl cellulose, coffee flavor (contains corn maltodextrin), glycine, sodium saccharin, and pearlitol 200 SD.

Appearance of the medicine and contents of the pack

Kilor is presented as white, oblong tablets with brown specks.

Each pack 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

Date of the most recent review of this leaflet: September 2021

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