Ferosac 100 mg / 5 ml ( Iron 20 mg / ml ) 5 Ampoules Concentrate for solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ferosac 20 mg iron /ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
Read all of this leaflet carefully before you are given this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
In this leaflet:
1. What Ferosac is and what it is used for
2. Before Ferosac is given to you
3. How Ferosac is given
4. Possible side effects
5. How to store Ferosac
6. Further information

1. WHAT FEROSAC IS AND WHAT IT IS USED FOR
Ferosac is a medicine that contains iron.
Medicines that contain iron are used when you do not have enough iron in your body. This is
called “iron deficiency”.
Ferosac is given when:
You cannot take iron by mouth - such as when iron tablets make you feel ill.
You have taken iron by mouth - and it has not worked.

2. BEFORE FEROSAC IS GIVEN TO YOU
You must not be given Ferosac if:
 You are allergic (hypersensitive) to any of the ingredients of Ferosac (listed in Section 6).
 You have anemia which is not caused by a shortage of iron.
 You have too much iron in your body or a problem in the way your body uses iron.
 You have ever had asthma, eczema or other allergies. This is because you are more likely
to have an allergic reaction.
 You are in the first three months of pregnancy.
You must not be given Ferosac if any of the above applies to you. If you are not sure, talk to
your doctor before having Ferosac.
Take special care with Ferosac
Check with your doctor before you are given Ferosac if:
 You have any infections.
 You have liver problems.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you
are given Ferosac.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines obtained without a prescription, including herbal medicines.
This is because Ferosac can affect the way some other medicines work. Also some other medicines
can affect the way Ferosac works.
In particular tell your doctor or pharmacist if you are taking: 
Medicines that contain iron which you take by mouth. These may not work if they are taken at the
same time that Ferosac is given to you. When you have finished treatment with Ferosac, wait 5
days before taking iron by mouth.
Pregnancy and breast-feeding
Ferosac should not be given during the first three months of pregnancy. Your doctor will decide if
Ferosac can be used during the fourth to ninth months of pregnancy.
It is unlikely that Ferosac can pass into the mother’s milk. Therefore breast-feeding when you are
being given this medicine should not harm your baby.
Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breastfeeding.
Pregnancy category: B
Driving and using machines
You may feel dizzy, confused or light-headed after being given Ferosac. If this happens, do not
drive or use any tool or machines. Ask your doctor if you are not sure.

3. HOW FEROSAC IS GIVEN
Ferosac will be given to you by a doctor.
Your doctor will decide how much Ferosac to give you. He or she will also decide how often you
need it and for how long. Your doctor will do a blood test to help work out the dose.
If you have never had Ferosac before, you will have a small amount of the medicine first (a test
dose). This is to check that you are not allergic to it.
How Ferosac is given
Ferosac can be given in 3 different ways:
 Slow injection into your vein – 1 to 3 times per week.
 As an infusion (drip) into your vein – 1 to 3 times per week.
 During dialysis – it will be put into the venous limb of the dialyzer.
Ferosac is a brown liquid and so the injection or infusion will look brown.
Children
Ferosac is not recommended for use in children.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ferosac can cause side effects, although not everybody gets them.
Allergic reactions (affects less than 1 in 1,000 people)
If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:
 Low blood pressure (feeling dizzy, light-headed or faint).
 Swelling of your face.
 Difficulty breathing.
Tell your doctor or nurse straight away if you think you are having an allergic reaction.
Other side effects include:
Common (affects less than 1 in 10 people)
 Changes in your taste such as a metallic taste. This does not usually last very long.
Uncommon (affects less than 1 in 100 people)
 Fast pulse rate.
 Headache or feeling dizzy.
 Low blood pressure and collapse.
 Pounding heart beat (palpitations).
 Stomach pain or diarrhea.
 Feeling sick (nausea) or being sick (vomiting).
 Wheezing, difficulty in breathing. 
 Itching, hives, rash or skin redness.
 Muscle cramps or muscle pain.
 Flushing.
 Fever or shivering.
 Chest pain and chest tightness.
 Reactions around the site of injection such as inflammation, a feeling of burning and
swelling.
Rare (affects less than 1 in 1,000 people)
 Fainting.
 Loss of consciousness.
 Tingling or”pins and needles”.
 A feeling of burning.
 High blood pressure.
 Feeling hot.
 Swelling (dropsy).
 Pain in your joints.
 Swelling of hands and feet.
 Tiredness, weakness or general feeling of illness.
Other side effects include: feeling less alert, light-headed or confused; swelling of your joints, face
and tongue; increased sweating; back pain; low pulse rate; changes to the color of your urine.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

5. HOW TO STORE FEROSAC
Keep out of the reach and sight of children.
Do not use Ferosac after the expiry date which is stated on the label.
Do not store above 25C. Do not freeze. Keep the ampoules or vials in the outer carton.
Once the Ferosac ampoules or Ferosac vials have been opened, they should be used immediately.
After dilution with sodium chloride solution, the diluted solution should be used immediately.
Ferosac will normally be stored for you by your doctor or the hospital.

6. FURTHER INFORMATION
What Ferosac contains
The active substance is iron (as Iron (III)-Hydroxide Sucrose Complex). Each milliliter contains 20
mg iron.
The other ingredients are water for injections and sodium hydroxide.
What Ferosac looks like and contents of the pack
Ferosac is a dark brown, non transparent, aqueous solution.
Ferosac comes in following pack-sizes:
5 Glass ampoules of 5 ml. Each ampoule of 5 ml corresponds to 100 mg of iron.
Marketing Authorisation Holder and Manufacturer
SPIMACO
AlQassim pharmaceutical plant
Saudi Pharmaceutical Industries & Medical Appliance Corporation
This leaflet was approved in: June 2012. Version: 1

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