Health Tooty Fruity

PRESCRIBING INFORMATION
PRESENTATION:
 Clear, colorless capsules, opaque, white-capped and filled with a mixture of red, orange-yellow, pale-yellow and white pellets. Each 'spansule' sustained-release capsule contains 150mg dried ferrous sulphate (47mg elemental iron), SOO micrograms folic acid, 2mg thiamine mononitrate, 2mg riboflavine, 1 mg pyridoxins hydrochloride, 10mg nicotinamide and SOmg ascorbic acid. The iron is specially formulated for sustained release over a period of several hours.

USES: Fefol-Vit is a haematinic with added vitamins, for prophylaxis of iron and folic-acid deficiency during pregnancy particularly when inadequate diet calls for supplementary vitamins 8 and C.

DOSAGE & ADMINISTRATION:
 Adults Only: T Fefol-Vit Spansule Capsule a day during pregnancy and where appropriate for one month post-partum. Some pregnant patients may need a higher prophylactic dose of iron because of dietary or other factors.

CONTRA-INDICATIONS, WARNINGS, ETC:
 Contra-indications: Do not use in patients hypersensitive to the product or those with iron overload. Precautions: Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. The folic acid content of one capsule a day is unlikely to mask pernicious anaemia, should this condition be present; pregnancy during pernicious anaemia is very rare. Iron chelates with tetracyclines and absorption of both agents may be impaired Absorption of iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating administration of each product by several hours. Use in Pregnancy: Fefol Vit should not be used during the first trimester of pregnancy. Prophylaxis of iron and folate deficiency where inadequate diet calls for supplementary vitamins B and C is justified during the remainder of pregnancy.

Adverse Reactions:
Dark stools are usual during iron therapy, and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered, Fefol Vit Spansule capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions.

 OVERDOSAGE:
Iron overdosage is dangerous, particularly in children, and requires immediate attention. Treatment is necessary if more than 30 mg elemental iron per Kilogram body weight has been ingested. In the first phase, 30 minutes to 6 hours after ingestion, symptoms may include abdominal pain, vomiting, diarrhoea and haematemesis, with in even more severe cases, coma, convulsions and shock. Symptoms then abate, with either recovery, or within 12 hours, after ingestion, deterioration. Symptoms can then include severe lethargy or coma, gastrointestinal haemorrhage, severe shock, metabolic acidosis, convulsions, jaundice, coagulation disorders, hypoglycaemia, renal failure and pulmonary oedema,These may last up to 48 hours after ingestion. In the last phase, 2 to 5 weeks after ingestion, effects such as encephalopathy, hepatic necrosis and pyloric stenosis may occur. The sustained release Spansule capsule presentation of ferrous sulphate may delay excessive absorption of iron and allow more time for initiation of appropriate counter measures. Gastric lavage should be carried out in the early stages, or if this is not possible, vomiting should be induced. Give oral desferrioxamine {2g for a child or 5g for an adult) and demulcents. If serum iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8mg/l in an adult, or if the patient is in shock or coma, intramuscular or intravenous desferrioxamine should be used according to instructions for this product. Symptomatic and supportive measures should be given as required.

 PHARMACEUTICAL PRECAUTIONS:
 Store in a dry place below 2S°C and protect from light. PACKAGE QUANTITY: 'Fefol-Vit Spansule' Capsules are available in containers of 30 in blister strips.

FURTHER INFORMATION:
Fefol Vit Spansule capsules are formulated to release the iron in the small intestine, where absorption is greatest, rather than in the stomach, where gastric irritation may be caused. Keep out of children's reach to avoid accidental iron poisoning. Inactive ingredients include sucrose.

FefolVlt
(IRON + VITAM1HS WITH FOLIC ACID)
Provides Balanced combination to meet increased nutrient demands of pregnancy & lactation.

• Ferrous Sulphate is the iron salt of choice for treating Iron deficiency anaemia.3
• Folic Acid is essential during pregnancy to meet fetal growth demands:
• Vitamin C helps in the absorption of Iron and makes it available for producing hemoglobin.
• Vitamin B is necessary for the production of energy. Maximum patient compliance.
• Reduction of side effects. m Once-daily dosage"