When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Adults and the Elderly: Fer-In-Sol is not recommended for use in adults
Adults:
Prevention: 1.6 ml daily (equivalent to 200 mg ferrous sulphate)
Treatment: 1.6 ml 2-3 times daily
There is no evidence that the dosage should differ in the elderly Section 4.3: Contra-indications Use in patients with known hypersensitivity to any of the ingredients. Individuals with haemochromatosis and iron overload syndromes.
Section 4.4: Special Warnings and Special Precautions for Use This product should only be used for the treatment of iron deficiency anaemia diagnosed by laboratory testing, under the supervision of a medical doctor. This product should be used with caution in patients with haemochromatosis and haemolytic anaemias. Caution is also advised in individuals with a family history of haemochromatosis or iron overload syndromes. It should be noted that these conditions may be underdiagnosed. Overdose may be fatal, particularly in children.
Section 4.5: Interactions with Other Medicinal Products and Other Forms of Interaction The absorption of iron salts is decreased in the presence of antacids, trientine, zinc and tetracyclines. Iron salts diminish the absorption of tetracyclines, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, bisphosphates, zinc salts and penicillamine. It may also reduce the absorption of entacapone and levodopa. Ferrous sulphate also reduces the hypotensive effect of methyldopa. Section 4.6: Pregnancy and Lactation Fer-in-Sol should not be taken in the first 13 weeks of pregnancy. If iron containing products are considered essential during the first 13 weeks of pregnancy they should only be taken under medical supervision. Prophylaxis of iron deficiency during the remainder of pregnancy is justified. No contraindications are known to use in lactation. Section 4.8: Undesirable Effects Side effects including nausea, vomiting, diarrhoea and/or constipation may occur. Hypersensitivity reactions have been reported. These range from rashes, sometimes severe to anaphylaxis.
Interactions with Other Medicinal Products and Other Forms of Interaction
The absorption of iron salts is decreased in the presence of antacids,
trientine, zinc and tetracyclines.
Iron salts diminish the absorption of tetracyclines,
ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, bisphosphates, zinc salts and penicillamine. It may also reduce the absorption of entacapone and levodopa. Ferrous sulphate also reduces the hypotensive effect of methyldopa.
Ferrous sulphate also reduces the hypotensive effect of methyldopa.
Section 4.6:
Pregnancy and Lactation
Fer-in-Sol should not be taken in the first 13 weeks of pregnancy. If iron containing products are considered essential during the first 13 weeks of pregnancy they should only be taken under medical supervision.
Prophylaxis of iron deficiency during the remainder of pregnancy is justified. No contraindications are known to use in lactation.
Section 4.8:
Undesirable Effects
Side effects including nausea, vomiting, diarrhoea and/or constipation may occur.
Hypersensitivity reactions have been reported. These range from rashes, sometimes severe to anaphylaxis.
The following sections have been amended in the SPC: Section 1: TRADE . NAME OF THE MEDICINAL PRODUCT
FER-IN-SOL Fer-In-Sol 25mg/ml oral drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of liquid contains 125mg of Ferrous Sulphate equivalent to 25mg of available iron. Also contains Sucrose 383.1 mg/ml, Sorbitol Solution (70%) 309.1 mg/ml and Ethanol 1.612 mg/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral drops, solution. A colourless or light bluish green to yellowish brown liquid. 6.1 List of Excipients Citric acid anhydrous, ethanol, lemon andoil, peppermint flavours, oil, sulphuric acid, sorbitol, sucrose, sulphuric acid, purified water. 6.2 Incompatibilities None Not applicable 6.3 Shelf Life 24 months 2 years 6.4 Special Precautions for Storage Keep the bottle tightly closed. Do not store above 25°C. 6.6 Instructions for Use/Handling None No special requirements’
Fer-In-Sol 25mg/ml oral drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of liquid contains 125mg of Ferrous Sulphate equivalent to 25mg of available iron. Also contains Sucrose 383.1 mg/ml, Sorbitol Solution (70%) 309.1 mg/ml and Ethanol 1.612 mg/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral drops, solution. A colourless or light bluish green to yellowish brown liquid. 6.1 List of Excipients Citric acid anhydrous, ethanol, lemon andoil, peppermint flavours, oil, sulphuric acid, sorbitol, sucrose, sulphuric acid, purified water. 6.2 Incompatibilities None Not applicable 6.3 Shelf Life 24 months 2 years 6.4 Special Precautions for Storage Keep the bottle tightly closed. Do not store above 25°C. 6.6 Instructions for Use/Handling None No special requirements’
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of liquid contains 125mg of Ferrous Sulphate equivalent to 25mg of available iron. Also contains Sucrose 383.1 mg/ml, Sorbitol Solution (70%) 309.1 mg/ml and Ethanol 1.612 mg/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral drops, solution. A colourless or light bluish green to yellowish brown liquid.
For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral drops, solution. A colourless or light bluish green to yellowish brown liquid.
3. PHARMACEUTICAL FORM
Oral drops, solution.
A colourless or light bluish green to yellowish brown liquid.
6.1 List of Excipients
Citric acid anhydrous, ethanol, lemon andoil, peppermint flavours, oil, sulphuric acid, sorbitol, sucrose, sulphuric acid, purified water.
6.2 Incompatibilities
None Not applicable 6.3 Shelf Life 24 months 2 years 6.4 Special Precautions for Storage Keep the bottle tightly closed. Do not store above 25°C.
Not applicable 6.3 Shelf Life 24 months 2 years 6.4 Special Precautions for Storage Keep the bottle tightly closed. Do not store above 25°C.
6.3 Shelf Life
24 months 2 years 6.4 Special Precautions for Storage Keep the bottle tightly closed. Do not store above 25°C.
2 years 6.4 Special Precautions for Storage Keep the bottle tightly closed. Do not store above 25°C.
6.4 Special Precautions for Storage
Keep the bottle tightly closed. Do not store above 25°C.
6.6 Instructions for Use/Handling
None No special requirements’
No special requirements’