Feronia XT Tablets

Ferrous ascorbate and Folic Acid tablets

Each Film-coated tablet contains:

Ferrous ascorbate IP

equivalent to Elemental iron 100 mg

Folic Acid IP 1.5 mg

Appropriate overages of Vitamin added.

Excipients q.s.

Colour: Red Oxide of Iron and Titanium Dioxide IP

Film coated tablet

Ferrous Ascorbate + Folic Acid [100 mg + 1.5 mg]

4.1 Therapeutic indications

For the treatment of iron deficiency anemia.

4.2 Posology and method of administration

Adults

One tablet once daily.

Method of administration

For oral administration. Pediatric population: Not applicable.

4.3 Contraindications

• Hypersensitivity to the active substances or any of the excipients.
• Known hypersensitivity to the product, Vitamin B12 deficiency, paroxysmal nocturnal hemoglobinuria, hemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusion, regional enteritis and ulcerative colitis.
• Feronia XT Tablets must not be used in the treatment of anemias other than those due to iron deficiency.

4.4 Special warnings and precautions for use

• Feronia XT Tablets Contains Iron. Keep out of reach and sight of children, as overdose may be fatal.
• Some post-gastrectomy patients show poor absorption of iron. Care is needed when treating iron deficiency anemia in patients with treated or controlled peptic ulceration. Caution should be exercised when administering folic acid to patients who may have folate dependent tumors.
• Since anemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency.

4.5 Interaction with other medicinal products and other forms of interaction

• Iron reduces the absorption of penicillamine. Iron compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
• Absorption of both iron and antibiotic may be reduced if Feronia XT is given with tetracycline.
• Absorption of both iron and zinc are reduced if taken concomitantly. Concurrent administration of antacids may reduce absorption of iron. Co- trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides may interfere with folate metabolism. Serum levels of anticonvulsant drugs may be reduced by administration of folate.
• Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
• Some inhibition of iron absorption may occur if it is taken with cholestyramine, trientine, tea, eggs or milk.
• Administration of oral iron may increase blood pressure in patients receiving methyldopa.
• Coffee may be a factor in reducing iron bioavailability. Neomycin may alter the absorption of iron.

4.6 Fertility, pregnancy and lactation

Pregnancy and lactation:

Feronia-XT tablet is suitable for use during pregnancy and breastfeeding.

Fertility:

No fertility data is available

4.7 Effects on ability to drive and use machines

Feronia XT Tablets has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Side effects may be minimised by taking the product with or after food or by starting with a small dose and increasing gradually. The incidences of undesirable effects are tabulated below. They are listed by system organ class and frequency defined as follows:

Very rare (<1/10,000)

Immune System Disorders: Rarely allergic reactions may occur.

Rare (≥1/10,000 to <1/1,000)

Gastro-intestinal disturbances (e.g. nausea, vomiting, constipation, diarrhoea)

Frequency Not known

• Renal and urinary disorders: darkening of the stools may occur.
• Metabolism and Nutrition Disorders: Haemosiderosis may occur as a result of excessive or mistaken therapy.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: http://www.zuventus.co.in/safety.aspx

4.9 Overdose

Symptoms:

Symptoms and signs of abdominal pain, vomiting and diarrhea appear within 60 minutes. Cardiovascular collapse with coma may follow. Some improvement may occur after this phase which, in some patients, is followed by recovery. In others, after about 16 hours, deterioration may occur involving diffuse vascular congestion, pulmonary edema, convulsions, anuria, hypothermia, severe shock, metabolic acidosis, coagulation abnormalities and hypoglycemia.

Management:

Vomiting should be induced immediately, followed as soon as possible by parenteral injection of desferrioxamine mesylate, and then gastric lavage. In the meantime, it is helpful to give milk and/or 5% sodium bicarbonate solution by mouth.

Dissolve 2g desferrioxamine mesylate in 2 to 3ml of water for injections and give intramuscularly. A solution of 5g desferrioxamine in 50 to 100ml of fluid may be left in the stomach. If desferrioxamine is not available, leave 300ml of 1 % to 5 % sodium bicarbonate in the stomach. Fluid replacement is essential.

Recovery may be complicated by long-term sequelae such as hepatic necrosis, pyloric stenosis or acute toxic encephalitis which may lead to CNS damage. Pediatric Population: Acute overdose of oral iron requires emergency treatment. In young children 200-250mg/kg Ferrous Ascorbate is considered to be extremely dangerous.

