Ironorm 125mg/ml oral drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous sulfate

Available from:

Wallace Manufacturing Chemists Ltd

ATC code:

B03AA07

INN (International Name):

Ferrous sulfate

Dosage:

125mg/1ml

Pharmaceutical form:

Oral drops

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010101; GTIN: 05034593020409

Patient Information leaflet

#
wallace
In this leaflet
1.
What Ironorm Drops are and what do they do?
2.
What should I know before using Ironorm Drops?
3.
How do I use Ironorm Drops?
4.
Do Ironorm Drops have any side effects?
5.
How do I store Ironorm Drops?
6.
Further Information.
1.
What Ironorm Drops are and what do they do?
The name of your medicine is Ironorm Drops. Ironorm Drops contain
Ferrous Sulfate. It is used to prevent or treat iron
deficiency anaemia.
2.
What should I know before using Ironorm Drops?
YOU SHOULD NOT USE THIS MEDICINE IF YOU:
#
Are sensitive to any of the ingredients (full list provided in Section
6).
#
You suffer from an inherited condition of abnormal iron metabolism.
#
You have an active peptic ulcer.
#
You are undergoing repeated blood transfusions.
#
You suffer from a severe stomach upset or ulcerative colitis.
#
You have been diagnosed with a haemolytic anaemia which are anaemias
that cause break down of the red blood cells.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE IF YOU:
#
Have had a recent operation on your stomach.
#
Have previously suffered from a peptic ulcer.
#
You are already receiving treatment for other forms of anaemia.
#
You suffer from intestinal blockages.
#
You are elderly (there is an increased risk of intestinal blockage).
IF YOU HAVE RECENTLY GIVEN BIRTH:
#
Treatment is not normally required more than 1 or 2 months after
childbirth.
IS IT SAFE TO DRIVE OR OPERATE MACHINERY AFTER TAKING IRONORM DROPS?
Ironorm Drops do not affect your ability to drive or operate
machinery.
ARE THERE ANY MEDICINES OR FOODS THAT INTERACT WITH IRONORM DROPS?
Ironorm Drops may react with other medicines you are taking.
TALK TO A PHARMACIST OR DOCTOR IF YOU ARE TAKING THE FOLLOWING SINCE
THEY WILL REDUCE EACH OTHER’S POTENCY:
#
Tetracyclines, a type of antibiotic.
#
Antacids.
#
Cholestyramine, used to remove bile from the gut. It is sometimes used
to reduce blood cholesterol levels.
#
Penicillamine, a treatment for rheumatoid arthritis and a few other
rare inherited conditions.
TALK TO A PHA

Summary of Product characteristics

OBJECT 1
IRONORM DROPS
Summary of Product Characteristics Updated 06-Jan-2017 | Wallace
Manufacturing Chemists Ltd
1. Name of the medicinal product
IRONORM DROPS
2. Qualitative and quantitative composition
Each ml contains:-
Ferrous Sulfate BP 125mg
(equivalent to 25mg Iron per ml).
3. Pharmaceutical form
Solution (Oral Drops).
4. Clinical particulars
4.1 Therapeutic indications
For prevention and treatment of iron deficiency anaemias.
4.2 Posology and method of administration
Oral administration.
Prophylactic:
A daily dose of 5 mg of elemental iron as prophylactic iron
supplementation for babies of low birth
weight who are solely breast-fed is recommended. Higher doses up to
2mg/kg of elemental iron per day
might be needed to cover the needs of growing exclusively breastfed
infants. Supplementation is started
4-6 weeks after birth and continued until mixed feeding is
established.
Older infants and children to 6 years: 0.5 – 1.2 ml per day (12.5
– 30 mg elemental iron).
Older children: 2.4 ml per day (60 mg elemental iron).
Adults and Elderly: 2.4 – 4.8 ml per day (60 – 120 mg of elemental
iron)
Therapeutic:
Paediatric: 0.12ml to 0.24ml (3mg – 6mg elemental iron) per kg body
weight, up to a maximum of 8ml
(200mg elemental iron) given daily in two or three divided doses.
Adults: 4.0 ml once or twice per day (100 – 200 mg elemental iron)
4.3 Contraindications
• Hypersensitivity to the product or ingredients
• Haemosiderosis and haemocromatosis
• Active peptic ulcer
• Repeated blood transfusion
• Regional enteritis and ulcerative colitis
• Haemolytic anaemias
4.4 Special warnings and precautions for use
• Patients post-gastrectomy have poor absorption of iron.
• Caution is advised when prescribing iron preparations to
individuals with history of peptic ulcer.
• Duration of treatment should generally not exceed 1-2 months after
end of pregnancy.
• Coexisting deficiency of dietary vitamin B12 should be ruled out
since combined deficiency produces
microcytic blood film.
• Care should b