Fefol Spansules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous sulfate dried; Folic acid

Available from:

Esteve Pharmaceuticals Ltd

ATC code:

B03AD03

INN (International Name):

Ferrous sulfate dried; Folic acid

Dosage:

150mg ; 500microgram

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 09010101; GTIN: 5039021011196

Summary of Product characteristics

OBJECT 1
FEFOL SPANSULE CAPSULES
Summary of Product Characteristics Updated 25-Jan-2017 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Fefol Spansule Capsules.
2. Qualitative and quantitative composition
Dried ferrous sulfate 150 mg (equivalent to 47 mg elemental iron);
Folic Acid BP 500 micrograms.
Excipients with known effect:
Sucrose 105 mg.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Spansule capsules.
4. Clinical particulars
4.1 Therapeutic indications
Fefol is a haematinic preparation for prophylaxis and treatment of
iron deficiency and prophylaxis of folic
acid deficiency during pregnancy.
4.2 Posology and method of administration
Dosage
Adults only: one 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.
The capsules should not be sucked, chewed or kept in the mouth, but
swallowed whole with water.
Capsules should be taken before meals or during meals, depending on
gastrointestinal tolerance.
Method of administration
Oral.
4.3 Contraindications
Hypersensitivity to any ingredients in the formulation; patients
receiving repeated blood transfusions;
concomitant parenteral iron; haemochromatosis and other iron overload
syndromes.
4.4 Special warnings and precautions for use
Administer with caution in patients with haemolytic anaemia,
haemoglobinopathies, iron storage or iron
absorption diseases, existing gastrointestinal disease.
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.
This product contains sucrose. Patients with rare hereditary problems
of galactose intolerance or fructose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption or sucrase-isomaltase
insufficiency should not take this medicinal product.
Due to the risk of mouth ulcerations and toot