Sorbifer durules

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Sorbifer Durules
100 mg Fe(II) + 60 mg, prolonged-release tablets
Ferrosi sulfas + Acidum ascorbicum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Sorbifer Durules is and what it is used for
2. What you need to know 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 Sorbifer Durules is and what it is used for

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

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

Sorbifer Durules is intended for use in adults and children above 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 stricture or other disorders impairing gastrointestinal motility;
• 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 repeated blood transfusions.

Warnings and precautions
Before starting treatment with Sorbifer Durules, consult a doctor or pharmacist.
Due to the risk of oral ulceration and tooth discoloration, tablets must not be sucked, chewed, or held in the mouth. Instead, they should be swallowed whole with water. If following this instruction is not possible or if swallowing difficulties occur, contact a doctor.

Swallowing difficulties
In case of accidental inhalation of the tablet, contact a doctor as soon as possible. This is because there is a risk of developing bronchial ulcers and strictures if the tablet enters the respiratory tract. This may result in persistent cough, coughing up blood, and/or sensation of breathlessness, even if the inhalation occurred several days to several months earlier. Therefore, it is essential to promptly assess whether the tablet has damaged the respiratory tract.

The medicine may cause dark discoloration of the stool.

Children and adolescents
Sorbifer Durules must not be administered to infants or children under 12 years of age.
Sorbifer Durules may cause poisoning in children.

Sorbifer Durules and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Concomitant use with the following medicines should be avoided:

• Antibiotics (antibacterial agents) of the fluoroquinolone group (e.g. ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin);
• Mycophenolate mofetil, an immunosuppressive agent;
• Antibiotics (antibacterial agents) of the tetracycline group (e.g. tetracycline, oxytetracycline, doxycycline, minocycline).

When Sorbifer Durules is used concomitantly with the following medicines, dosage adjustments may be necessary. Ensure the longest possible interval (at least 2 hours) between taking Sorbifer Durules and the following medicines:

• Antacids containing aluminium hydroxide or magnesium carbonate;
• Captopril (a medicine used to reduce blood pressure);
• Bone disorder treatments of the bisphosphonate group, such as alendronate, clodronate, risedronate;
• Thyroid hormones (thyroxine);
• Penicillamine (a metal-chelating agent);
• Medicines used in Parkinson's disease, such as levodopa;
• Antihypertensive medicines containing methyldopa.

Taking Sorbifer Durules with food and drink
Iron absorption may be reduced when consuming tea, coffee, eggs, dairy products, wholemeal bread, cereal products, or foods rich in plant fiber (fiber). Ensure the longest possible interval between taking Sorbifer Durules and consuming these products.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, only the doses recommended by a doctor should be taken (see section 3).

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to take Sorbifer Durules

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Strictly follow the prescribed dosage and duration of treatment.
The tablet should be swallowed whole with water. Do not suck, chew, or hold the tablet in the mouth.
Take tablets before or during meals, depending on gastrointestinal tolerance.
Tablets should never be taken 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 daily (in the
morning and evening). If necessary due to adverse effects, the dose may be reduced by half (1 tablet
per day).
In iron deficiency anaemia, the dose may be increased, if needed, up to 3 or 4 tablets per day, given
in two divided doses (morning and evening).

Use in children
This medicine must not be given to infants or children under 12 years of age.

Pregnant women
The recommended dose during pregnancy is 1 tablet per day for prevention of iron deficiency
(prophylactic use).
In case of iron deficiency, 1 tablet twice daily (morning and evening) is usually prescribed.
The treating physician will determine the individual duration of treatment based on iron metabolism
tests in the patient.

Use in children (under 12 years of age)
This medicine must not be given to infants or children under 12 years of age.

Accidental overdose of Sorbifer Durules
If a patient accidentally takes too many tablets, contact a doctor immediately or go to the nearest
hospital.
Overdose is particularly dangerous in young children.

Missed dose of Sorbifer Durules
Do not take a double dose to make up for a missed dose.

Stopping treatment with Sorbifer Durules
Do not discontinue treatment immediately after correction of iron deficiency without consulting your
doctor. Continue treatment as advised by the physician to replenish body iron stores (approximately
2 months). In cases of symptomatic iron deficiency, treatment usually lasts 3 to 6 months.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions (may occur in up to 1 in 10 patients):

• nausea,
• abdominal pain,
• diarrhoea,
• constipation.

Uncommon adverse reactions (may occur in up to 1 in 1,000 patients):

• open lesions of the oesophageal lining (oesophageal ulcers),
• narrowing (stenosis) of the oesophagus.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylactic reaction). Seek immediate medical help.
• severe allergic reaction causing swelling of the face or throat (angioedema). Seek immediate medical help.
• skin rash.
• vomiting.
• oral cavity ulceration (in case of improper use, when tablets are sucked, chewed, or held in the mouth).
• All patients, but especially elderly patients and patients with swallowing disorders, are additionally at risk of developing ulcers in the throat or oesophagus (the tube connecting the mouth to the stomach). If a tablet enters the airways, there is a risk of bronchial ulceration (in the main respiratory passages of the lungs), which may lead to bronchial narrowing.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Sorbifer Durules

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must 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. Package contents and other information

What Sorbifer Durules contains
The active substances in the medicine are: 100 mg of iron(II) in the form of dried ferrous sulfate and
60 mg of ascorbic acid in one tablet.
Other ingredients are:
Tablet core: povidone K 25, polyethylene powder, carbomer 934 P, magnesium stearate.
Coating composition: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172),
paraffin wax.

What Sorbifer Durules looks like and contents of the pack
Ochre-coloured, slightly biconvex tablets with the mark "Z" on one side.
The medicine comes in brown glass bottles closed with a PE cap equipped with a locking mechanism preventing tablet movement inside the bottle, containing 50 prolonged-release tablets, packed in a cardboard box.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible entity in Slovakia, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Mátyás király u 65.
9900 Körmend
Hungary

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization number in Slovakia, country of export: 12/0416/91-S
Parallel import authorization number: 12/21