Feronia XT Suspension

Ferrous Ascorbate Suspension

Each 5 ml contains:

Ferrous Ascorbate

equivalent to Elemental Iron 30 mg

Excipients q.s.

Colour : Caramel USP-NF

Suspension

30mg/5ml, 150 ml bottle

4.1 Therapeutic indication

Prophylaxis and treatment of iron deficiency anemia.

4.2 Posology and method of administration

Prevention of iron deficiency:

Adults and elderly:

Feronia XT Suspension one 5 ml spoonful two to three times a day.

Paediatric population:

6-24 months of age: 12.5mg/day

2-5 years of age: 20-30mg/day

6-11 years of age: 30-60mg/day

Older children: 60mg/day

Premature infants: 5mg elemental iron per day. Iron supplementation in premature infants is only recommended in those of low birth weight who are solely breast fed. Higher doses up to 2mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation should be commenced 4-6 weeks after birth and continued until mixed feeding is established.

Treatment of iron deficiency:

Adults and elderly:

Paediatric population:

Feronia XT Suspension 10 ml three times a day

Full term infants and children: 3 to 6 mg elemental iron/Kg/day given in 2 to 3 divided doses. Total daily dose should not exceed 180 mg elemental iron.

Administration to infants and children should take place under medical advice.

Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect an underlying disease process.

Method of administration: Oral

4.3 Contraindications

• Known hypersensitivity to the active substance or to any of the excipients of the product.
• Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis.
• Active peptic ulcer. Repeated blood transfusions. Regional enteritis and ulcerative colitis. Must not be used in anaemias other than those due to iron deficiency.

4.4 Special warnings and precautions for use

• Some post-gastrectomy patients show poor absorption of iron. Care is required when treating patients with iron deficiency anaemia who have treated or controlled peptic ulceration.
• Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (3 months after reversal of the anaemia has been achieved).
• Because anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin B12 or folate deficiency.
• Paediatric population
• Feronia XT suspension should be kept out of the reach of children.
• Long-term treatment with Feronia XT suspension may increase the risk of dental caries. Adequate dental hygiene must be maintained.

4.5 Drugs interactions

Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, zinc. Absorption of both iron and antibiotic may be reduced if Feronia XT suspension is given with tetracycline. Absorption of oral iron is reduced by calcium salts, magnesium salts (as magnesium trisilicate), Trientine.

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, tea, eggs or milk.

Avoid concomitant use of iron with dimercaprol.

Oral iron antagonises hypotensive effect of methyldopa.

4.6 Use in special populations

Pregnancy

Ferrous ascorbate can be used during pregnancy if clinically indicated.

Lactation

No adverse effects of ferrous ascorbate have been shown in breastfed infants of treated mothers. Feronia XT suspension can be used during breast-feeding if clinically indicated.

4.7 Effects on ability to drive and use machines

The medicine is considered unlikely to impair the ability to drive or to operate machinery safely.

4.8 Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention:

Not known: frequency cannot be estimated from the available data

Gastrointestinal disorders:

The commonest side effects relate to gastrointestinal irritation (nausea, epigastric pain, constipation or diarrhoea). In the event of these ADRs, it may be helpful to reduce the dose or switch to an alternative iron salt.

Darkening of stools, black discoloration of the teeth and allergic reactions (due to metabisulphite in the syrup vehicle) may also occur.

Reporting of side effects

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. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

4.9 Overdose

Symptoms:

Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account. The serum iron taken at about 4 hours after ingestion is the best laboratory measure of severity.

Serum Iron

< 3 mg/L (55 micromol/L)

3-5 mg/L (55-90 micromol/L)

> 5 mg/L (90 micromol/L)

Severity

Mild toxicity

Moderate toxicity

Severe toxicity

Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea. The vomit and stools may be grey or black.In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity. In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion. Shock can result from hypovolaemia or direct cardiotoxicity. Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis. Poor tissue perfusion may lead to renal failure. Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.

