FERSINOL ORAL DROPS 50MG/ML [SIN17268P]

Product Info

FERSINOL ORAL DROPS 50MG/ML

[SIN17268P]

Indication

1. What FERSINOL is and what it is used for?
FERSINOL is a drop presented in a 30 ml colored bottle.
FERSINOL contains Iron III hydroxide polymaltose complex as active substance.

It is an iron preparation for the treatment of iron deficiency without anaemia and iron deficiency anaemia. It can also supplement iron requirement in pregnancy, lactation, children, adolescents and adults (e.g. vegetarians and elderly).

Iron is an important constituent of haemoglobin, myoglobin, and iron-containing enzymes. In general, iron deficiency can cause chronic fatigue, lack of concentration and reduced mental performance, irritability, anxiety, headache, loss of appetite, susceptibility to infection, conspicuous paleness, cracks at the corners of the mouth (rhagades), dry skin and brittle hair and nails.

Dosing

3. How to take FERSINOL

• Instructions for appropriate usage and dose/administration frequency:

– FERSINOL dosage and duration of therapy depends on the extent of iron deficiency.
– Iron deficiency anaemia: Therapy takes about 3 – 5 months until haemoglobin value reaches acceptable range. Thereafter, you should continue therapy for several weeks, or for pregnant women, at least until the end of pregnancy with dosage described for iron deficiency without anaemia.
– Iron deficiency without anaemia: Therapy takes about 1 – 2 months.
– Refer to table below for FERSINOL dosage according to age and body weight:

Dosage of FERSINOL Oral Drops According to Age

Dosage of FERSINOL Oral Drops According to Body Weight

• Administration Route and Method:

– FERSINOL is only for oral use.

Drop product to the spoon with oblique angle. If it is difficult to drop, drop product by shaking with same angle so that the drops can be counted. It should be used directly by dropping into the mouth.

Special use conditions:
Renal/hepatic impairment:
Do not use FERSINOL in severe hepatic and renal diseases.

If you take more FERSINOL than you should
If you take excessive amount; diarrhoea, stomach pain and vomiting may occur, and in more advanced cases, metabolic acidosis, severe muscle spasms and coma may be seen.

In children below 6 years of age, accidental taken/ingestion of iron-containing products causes fatal poisoning. Therefore, keep these medicines out of the reach of children. In case of overdose, patients should be advised about call a doctor or poison consultation.

If you take more FERSINOL than you should, talk to your doctor or pharmacist.

If you forget to take FERSINOL
Do not take a double dose to make up for a forgotten dose.

Contraindications

2. Before you take FERSINOL
Do not take FERSINOL in the following conditions:

• If you are allergic or have intolerance to iron polymaltose or to any of the excipients,

• In case of iron loading (hemochromatosis, chronic haemolysis),

• In case of the other anaemia which are not iron deficiency (for example: hemolytic anaemia),

• If you have iron utilization disturbances (anaemia from lead-poisoning, sideroachrestic anaemia),

• If you have thalassemia,

• If you have progressive and chronic joint inflammation,

• If you have regular blood transfusions,

• If you have HIV infection and your anemia related to iron deficiency is not clinically confirmed,

• If you have severe liver and renal diseases.