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BASE LABEL WITH BOOKLET IN POSITION

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Sodium Feredetate

I90mg/5mlj Oral Solution

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Each 5ml dose contains Sodium Feredetate 190mg l(equivalent to27.5mg ofelementaliron/5ml) _MJ Also contains sorbitol (E420), methyl hydroxybenzoate (E218), ipropyl hydroxybenzoate (E216), ponceau 4R lake (E124) and ethanol.

For oral administration. Read the package leaflet before use. Keep out of the sight and reach of children.

Important warning: Contains iron. Keep out of the sight

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[POM PL 44710/0007 PL Holder:

Kinedexe UK Limited Unit 15Moorcroft Harlington Road Uxbridge UB8 3HD UK

and reach of children, as overdose may be fatal.

Store in the original package in order to protect from light. Use with in three months of opening.

Use as directed by your physician.

500ml Solution Kinedex

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Sodium Feredetate

190mg/5ml ) Oral Solution

Each 5ml dose contains Sodium Feredetate 190mg (equivalentto27.5mgofelemental iron/5ml)

Also contains sorbitol (E420), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), ponceau 4R lake (E124) and ethanol.

For oral administration. Read the package leaflet before use. Keep out of the sight and reach of children.

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

Store in the original package in order to protect from light.

Use with in three months of opening.

Use as directed by your physician.

500ml Solution    5

[POM PL 44710/0007 PLHolder:

Kinedexe UK Limited Unit 15Moorcroft Harlington Road Uxbridge UB8 3HD UK

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIUM FEREDETATE 190 MG/5 ML ORAL SOLUTION

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(equivalent to 27.5 mg of elemental iron/5ml)

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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 only. Do not pass it on to others. It may harm them, even t their signs of illness are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet

3

What Sodium Feredetate is and what it is used for

What you need to know before you take Sodium Feredetate

How to take Sodium Feredetate

Possible side effects

How to store Sodium Feredetate

Contents of the pack and other information

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1. WHAT SODIUM FEREDETATE IS AND WHAT IT IS USED FOR

The name of your medicine is Sodium Feredetate 190 mg/5 ml Oral Solution (called Sodium Feredetate throughout this leaflet).

Sodium Feredetate is used to treat anaemia caused by too little iron in the body (iron deficiency anaemia). The form of iron used in this product means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not discolour teeth.

It is to be taken by:

-    pregnant women when other forms of oral iron may not be well tolerated

-    children and adults who have become anaemic as a result of having rheumatoid arthritis.

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₅ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM FEREDETATE_

Do NOT take Sodium Feredetate and tell your doctor if you:

•    are allergic to sodium feredetate (also known as sodium iron edetate) or any of the ingredients of this medicine (listed in section 2 and 6)

•    have a history of sensitivity to iron-containing preparations.

•    have a disorder in which there is excessive absorption and storage of (iron haemochromatosis or haemosiderosis).

•    have repeated blood transfusions or have had them in the past.

•    are currently having iron injections.

Warnings and precautions

Talk to your doctor or pharmacist before using Sodium Feredetate:

I- if you have haemolytic anaemia - if you have an iron storage or absorption disease —if you Jaave-gastrorniestinaJ-disease- — — — — — — — — — —

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-    if a child has been taking Sodium feredetate for a long time or at high doses as this can lead to toxic accumulation in the body

-    if you are having tests on your stools as iron preparations colour the faeces black and can interfere with test results

Other medicines and Sodium Feredetate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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This includes any medicines you buy without a prescription, including iron-containing medicines or tonics. This is because Sodium Feredetate can affect the way in which some other medicines work. Also some medicines can affect the way Sodium Feredetate works.

Tell your doctor if you are taking any of the following:

-    dimercaprol (for metal poisoning)

3- iron-containing medicines or tonics

|- chloramphenicol, fluoroquinolones or tetracyclines (to treat infections)

-    penicillamine (for rheumatoid arthritis)    I

-    methyldopa (for high blood pressure)    |

I- mycophenolate (to prevent organ transplant rejection)

|- levodopa, carbidopa or entacapone (for Parkinson's disease)

.- bisphosphonates (for osteoporosis)    I

-    thyroxine (for thyroid problems)    |

I- trientine (for Wilson's Disease)

|- cholestyramine (for high cholesterol)

.- proton-pump-inhibitors e.g. omeprazole (for stomach ulcers)    I

-    bicarbonates, carbonates, calcium, magnesium, zinc and other mineral supplements (indigestion and antacid remedies)

1- Jeamoffee, eggsjmJt ascorbic acid (vitamin cland citric acidjbesemay interfere with-Sediumieredetate

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Pregnancy and breast-feeding — — — — — — — — — — — — — — — — —

If you are pregnant, planning to have a baby or breast-feeding, ask your doctor for advice before taking this medicine.

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Driving and using machines

Sodium Feredetate is not expected to have an effect on your ability to drive or operate machinery.

Sodium Feredetate contains:

-    methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216). These ingredients may cause I allergic reactions (possibly delayed).

|- ponceau 4R (E124). This ingredient may cause allergic reactions.

-    sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Sorbitol may also cause mild laxative effects.

-    ethanol (alcohol). Sodium Feredetate contains small amounts of ethanol less than 100 mg per 5 ml.

-    sodium. Sodium Feredetate contains approximately 11.51 mg of sodium per 5 ml dose. Take this into account if you are on a controlled sodium diet.

3. HOW TO TAKE SODIUM FEREDETATE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

The oral solution is to be taken by mouth.

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The recommended dose is:

Treatment of anaemia

Adults (including elderly older than 65 years): o 1 or 2 x 5 ml spoonful 3 times a day.

Children:

o 3 to 6 mg of elemental iron per 1 kg of body weight. o The maximum daily dose is 200 mg of elemental iron* (36.3 ml of Sodium Feredetate), divided into 2 or 3 daily doses.

o To be given by a healthcare professional only.

Prevention of anaemia

- Adolescents

o 2 x 5 ml spoonful daily.

*Elemental iron is iron your body can absorb.

If you t

take more Sodium Feredetate than you should

If you accidentally take too much Sodium Feredetate or give too much to a child, tell your doctor or contact your hospital immediately. Take this leaflet, the container and any remaining oral solution with you.

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Babies of low birth-weight who are solely breast-fed:

o 5 mg of elemental iron* (0.9 ml of Sodium Feredetate given in a 1 ml syringe) daily. o Depending on the body weight, a higher dose (up to 2 mg per 1 kg of body weight) of elementa iron* daily may be required for exclusively breast-fed babies. o To be given by a healthcare professional only.

Babies (6 to 24 months):

o 1 x 2.5 ml spoonful daily.

Children (2 to 5 years):

o 1 x 5 ml spoonful daily.

Children (6 to 11 years):

l _o_1 -.2 xiiTtspoonfui daily___________________

An overdose may cause:

-    you to feel sick (nausea)

-    you to be sick (vomiting, which may contain blood) f stomach pains |- diarrhoea

-    blood in your stools

-    tiredness

-    cold and sweaty skin

-    fast heart beat

-    high blood sugar

|- high blood acidity (metabolic acidosis).

If you forget to take Sodium Feredetate

If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do NOT take a double dose to make up for a forgotten dose.

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If you have any further questions on the use of this

m|didjie,-ask[y<

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our doctor or pharmacist.

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4. POSSIBLE SIDE EFFECTS

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Like all medicines, Sodium Feredetate can cause side effects, although not everybody gets them.

You may feel sick (nausea) or have mild diarrhoea in the early stages of treatment. These effects should quickly disappear if you stop taking Sodium Feredetate for a short time.

When treatment is restarted, a lower dose of your medicine should be taken. If you are not sure what your dose should be, talk to your doctor.

If your doctor tells you to take Sodium Feredetate at doses higher than is stated in this leaflet, you may experience mild diarrhoea

If you experience any of the following side effects, STOP taking Sodium Feredetate and see |a doctor or go to a hospital IMMEDIATELY:

allergic reactions - symptoms may include itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SODIUM FEREDETATE_

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the bottle label after EXP. The expiry date refers to the last day of the month.

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Do not use Sodium Feredetate after the bottle has been opened for more than 3 months.

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Store in the original package in order to protect from light.

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 protect the environment.

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6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sodium Feredetate contains

The active substance is sodium feredetate (also known as sodium iron edetate) 190 mg/5 ml The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), citric acid g monohydrate, saccharin sodium, glycerol, sorbitol (E420), ethanol, ponceau 4R (E124), black cherr

flavouring and water.

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What Sodium Feredetate looks like and contents of the pack

Sodium feredetate is a red coloured liquid. It is supplied in amber-coloured glass bottles with a child resistant cap containing 500ml of oral solution.

Marketing Authorisation Holder & Manufacturer

Kinedexe UK Limited, Unit 15 Moorcroft, Harlington Road, Uxbridge, UB8 3HD, United Kingdom.

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This leaflet was last revised in 12/2015.

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Arta Creative Solutions Ltd Suite 1, Interlinks House 81c Church Road London, NW4 4DP

020 8203 5976 020 8203 2357 info@artacreative.co.uk www.artacreative.co.uk

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