Ferrous fumarate 140mg/5ml oral solution

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Ferrous fumarate

Доступно од:

Advanz Pharma

АТЦ код:

B03AA02

INN (Међународно име):

Ferrous fumarate

Дозирање:

28mg/1ml

Фармацеутски облик:

Oral solution

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 09010101; GTIN: 5021691018179

Информативни летак

PATIENT INFORMATION LEAFLET
FERROUS FUMARATE 140MG/5ML ORAL SUSPENSION
Please read this leaflet carefully before you start to take your
medicine.
This leaflet does not contain all the information about your medicine.
If you have any questions, or you are not sure about anything, ask
your doctor or pharmacist.
THE NAME OF YOUR MEDICINE IS:
Ferrous Fumarate 140mg/5ml Oral Suspension.
ACTIVE INGREDIENT:
The active ingredient in Ferrous Fumarate 140mg/5ml Oral Suspension is
140mg Ferrous
Fumarate, in each 5ml spoonful. It is an oral iron preparation.
Ferrous Fumarate 140mg/5ml Oral
Suspension is a smooth brown suspension which separates on standing,
with an elderberry odour.
It is packed in amber glass bottles with polypropylene cap with
melinex/pulpboard/aluminium
foil wad. The bottle contains 200ml of suspension.
WHAT ELSE IS IN YOUR MEDICINE?
As well as the active ingredient Ferrous Fumarate 140mg/5ml Oral
Suspension also contains
nipastat
GL75,
methylcellulose
20,
glucose
liquid,
sucrose
granulated,
granular
lecithin,
elderberry flavor (bush C7529), sodium metabisulphite (E223), water
purified.
This medicinal product contains 4g of glucose per 5ml spoonful when
taken according to the
dosage recommendations, each dose supplies up to 8g of glucose. It
also contains 0.25g of
sucrose per 5ml
spoonful. When taken according to the dosage recommendations, each
dose
supplies up to 0.5g of
sucrose. This product is unsuitable if you have a hereditary fructose
intolerance, glucose-galactose malabsorption syndrome, or sucrose
isomaltase deficiency.
Ferrous Fumarate 140mg/5ml Oral Suspension is made for the Product
Licence Holder, Mercury
Pharmaceuticals Ltd, Capital House, 85 King William Street, London
EC4N 7BL, UK
PL 12762/0083
by Laleham Health and Beauty Limited, Fairfield, Bradshaw Lane,
Greenhalgh, Kirkham,
Preston, Lancashire, PR4 3JA, UK.
WHAT IS THIS MEDICINE USED FOR?
This medicine is taken by mouth to treat or prevent iron deficiency.
For prevention of deficiency
during pregnancy, a combination of iron and folic a

Карактеристике производа

OBJECT 1
FERROUS FUMARATE 140MG/5ML SYRUP
Summary of Product Characteristics Updated 24-Jul-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Fersamal 140mg/5ml Syrup
Ferrous fumarate 140mg/5ml Syrup
2. Qualitative and quantitative composition
Each 5ml of syrup contains approximately 140mg ferrous fumarate BP
(45mg elemental iron).
3. Pharmaceutical form
Syrup
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis and treatment of iron deficiency states.
For prophylaxis during pregnancy, a combination of iron and folic acid
is usually recommended.
4.2 Posology and method of administration
Each 5 ml of Fersamal syrup contains 140 mg Ferrous Fumarate which
approximates to 45 mg of
elemental iron - section 2 SmPC.
For oral administration
Prevention of iron deficiency:
Adults and elderly:
Fersamal syrup one 5 ml spoonful twice a day.
Children:
6-24 months of age: 12.5mg/day
2-5 years of age: 20-30mg/day
6-11 years of age: 30-60mg/day
Older children: 60mg/day
Premature infants: 5mg elemental iron per day. Iron supplementation in
premature infants is only
recommended in those of low birth weight who are solely breast
fed.Higher doses up to 2mg/kg of
elemental iron per day might be needed to cover the needs of growing
exclusively breastfed infants.
Supplementation should be commenced 4-6 weeks after birth and
continued until mixed feeding is
established.
Treatment of iron deficiency:
Adults and elderly:
Fersamal syrup two 5 ml spoonfuls twice a day
Children:
Full term infants and children: 3 to 6 mg elemental iron/Kg/day given
in 2 to 3 divided doses. Total daily
dose should not exceed 180 mg elemental iron.
Administration to infants and children should take place under medical
advice.
Medical advice should be sought if symptoms do not improve after four
weeks of use of this product as
these symptoms may reflect an underlying disease process.
4.3 Contraindications
Known hypersensitivity to any of the ingredients of the product.
Paroxysmal nocturnal haemoglobinuria.
Haemosiderosis,