FERSAMAL 140MG/5ML SYRUP

Active substance: FERROUS FUMARATE

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5. HOW TO STORE FERSAMAL 140MG/5ML SYRUP
PATIENT INFORMATION LEAFLET

Important warning: contains iron.
Keep out of the sight and reach of children, as overdose may be fatal.

Fersamal® 140mg/5ml Syrup
Ferrous Fumarate

Do not store above 25˚C. Keep the bottle in the outer carton in order
to protect from light. Shake the bottle before use.
Replace the cap after taking your dose.
If you have any of your medicine left after finishing your treatment, return
it to your pharmacist.
Do not use this medicine if the bottle is damaged or after the Expiry Date
which is stated on the bottle after ‘Exp’. The expiry date refers to the last
day of that month.

Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to
take Fersamal 140mg/5ml Syrup carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve
after a few days
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

REMEMBER
This medicine is for YOU. Never give it to anyone else. It may harm
them, even if their symptoms are the same as yours.

In this leaflet:
1. What Fersamal 140mg/5ml Syrup is and what it is used for
2. Before you take Fersamal 140mg/5ml Syrup
3. How to take Fersamal 140mg/5ml Syrup
4. Possible side effects
5. How to store Fersamal 140mg/5ml Syrup
6. Further information

6. FURTHER INFORMATION
The active substance is ferrous fumarate. Each 5 ml spoonful contains
140mg ferrous fumarate. Ferrous fumarate is an iron compound.
The other ingredients are nipastat GL 75, methyl cellulose 20, glucose
liquid, sucrose, granular lecithin (97% Al), elderberry flavour (bush)
C7529, sodium metabisulphite (E223) and purified water.
Nipastat GL 75 contains methyl hydroxybenzoate, ethyl hydroxybenzoate,
propyl
hydroxybenzoate, butyl hydroxybenzoate and isobutyl
hydroxybenzoate.

1. WHAT FERSAMAL 140MG/5ML SYRUP IS AND WHAT IT IS USED FOR
Fersamal Syrup contains a form of iron called ferrous fumarate. Iron is
usually found in foods and is necessary for the normal development of
red blood cells. A lack of iron affects the development of the red blood
cells and causes iron deficiency anaemia.
Fersamal Syrup is used to prevent or treat iron deficiency anaemia.
The prevention of iron deficiency during pregnancy usually requires a
combination of iron and folic acid.

What Fersamal 140mg/5ml Syrup looks like and contents of pack
Fersamal Syrup is a smooth brown suspension which separates on
standing with an elderberry smell. It is packed in amber glass bottles
containing 200ml suspension.
Marketing authorisation holder
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK

2. BEFORE YOU TAKE FERSAMAL 140MG/5ML SYRUP

Manufacturer:
Universal Products Ltd.,
Fairfield, Bradshaw Lane, Greenhalgh,
Kirkham, Preston, Lancashire, PR4 3JA, UK
This leaflet was last revised in December 2013.

DO NOT take Fersamal Syrup if:
• You know that you are allergic to ferrous fumarate or any of the other
ingredients (see section 6 of this leaflet), or to any other medicine
containing iron
• You have noticed blood in your urine
• You suffer from any form of anaemia, other than iron deficiency
anaemia, or from any other condition where your body’s iron is
affected (your doctor will be able to advise you)
• You have bronze markings on your skin or you have been told that
you have increased stores of iron in your tissues
• You are suffering from a recently diagnosed stomach or duodenal ulcer
• You are undergoing repeated blood transfusions
• You suffer from ulcerative colitis or any other inflammatory condition
of the bowels.
Speak to your doctor if any of these apply to you before you take your
medicine.

100024/LF/4
Fersamal is a registered trademark of Mercury Pharma Group Limited.

4

1

Date of Approval:

PROOF

N/A

1

To be implemented by:

N/A

13/12/2013
Product Description:

Originated by

Date:

Tech Approved

Date:

Fersamal® 140mg/5ml Syrup

DMN

28/11/2011

Yes

09/12/2011

Component:

Revised by

Version:

Leaflet

PAT

100024/LF/4

Manufacturer:

File Name:

CRF No.:

UPL

100024LF Fersamal Syrup UPL v4_1 AMCo.CRF.133.2013

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

9.5pt Swiss 721BT

128 x 252mm

NA

Colours:

Key Line:

Black

Magenta

continued over

Take special care with Fersamal 140mg/5ml Syrup if:
• You suffer or have suffered from a peptic ulcer
• You have problems associated with narrowing of your intestine
(stricture) or outpocketing of the inner layer of your intestine
(diverticular disease)
• You have difficulty in absorbing certain sugars (glucose or galactose)
• You have had some or all of your stomach removed as this may make
it difficulty for you to absorb iron
• You have diabetes.
If any of these conditions apply to you, speak to your doctor before you
take this medicine. Your doctor will want to watch you closely, and will
advise you if any additional medicine is required to treat your condition.

