Sorbifer durules

Patient Information Leaflet

Warning! Keep this leaflet! 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 this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• 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

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 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 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 repeated blood transfusions.

Warnings and precautions
Before starting treatment with Sorbifer Durules, consult 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.
Swallowing difficulties
If a tablet is accidentally inhaled, contact your doctor as soon as possible. This is because of the risk of developing bronchial ulcers and narrowing of the airways 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 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 darkening of the stool.
Children and adolescents
Sorbifer Durules must not be given to infants or children under 12 years of age.
Sorbifer Durules may cause poisoning in children.
Sorbifer Durules and other medicines
Inform your doctor or pharmacist about any medicines currently taken or recently taken, as well as any medicines planned for future use.
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 agent;
• antibiotics from 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:

• antacids containing aluminium hydroxide or magnesium carbonate;
• captopril (a medicine used to lower blood pressure);
• bone disorder treatments from 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, or foods rich in dietary fibre (plant fibre). A sufficiently long interval should be maintained between taking Sorbifer Durules and consuming these foods.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, the dose 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

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.
Take the tablets 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 (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 daily, given 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, usually 1 tablet twice daily (morning and evening) is recommended.
The attending 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 of accidental ingestion of an excessive number of 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 recommended by the physician to replenish body iron stores (approximately
2 months). In 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 will experience them.

Adverse reactions occurring frequently (may affect up to 1 in 10 patients):

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

Adverse reactions occurring rarely (may affect up to 1 in 1000 patients):

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

Adverse reactions with unknown frequency (frequency cannot be estimated from the 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 mucosal 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 is a risk of bronchial ulceration (in the main lung air passages), which may 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 the medicine out of sight and reach of children.
Store below 25°C in the original packaging 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Sorbifer Durules contains
The active substances in the medicine are: 100 mg of iron(II) in the form of dried ferrous sulfate, and
60 mg of ascorbic acid in one tablet.
Other ingredients: povidone K 25, polyethylene powder, carbomer 934 P, magnesium stearate.
Coating composition: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (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, with a characteristic odour, marked with the letter "Z" on one side.
A brown glass bottle closed with a polyethylene cap containing 50 prolonged-release tablets, placed in a cardboard box.

For more detailed information, please contact the responsible party or parallel importer.

Responsible party in the Slovak Republic, country of export:
Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary

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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Authorisation number in the Slovak Republic, country of export: 12/0416/91-S
Parallel import authorisation number: 344/19