Ferrous Sulfate Tablets 200mg Taj Pharma

1.NAME OF THE MEDICINAL PRODUCT
a) Ferrous Sulfate Tablets 200mg Taj Pharma.
b) Ferrous Sulfate Tablets 325mg Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains
Dried Ferrous Sulfate USP 200mg
Equivalent to 65mg elemental iron.

b) Each tablet contains
Dried Ferrous Sulfate USP 325mg
Equivalent to 65mg elemental iron.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Sugar-coated tablet.
White, circular, biconvex sugar-coated tablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
For the prevention and treatment of iron-deficiency anaemias.

4.2 Posology and method of administration
Posology
Each 200mg ferrous sulfate tablet is equivalent to 65mg of ferrous iron.

Adults:

Treatment: 130-195mg ferrous iron (2-3 tablets) daily in divided doses.

Prophylaxis: 65mg ferrous iron (1 tablet) daily.

Elderly:

The usual adult dose can be administered (see section 4.4).

Children 6-12 years:
Treatment: Children weighing over 22kg – one tablet daily.

Children weighing over 44kg – one tablet twice daily.

Children weighing over 66kg – one tablet three times daily.

Children under 6 years or weighing less than 22kg: Not recommended.

Method of Administration
For oral administration.

The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water. Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.

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

Paroxysmal nocturnal haemoglobinuria.
Haemosiderosis and haemochromatosis.
Active peptic ulcer.
Patients receiving repeated blood transfusions.
Regional enteritis and ulcerative colitis.
Haemolytic anaemia
Oral and parenteral iron preparations should not be used concomitantly.

4.4 Special Warnings and precautions for use
Some post-gastrectomy patients show poor absorption of iron.

Administer with caution in patients with haemoglobinopathies, iron-storage or iron-absorption diseases, existing gastrointestinal disease.

Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer, and inflammatory bowel disease, including regional enteritis and ulcerative colitis. Care should be taken in patients with intestinal strictures or diverticulae. Duration of treatment should generally not exceed 3 months after correction of anaemia.

Dental caries is a definite risk following long term treatment with this product.

Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.

These tablets contain sugar and should be administered with care to patients with diabetes.

Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.

Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiency produces microcytic blood film.

Aspiration of iron sulfate tablets can cause necrosis of the bronchial mucosa which may result in coughing, haemoptysis, bronchostenosis and/or pulmonary infection (even if aspiration happened days to months before these symptoms occurred). Elderly patients and patients who have difficulties swallowing should only be treated with iron sulfate tablets after a careful evaluation of the individual patient’s risk of aspiration. Alternative formulations should be considered. Patients should seek medical attention in case of suspected aspiration.

Patients with rare heriditary problems of galactose intolerance or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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
Antibacterials: Iron and tetracyclines reduce the absorption of each other when administered concomitantly. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours.

The absorption of ciprofloxacin, levofloxacin, norfloxacin and ofloxacin may be reduced by oral iron.

Quinolones: Iron may reduce the absorption of quinolones. Administration of iron preparations and quinolones should be separated by at least 2 hours.

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

Antacids and mineral supplements: Compounds containing calcium, magnesium (including antacids and mineral supplements), bicarbonates, carbonates, oxalates or phosphates may impair the absorption of iron.

Administration of iron preparations with such compounds should be separated by at least 2 hours.

Bisphosphonates: The absorption of bisphosphonates is reduced when taken concurrently with iron preparations. Administration should be separated by at least 2 hours.

Cholestyramine: Absorption of iron is impaired by cholestyramine.

Dimercaprol: Concomitant administration of oral iron preparations and dimercaprol should be avoided.

Dopaminergics: Oral iron preparations may reduce the absorption of dopaminergics such as co-careldopa, entacapone and levodopa.

Food products: Absorption of iron is impaired by tea, eggs or milk. Absorption of iron salts is enhanced by ascorbic acid and meat.

Methyldopa: Oral iron preparations may antagonise the antihypertensive effect of methyldopa.

Mycophenolate mofetil: Oral iron preparations significantly reduce the absorption of mycophenolate mofetil.

Penicillamine: Oral iron preparations can reduce the absorption of penicillamine. Also the absorption of iron is impaired by penicillamine.

Thyroid hormone: Ferrous sulphate reduces the absorption of levothyroxine and so should be taken at least 2 hours apart.

Trientine: The absorption of oral iron preparations is reduced by trientine. Administration should be separated by at least 2 hours.

Zinc: Iron preparations and zinc preparations can reduce the absorption of each other.

4.6 Fertility, Pregnancy and lactation
Pregnancy

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of iron during the first trimester however requires evidence of iron deficiency. Prophylaxis of iron deficiency during the remainder of pregnancy is justified.

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

4.8 Undesirable Effects
Immune system disorders:
Allergic reactions have been reported

Gastro-intestinal disorders: abdominal pain, nausea and vomiting (these are usually dose related), constipation, diarrhoea and dark stools.

Contact irritation can occur with ferrous sulphate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.

Gastro-intestinal, including discomfort and anorexia.

Post marketing: The following ADR has been reported during post-marketing surveillance. The frequency of this reaction is considered not known (cannot be estimated from the available data).

Gastrointestinal disorders:

Mouth ulceration*

*in the context of incorrect administration, when the tablets are chewed, sucked or kept in the mouth. Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis or bronchial stenosis (see section 4.4), in case of false route.

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
Symptoms
Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea, predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally pass this first phase. The second phase may occur at 6-24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation. In the third phase gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. The fourth phase may occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.

Overdosage of ferrous salts is particularly dangerous to young children.

Management
Treatment consists of gastric lavage followed by the introduction of 5g desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases iv desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline cathartics (eg sodium sulfate 30g for adults); milk and eggs with 5g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory embarrassment.Chelating agents (eg disodium calcium edetate) may be tried (500mg/500ml by continuous iv infusion). Dimercaprol should not be used since it forms a toxic complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated with desferrioxamine at a dose of 90mg/kg im followed by 15mg/kg per hour iv until the serum iron is within the plasma binding capacity.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Ferrous sulfate is used in the treatment of iron deficiency anaemias.
Iron preparations have no intrinsic therapeutic activity except as a nutrient source: their use without evidence of iron deficiency, or reasonable expectation of its occurrence, is to be deprecated. Iron, in excess, is toxic and haemochromatosis may result from chronic injection of iron preparations used as tonics, especially in individuals with undiagnosed blood disorders. Patients with chronic anaemia are particularly at risk from iron storage disease. Recently a severe iron overload myopathy has been described in patients given prophylactic iron indiscriminately while receiving haemodialysis. Genetic factors probably contribute to the risk of iron overload.

It should be clear that although iron deficiency is readily treated, its detection does not constitute a complete diagnosis. Every effort should be made to determine why the patient has entered a state of negative iron balance. Attention should be given to hidden sources of haemorrhage (which may indicate serious urinary or gastrointestinal conditions) and also the possibility of malabsorption of iron caused by latent disease of the small intestine.

5.2 Pharmacokinetic properties
Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids and is more readily effected when the iron is in the ferrous state or is part of the haem complex (haem-iron). Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if the body stores are overloaded. Only about 5-15% of the iron ingested in food is normally absorbed.

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 SPC.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
The tablet core contains:
Spray dried liquid glucose
Stearic acid
Magnesium stearate
Microcrystalline cellulose (101) (E460)
Lactose granules containing lactose
Maize starch
Pregelatinised maize starch

The coating contains:
Purified talc (E553)
Acacia (E414)
Gelatin
Sucrose
Titanium dioxide (E171)

The tablets may also contain:
Yellow carnauba wax

6.2 Incompatibilities
None known.

6.3 Shelf life
Shelf-life
Two years from the date of manufacture.

Shelf-life after dilution/reconstitution
Not applicable.

Shelf-life after first opening
Not applicable.

6.4 Special precautions for storage
Store below 25°C in a dry place.

6.5 Nature and contents of container
Child-resistant blister pack:
(i) 250µm white rigid PVC
(ii) 9µm soft aluminium / 35g/m² glassine paper. Compliant with BS8404.
Pack size: 28, 30, 60.
PE tablet container with a child-resistant PP closure. Compliant with ISO8317.
Pack size: 30, 60, 100.

6.6 Special precautions for disposal and other handling
Not applicable.

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

Package leaflet: Information for the patient

a) Ferrous Sulfate Tablets 200mg Taj Pharma.
b) Ferrous Sulfate Tablets 325mg 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 Ferrous Sulfate Tablets is and what it is used for
2. Before you are given Ferrous Sulfate Tablets
3. How you will be given Ferrous Sulfate Tablets
4. Possible side effects
5. How Ferrous Sulfate Tablets is stored
6. Further Information

1. What Ferrous Sulfate Tablets is and what it is used for
Ferrous Sulfate tablets belong to a group of medicines called iron supplements. These medicines work by replacing body iron. Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron-deficiency anaemia.
Ferrous Sulfate tablets are used for the prevention and treatment of iron-deficiency anaemia.

2. Before you are given Ferrous Sulfate Tablets
Do not takeFerrous Sulfate tablets if you:
• are allergic to dried ferrous sulfate or any of the other ingredients of this medicine (listed in section 6)
• are receiving repeated blood transfusions
• are receiving iron intravenously
• have a disorder in which there is excessive absorption and storage of iron such as haemosiderosis or haemochromatosis
• notice blood in your urine (paroxysmal nocturnal haemoglobinuria)
• have an active stomach ulcer (peptic ulcer)
• suffer from inflammation which causes abdominal pain or diarrhoea (ulcerative colitis) or any other inflammatory condition of the bowels (regional enteritis)
• suffer from haemolytic anaemia (anaemia due to destruction of red blood cells)
• are already being treated with iron supplements.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferrous Sulfate tablets if you have:
• had a gastrectomy (operation to remove all or part of the stomach) • history of
stomach ulcer
• diabetes
• inflammatory bowel disease
• diverticulicular disease (where pouches form in the bowel wall)
• intestinal strictures (abnormal narrowing of the bowel often caused by inflammation)
• co-existing deficiency of Vitamin B12 or folic acid
• haemoglobinopathies (blood disorders)
• iron overload
• difficulty swallowing.

Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water. If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.

If you accidentally choke on a tablet, please contact your doctor as soon as possible. This is because there is a risk of ulcers and narrowing of the bronchus occurring if the tablet enters the airways. This may result in persistent coughing, coughing up blood and/or feeling out of breath, even if the choking happened days to months before these symptoms occurred. Therefore you need to be urgently assessed to make sure that the tablet doesn’t damage your airways.

Other medicines and Ferrous Sulfate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
• penicilliamine (for rheumatoid arthritis)
• colestyramine (to treat high blood cholesterol)
• dimercaprol (for metal poisoning)
• medicines for Parkinsonism (e.g. co-careldopa, entacapone, levodopa)
• methyldopa (to treat high blood pressure)
• zinc or ascorbic acid (vitamin C)supplements
• mycophenolate mofetil (to suppress the immune system and stop organ rejection after transplant).

It is important not to take the following medicines for two hours before or after taking Ferrous Sulfate tablets:
• medicines to treat infections (e.g. tetracyclines, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, chloramphenicol, quinolones)
• medicines used to treat bone problems e.g. bisphosphonates
• medicines used to treat indigestion (antacids and mineral supplements containing calcium, magnesium, bicarbonates, carbonates, oxalates and phosphates)
• levothyroxine (for under-active thyroid glands)
• trientine (for Wilson’s disease).

Ferrous Sulfate tablets with food and drink
Ferrous Sulfate tablets should not be taken within one hour before or two hours after eating or drinking the following products: tea, milk, eggs and whole grains. These products can reduce the absorption of iron. Meat and products containing vitamin C can increase the absorption of iron. Follow the advice of your dietician or doctor when taking Ferrous Sulfate tablets with any of the food or drink listed.

Pregnancy, breast-feeding and fertility
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.

During the first 12 weeks of pregnancy only take this medicine if your doctor has specifically recommended it. For the remainder of the pregnancy Ferrous Sulfate tablets can be taken to prevent iron deficiency.

Ferrous Sulfate tablets contain glucose, sucrose and lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How you will be given Ferrous Sulfate Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets wholewith water. Do not suck, chew or keep the tablet in your mouth. Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side effects.

The recommended dose is
Adults and the elderly
Treatment: one tablet, two to three times daily.
Prevention: one tablet a day.

Children 6-12 years
Treatment:
Children weighing over 22kg: one tablet a day.
Children weighing over 44kg: one tablet twice a day.
Children weighing over 66kg: one tablet three times a day.

Children under 6 years or weighing less than 22kg
Not recommended.

If you take more Ferrous Sulfate tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include:
• Up to 24 hours: stomach and intestinal poisoning including being sick and diarrhoea, heart disorders such as low blood pressure (hypotension) and a racing heart (tachycardia), metabolic changes such as too much acid in the body (acidosis) and high blood sugar (hyperglycaemia), nervous system depression ranging from tiredness to coma, temporary relief of symptoms may occur.
• After 24 hours: stomach and intestinal poisoning and obstruction, shock, too much acid in the body (acidosis), fits, coma, liver failure, jaundice (yellowing of the skin or whites of the eyes), low blood sugar, problems with blood clotting, low production of urine, kidney failure, fluid in the lungs.

If you forget to take Ferrous Sulfate tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

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

4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor at once if you have an allergic reaction e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects:
Not known (frequency cannot be estimated from the available data)
• constipation, diarrhoea, stomach pain, feeling sick, blackened stools, loss of appetite (the link between dose and altered bowel habit is not clear).
• irritation and ulceration of the gullet can occur if the tablets become stuck, so take with water
• increased risk of tooth decay and infections (during prolonged use)
• mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth)
• all patients, but especially elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach). If the tablet enters the airways, there may be a risk of ulceration of the bronchus (the major air passages of the lungs), resulting in bronchial narrowing.

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 Ferrous Sulfate Tablets is stored
Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment.

6. Further information

What Ferrous Sulfate Tablets contains
The active substance (the ingredient that makes the tablets work) is dried ferrous sulfate USP.
a) Each tablet contains
Dried Ferrous Sulfate USP 200mg
Equivalent to 65mg elemental iron.

b) Each tablet contains
Dried Ferrous Sulfate USP 325mg
Equivalent to 65mg elemental iron.

The other ingredients are spray dried liquid glucose, stearic acid, magnesium stearate, microcrystalline cellulose (101) (E460), lactose granules containing lactose, maize starch, pregelatinised maize starch, purified talc (E553), acacia (E414), gelatin, sucrose, titanium dioxide (E171) and yellow carnauba wax.

What Ferrous Sulfate Tablets looks like and contents of the pack
Ferrous Sulfate tablets are white, circular, biconvex, sugarcoated tablets.
Pack size is 7, 14, 28, 30, 50, 90, 100 and 500 tablets.
Not All Packs May Not Be Marketed.