3. HOW TO TAKE FERSAMAL 140MG/5ML SYRUP
It is important to take your medicine at the right time. You must take it as
directed by your doctor. The label will tell you how much to take and how
often. If you are not sure, ask your doctor or pharmacist.
Adults and the elderly:
The usual dose to prevent Iron deficiency anaemia is one spoonful (5ml)
twice a day.
Children and infants:
For children and premature infants, your doctor will decide the dose,
according to the age and weight of the child and infant.
Your doctor will advise you on how long you should take the medicine,
which is normally not more than six months. It is usually stopped three
months after the anaemia has been corrected.
If you have to go to another doctor or to the hospital tell them you are
taking Fersamal Syrup.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. The effects of any of these medicines or of Fersamal Syrup
may change, particularly if you are taking:
• Certain medicines for treating infections (e.g. chloramphenicol,
tetracyclines, ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin,
norfloxacin)
• Medicines containing zinc, calcium or magnesium salts
• Levothyroxine, used for thyroid gland problems
• Medicines used for a disease known as ‘Parkinson’s disease’
(e.g. levodopa, entacapone).
• Methyl dopa, used for increase in blood pressure
• Antacids used to treat indigestion
• Penicillamine used in the treatment of rheumatoid arthritis.
• Colestyramine used to reduce cholesterol and fats in the blood.
• Medicines for bone diseases (bisphosphonates)
• Trientine, used for high copper levels in blood
• Dimercaprol, used for various metal poisonings
• Mycophenolate, used during change of organs (transplant).

If you take more Fersamal 140mg/5ml Syrup than you should:
Contact your nearest hospital casualty department or doctor
immediately. Take any remaining medicine and this leaflet with you so
that the medical staff know exactly what you have taken.
Your medicine is very dangerous if too much is taken by young children
and care should be taken to keep the medicine safely out of the reach
of children.
If you forget to take your Fersamal 140mg/5ml Syrup:
Take your dose as soon as you remember. Then go on as before. If it is
almost time for the next dose, then do not take the missed dose at all.
If you stop taking Fersamal 140mg/5ml Syrup:
If you are having no problems with Fersamal Syrup, do not stop taking
it until your doctor tells you to.
If you have any further questions about this medicine, ask your
doctor or pharmacist.

Taking with food and drink
Fersamal Syrup may be taken with meals. This may help to relieve any
stomach-related side effects. However, it is advisable not to take your
medicine with tea, eggs or milk as this may reduce its effect.

4. POSSIBLE SIDE EFFECTS
All medicines can cause allergic reactions although serious allergic
reactions are rare. Any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching (especially affecting
your whole body) should be reported to a doctor immediately.
Other side effects may include:
• stomach discomfort
• pain in upper part of the stomach
• vomiting sensation
• difficulty in passing stools
• loose stools.
Also, you might find your stools are darker in colour after you have taken
this medicine. This is quite commonly seen with all iron preparations and
is normal.
If you use Fersamal Syrup for a long time the sugar content may increase
the risk of tooth decay. It may also result in blackish discolouration of the
teeth. This can be reduced by daily brushing of the teeth.
If these side effects get serious, or if you notice any other side effect not
listed in this leaflet, please tell your doctor or pharmacist.

Pregnancy and lactation
If you are pregnant, planning to become pregnant or are breast feeding
ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Fersamal
140mg/5ml Syrup
Fersamal
Syrup
contains
sodium
metabisulphite
and
parahydroxybenzoates as preservatives. Sodium metabisulphite may
rarely cause severe allergic (hypersensitivity) reactions and wheezing.
Parahydroxybenzoates (methyl hydroxybenzoate, ethyl hydroxybenzoate,
propyl hydroxybenzoate) may cause allergic reactions (possibly
delayed). This medicinal product contains less than 1mmol sodium
(23mg) per dose (essentially ‘sodium – free’).
This medicine also contains Sucrose and Glucose Liquid. If you have
been told by your doctor that you are intolerant to some sugars, contact
your doctor before taking this medicinal product.

2

3

Date of Approval:

PROOF

N/A

1

To be implemented by:

N/A

13/12/2013
Product Description:

Originated by

Date:

Tech Approved

Date:

Fersamal® 140mg/5ml Syrup

DMN

28/11/2011

Yes

09/12/2011

Component:

Revised by

Version:

Leaflet

PAT

100024/LF/4

Manufacturer:

File Name:

CRF No.:

UPL

100024LF Fersamal Syrup UPL v4_1 AMCo.CRF.133.2013

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

9.5pt Swiss 721BT

128 x 252mm

NA

Colours:

Key Line:

Black

Magenta

continued over

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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