Sorbifer durules

Package leaflet: Information for the user

Warning! Keep this leaflet, information on the immediate 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 to be able to read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• 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 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 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 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, 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
If a tablet is accidentally aspirated, contact a doctor as soon as possible. This is because of the risk of bronchial ulcers and narrowing if the tablet enters the respiratory tract. This may result in persistent cough, coughing up blood, and/or a feeling of breathlessness, even if aspiration 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 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use with the following medicines should be avoided:

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

When Sorbifer Durules is taken concomitantly with 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 aluminum hydroxide, magnesium carbonate;
• captopril (a medicine for lowering blood pressure);
• bisphosphonates used in the treatment of bone disorders, 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 plant fiber (dietary fiber). A maximum interval should be maintained 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 become pregnant, 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 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.
Always follow carefully 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 (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 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 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 individually 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, 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 recommended by your 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 everybody gets them.

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

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

Rare adverse reactions (may occur in up to 1 in 1000 patients):

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

Adverse reactions of unknown 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 additionally be at risk of throat or oesophageal ulceration (the tube connecting the mouth to the stomach). If a tablet enters the airways, there may be a risk of bronchial ulceration (main lung airways), which could lead to bronchial stenosis.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 the medicine.

5. How to store the medicine Sorbifer Durules

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep in a tightly closed bottle 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 in use. This will help protect the environment.

6. Package contents and other information

What Sorbifer Durules contains
The active substances in this medicinal product are: 100 mg of iron(II) ions in the form of dried iron(II) sulfate
(iron(II) sulfate monohydrate) and 60 mg of ascorbic acid in one tablet.
Other components:
Tablet core: povidone K 25, polyethylene, carbomer 934, magnesium stearate.
Coating layer: hypromellose, polyethylene glycol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), solid 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.
Brown glass bottles with white tamper-evident closure made of PE and flexible PE insert, packed in a cardboard box containing 30, 60, or 100 prolonged-release tablets.

For more 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
1106 Budapest, Keresztúri út 30-38.
Hungary

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

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

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

Marketing authorisation number in the Czech Republic, country of export: 12/416/91-S/C
Parallel import authorisation number: 44/24