KILOR 80 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Kilor 80 mg Granules for Oral Solution

ferrimanitol ovoalbúmina

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 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 medications called oral iron trivalent preparations.

Kilor normalizes altered hematological parameters in iron deficiency states.

Kilor is used in adult patients for the 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 medication (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.
• 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 medication, tetracyclines, quinolones, calcium salts, or levodopa.

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

Other Medications and Kilor

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

Kilor should not be administered concomitantly 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 by at least 2 hours from the administration of Kilor.

Taking Kilor with Food and Drinks

Kilor should not be administered concomitantly with milk or dairy products.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

In studies conducted with ferrimanitol ovoalbúmina in pregnant women, no problems for the fetus have been detected. 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 impairment of the ability to drive vehicles or use machinery have been reported.

Kilor contains lactose, sucrose, benzyl alcohol, and sodium

This medication contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause tooth decay.

This medication 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 or breastfeeding, or if you have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in your body and cause side effects (metabolic acidosis).

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

3. How to Take Kilor

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, 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 in adults is 1 sachet daily after the main meal. Pour the contents of the sachet into 200 ml of water and shake until a uniform solution is obtained. The solution should be ingested immediately.

In children, use Kilor 40 mg granules for oral solution.

If you think 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 Toxicology Information Service, phone 91 562 04 20.

If you forget to take Kilor

In case 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 missed doses.

Symptoms of gastrointestinal irritation with nausea and vomiting may be observed.

If you interrupt treatment with 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Kilor

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. 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 600 mg of ferrimanitol ovoalbúmina (equivalent to 80 mg of Fe3+).

• The other components are: banana flavor (contains benzyl alcohol), ethyl vanillin, lactose monohydrate, sodium chloride, and sucrose.

Appearance of the Product and Package Contents

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

Each package contains 15 or 30 sachets.

Only certain package sizes may be marketed.

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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/