General

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Iron Deficiency Medication

Parental Iron Therapy (IV or IM)

Sucrofer-RGB

SCHEDULING STATUS: S3

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
SUCROFER (injection)

Please read this patient information leaflet carefully before you are administered SUCROFER.

  • Keep this information. You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • SUCROFER has been prescribed for you personally and you should not share your medicine with other people.  It may harm them, even if their symptoms are the same as yours.

WHAT SUCROFER CONTAINS

  • The active substance is iron sucrose.  Each 1 ml contains 333 mg iron sucrose equivalent to 20 mg elemental iron.
  • Contains sugar.
  • Contains no preservatives.
  • The other ingredients are sodium hydroxide and water for injection.

WHAT SUCROFER IS USED FOR

SUCROFER is administered in adult patients with severe iron deficiency who are not responding to or not able to take oral iron treatment.  It is recommended that

SUCROFER only be used when a doctor has done the appropriate investigations and the indication is definite.

BEFORE YOU ARE ADMINISTERED SUCROFER

You should not be administered SUCROFER:

  • If you are hypersensitive (allergic) to iron sucrose complexes (mono- or di-saccharide), SUCROFER or any of its ingredients (see WHAT SUCROFER CONTAINS).
  • If you have too much iron in your body or a problem in the way your body uses iron.
  • If you have any liver disorders.
  • If you have infectious hepatitis.
  • If you have any infections.
  • If you have ever had asthma, eczema or other allergies.  This is because you are more likely to have an allergic reaction.
  • If you suffer from anaemia not caused by a shortage of iron.
  • If you are in the first three months of your pregnancy.
  • If your are breastfeeding your baby.  This is because it has not been shown that SUCROFER is safe for the breastfed baby.
  • If you are a child.

Take special care with SUCROFER:

  • SUCROFER may cause severe allergic reactions.
  • Your doctor will inject a test dose of SUCROFER into your vein before administering the complete dose.  You will have to wait for 15 minutes after the test dose to determine if you are able to receive SUCROFER.  This is to check that you are not allergic to it.
  • Tell your doctor if you have porphyria.  This is because it has not been shown that SUCROFER is safe to use for patients with porphyria.

Pregnancy and Breastfeeding:

  • Do not use SUCROFER in the first three months of pregnancy.  If you are planning to become pregnant or breastfeeding.
  • Your doctor will decide whether SUCROFER can be used during the last six months of pregnancy.  You should only receive SUCROFER if you have severe iron deficiency anaemia and if your body does not absorb or tolerate oral iron formulations.

Driving and using machinery:

  • SUCROFER may make you feel dizzy, confused or light-headed.  If this happens do not drive or use any tools or machines.

Taking other medicines while receiving SUCROFER:

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of SUCROFER with the medicines may cause undesirable interactions.  Please consult your doctor, pharmacist or other healthcare professional for advice. 

Inform your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop.

The use of SUCROFER with oral iron preparations is not recommended as it may cause the oral iron preparations to become ineffective.

HOW SUCROFER INJECTION WILL BE ADMINISTERED TO YOU

SUCROFER is not recommended for use in children.

SUCROFER will be administered to you by your doctor or other healthcare professional either as a single injection or as a continuous infusion (over a longer period of time) into a vein.

The collective dose of SUCROFER is determined by your haemoglobin level and your body weight.

The doctor will decide on the dose and dosage schedule for you based on the calculation of your total iron shortage.

Before the administered dose, you will receive a small test dose to check that you are not allergic to it.

If you are given more SUCROFER than you should have:
In the event of overdosage, consult your doctor or pharmacist.  If neither is available, seek help at the nearest hospital or poison control centre.

POSSIBLE SIDE EFFECTS

SUCROFER may have side effects.

Not all side effects reported for SUCROFER are included in this leaflet.  Should your general health worsen while being administered SUCROFER, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, tell hour doctor or other healthcare professional immediately:

  • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
  • Rash or itching.
  • Low blood pressure (feeling dizzy, light-heady or faint.

These are all very serious side effects.  If you have them, you may have had a serious allergic reaction to SUCROFER.  You may need urgent medical attention.

Other side effects include:
Frequent

  • Headache
  • Dizziness
  • Vomiting
  • Changes in your tastes such as metallic taste

Less frequent:

  • Reduced feeling of consciousness
  • Light-headed feeling
  • Confusion
  • Tingling or “pins and needles”
  • Fast pulse rate
  • Pounding heart beat (palpitations)
  • Chest pain or tightness
  • Low blood pressure and collapse
  • Swelling of ankles, feet or hands
  • Wheezing or difficulty breathing
  • Stomach pain or diarrhoea
  • Feeling sick (nausea)
  • Itching, hives, rash or skin redness
  • Muscle craps or muscle pain
  • Swelling of joints or joint pain
  • Back pain
  • Flushing
  • Fever of shivering
  • Increase sweating
  • Tiredness, weakness or general feeling of illness
  • Reactions around the site of injection such as inflammation, a feeling of burning and swelling

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or other healthcare professional.

STORAGE AND DISPOSING OF SUCROFER

  • Keep all medicines out of reach and sight of children.
  • Store at or below 30 °C.
  • Discard any unused contents after use.
  • Do not use SUCROFER if the ampoule is damaged or if any residue has formed.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF SUCROFER

Type I clear glass ampoules with dot for 5 ml fill capacity.
25 ampoules per outer carton.

IDENTIFICATION OF SUCROFER

Dark brown to slightly viscous liquid free from visible particles or sediment.

REGISTRATION NUMBER

45/8.3/0252

NAME AND BUSINESS ADDRESS OF THE HOLDER

Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Silverwood Close,
Westlake, 7945
Cape Town, South Africa

DATE OF PUBLICATION

06 March 2014
Version: PD9034A

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