Sorbifer Durules

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Sorbifer Durules

100 mg Fe(II) + 60 mg, prolonged-release tablets

Ferrous sulfate + Ascorbic acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sorbifer Durules and what is it 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 package and other information

1. What is Sorbifer Durules and what is it used for

Sorbifer Durules contains ferrous sulfate and ascorbic acid, which increases iron absorption.
Sorbifer Durules is used in:

• treatment of iron deficiency anemia,
• treatment of latent iron deficiency,
• prophylaxis during pregnancy.

Sorbifer Durules is used 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 (II), ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• If the patient has esophageal stenosis or other disorders that make it difficult for food to pass through the digestive 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, you should discuss it with your doctor or pharmacist.

• Due to the risk of oral mucosa ulceration and tooth discoloration, the tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole, with water. If it is not possible to follow these instructions or if there are difficulties with swallowing, you should contact your doctor.

Swallowing difficulties
In case of accidental inhalation of a tablet, you should contact your doctor as soon as possible.
This is because there is a risk of esophageal ulcers and stenosis if the tablet gets into the airways. This can result in persistent cough, hemoptysis, and (or) shortness of breath, even if the inhalation occurred several days to several months before the onset of these symptoms. Therefore, it should be assessed as soon as possible whether the tablet has damaged the airways.
The medicine may cause dark discoloration of the stool.

Children and adolescents

Sorbifer Durules should not be given to infants and children under 12 years of age. The medicine can cause poisoning in children.

Sorbifer Durules and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should avoid taking the following medicines at the same time:

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

If Sorbifer Durules is taken at the same time as the following medicines, it may be necessary to change the dosage of these medicines. You should 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 that lowers blood pressure);
• medicines used to treat bone disorders from the bisphosphonate group, such as alendronate, clodronate, risedronate;
• thyroid hormones (thyroxine);
• penicillamine (a medicine that binds metals in the body);
• medicines used to treat Parkinson's disease, such as levodopa;
• medicines used to treat high blood pressure containing methyldopa.

Taking Sorbifer Durules with food and drink

Iron absorption may decrease when taken with tea, coffee, eggs, dairy products, wholemeal bread, cereals, and foods high in dietary fiber (plant fiber). You should ensure the longest possible interval between taking Sorbifer Durules and consuming these products.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, you should take the recommended doses (see section 3).

Driving and using machines

The medicine does not affect the ability to drive or use machines.

3. How to take Sorbifer Durules

This medicine should always be taken strictly according to the doctor's instructions. In case of doubts, you should consult your doctor or pharmacist.
You should follow the dosage and treatment duration exactly.
The tablet should be swallowed whole, with water. It should not be sucked, chewed, or kept in the mouth.
The tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
The 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 a day (morning and evening). If necessary, due to side effects, the dose can be reduced by half (1 tablet per day).
In iron deficiency anemia, if necessary, the dose can be increased to 3 or 4 tablets per day, given in two divided doses (morning and evening).

Use in children

Sorbifer Durules should not be given to infants and children under 12 years of age.

Pregnant women

The recommended dose during pregnancy is 1 tablet per day to prevent iron deficiency (prophylactically).
In case of iron deficiency, 1 tablet is usually taken twice a day (morning and evening).
The attending physician will determine the duration of treatment individually based on the patient's iron metabolism tests.

Use in children (under 12 years of age)

Sorbifer Durules should not be given to infants and children (under 12 years of age).

Taking a higher dose of Sorbifer Durules than recommended

In case of accidental ingestion of too many tablets, you should contact your doctor or go to the nearest hospital immediately. Overdose is particularly dangerous for small children.

Missing a dose of Sorbifer Durules

You should not take a double dose to make up for a missed dose.

Stopping treatment with Sorbifer Durules

You should not stop taking the medicine after iron deficiency has been replenished without consulting your doctor, but continue treatment according to your doctor's recommendations to replenish iron stores in the body (about 2 months). In case of symptomatic iron deficiency, treatment usually lasts 3 to 6 months.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sorbifer Durules can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• nausea,
• abdominal pain,
• diarrhea,
• constipation.

Uncommon side effects (may affect up to 1 in 100 people):

• esophageal ulcers (esophageal ulcers),
• esophageal stenosis.

Side effects with unknown frequency (cannot be estimated from the available data):

• severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction). You should seek medical help immediately.
• severe allergic reaction causing facial or throat swelling (angioedema). You should seek medical help immediately.
• skin rash,
• vomiting,
• oral mucosa ulceration (in case of improper use, when tablets are sucked, chewed, or kept in the mouth).
• All patients, but especially elderly patients and patients with swallowing disorders, may also be at risk of esophageal or pharyngeal ulcers (the tube connecting the mouth to the stomach). If a tablet gets into the airways, there is a risk of tracheal ulcers (main airways of the lungs), which can cause tracheal stenosis.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Sorbifer Durules

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the package and other information

What Sorbifer Durules contains

The active substances of the medicine are: 100 mg of iron (II) in the form of iron (II) sulfate, dried, and 60 mg of ascorbic acid in one tablet .
The other ingredients are: povidone K 25, polyethylene powder, carbomer 934 P, magnesium stearate.
Coating: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172),
paraffin wax.

What Sorbifer Durules looks like and what the package contains

The tablets are ochre-colored, slightly convex on both sides, with the marking "Z" on one side.
A brown glass bottle with a PE cap with a locking mechanism that holds the tablets in the bottle, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Slovakia, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király u 65.
9900 Körmend
Hungary

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Slovakia, the country of export: 12/0416/91-S

Parallel import authorization number: 244/22 Date of approval of the leaflet: 03.06.2022

[Information about the trademark]