Sorbifer Durules

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 packaging 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, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• If the patient has esophageal narrowing 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 to use 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
If a tablet is accidentally inhaled, you should contact your doctor as soon as possible. This is because there is a risk of ulcers and esophageal narrowing if the tablet enters the airways. This can result in persistent coughing, coughing up blood, 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, and about 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 be reduced when taken with tea, coffee, eggs, dairy products, wholemeal bread, grain products, and foods high in dietary 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 are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, you should take the doses recommended by your doctor (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 be taken always exactly as instructed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
You should follow the dosing and duration of treatment 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 doctor 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

If you have taken 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 Sorbifer Durules treatment

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.
If you have any further doubts about using 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.

Rare side effects (may affect up to 1 in 1000 people):

• esophageal ulcers (esophageal ulcers),
• esophageal narrowing (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 throat ulcers (esophagus). If a tablet enters the airways, there is a risk of tracheal ulcers (main airways of the lungs), which can cause tracheal narrowing.

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, 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.
By reporting side effects, you can help provide 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 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 month stated.
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 packaging and other information

What Sorbifer Durules contains

The active substances 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.
The coating contains: hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), paraffin.

What Sorbifer Durules looks like and contents of the packaging

Prolonged-release tablets of ochre color, slightly convex on both sides, with a characteristic smell, marked with "Z" on one side.
A brown glass bottle with a PE cap containing 50 prolonged-release tablets, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Slovak Republic, the 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

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Slovak Republic, the country of export:12/0416/91-S
Parallel import authorization number:344/19

Date of leaflet approval: 10.09.2024

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