FERSADAY 322MG TABLETS

Active substance: FERROUS FUMARATE

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Date of Approval:

PROOF

1

To be implemented by:

29/05/2013
Product Description:

Originated by

Component:

Revised by

Date:

Tech Approved

Date:

07/03/2013

Fersaday® 322mg Tablets

Yes

04/03/2013

Version:

Leaflet

100023/LF/2

Manufacturer:

File Name:

Millmount

100023LF FersadayTabs MM v2_1 QA.CRF.075.2012

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

CRF No.:

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8.5pt Swiss 721BT

148 x 330mm

NA

Colours:

Key Line:

Black

Red

PATIENT INFORMATION LEAFLET

Fersaday® 322mg Tablets
Ferrous Fumarate

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. 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.
Fersaday 322mg Tablets was previously known as Fersaday 100mg Tablets. The product has
been renamed to reflect the amount of ferrous fumarate instead of elemental iron content.
The name of your medicine is Fersaday 322mg Tablets. It will be referred to as Fersaday
Tablets for ease hereafter.
What is in this leaflet
1. What Fersaday Tablets are and what they are used for
2. What you need to know before you take Fersaday Tablets
3. How to take Fersaday Tablets
4. Possible side effects
5. How to store Fersaday Tablets
6. Contents of the pack and other information
1. WHAT FERSADAY TABLETS ARE AND WHAT THEY ARE USED FOR
Fersaday Tablets contain 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.
Fersaday Tablets are used to prevent or treat iron deficiency anaemia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERSADAY TABLETS
DO NOT take Fersaday Tablets 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.
Take special care with Fersaday Tablets if:
• You have had a stomach or duodenal ulcer in the past, or have one which is now under
control with treatment
• You have problems associated with narrowing of your intestine (stricture) or outpocketing of
the inner layer of your intestine (diverticular disease)
• You have had major surgery to your stomach.
If any of these conditions apply to you, speak to your doctor before you take these tablets.
Your doctor will want to watch you closely, and will advise you if any additional medicine is
required to treat your condition.
Other medicines and Fersaday Tablets
Tell your doctor or pharmacist if you are taking or having recently taken or might take any
other medicines, including medicines obtained without a prescription. The effects of any of
these medicines or of Fersaday Tablets 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.
• Cholestyramine 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).
Fersaday Tablets with food and drink
Fersaday Tablets may be taken with meals. This may help to relieve any stomach-related sideeffects. However, it is advisable not to take your medicine with tea, eggs or milk as this may
reduce the effect of the tablets. Fersaday Tablets should be taken with a glass of water.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.

3. HOW TO TAKE FERSADAY TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The usual dose is one tablet a day. Occasionally it may be increased to one tablet twice a day.
To help you to remember to take your medicine, select the tablet(s) for the appropriate day of
the week marked on the strips.
Swallow the tablets with a glass of water. Taking Fersaday Tablets with meals may help to
relieve any stomach related side effects.
Your doctor will advise you on how long you should take the tablets. Normally this will be for 3 - 6
months after the anaemia has been rectified.
If you have to go to another doctor or to hospital, tell them you are taking Fersaday tablets.
Fersaday not suitable for children.
Your medicine is very dangerous if taken by young children and great care should be taken to
keep the medicine safely out of sight and reach of children. If a child has taken or is suspected
of taking any of the tablets, immediate medical advice should be sought (see below - If you
take more Fersaday tablets than you should).
If you take more Fersaday tablets than you should
If you take too many tablets, or a child takes or is suspected of taking any tablets at all,
contact your nearest hospital casualty department or doctor immediately. Take any remaining
tablets and this leaflet with you so that the medical staff know exactly what has been taken.
If you forget to take your Fersaday Tablets
Take another from the pack as soon as you remember, according to the day of the week. 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 Fersaday Tablets
If you are having no problems with your tablets, do not stop taking them until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Fersaday Tablets can cause side-effects, although not everybody gets
them. These might be:
• Stomach discomfort
• pain in upper part of the stomach
• vomiting sensation
• difficulty in passing stools
• loose stools.
Also, you may find that 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 get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.
5. HOW TO STORE FERSADAY TABLETS
Important warning: Contains Iron.
Keep out of the sight & reach of children, as overdose may be fatal.
Do not use this medicine after the expiry date which is stated on the carton and blister after
“Exp”. The expiry date refers to the last day of that month.
Do not store above 30˚C.
Store in the original package in order to protect from light.
Do not use your medicine if the pack is damaged.
Disposal of the product:
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.
REMEMBER
This medicine is for YOU. Never give it to anyone else. It may harm them, even if their signs
of illness are the same as yours.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The active substance is ferrous fumarate. Each tablet contains 322 mg ferrous fumarate
(equivalent to approximately 106 mg elemental iron). Ferrous fumarate is an iron compound.
The other ingredients are maize starch, sodium lauryl sulphate, gelatin and liquid paraffin. The
film coating of the tablets contains hypromellose, acetylated monoglyceride, hydroxypropyl
cellulose, titanium dioxide (E171), talc, iron oxide yellow (E172) and iron oxide red (E172).
What Fersaday Tablets look like and contents of the pack
Each film coated tablet is brown ochre in colour and engraved Fersaday on one face.
Fersaday Tablets are usually available in cartons containing two blister strips of 14 tablets,
therefore 28 tablets altogether. However, pots of 1000 tablets may also be available. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharma Group Ltd., No.1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK.
Manufacturer:
Custom Pharmaceuticals, Tecore House, Conway Street, Hove, East Sussex, BN3 3LW.
This leaflet was last revised in May 2013.
Fersaday is a registered trademark of Mercury Pharma Group Ltd.
100023/LF/2

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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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