Sorbifer durules

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging 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 using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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

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 indicated for:

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

Sorbifer Durules is intended for use 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 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 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
If a tablet is accidentally inhaled, contact your doctor as soon as possible. This is because of the risk of 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 inhalation occurred several days to several months earlier. Therefore, it is important to promptly assess whether the tablet has damaged the respiratory tract.
This medicine may cause darkening of the stool.

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

Sorbifer Durules and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 medicine;
• 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, a dose adjustment may be necessary. A maximum interval (at least 2 hours) should be maintained between taking Sorbifer Durules and the following medicines:

• antacids containing aluminium hydroxide, magnesium carbonate;
• captopril (a medicine used to reduce 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 medicine);
• 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, wholemeal bread, cereal products, and foods rich in dietary fibre (plant fibre). A maximum 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 using machines
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.
Tablets should be taken before meals 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, 1 tablet twice daily (morning and evening) is usually administered.
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 the 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 correcting 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone 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 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 developing ulcers in the throat or oesophagus (the tube connecting the mouth to the stomach). If a tablet enters the airways, there may be a risk of bronchial ulceration (in the main lung airways), which could lead to bronchial narrowing.

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 Adverse Drug Reactions at 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
Adverse effects may also be reported to the marketing authorisation holder or the parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sorbifer Durules

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in a tightly closed container 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 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 the medicine Sorbifer Durules contains
The active substances in the medicine are: 100 mg of iron(II) ions in the form of 320 mg of hydrated iron(II) sulfate
and 60 mg of ascorbic acid in one tablet.
Other ingredients are:
Tablet core: povidone K 25, polyethylene, carbomer 934 P, magnesium stearate.
Coating layer: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172),
and hardened paraffin.

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.
The tablets are packed in extended-release formulation.
Brown glass bottles with white tamper-evident closure made of PE and flexible PE insert, containing 30, 40, 50, 60, 70, 80, 90, 100, 110 or 120 tablets, packed in a cardboard box.

For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, 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:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego Street 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
and
Synoptis Industrial Sp. z o.o.
Forteczna Street 35-37
87-100 Toruń
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 12/416/91-S/C
Parallel Import Licence Number: 319/24