Ascofer

Package Leaflet: Information for the Patient

ASCOFER, 23.2 mg iron(II) ions, coated tablets

Ferrous gluconate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 30 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Ascofer and what is it used for
• 2. Important information before taking Ascofer
• 3. How to take Ascofer
• 4. Possible side effects
• 5. How to store Ascofer
• 6. Contents of the pack and other information

1. What is Ascofer and what is it used for

Ascofer coated tablets contain 200 mg of iron(II) gluconate hydrate, which corresponds to 23.2 mg of iron(II) ions, and are used to supplement iron deficiencies in the body. Iron deficiencies can disrupt the production of red blood cells and tissue respiration by reducing the amount of oxygen-carrying proteins (hemoglobin and myoglobin).

Indications for use:

• Iron deficiency conditions associated with blood loss;
• Conditions with increased demand for iron (in children during intense growth, during pregnancy and breastfeeding);
• Conditions related to impaired absorption or a diet low in iron.

2. Important information before taking Ascofer

When not to take Ascofer:

Warnings and precautions

Before starting to take Ascofer, the patient should discuss it with their doctor or pharmacist.

• do not exceed the recommended doses of the medicine, especially in children;
• do not take Ascofer on the basis of suspected iron deficiency in the body (it should be confirmed);
• do not take iron-containing medicines for long periods without a doctor's recommendation, as this may lead to harmful accumulation of excess iron in the body;
• inform the doctor if the patient has liver inflammation or liver function disorders, kidney diseases, intestinal inflammation, or active gastric and/or duodenal ulcer disease;
• taking the medicine may cause black discoloration of stools due to the presence of unabsorbed iron; this does not affect the efficacy of the medicine and does not pose a health risk;
• in elderly patients, there is an increased risk of side effects.

Ascofer with other medicines

Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Iron absorption is reduced by antacids, some antibiotics (e.g., tetracycline derivatives, neomycin), cholestyramine, magnesium trisilicate, trientine, entacapone, proton pump inhibitors, calcium and bismuth salts, and pancreatic extracts.
Absorption of iron salts and tetracycline antibiotics may be reduced when these medicines are taken together.
Absorption of iron and zinc may be reduced when taken together.
Absorption of iron is increased in the presence of ascorbic acid (vitamin C).
Oral iron compounds weaken the effect of methyldopa, levodopa, carbidopa, bisphosphonates, and thyroxine (exacerbate hypothyroidism symptoms).
Iron reduces the absorption of penicillamine, fluoroquinolones (ciprofloxacin, norfloxacin, levofloxacin, ofloxacin), and mycophenolate mofetil (a medicine used in transplant patients).
The antibiotic chloramphenicol may delay the effect of iron.
Avoid combining iron with dimercaprol.
Concomitant use of medicines containing carbonates, bicarbonates, oxalates, or phosphates reduces iron absorption.
When taking oral iron preparations, maintain an interval of at least one hour before or two hours after the mentioned medicines.

Ascofer with food and drink

It is not recommended to take the medicine at the same time as coffee, tea, eggs, food containing carbonates, bicarbonates, oxalates, or phosphates, milk or its products, whole grain bread or cereal flakes, and other products containing fiber, as they may reduce iron absorption.
Do not take oral iron preparations within one hour before or two hours after consuming the mentioned food products.

Taking Ascofer in patients with kidney or liver function disorders

Before taking the medicine, consult a doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.

Driving and using machines

Ascofer does not affect the ability to drive or operate machines.

Ascofer contains the azo dye Allura Red AC, lake (E 129)

The medicine may cause allergic reactions.

3. How to take Ascofer

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
Recommended dose

Adults

Therapeutically: usually 2 coated tablets three times a day during or after meals; in significant deficiencies, 2 coated tablets four times a day.
Prophylactically: about 60 mg of iron (3 coated tablets) per day in divided doses.

Use in children

Therapeutically in children over 3 years: 4 mg to 6 mg of iron per kg of body weight per day in divided doses.
Prophylactically: 2 mg per kg of body weight per day in divided doses.
Achieving the full therapeutic effect requires regular and prolonged use.

Taking a higher dose of Ascofer than recommended

In case of taking a higher dose than recommended, consult a doctor or pharmacist.
In case of taking a significantly higher dose than recommended (e.g., by a child), immediately go to a clinic or hospital, as swallowing a large number of tablets may cause severe poisoning.

Missing a dose of Ascofer

Do not take a double dose to make up for a missed dose.

Stopping Ascofer treatment

Ascofer should be taken as directed by the doctor. Do not stop treatment without consulting a doctor.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders:
Diarrhea, constipation, nausea, vomiting, heartburn, abdominal pain.
In such cases, it is recommended to reduce the dose of the medicine.
Immune system disorders
Allergic reactions.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ascofer

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ascofer contains:

• The active substance of the medicine is iron(II) gluconate hydrate in a dose of 200 mg, which corresponds to 23.2 mg of iron ions. 1 coated tablet contains 200 mg of iron(II) gluconate hydrate.
• The other ingredients (excipients) are: ascorbic acid, talc, potato starch, stearic acid, propylene glycol, and the AquaPolish P red coating with the composition: hypromellose, hydroxypropyl cellulose, macrogol, saturated fatty acid triglycerides, talc, titanium dioxide (E 171), Allura Red AC, lake (E 129), iron oxide black (E 172), iron oxide red (E 172).

What Ascofer looks like and what the pack contains

The pack contains 50 coated tablets (2 blisters of 25 coated tablets each).

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208,
30-133 Kraków, Poland
phone: 12 639 27 27

Information for the blind and visually impaired: 800-007-777

Date of the last update of the leaflet: