FERRUM FOL 100 Milligram Tablets Chewable
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
IRON POLYMALTOSE, FOLIC ACID
Available from:
Vifor France
ATC code:
B03AD02
INN (International Name):
IRON POLYMALTOSE, FOLIC ACID
Dosage:
100 Milligram
Pharmaceutical form:
Tablets Chewable
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Iron bivalent, oral preparations
Authorization status:
Authorised
Authorization date:
2002-04-22
Patient Information leaflet
PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
Page 1/5
Vifor (International) Inc.
PIL-YT260/IE/E05
PACKAGE LEAFLET : INFORMATION FOR THE USER
FERRUM FOL 100 MG / 350 MICROGRAMS CHEWABLE TABLETS
FERRUM FOL 100 MG / 350 MICROGRAMS
CHEWABLE TABLETS
iron as iron(III)-hydroxide polymaltose complex / folic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk
to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Ferrum Fol chewable tablets is and what it is used for
2.
What you need to know before you take Ferrum Fol chewable
tablets
3.
How to take Ferrum Fol chewable tablets
4.
Possible side effects
5.
How to store Ferrum Fol chewable tablets
6.
Contents of the pack and other information
PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
Page 2/5
Vifor (International) Inc.
PIL-YT260/IE/E05
1.
WHAT FERRUM FOL CHEWABLE TABLETS IS AND WHAT IT IS USED
FOR
It is used in women before and during pregnancy, and
during breast-feeding to
• treat iron deficiency
• prevent iron and folic acid deficiency
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERRUM FOL
CHEWABLE TABLETS
DO NOT TAKE FERRUM FOL CHEWABLE TABLETS
if you are/have
• ALLERGIC to iron(III)-hydroxide po
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrum Fol 100mg / 350 micrograms Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of Iron in the form of iron polymaltose and
350 micrograms of Folic Acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Brown-white speckled chewable, round and flat tablets with score-line on one side. This score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prophylaxis of iron and folic acid deficiency during pregnancy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults only:
1 tablet a day throughout pregnancy.
Tablets may be chewed.
Route of administration:
Oral.
4.3 CONTRAINDICATIONS
1.
Use in patients with a known hypersensitivity to any of the active ingredients.
2.
Use in patients with anaemia of undiagnosed aetiology.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used with caution in patients with haemochromatosis and haemolytic anaemias.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
1.
The absorption of iron salts is decreased in the presence of antacids.
2.
Iron chelates with tetracyclines, absorption of both agents may be impaired.
4.6 FERTILITY, PREGNANCY AND LACTATION
No information submitted.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/07/2013_
_CRN 2134217_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No information submitted.
4.8 UNDESIRABLE EFFECTS
Side effects include nausea, diarrhoea, constipation may occur rarely.
4.9 OVERDOSE
Symptoms of overdosage with iron salts include nausea and vomiti
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