Management:

Supportive and symptomatic measures include ensuring a clear airway, monitor cardiac rhythm, BP and urine output, establishing IV access and administering sufficient fluids to ensure adequate hydration. Consider whole bowel irrigation. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, an initial dose of 50 mmol sodium bicarbonate may be given and repeated as necessary, for adults guided by arterial blood gas monitoring (aim for a pH of 7.4). Consider the use of desferrioxamine, if /the patient is symptomatic (other than nausea), serum iron concentration is between 3-5 mg/L (55-90 micromol/L) and still rising. Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Iron bivalent, oral preparations Iron is an essential constituent of the body, and is necessary for haemoglobin formation and the oxidative processes of living tissues. Iron and iron salts should be given for the treatment or prophylaxis of iron deficiency anaemias. Preparations of iron are administered by mouth, by intramuscular or intravenous injection.

Soluble ferrous salts are most effective by mouth. Ferrous ascorbate is an easily absorbed source of iron for replacement therapy. It is a salt of ferrous iron with an organic acid and is less irritant to the gastro-intestinal tract than salts with inorganic acids.

5.2 Pharmacokinetic properties

Absorption

In the acid conditions of the gastric contents, ferrous ascorbate is dissociated and ferrous ions are liberated. These ions are absorbed in the proximal portion of the duodenum. The ferrous iron absorbed by the mucosal cells of the duodenum is oxidised to the ferric form, and this is bound to protein to form Ferritin.

Distribution

Ferritin in the mucosal cells releases iron into the blood, where it is bound to transferrin and passed into the iron stores - liver, spleen, and bone marrow. These stores are a reserve of iron for synthesis of haemoglobin, myoglobin, and iron containing enzymes.

Elimination

Iron is lost from the body through loss of cells in urine, faeces, hair, skin, sputum, nails, and mucosal cells, and through blood loss.

Ferrous ascorbate has the same pattern of absorption and excretion as dietary iron.

Animal Toxicology or Pharmacology

As per the toxicity reports, designed to determine the acute oral toxicity of ferrous ascorbate Complex to Sprague Dawley rats. No signs of intoxication were observed in animals treated at the dose level of 2000 mg/kg of the test substance. All animals survived through the study period of 14 days. Animals from control and 2000 mg/kg dose group exhibited normal body weight gain on day 7 and day 14. Gross pathological examination did not reveal any abnormalities attributable to the treatment.

Ferrous Ascorbate is a synthetic molecule of ascorbic acid and iron and is used as a source of iron for iron deficiency anaemia.

8.1 Incompatibilities

Not applicable

8.2 Shelf life

24 months

8.3 Packaging Information

Amber glass bottle with polypropylene, child resistant, tamper evident closure with PET faced Aluminium foil/EPE wads. Pack size: 1 x 150 ml

8.4 Special precautions for storage

Store below 30°C. Protect from light.

8.5 Storage and handing Instructions

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Do not administer Feronia XT suspension

• if the patient is allergic to active substances or any of the other ingredients of this medicine.
• if the patient suffers from Vitamin B12 deficiency.
• if the patient suffers from a blood disorder.
• if the patient had or is having repeated blood transfusions.
• if the patient has a stomach ulcer or other digestive conditions such as regional enteritis or ulcerative colitis.
• if the patient is suffering from anemia that is not due to lack of iron.

If any of the above applies to the patient, talk to your doctor.

Talk to your doctor before starting Feronia XT suspension

• if the patient has been or is being treated for a stomach ulcer.
• if the patient had or has folate dependent tumour.
• if the patient had all or part of the stomach removed.

Keep out of reach and sight of children, as overdose of iron may be fatal.

Other medicines and Feronia XT suspension

Tell your doctor if the patient is taking any other medicines.

• Antibiotics e.g. fluoroquinolones, cotrimoxazole, chloramphenicol, sulphonamides, tetracyclines, neomycin (used for infections).
• Anticonvulsant medicines (used for epilepsy).
• Antacids.
• Penicillamine (used for rheumatoid arthritis).
• Sulfasalazine (used for rheumatoid arthritis and bowel disease, e.g. Crohn’s disease).
• Cholestyramine (used for reducing blood cholesterol or control diarrhoea).
• Thyroxine (used for thyroid disease).
• Bisphosphonates (used for bone disease).
• Aminopterin and Methotrexate (used for certain cancers).
• Pyrimethamine (used for malaria).
• Trientine (used for Wilson’s disease).
• Methyldopa (used for high blood pressure).
• Zinc.
• Any other medicine, including medicines obtained without a prescription

Feronia XT suspension with food and drink

If tea, coffee or milk or eggs are taken at the same time as Feronia XT suspension, the body may absorb less of the iron supplement, which may reduce the effect of this medicine.