5.1 Mechanism of Action

Ferrous Ascorbate is a synthetic molecule of ascorbic acid and iron and is used as a source of iron for iron deficiency anaemia. Ascorbate increases iron uptake in part by acting as weak chelator to help to solubilize the metal in the duodenum. Iron is readily transferred from these compounds into the mucosal lining cells. The absorbed iron is bound to transferrin and used for Hb synthesis in the bone marrow or stored, primarily in the liver, bound to ferritin.

Folic acid (folate) belongs to the group of B vitamins. It is a precursor to tetrahydrofolate, a coenzyme that is involved in various metabolic processes, including the biosynthesis of purines and thymidylates of nucleic acids. Folic acid is required for nucleoprotein synthesis and to maintain normal erythropoiesis.

Folic acid is the precursor of tetrahydrofolic acid which is active and acts as a co-factor for 1-carbon transfer reactions in the biosynthesis of purines and thymidylates of nucleic acids.

5.2 Pharmacodynamic properties

Pharmacotherapeutic group – Iron in combination with Folic Acid

ATC code – B03AD

There is evidence that a daily dose of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers. If a mild iron deficiency is present when Feronia-XT Tablets administration is started, this will be corrected by increased absorption of Iron. The daily folate requirement rises steeply during the final trimester of pregnancy, and evidence of maternal depletion may be found. The dose of folic acid required varies depending on the clinical condition. The most common therapeutic dose is in the range of 1-3 mg daily. To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 1.5mg is required during the second and third trimester of pregnancy.

5.3 Pharmacokinetic properties

Absorption

Iron is absorbed chiefly in the duodenum and jejunum. Folic Acid is absorbed mainly from the proximal part of the small intestine.

Distribution

The amounts of Folic Acid absorbed from normal diets are rapidly distributed in body tissues.

Biotransformation

Absorption being aided by the acid secretion of the stomach and being more readily affected when the iron is in the ferrous state. Folic acid rapidly appears in the blood, where it is extensively bound to plasma proteins. When larger amounts are absorbed, a high proportion is metabolized in the liver to other active forms of folate and a proportion is stored as reduced and methylated folate.

Elimination Larger amounts of folate are rapidly excreted in the urine and about 4 to 5 micrograms is excreted in the urine daily.

Elimination

Larger amounts of folate are rapidly excreted in the urine and about 4 to 5 micrograms is excreted in the urine daily.

This Feronia-XT tablet contains: Ferrous Ascorbate & Folic Acid as active ingredients, for the treatment of iron deficiency anemia.

Ferrous Ascorbate is an iron supplement used to treat or prevent low blood levels of iron (such as those caused by anemia or during pregnancy). Ascorbic acid (vitamin C) improves the absorption of iron from the stomach.

Molecular Formula- C₁₂H₁₄FeO₁₂

Molecular Weight: 406.08g/mol

Chemical structure of ferrous ascorbate

Folic acid is used to treat anemia caused by folate deficiency. Folic acid is also used as a supplement by women during pregnancy to reduce the risk of neural tube defects (NTDs) in the baby.

Molecular Formula-C₁₉H₁₉N₇O₆

Molecular Weight- 441.4 g/mol

Chemical structure of Folic acid

7.1 Incompatibilities

Not applicable.

7.2 Shelf-life

Refer on pack

7.3 Packaging information

10 Blister strips of 15 tablets each

7.4 Storage and handing instructions

Store at a temperature not exceeding 25°C. Protect from light. Keep out of reach of children.

Instruction for Handling:

• Tablets are hygroscopic in nature. Exposure to humid conditions may soften the tablets affecting their appearance and shape. Cutting of strip to be avoided while dispensing / usage.
• User should have dry hands while removal of tablet.
• Tablet should not be kept in open pocket or in open condition after removal from strip.

Do not take Feronia XT tablets:

• if you are allergic to Ferrous Ascorbate and Folic Acid or any of the other ingredients of this medicine
• if you are breast-feeding or trying to become pregnant
• if you have been told you suffer from Vitamin B12 deficiency
• if you suffer from a blood disorder
• if you have had or are having repeated blood transfusions
• if you have a stomach ulcer or other digestive conditions such as regional enteritis or ulcerative colitis
• if you are suffering from anaemia that is not due to a lack of iron

Tell your doctor if you are taking any other medicines.

If you drink tea, coffee or milk or eat eggs at the same time as taking Feronia XT your body may absorb less of the iron supplement, which may reduce the effect of this medicine.

If you are pregnant or think you may be pregnant, ask your doctor for advice before taking this medicine.

Only use if you are more than 13 weeks pregnant. Do not use if you are breast-feeding or trying to become pregnant.

Always take Feronia XT Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the tablet whole with a glass of water.