Sorbifer Durules

Package Leaflet: Information for the Patient

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

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

• Keep this leaflet, so you can read it again if you need to.
• 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 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 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 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, the patient should discuss it with their 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, 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 stenosis if the tablet enters 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 is necessary to assess 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 (anti-bacterial medicines) from the fluoroquinolone group (e.g., ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin);
• mycophenolate mofetil, an immunosuppressive medicine;
• antibiotics (anti-bacterial 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 be taken strictly according to the doctor's instructions. In case of doubts, the patient should contact 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 case of 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).

Overdose 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.

Missed dose of Sorbifer Durules

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

Stopping 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.
If the patient has any further doubts about taking this medicine, they 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.

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

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

Side effects of unknown frequency (cannot be estimated from the 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 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 (ulcers of the tube connecting the mouth to the stomach). If a tablet enters the airways, there is a risk of tracheal ulcers (ulcers of the main airways of the lungs), which can cause tracheal stenosis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 or parallel importer.
Reporting side effects will help to gather more information on the safety of the 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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) ions in the form of dried ferrous sulfate and 60 mg of ascorbic acid in one tablet.
The other ingredients are:
Tablet 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, closed with a PE cap with a compensator, containing 30, 40, 50, 60, 70, 80, 90, 100, 110, or 120 film-coated tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the 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.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń

Marketing authorization number in Romania, the 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 authorization number: 320/24

Date of leaflet approval: 07.08.2024

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