Sorbifer durules

Package leaflet: Information for the patient

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 the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Sorbifer Durules is and what it is 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 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 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 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 difficulty swallowing occurs, contact your doctor.

Difficulty swallowing
In case of accidental inhalation of the tablet, contact your doctor as soon as possible. This is because of 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 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.

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 medicine;
• antibiotics (antibacterial agents) of the tetracycline group (e.g. tetracycline, oxytetracycline, doxycycline, minocycline).

When Sorbifer Durules is taken concomitantly with any of 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:

• acid-neutralizing agents containing aluminium hydroxide or magnesium carbonate;
• captopril (a medicine used to lower 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 (fiber). Allow 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 baby, 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 doctor. If in 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 (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, if needed, the dose may be increased to 3 or 4 tablets per day, administered in two divided doses (in the 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 (in the morning and evening) is usually prescribed.
The treating physician will determine the individual duration of treatment based on laboratory tests assessing iron metabolism 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, seek immediate medical advice from a doctor 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 stop taking the medicine immediately after correcting iron deficiency without consulting the doctor. Continue treatment as advised by the 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 will experience 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 1000 patients):

• esophageal mucosal ulcers (esophageal ulcers),
• narrowing (stenosis) of the esophagus.

Adverse reactions with unknown frequency (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 esophageal ulceration (the tube connecting the mouth to the stomach). If the tablet enters the airways, there may be a risk of bronchial ulceration (main lung airways), 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 a doctor, pharmacist or nurse. Adverse reactions can 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, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of this 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 container. 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. Contents of the packaging and other information

What the medicine Sorbifer Durules contains
The active substances are: 100 mg of iron(II) ions in the form of dried iron(II) sulfate 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, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172),
white 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 bottle closed with a PE screw cap equipped with a tamper-evident seal, containing 30, 40, 50,
60, 70, 80, 90, 100, 110 or 120 coated tablets, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.

Responsible party 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:
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 Synoptis Industrial Sp. z o.o.
Działkowa Street 56 Forteczna Street 35-37
02-234 Warsaw 87-100 Toruń
Poland

Marketing authorisation numbers in Romania, country of export:
6512/2014/01
6512/2014/02
6512/2014/03
6512/2014/04
6512/2014/05
6512/2014/06
6512/2014/07
6512/2014/08
6512/2014/09
6512/2014/10

Parallel import authorisation number: 320/24