Package Leaflet: Information for the User

Kilor 80 mg Oral Suspension Granules

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, ask your doctor or pharmacist.
• This medicine has been prescribed for 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 leaflet. See section 4.

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

Kilor normalizes altered hematological parameters in iron-deficient states.

Kilor is used in adult patients for the treatment of iron-deficiency anemia and iron-deficient states.

Do not take Kilor:

• if you are allergic to ferrimanitol ovoalbumin or any of the other components of this medication (listed in section 6).
• 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.
• if you have chronic inflammation of the pancreas 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 diseases, ulcerative colitis, or liver insufficiency.

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

Consult your doctor if any of the previously mentioned circumstances have occurred at any time.

Other medications and Kilor

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

Kilor 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, because 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.

Kilor with food and beverages

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

Pregnancy, breastfeeding, and fertility

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

Studies conducted with ferrimanitol ovoalbumin in pregnant women have not detected any problems for the fetus. There is no data available on the excretion of ferrimanitol ovoalbumin in breast milk.

See the section Kilor contains lactose, saccharose, benzyl alcohol, and sodium to see the effect of benzyl alcohol on pregnancy and breastfeeding.

Driving and operating machinery

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

Kilor contains lactose, saccharose, benzyl alcohol, and sodium

This medication contains lactose and saccharose. If your doctor has indicated 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 packet.

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. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 tablet per day after the main meal. Pour the contents of the tablet into 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 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.

This medication does not require special storage conditions.

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.

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

Kilor Composition

• The active principle is ferrimanitol ovoalbumin. Each sachet contains approximately 600 mg of ferrimanitol ovoalbumin (equivalent to 80 mg of Fe3+).

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

Appearance of the product and content of the packaging

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

Each package contains 15 or 30 sachets.

Only some package sizes may be commercially available.

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 leaflet:September 2021

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/