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 carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so 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. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences 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 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 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 narrowing 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 multiple 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 swallowing difficulties occur, contact your doctor.

Swallowing difficulties
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 strictures if the tablet enters the respiratory tract. This may result in persistent cough, coughing up blood, and/or a 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.
This medicine may cause dark discoloration of stools.
Children and adolescents
Sorbifer Durules must not be given 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 any medicines the patient is currently taking, has recently taken, or plans to take.

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 taken concomitantly with the following medicines, dosage adjustments may be necessary. A maximum possible interval (at least 2 hours) should be maintained between the intake of Sorbifer Durules and the following medicines:

• Antacids containing aluminium hydroxide, magnesium carbonate;
• Captopril (a medicine used to lower blood pressure);
• Medicines used in the treatment of bone disorders belonging to 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 taken simultaneously with tea, coffee, eggs, dairy products, whole-grain bread, cereal products, or foods rich in dietary fiber (plant fiber). A maximum possible interval should be maintained between taking Sorbifer Durules and consuming 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 your doctor. If in 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.
Tablets should be taken 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, administered 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 the prevention of iron deficiency (prophylactic use).
In case of iron deficiency, the usual dose is 1 tablet twice daily (morning and evening).
The attending 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
If a patient accidentally takes more tablets than recommended, seek immediate medical advice 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 advised by your doctor 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 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 sores (ulceration) of the oesophageal lining (oesophageal ulcers),
• narrowing (stenosis) of the oesophagus.

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

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylactic reaction). Immediate medical attention is required.
• severe allergic reaction causing swelling of the face or throat (angioedema). Immediate medical attention is required.
• 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 also be at risk of throat or oesophageal ulceration (the tube connecting the mouth to the stomach). If the tablet enters the airways, there is a risk of bronchial ulceration (main lung air passages), which may lead to bronchial stenosis.

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 at the 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 safety of this 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 carton after "expiry date (EXP)". 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 pack and other information

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

What Sorbifer Durules looks like and contents of the pack
Ochre-coloured coated tablets, slightly convex on both sides, marked with the letter "Z" on one side.
Packaged in a brown glass bottle closed with a PE cap equipped with a locking mechanism securing the tablets inside the bottle, placed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Slovakia, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing authorisation number in Slovakia, country of export: 12/0416/91-S
Parallel import authorisation number: 244/22