Sorbifer Durules

Package Leaflet: Information for the Patient

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

Ferrous sulfate + Ascorbic acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 not listed in this leaflet, they should inform 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 pack 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 for:

• 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 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 treatment with Sorbifer Durules, the patient should discuss it with their doctor or pharmacist.

• Due to the risk of oral mucosa ulcers and tooth discoloration, the tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole with water. If following these instructions is not possible or there are difficulties with swallowing, the patient should contact their doctor.

Difficulty swallowing
In case of accidental inhalation of a tablet, the patient should contact their doctor as soon as possible. This is due to the risk of esophageal ulcers and narrowing of the airways if the tablet enters the respiratory tract. 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient 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. The patient 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. The patient should ensure the longest possible interval between taking Sorbifer Durules and consuming these products.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, the patient should take the recommended dose (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 exactly as instructed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The patient 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 for the prevention of iron deficiency (prophylactically).
In case of iron deficiency, 1 tablet is usually taken twice a day (morning and evening).
The treating 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 more than the recommended dose of Sorbifer Durules

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

Missing a dose of Sorbifer Durules

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

Stopping treatment with Sorbifer Durules

The patient should not stop taking the medicine after iron deficiency has been replenished without consulting their doctor, but should continue treatment according to the 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 taking this medicine, the patient should consult their 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 narrowing (stenosis).

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

• severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction). The patient should seek medical help immediately.
• severe allergic reaction causing swelling of the face or throat (angioedema). The patient should seek medical help immediately.
• skin rash,
• vomiting,
• oral ulcers (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 (the tube connecting the mouth to the stomach). If a tablet enters the airways, there is a risk of tracheal ulcers (main airways of the lungs), which can cause narrowing of the airways.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Sorbifer Durules

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiration date stated on the carton after "expiration date (EXP)". The expiration date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sorbifer Durules contains

The active substances of the medicine are: 100 mg of iron(II) in the form of ferrous sulfate and 60 mg of ascorbic acid in one tablet .
The other ingredients are:
Core: 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 contents of the pack

The tablets are ochre-colored, slightly convex on both sides, with the marking "Z" on one side.
A brown glass bottle with a white PE cap, containing 30, 40, 50, 60, 70, or 80 prolonged-release tablets, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary

Manufacturer

Egis Pharmaceuticals PLC
Mátyás király út 65
9900 Körmend
Hungary
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw

Date of last revision of the leaflet: