Sodium Feredetate 190mg/5ml Oral Solution PIL, Taj Pharmaceuticals

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Rx SODIUM FEREDETATE ORAL SOLUTION 190MG/5ML Package leaflet: Information for the patient Sodium Feredetate 190mg/5ml Oral Solution.

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 if their signs of illness are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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 ironcontaining medicines, and will not discolour teeth.

It is to be taken by:  

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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:    

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if you have haemolytic anaemia if you have an iron storage or absorption disease if you have gastrointestinal disease 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

2. Before you are given Sodium Feredetate Do NOT take Sodium Feredetate and tell your doctor if you: 

What is in this leaflet 1. What Sodium Feredetate is and what it is used for 2. Before you are given Sodium Feredetate 3. How you will be given Sodium Feredetate 4. Possible side effects 5. How Sodium Feredetate is stored 6. Further Information

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

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

This includes any medicines you buy without a prescription, including ironcontaining 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) iron-containing medicines or tonics

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chloramphenicol, fluoroquinolones or tetracyclines (to treat infections) penicillamine (for rheumatoid arthritis) methyldopa (for high blood pressure) mycophenolate (to prevent organ transplant rejection) levodopa, carbidopa or entacapone (for Parkinson’s disease) bisphosphonates (for osteoporosis) thyroxine (for thyroid problems) trientine (for Wilson’s Disease) cholestyramine (for high cholesterol) proton-pump-inhibitors e.g. omeprazole (for stomach ulcers) bicarbonates, carbonates, calcium, magnesium, zinc and other mineral supplements (indigestion and antacid remedies) tea, coffee, eggs, milk, ascorbic acid (vitamin c) and citric acid, these may interfere with Sodium feredetate

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.

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

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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. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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3. How you will be given Sodium Feredetate

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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.

The recommended dose is:

Prevention of anaemia  o o

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Babies of low birth-weight who are solely breast-fed: 5 mg of elemental iron* (0.9 ml of Sodium Feredetate given in a 1 ml syringe) daily.

Depending on the body weight, a higher dose (up to 2 mg per 1 kg of body weight) of elemental iron* daily may be required for exclusively breastfed babies.

To be given by a healthcare professional only.

Babies (6 to 24 months): 1 x 2.5 ml spoonful daily.

Children (2 to 5 years): 1 x 5 ml spoonful daily.

Children (6 to 11 years): 1 - 2 x 5 ml spoonful daily.

Adolescents 2 x 5 ml spoonful daily.

Treatment of anaemia

*Elemental iron is iron your body can absorb.

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If you take more Sodium Feredetate than you should

Sodium Feredetate contains:

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

To be given by a healthcare professional only.

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

Children: 3 to 6 mg of elemental iron per 1 kg of body weight.

The maximum daily dose is 200 mg of elemental iron* (36.3 ml of Sodium Feredetate), divided into 2 or 3 daily doses.

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.

An overdose may cause:

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you to feel sick (nausea) you to be sick (vomiting, which may contain blood) stomach pains diarrhoea blood in your stools tiredness cold and sweaty skin fast heart beat high blood sugar high blood acidity (metabolic acidosis).

this leaflet, you may experience mild diarrhoea.

you no longer use. These measures will help protect the environment.

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

6. Further information

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

If you forget to take Sodium Feredetate

Reporting of side effects

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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects 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

5. How Sodium Feredetate is stored

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 monohydrate, saccharin sodium, glycerol, sorbitol (E420), ethanol, ponceau 4R (E124), black cherry flavouring and water.

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.

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.

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

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

Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India At: 615, GIDC, Kerala, Bavla, Dist.

Ahmedabad 438225, Gujarat, INDIA This leaflet was last revised in November 2019