Ferodan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ferrous sulfate heptahydrate 30 mg/mL

Available from:

Viatris Limited

INN (International Name):

Ferrous sulfate heptahydrate 30 mg/mL

Dosage:

30 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Ferrous sulfate heptahydrate 30 mg/mL Excipient: Citric acid Glycerol Lemon flavour 101805 Lemon flavour MC002252 Pineapple flavour FN-15402 Purified water Sodium benzoate Sodium bisulfite Sorbitol Strawberry Flavour FN-20072 Sucrose

Units in package:

Bottle, plastic, amber,metric,round,PETE bottle, 250 mL

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Dr Paul Lohmann GmbH KG

Therapeutic indications:

Iron deficiency anaemia.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, amber,metric,round,PETE bottle - 250 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, amber, round, PETE bottle with polypropylene child proof cap - 500 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2003-08-11

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
FERODAN
_FERROUS SULFATE HEPTAHYDRATE ORAL SOLUTION 30 MG/ML_
_(EQUIVALENT TO 6 MG/ML ELEMENTAL IRON)_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking FERODAN.
This leaflet answers some common
questions about FERODAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
FERODAN against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT FERODAN IS
TAKEN FOR
FERODAN is taken to prevent or
treat iron deficiency anaemia. You
should only take iron on advice from
your doctor or pharmacist.
FERODAN contains the active
ingredient ferrous sulfate which is a
form of iron.
Iron is usually found in foods and is
necessary for the normal
development of red blood cells. A
lack of iron affects the development
of the red blood cells and causes
iron deficiency anaemia.
Your doctor or pharmacist may
have advised you to take
FERODAN for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY YOU WERE ADVISED TO TAKE
THIS MEDICINE.
This medicine is available only from
your pharmacy.
BEFORE YOU TAKE
FERODAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FERODAN IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing iron
(ferrous sulfate)
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT TAKE FERODAN IF:
•
you have haemochromatosis (a
disorder in which there is too
much iron in your blood)
•
you are receiving repeated
blood transfusions
•
you are receiving iron
intravenously
•
you

Summary of Product characteristics

Page 1 of 7
NEW ZEALAND DATA SHEET
FERODAN
1. PRODUCT NAME
FERODAN, 30 mg/mL, oral solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL oral solution contains 30 mg of ferrous sulfate heptahydrate
(equivalent to 6 mg elemental
iron).
Excipients with known effects: sucrose, sodium benzoate, sodium
bisulfite and sorbitol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
FERODAN is a syrupy liquid with a fruity odour. The colour of FERODAN
may vary from bluish green
to very light yellow to gold. Colour variations within this range will
not affect the effectiveness of the
product.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Iron deficiency anaemia
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
Children 0-2 years: Use only on medical advice.
Children 2-6 years: Up to 5 mL daily (in three divided doses), for
example, 2 mL in the morning, 1 mL
at lunchtime and 2 mL at night.
Children 6-12 years: 5 – 20 mL daily (in three divided doses), for
example, 5 mL three times daily.
Adults and children 12 years and over: 15 – 30 mL daily (in three
divided doses), for example,
5-10 mL three times daily.
METHOD OF ADMINISTRATION
Shake well before use.
The absorption of FERODAN is optimised when taken on an empty stomach
(one hour before meals
or three hours after a meal). Certain food, drinks and medicine can
affect iron absorption (see section
4.5)
Treatment should not be extended beyond 3 months without review.
Page 2 of 7
_4.3_
_CONTRAINDICATIONS_
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Paroxysmal nocturnal haemoglobinuria
•
Haemosiderosis and haemochromatosis
•
Active peptic ulcer
•
Patients receiving repeated blood transfusions
•
Regional enteritis and ulcerative colitis
•
Haemolytic anaemia
•
Oral and parenteral iron preparations should not be used
concomitantly.
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
Some post-gastrectomy patients show poor absorption of iron.
Administer with caution in patients