Sorbifer Durules

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Sorbifer Durules, 100 mg Fe(II) + 60 mg, prolonged-release tablets

Ferrous sulfate + Ascorbic acid

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Sorbifer Durules and what is it used for

Sorbifer Durules contains ferrous sulfate and ascorbic acid, which increases iron absorption.
Sorbifer Durules is used in:

• treatment of iron deficiency anemia;
• treatment of latent iron deficiency;
• prophylaxis during pregnancy.

Sorbifer Durules is used in adults and children over 12 years of age.

2. Important information before taking Sorbifer Durules

When not to take Sorbifer Durules

• If the patient is allergic to ferrous sulfate, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6);
• If the patient has esophageal narrowing or other disorders that make it difficult for food to pass through the digestive tract;
• If the patient has excessive iron stores in the body (hemochromatosis, hemosiderosis);
• If the patient has anemia not caused by iron deficiency;
• If the patient has received multiple blood transfusions.

Warnings and precautions

Before starting treatment with Sorbifer Durules, discuss it with your doctor or pharmacist.

• Due to the risk of oral mucosa ulcers and tooth discoloration, the tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole with water. If it is not possible to follow these instructions or if there are difficulties with swallowing, consult a doctor.

Swallowing difficulties
In case of accidental inhalation of a tablet, consult a doctor as soon as possible.
This is due to the risk of esophageal ulcers and narrowing of the airways if the tablet enters the respiratory tract. This can result in persistent cough, hemoptysis, and (or) shortness of breath, even if the inhalation occurred several days to several months before the onset of these symptoms. Therefore, it should be assessed as soon as possible whether the tablet has damaged the airways.
The medicine may cause dark discoloration of the stool.

Children and adolescents

Sorbifer Durules should not be given to infants and children under 12 years of age.
The medicine can cause poisoning in children.

Sorbifer Durules and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Avoid taking the following medicines at the same time:

• antibiotics (antibacterial medicines) from the fluoroquinolone group (e.g., ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin);
• mycophenolate mofetil, an immunosuppressive medicine;
• antibiotics (antibacterial medicines) from the tetracycline group (e.g., tetracycline, oxytetracycline, doxycycline, minocycline).

If Sorbifer Durules is taken at the same time as the following medicines, it may be necessary to change the dosage of these medicines. Ensure the longest possible interval (at least 2 hours) between taking Sorbifer Durules and the following medicines:

• antacids containing aluminum hydroxide, magnesium carbonate;
• captopril (a medicine that lowers blood pressure);
• medicines used to treat bone disorders from the bisphosphonate group, such as alendronate, clodronate, risedronate;
• thyroid hormones (thyroxine);
• penicillamine (a medicine that binds metals in the body);
• medicines used in the treatment of Parkinson's disease, such as levodopa;
• medicines used to treat high blood pressure containing methyldopa.

Taking Sorbifer Durules with food and drink

Iron absorption may decrease when taken with tea, coffee, eggs, dairy products, wholemeal bread, cereals, and foods high in dietary fiber (plant fiber). Ensure the longest possible interval between taking Sorbifer Durules and consuming these products.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take the doses recommended by your doctor (see section 3).

Driving and using machines

The medicine does not affect the ability to drive or use machines.

3. How to take Sorbifer Durules

Take this medicine always exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Follow the dosage and duration of treatment exactly.
Swallow the tablet whole with water. Do not suck, chew, or keep it in your mouth.
Take the tablets before meals or during meals, depending on gastrointestinal tolerance.
Never take the tablets while lying down.
Adults and adolescents over 12 years of age
The recommended dose for adults and adolescents over 12 years of age is 1 tablet twice a day (morning and evening). If necessary due to side effects, the dose can be reduced by half (1 tablet per day).
In iron deficiency anemia, if necessary, the dose can be increased to 3 or 4 tablets per day, given in two divided doses (morning and evening).

Use in children

Sorbifer Durules should not be given to infants and children under 12 years of age.

Pregnant women

The recommended dose during pregnancy is 1 tablet per day to prevent iron deficiency (prophylactically).
In case of iron deficiency, 1 tablet is usually taken twice a day (morning and evening).
The attending doctor will determine the duration of treatment individually based on the patient's iron metabolism tests.

Use in children (under 12 years of age)

Sorbifer Durules should not be given to infants and children (under 12 years of age).

Overdose of Sorbifer Durules

In case of accidental ingestion of too many tablets, consult a doctor immediately or go to the nearest hospital.
Overdose is particularly dangerous for small children.

Missed dose of Sorbifer Durules

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

Stopping Sorbifer Durules

Do not stop taking the medicine after iron deficiency has been replenished without consulting your doctor, but continue treatment according to your doctor's recommendations to replenish iron stores in the body (about 2 months). In case of symptomatic iron deficiency, treatment usually lasts 3 to 6 months.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sorbifer Durules can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)

• nausea,
• abdominal pain,
• diarrhea,
• constipation.

Uncommon side effects (may affect up to 1 in 100 people)

• esophageal ulcers (esophageal ulcers),
• esophageal narrowing (stenosis).

Frequency not known (cannot be estimated from the available data)

• severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction). Seek medical help immediately;
• severe allergic reaction causing facial or throat swelling (angioedema). Seek medical help immediately;
• skin rash,
• vomiting,
• oral mucosa ulcers (in case of improper use, when tablets are sucked, chewed, or kept in the mouth),
• all patients, but especially elderly patients and patients with swallowing disorders, may also be at risk of esophageal or pharyngeal ulcers (the tube connecting the mouth to the stomach). If the tablet enters the airways, there is a risk of tracheal ulcers (main airways of the lungs), which can cause airway narrowing.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Sorbifer Durules

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

6. Contents of the pack and other information

What Sorbifer Durules contains

The active substances are: 100 mg of iron (II) in the form of 320 mg of dried ferrous sulfate (anhydrous ferrous sulfate) and 60 mg of ascorbic acid in one tablet.
The other ingredients are: povidone K 25, powdered polyethylene, carbomer 934 P, magnesium stearate.
The coating contains: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), paraffin.

What Sorbifer Durules looks like and contents of the pack

Prolonged-release tablets of ochre color, slightly convex on both sides, with the marking "Z" on one side.
A brown glass bottle, closed with a PE cap with a locking mechanism, containing 120 prolonged-release tablets, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest, Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király út 65
9900 Körmend, Hungary

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:6512/2014/10

Parallel import authorization number: 343/22 Date of leaflet approval: 20.09.2022

[Information about the trademark]