1.NAME OF THE MEDICINAL PRODUCT
Sodium Feredetate Oral Solution USP 190mg/5ml Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose contains

Sodium Feredetate 190mg
(equivalent to 27.5mg of elemental iron/5ml)

Excipients with known effect: Ponceau 4R lake (E124), Methyl hydroxybenzoate (E218), Propyl hydroxybenzoate (E216), Sorbitol liquid (E420), Ethanol
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Oral Solution.
Red coloured liquid.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Sodium Feredetate is indicated for Iron deficiency anaemia,

  • Notably in paediatrics.
  • In pregnancy when other forms of oral iron may not be well tolerated.
  • Anaemias secondary to rheumatoid arthritis.

4.2  Posology and method of administration
Posology:
Treatment:
Children:
Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200 mg) of elemental iron daily given in 2-3 divided doses.

Adults: 5ml increasing gradually to 10ml three times daily.

Elderly (over 65 years): As for adults.

Prophylaxis:

Babies of low birth weight who are solely breast-fed:
A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2 mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.

Other children (elemental iron per day):
Age 6 – 24 months: 12.5 mg

Age 2 – 5 years: 20-30 mg

Age 6 – 11 years: 30 – 60 mg

Adolescents: 60 mg

Method of administration
Oral

For instructions on dilution of the medicinal product before administration, see section 6.6.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Iron preparations are contraindicated in patients with haemochromatosis and haemosiderosis.

Iron is contraindicated in patients receiving repeated blood transfusions or in patients receiving parenteral iron therapy.

4.4 Special Warnings and precautions for use
Care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases or existing gastrointestinal diseases.

Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools.

Prolonged or excessive use in children may lead to toxic accumulation.

This medicinal product contains the following:

– Sorbitol; patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol may also cause mild laxative effects.

– Methyl hydroxybenzoate (E218)) and Propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

– Ponceau 4R (E124) which may cause allergic reactions.

– Small amounts of ethanol (alcohol), less than 100mg per ml.

The label will state:

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

This will appear on the front of the pack within a rectangle in which there is no other information.

4.5 Interaction with other medicinal products and other forms of interaction
Avoid concomitant administration of oral iron with dimercaprol (formation of toxic compounds).

Iron reduces the absorption of penicillamine, mycophenolate, fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.

Administration of oral iron may reduce the hypotensive effect of methyldopa.

Iron and tetracyclines reduce the absorption of each other.

Iron and zinc reduce the absorption of each other.

Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.

Absorption of iron is reduced with entacapone, proton pump inhibitors, bicarbonates, carbonates, calcium, zinc, magnesium and other mineral supplements, trientine, antacids, cholestyramine, tea, eggs and/or milk, but may be increased by ascorbic acid and/or citric acid.

Coffee may be a factor in reducing iron bioavailability.

4.6 Fertility, Pregnancy and lactation
Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained. No adverse events associated with sodium feredetate administration during pregnancy and lactation have been reported.

4.7 Effects on ability to drive and use machines
None known.

4.8 Undesirable Effects
Adverse reactions reported as possibly associated to sodium feredetate are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are used:

Very common (>1/10)
Common (>1/100, <1/10)
Uncommon (>1/1,000, <1/100)
Rare (>1/10,000, <1/1,000)
Very rare (<1/10,000)

Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”.

Tabulated summary of adverse reactions

SYSTEM ORGAN CLASS (SOC)FREQUENCYADVERSE REACTION
Immune system disordersUnknownHypersensitivity
Gastrointestinal disordersUnknownNausea, mild diarrhoea

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose
Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur.

Treatment of overdosage

  1. Administer an emetic.
  2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). Desferrioxamine 5g in 50ml to 100ml water should be introduced into the stomach following gastric emptying.
  3. Keep the patient under constant surveillance to detect possible aspiration of vomitus. Maintain suction apparatus and standby emergency oxygen in case of need.
  4. In adults, a drink of mannitol or sorbitol should be given to induce small bowel emptying. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children.
  5. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (adults >142μmol/l, children >90μmol/l), immediate supportive measures should be introduced. Desferrioxamine should be given by slow iv infusion (adults 5mg/kg/h, children 15mg/kg/h). The maximum dose is 80mg/kg/24h. Warning: hypotension may occur if the infusion rate is too rapid.
  6. Less severe poisoning: im desferrioxamine should be administered (adults 50mg/kg to a maximum of 4g, children 1g 4 to 6 hourly).

Serum iron levels should be monitored throughout.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Iron preparations

After absorption, elemental iron is available for haemoglobin regeneration and reversal of anaemia associated with iron-deficient states.

 5.2 Pharmacokinetic properties
Sodium Feredetate is not an iron salt as it contains iron in an un-ionised form. In this compound the iron is “insulated” or “sequestered” with the sodium salt of ethylenediamine tetra-acetic acid (EDTA) to form a chelate. This accounts for the fact that Sodium Feredetate is not astringent and does not discolour teeth. Studies using radioactive tracers have shown that the iron chelate is split within the gastro-intestinal tract, releasing elemental iron which is absorbed and rendered available for haemoglobin regeneration.

Iron absorption is enhanced in iron-deficiency states. Post-absorption distribution of elemental iron is as follows: 60% to 70% is incorporated into haemoglobin and most of the remainder is present in storage forms, either as ferritin or haemosiderin, in the reticulo-endothelial system and to a lesser extent, hepatocytes. A further 4% is present in myoglobin and haeme-containing enzymes, or bound to transferrin in plasma. Excretion is mainly in the faeces.

EDTA passes through the body unchanged. The compound is poorly absorbed, and that which reaches the bloodstream is eliminated by both glomerular filtration and tubular excretion.

5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Saccharin Sodium
Glycerol
Sorbitol liquid (E420)
Ethanol
Black cherry flavor
Ponceau 4R (E124)
Citric acid monohydrate
Water

6.2 Incompatibilities
None known.

6.3  Shelf life
Unopened: 3 years.
Opened: 3 months from date of opening

6.4 Special precautions for storage
Store in the original package in order to protect from light.

6.5 Nature and contents of container
Amber glass bottle with a white child resistant tamper evident plastic cap. Each bottle contains 500ml of Sodium Feredetate oral solution.

6.6 Special precautions for disposal and other handling
None.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Sodium Feredetate Oral Solution USP 190mg/5ml Taj Pharma

Package leaflet: Information for the patient

Sodium Feredetate Oral Solution USP 190mg/5ml Taj Pharma.

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.

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

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.

2. Before you are given 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:

  • 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
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 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)
  • iron-containing medicines or tonics
  • 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.

Sodium Feredetate contains:

  • methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216).These ingredients may cause allergic reactions (possibly delayed).
  • ponceau 4R (E124).This ingredient may cause allergic reactions.
  • 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.
  • This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How you will be given 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.

The recommended dose is:

Treatment of anaemia

  • 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.
    • To be given by a healthcare professional only.

Prevention of anaemia

  • 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 breast-fed 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.

*Elemental iron is iron your body can absorb.

If you 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.

An overdose may cause:

  • 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).

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.

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

5. How Sodium Feredetate is stored
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 you no longer use. These measures will help protect the environment.

6. Further information

What Sodium Feredetate contains
The active substance is sodium feredetate.
Each 5ml dose contains
Sodium Feredetate 190mg
(equivalent to 27.5mg of elemental iron/5ml)

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.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com