SORBIFER DURULES

Patient Information Leaflet

Warning! Keep this leaflet. 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 this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

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

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

Sorbifer Durules is used 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 been diagnosed with esophageal stricture or other disorders impairing food passage through the gastrointestinal tract;
• If the patient has excessive iron stores in the body (hemochromatosis, hemosiderosis);
• If the patient has anaemia not caused by iron deficiency;
• If the patient has received repeated blood transfusions.

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

Difficulty swallowing
In case of accidental inhalation of a tablet, contact your doctor as soon as possible. This is due to the risk of developing ulcers and bronchial stricture 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 faeces.

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

Sorbifer Durules and other medicines
Inform your doctor or pharmacist about all medicines currently used 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 any of 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, magnesium carbonate;
• Captopril (a medicine reducing arterial blood pressure);
• Medicines used in the treatment of bone disorders belonging to the group of bisphosphonates, 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 fibre (fibre). Ensure the longest possible interval between taking Sorbifer Durules and consumption of the above-mentioned products.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, only the doses recommended by the 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 (morning
and evening). If necessary due to adverse effects, the dose may be reduced by half (1 tablet per day).
In iron deficiency anemia, the dose may be increased, if needed, up to 3 or 4 tablets per day, divided
into two 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 the 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 individually determine the 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
In case a patient accidentally takes too many tablets, seek immediate medical advice from a doctor
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 correcting iron deficiency without consulting your
doctor. Continue treatment as recommended by the physician to replenish body iron stores
(approximately 2 months). In 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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

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

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

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

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

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylactic reaction). Immediate medical help should be sought;
• severe allergic reaction causing swelling of the face or throat (angioedema). Immediate medical help should be sought;
• skin rash;
• vomiting;
• oral 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, may be at increased risk of throat or oesophagus ulceration (the tube connecting the mouth to the stomach). If a tablet enters the airways, there is a risk of bronchial ulceration (main lung air passages), which may lead to bronchial stenosis.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Sorbifer Durules

Keep this medicine out of 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 container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Sorbifer Durules contains
The active substances are: 100 mg of iron(II) in the form of dried ferrous sulfate, and
60 mg of ascorbic acid in one tablet.
Other ingredients: 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
Prolonged-release tablets, ochre in colour, slightly convex on both sides, with a characteristic odour, marked with the letter "Z" on one side.
Packaged in a brown glass bottle with a polyethylene closure equipped with a tablet immobilizing mechanism, placed in a cardboard box.

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

Responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorization number in Slovakia, country of export: 12/0416/91-S
Parallel Import Authorization number: 312/20