Sorbifer durules
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this 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 the following information 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, ask 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 reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of Contents:
- What Sorbifer Durules is and what it is used for
- Important information before taking Sorbifer Durules
- How to take Sorbifer Durules
- Possible side effects
- How to store Sorbifer Durules
- 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 anemia;
- treatment of latent iron deficiency;
- prophylaxis during pregnancy.
Sorbifer Durules is intended for use in adults and children aged 12 years and older.
2. Important information before taking Sorbifer Durules
When not to take Sorbifer Durules
- If the patient is allergic to iron(II) 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, 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 is difficult, contact your doctor. Page 1 of 5
Difficulty swallowing
If a tablet is accidentally aspirated, contact your doctor as soon as possible. This is because there is a risk of developing bronchial ulcers and strictures if the tablet enters the respiratory tract. This may result in persistent cough, coughing up blood, and/or a feeling of breathlessness, even if the aspiration occurred several days to several months earlier. Therefore, it is essential to promptly evaluate 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.
This 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.
Concomitant use should be avoided 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 consuming tea, coffee, eggs, dairy products, wholemeal bread, cereal products, and foods rich in dietary fiber (plant fiber). Ensure the longest possible time interval 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 baby, 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
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This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Strictly follow the dosage and duration of treatment instructions.
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 must 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 (prophylactically).
In case of iron deficiency, 1 tablet twice daily (morning and evening) is usually recommended.
The treating physician will determine the individual duration of treatment based on iron metabolism test results.
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 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.
Stopping treatment with Sorbifer Durules
Do not discontinue treatment immediately after correcting iron deficiency without consulting your doctor. Continue treatment as directed by your doctor 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.
Common 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 1,000 patients):
- open lesions of the oesophageal lining (oesophageal ulcers),
- narrowing (stenosis) of the oesophagus.
Adverse reactions with unknown frequency (frequency cannot be determined 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 cavity ulceration (in case of incorrect 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 additional 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 (the 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 this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions allows the collection of further 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 Sorbifer Durules after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should 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 package and other information
What Sorbifer Durules contains
The active substances are: 100 mg of iron(II) in the form of 320 mg of dried ferrous sulfate and 60 mg of ascorbic acid per tablet.
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Other ingredients:
Tablet core: povidone K 25, polyethylene powder, carbomer 934 P, magnesium stearate.
Coating composition: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172),
solid paraffin.
What Sorbifer Durules looks like and contents of the pack
Prolonged-release tablets, ochre-coloured, slightly convex on both sides, marked with the letter "Z" on one side.
Brown glass bottle closed with a PE screw cap equipped with a compensator, placed in a cardboard box. The bottle contains 120 prolonged-release tablets.
For more 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:
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 Authorisation number in Romania, country of export: 6512/2014/10
Parallel Import Licence number: 153/24
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