ferrous sulfate 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if you do not feel better or if you feel worse.

This leaflet contains information on the following:

  1. What Duroferon is and what it is used for
  2. What you need to know before you use Duroferon
  3. How to use Duroferon
  4. Any side effects are
  5. How to store Duroferon
  6. Package contents and other information

1. WHAT DUROFERON IS AND WHAT IT IS USED FOR

Duroferon contains iron that is released at a steady rate for a long time, which makes it easier for the body to assimilate it.

Duroferon is used for anemia (iron deficiency anemia) and the prevention of pregnant women and blood donors.

BEFORE YOU USE DUROFERON

Do not use Duroferon

  • if you are hypersensitive to ferrous sulfate or any of the other ingredients of this medicine (listed in section 6).
  • if you have difficulty swallowing or have narrowing of the esophagus, iron tablets can get stuck and cause damage.

Warnings and cautions

Talk to your doctor before taking Duroferon if you:

– have an inflammatory bowel disease (such as enteritis, colitis, ulcerative colitis, Crohn’s disease )

– have difficulty swallowing

Due to the risk of mouth sores and discoloration of the teeth, the tablets must not be sucked, chewed, or kept in the mouth, but must be swallowed whole with water. Talk to your doctor if you can not follow these instructions.

If you accidentally put a tablet in your throat, contact a doctor immediately as there is a risk of ulcers and narrowing of the trachea if the tablet enters the airways. Symptoms of this include persistent cough, coughing up of blood, and/or difficulty in breathing. The symptoms may come days or months after you put the tablet in your throat. Therefore, you must be examined quickly to check that the tablet has not damaged your airways.

Always keep iron medicines out of the reach of children as iron tablets can cause poisoning in young children.

Iron medicines can darken the stool.

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Some medicines may affect or be affected by treatment with Duroferon, for example:

  • medicines for heartburn and acid reflux containing aluminum hydroxide and magnesium carbonate (antacids). The effect of Duroferon may be impaired if taken at the same time. The drugs should therefore be taken at least 2 hours apart.
  • drugs that contain thyroid hormones (thyroid hormones). Duroferon reduces the effect of these medicines if taken at the same time. The drugs should therefore be taken at least 2 hours apart.
  • certain medicines for infection ( tetracyclines ). Duroferon reduces the effect of these medicines if taken at the same time. The drugs should therefore be taken at least 3 hours apart.
  • other medicines for infection (eg ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin)
  • medicines for high blood pressure ( captopril, methyldopa)
  • medicines for Parkinson’s disease ( levodopa )
  • medicines for inflammation and rheumatism (penicillamine)
  • drugs for skeletal diseases (alendronate, clodronate, risedronate)
  • drugs that prevent rejection of transplanted organs (mycophenolate mofetil)

Pregnancy and breastfeeding

Duroferon can be used during pregnancy and lactation.

Driving and using machines

Duroferon does not affect the ability to drive or use machines.

3. HOW TO USE DUROFERON

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose in case of anemia in adults: 1 tablet morning and evening.

Prevention during pregnancy: 1 tablet in the evening.

Another dose according to the doctor’s prescription.

Swallow the tablet whole with water. The tablet must not be sucked, chewed, or kept in the mouth. The tablet should be taken in an upright position (sitting or standing).

If you use more Duroferon then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Duroferon

Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common ( may affect more than 1 person in 100 people ): Some people have a looser or slower stool than normal from iron medicines. Nausea and abdominal pain may occur and depend on the size of the dose.

Rare ( may affect up to 1 in 1,000 people ) : Rash.

Has been reported (occurs in an unknown number of users): Sores in the mouth (if used incorrectly, when the tablets are chewed, sucked, or kept in the mouth). All patients, but especially the elderly and patients with difficulty swallowing, also risk getting sores in the throat or esophagus. If the tablet enters the airways, there is a risk of ulcers in the trachea which can cause narrowing of the trachea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala


5. HOW TO STORE DUROFERON

Keep this medicine out of the sight and reach of children.

Store below 25 ° C. Store in the original package. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Content declaration

  • The active substance is iron sulfate corresponding to 100 mg Fe 2 + (= bivalent iron) per tablet.
  • The other ingredients are dyes (iron oxide E 172 and titanium dioxide E 171), ascorbic acid, povidone, polyethylene, carbomer, hypromellose, macrogol, magnesium stearate, synthetic paraffin.

What the medicine looks like and the contents of the pack

The tablets are yellow, round marked A / DD.

Blister (print packaging): 60 pcs, 100 pcs, and 200 pcs.

Marketing Authorization Holder :

ACO HUD NORDIC AB

Box 622

194 26 Upplands Väsby

Agent:

Avia Pharma AB

Svärdvägen 3B

182 33 Danderyd

Manufacturer:

Richard Bittner AG

Ossiacherstrasse 7

9560 Feldkirchen

Austria

Muhammad Nadeem

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