KILOR 40 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Kilor 40 mg Granules for Oral Solution

ferrimanitol ovoalbúmina

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only. Do not give it 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Kilor and what is it used for
2. What you need to know before taking Kilor
3. How to take Kilor
4. Possible side effects
5. Storage of Kilor
6. Package Contents and Additional Information

1. What is Kilor and what is it used for

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

Kilor normalizes altered hematological parameters in iron deficiency states.

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

2. What you need to know before taking Kilor

Do not take Kilor:

• If you are allergic to Ferrimanitol Ovoalbúmina or any of the other components of this medicine (listed in section 6).
• If you have hemosiderosis and hemochromatosis (iron deposition diseases).
• If you have anemia not related to iron deficiency, such as aplastic anemia, hemolytic anemia, 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 gastric or duodenal ulcers, inflammatory bowel disease, ulcerative colitis, or liver failure.

If you are taking or are about to start taking any anti-acid medicine, tetracyclines, quinolones, calcium salts, or levodopa.

Consult your doctor if any of the above circumstances have occurred to you.

Other Medicines and Kilor

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

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 medicines.
• Anti-acids, as they may decrease the absorption of iron preparations.

Take any of these medicines at least 2 hours apart from the administration of Kilor.

Taking Kilor with Food and Drinks

Kilor should not be administered with milk or dairy products.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant or breastfeeding, your doctor will decide whether to use this medicine. Studies with ferrimanitol ovoalbúmina in pregnant women have not shown any problems for the fetus.

There is no data available on the excretion of ferrimanitol ovoalbúmina in breast milk.

See the section Kilor contains lactose, sucrose, benzyl alcohol, and sodiumfor information on the effect of benzyl alcohol on pregnancy and breastfeeding.

Driving and Using Machines

No signs of affecting the ability to drive vehicles and use machinery have been reported.

Kilor contains lactose, sucrose, benzyl alcohol, and sodium

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause tooth decay.

This medicine contains 0.081 mg of benzyl alcohol in each sachet.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant, breastfeeding, or have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in your body and cause side effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years old unless your doctor or pharmacist has indicated it.

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

3. How to Take Kilor

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

Your doctor will indicate the duration of treatment with Kilor. Do not stop treatment before, as there is a risk of relapse of the disease.

The recommended dose is:

Adults: 1 sachet daily after the main meal.

Children over 3 years: ½ sachet after the main meal.

Children under 3 years: ¼ sachet 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 the action of Kilor is too strong or too weak, tell 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 Toxicology Information Service, phone 91 562 04 20.

If you forget to take Kilor:

If you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to make up for the forgotten doses. You may experience symptoms of gastrointestinal irritation with nausea and vomiting.

If you stop taking Kilor

Your doctor will indicate the duration of treatment with Kilor. Do not stop treatment before, even if you feel better.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Occasionally, gastrointestinal disorders (stomach pain, nausea, constipation, or diarrhea) have been reported, which usually disappear when the dose is reduced or after treatment is stopped. Black pigmentation of stools.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kilor

Keep this medicine out of the sight and reach of children.

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

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

Medicines should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Kilor

• The active ingredient is ferrimanitol ovoalbúmina. Each sachet contains approximately 300 mg of ferrimanitol ovoalbúmina (equivalent to 40 mg of Fe3+).
• The other ingredients are: banana flavor (contains benzyl alcohol), ethyl vanillin, lactose, sodium chloride, and sucrose.

Appearance and Packaging of the Product

Kilor is presented in the form of single-dose sachets containing a reddish-brown granulate with a vanilla odor and banana flavor.

Each package contains 30 sachets.

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 Last Revision of this Package Leaflet:September 2021

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