Fefol Spansule 150 mg/0.5 mg Modified Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dried ferrous sulphate; Folic acid

Available from:

Intapharm Labs Ltd

ATC code:

B03AD; B03AD03

INN (International Name):

Dried ferrous sulphate; Folic acid

Dosage:

150/0.5 milligram(s)

Pharmaceutical form:

Modified-release capsule, hard

Therapeutic area:

Iron in combination with folic acid; ferrous sulfate

Authorization status:

Not marketed

Authorization date:

1980-04-01

Patient Information leaflet

FEFOL SPANSULE 150 MG/ 0.5 MG MODIFIED RELEASE CAPSULES
PACKAGE LEAFLET TEXT 29/10/2020
FEFOL
SPANSULE CAPSULES
150 mg/0.5 mg MODIFIED RELEASE CAPSULES
Dried Ferrous Sulphate and Folic Acid
PATIENT
INFORMATION
LEAFLET
This leaflet contains a summary of the information about Fefol
Spansule Capsules. Please read it
before using the capsules and do not throw it away until you have
finished your course of treatment;
you may wish to read it again. If you have any questions about this
medicine, please ask your
doctor or pharmacist.
WHAT IS IN YOUR MEDICINE?
The name of your medicine is Fefol Spansule 150 mg/0.5 mg Modified
Release Capsules. The
capsules are clear and green with red, yellow and white pellets
inside. The box contains 30
capsules.
Each hard capsule contains 150 mg dried ferrous sulphate (equivalent
to 47mg iron) and 0.5 mg
folic acid as the active ingredients.
Fefol Spansule Capsules also contain, sucrose, maize starch, talc,
heavy kaolin, gelatin, titanium
dioxide (E171), red iron oxide (E172), povidone 30, glycerol
monostearate,white
beeswax,
calcium sulphate dihydrate, quinoline yellow (E104) and patent blue V
(E131).
Fefol Spansule Capsules are one of a group of medicines known as
haematinics,
which improve the
blood's ability to carry oxygen. They do this by increasing the amount
of
haemoglobin
which is
carried in the red blood cells.
MARKETING
AUTHORISATION
HOLDER
Intapharm Labs Ltd
Achamon 25
Lakatamia
2305 Nicosia
Cyprus
MANUFACTURER
Movianto Ltd, Progress Park
Elstow, Bedford, MK42 9XE,UK
WHAT IS YOUR MEDICINE USED FOR?
Fefol Spansule Capsules are used to prevent iron and folic acid
deficiency during pregnancy, after
the first thirteen weeks.
BEFORE USING THIS MEDICINE
Fefol Spansule capsules contain sucrose. If you have been told by your
doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
Before you use this medicine, please answer the following questions:
FEFOL SPANSULE 150 MG/ 0.5 MG MODIFIED RELEASE CAPSULES
PACKAGE LEAFLET TEXT 29/10/

Summary of Product characteristics

Health Products Regulatory Authority
11 November 2021
CRN00CNTW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fefol Spansule 150 mg/0.5 mg Modified Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release capsule contains 150 mg dried ferrous sulphate
(equivalent to 47 mg elemental iron) and 0.5 mg folic
acid.
Excipients - contains Sucrose 105.0 mg per capsule.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified release hard capsules
Modified release capsule containing red, yellow and white pellets in
size no.1 hard gelatin shells with clear bodies and
transparent green caps.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fefol is a haematinic with added folic acid used for the prophylaxis
of iron and folic acid deficiency, after the first 13 weeks of
pregnancy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
_Adults only:_
1 capsule a day during pregnancy. Some pregnant patients may need a
higher dose of iron because of dietary or other factors.
_Children and elderly:_
Not recommended.
Medical advice should be sought if symptoms do not improve after 4
weeks of use of this product as these symptoms may
reflect an underlying disease process.
Method of Administration:
Oral.
4.3 CONTRAINDICATIONS
Do not use in patients with a known hypersensitivity to any of the
active ingredients.
Use in patients with anaemias of undiagnosed aetiology.
Individuals with haemochromatosis and iron overload syndromes.
Health Products Regulatory Authority
11 November 2021
CRN00CNTW
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The label will state:
“Important warning: Contains Iron. Keep out of reach and sight of
children, as overdose may be fatal”
This will appear on the front of the pack within a rectangle in which
there is no other information.
Caution is advised in individuals with a family history of
haemochromatosis or iron overload syndromes. It should be noted
that these conditions may be under diagnosed.
Failure to respond