Sorbifer durules

Package leaflet: Information for the user

Warning! Keep the leaflet – the outer packaging label 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 using 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 someone else, 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. 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 the treatment of iron deficiency anaemia,
• for the treatment of latent iron deficiency,
• for prophylaxis during pregnancy.

Sorbifer Durules is indicated 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 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, do not suck, chew, or hold the tablet in the mouth; swallow it whole with water. If following this instruction is not possible or if you have difficulty swallowing, contact your doctor.

Difficulty swallowing
If the tablet is accidentally aspirated, contact your doctor as soon as possible. This is because of the risk of developing ulcers and narrowing of the airways if the tablet enters the respiratory tract. This may result in persistent cough, coughing up blood, and/or sensation of breathlessness, even if aspiration 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 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 and 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.
Avoid concomitant use with the following medicines:

• 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 aluminum hydroxide, 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 taken simultaneously with tea, coffee, eggs, dairy products, wholemeal bread, cereal products, and foods rich in dietary fiber (plant 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 child, she should consult her doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, take only the doses recommended by the doctor (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 a
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, 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 administered.
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
If the patient accidentally takes too many tablets, contact a doctor immediately or go to the nearest
hospital. Overdose is particularly dangerous for young children.

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

Discontinuation of Sorbifer Durules
Do not discontinue treatment after correcting iron deficiency without consulting the physician. Continue
treatment as directed 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.
Adverse reactions that are common (may occur in up to 1 in 10 patients):

• nausea;
• abdominal pain;
• diarrhoea;
• constipation.

Adverse reactions that are rare (may occur in up to 1 in 1000 patients):

• open lesions of the oesophageal mucosa (oesophageal ulcers);
• narrowing (stenosis) of the oesophagus.

Adverse reactions with unknown 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 also 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 respiratory airways of the lungs), which may lead to bronchial stenosis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 Sorbifer Durules

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
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. Contents of the packaging and other information

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

What Sorbifer Durules looks like and contents of the packaging
Prolonged-release tablets, ochre in colour, slightly convex on both sides, marked with the letter "Z" on one side.
Brown glass bottle closed with a PE cap equipped with a tamper-evident device immobilizing the tablets, containing 120 prolonged-release tablets, packed in a cardboard box.

For further detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Romania, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

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

Marketing Authorisation number in Romania, country of export: 6512/2014/10
Parallel import licence number: 106/25